Ignite Creation Date:
2025-12-24 @ 9:12 PM
Ignite Modification Date:
2026-01-01 @ 10:29 AM
Study NCT ID:
NCT03368404
Status:
COMPLETED
Last Update Posted:
2025-05-14
First Post:
2017-11-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Evaluate the Performance and Safety of CBL-102 Versus Vismed® Multi Eye Drops in the Management of Dry Eye
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015352', 'term': 'Dry Eye Syndromes'}], 'ancestors': [{'id': 'D007766', 'term': 'Lacrimal Apparatus Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'natasa.orlic-pleyer@bausch.com', 'phone': '+49 30 330 93', 'title': 'Associate Director, Global Clinical Operations', 'phoneExt': '318', 'organization': 'Bausch + Lomb'}, 'certainAgreement': {'otherDetails': 'Sponsor have at least 60 days to review any publication or presentation. The first release of results will involve all sites in this multicenter study.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'The participants were not masked to treatment as the compared products were provided in their original bottles to maintain their aseptic conditions but all the bottles were relabelled with no trade name. Labels and outer packaging were identical except for randomization number. Participants received sealed boxes and returned sealed boxes with instructions to keep the investigator masked.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected during the whole treatment period from the first instillation until the last study visit (90 ± 10 days).', 'description': 'Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the investigational medical device. Adverse event reports were elicited from the participants or resulted from the assessments at each study visit and recorded', 'eventGroups': [{'id': 'EG000', 'title': 'CBL-102 Eye Drops', 'description': 'Participants received CBL-102 Eye Drops, 3 to 6 times daily for 3 months in both eyes.\n\nCBL-102 Eye Drops: CE-marked medical device, tear substitute with 0.24% sodium hyaluronate, carbomer and triglycerides\n\nSafety population', 'otherNumAtRisk': 47, 'deathsNumAtRisk': 47, 'otherNumAffected': 0, 'seriousNumAtRisk': 47, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Vismed® Multi Eye Drops', 'description': 'Participants received Vismed® Multi eye drops, 3 to 6 times daily for 3 months in both eyes.\n\nVismed® Multi: CE-marked medical device, tear substitute with 0.18% sodium hyaluronate\n\nSafety population', 'otherNumAtRisk': 39, 'deathsNumAtRisk': 39, 'otherNumAffected': 2, 'seriousNumAtRisk': 39, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Eye discharge', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Eye pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'seriousEvents': [{'term': 'Breast cancer', 'notes': '76-year-woman was diagnosed with breast cancer after Day 28 visit. Study product stopped, no final visit. Remission of breast cancer after surgery \\& radiotherapy. Event was assessed as unrelated to study product or study procedure by investigator.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Ocular Surface Fluorescein Staining Score at Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CBL-102 Eye Drops', 'description': 'Participants received CBL-102 Eye Drops, 3 to 6 times daily for 3 months in both eyes.\n\nCBL-102 Eye Drops: CE-marked medical device, tear substitute with 0.24% sodium hyaluronate, carbomer and triglycerides'}, {'id': 'OG001', 'title': 'Vismed® Multi Eye Drops', 'description': 'Participants received Vismed® Multi eye drops, 3 to 6 times daily for 3 months in both eyes.\n\nVismed® Multi: CE-marked medical device, tear substitute with 0.18% sodium hyaluronate'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.1', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '-1.5', 'spread': '0.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.6', 'ciLowerLimit': '-1.34', 'ciUpperLimit': '0.13', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.4', 'estimateComment': 'Treatment difference : CBL-102 - Vismed Multi', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'A sample size of 33 evaluable patients per treatment group was calculated to provide at least 90% power to demonstrate non-inferiority of CBL-102 to Vismed Multi. Assumptions included a non-inferiority margin of 2 grades and a standard deviation of 2.5'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Day 0), Visit 4 (Day 28)', 'description': 'Mean change from baseline (CFB) in the study eye in Ocular Surface Fluorescein Staining (OSFS) scored according to the Oxford Scheme.\n\nThe Oxford Scheme is a validated scale consisting of a series of panels labelled A to E in order of increasing severity. Grade 0 corresponds to panel A increasing to Grade 5 corresponding to more than Panel E, with punctate dots representing staining. The 3 regions, cornea, nasal and temporal bulbar conjunctiva are graded separately from 0 (best outcome) to 5 (worst outcome), with the Ocular Surface Fluorescein Score (OSFS) ranging from 0 (best outcome) to 15 (worst outcome). The OSFS is the sum score of the 3 sub-scores (corneal, nasal and temporal regions).\n\nThe study eye was the eligible eye with the highest OSFS score at baseline, which needed to be ≥4 and ≤9 on the 15-grade Oxford Scheme. If both eyes were eligible and had the same OSFS score, the study eye was the right eye.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-protocol population: all randomized participants with at least one instillation and one post-baseline assessment without any major protocol deviation (defined as impacting the primary endpoint)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Ocular Surface Fluorescein Staining Score at Day 90 (Visit 5)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CBL-102 Eye Drops', 'description': 'Participants received CBL-102 Eye Drops, 3 to 6 times daily for 3 months in both eyes.\n\nCBL-102 Eye Drops: CE-marked medical device, tear substitute wit 0.24% sodium hyaluronate, carbomer and triglycerides'}, {'id': 'OG001', 'title': 'Vismed Multi Eye Drops', 'description': 'Participants received Vismed ® Multi eye drops, 3 to 6 times daily for 3 months in both eyes.\n\nVismed ® Multi: CE marked medical device, tear substitute with 0.18% sodium hyaluronate'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.1', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '-2.3', 'spread': '0.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0592', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Significance level of 0.05', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjustment for baseline'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Day 0), Visit 5 (Day 90)', 'description': 'Mean change from baseline (CFB) in the study eye in Ocular Surface Fluorescein Staining (OSFS) scored according to the Oxford Scheme.\n\nThe Oxford Scheme is a validated scale consisting of a series of panels labelled A to E in order of increasing severity. Grade 0 corresponds to panel A increasing to Grade 5 corresponding to more than Panel E, with punctate dots representing staining. The 3 regions, cornea, nasal and temporal bulbar conjunctiva are graded separately from 0 to 5, with the OSFS score ranging from 0 (best outcome) to 15 (worst outcome).\n\nThe study eye was the eligible eye with the highest OSFS score at baseline, which needed to be ≥4 and ≤9 on the 15-grade Oxford Scheme. If both eyes were eligible and had the same OSFS score, the study eye was the right eye.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Two participants of per-protocol population, one in each group withdrew before Day 90 visit.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Corneal Fluorescein Staining Score at Day 28 (Visit 4) and at Day 90 (Visit 5)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CBL-102 Eye Drops', 'description': 'Participants received CBL-102 Eye Drops, 3 to 6 times daily for 3 months in both eyes.\n\nCBL-102 Eye Drops: CE-marked medical device, tear substitute wit 0.24% sodium hyaluronate, carbomer and triglycerides'}, {'id': 'OG001', 'title': 'Vismed Multi Eye Drops', 'description': 'Participants received Vismed ® Multi eye drops, 3 to 6 times daily for 3 months in both eyes.\n\nVismed ® Multi: CE marked medical device, tear substitute with 0.18% sodium hyaluronate'}], 'classes': [{'title': 'CFB in Corneal Fluorescein Score at Day 28 (Visit 4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.8', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '-0.6', 'spread': '0.1', 'groupId': 'OG001'}]}]}, {'title': 'CFB in Corneal Fluorescein Score at Day 90 (Visit 5)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.0', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '-0.8', 'spread': '0.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '>0.05', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Significance level of 0.05', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjustment for baseline'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Day 0), Visit 4 (Day 28) and Visit 5 (Day 90)', 'description': 'Mean change from baseline (CFB) in the study eye in Corneal Fluorescein Staining (OSFS) scored according to the Oxford Scheme.\n\nThe Oxford Scheme is a validated scale consisting of a series of panels labelled A to E in order of increasing severity. Grade 0 corresponds to panel A increasing to Grade 5 corresponding to more than Panel E, with punctate dots representing staining. The Corneal Region is graded separately from 0 (best outcome) to 5 (worst outcome).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Two participants of the per-protocol population, one in each group withdrew before the Day 90 visit.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Nasal Conjunctival Fluorescein Staining Score at Day 28 (Visit 4) and at Day 90 (Visit 5)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CBL-102 Eye Drops', 'description': 'Participants received CBL-102 Eye Drops, 3 to 6 times daily for 3 months in both eyes.\n\nCBL-102 Eye Drops: CE-marked medical device, tear substitute wit 0.24% sodium hyaluronate, carbomer and triglycerides'}, {'id': 'OG001', 'title': 'Vismed Multi Eye Drops', 'description': 'Participants received Vismed ® Multi eye drops, 3 to 6 times daily for 3 months in both eyes.\n\nVismed ® Multi: CE marked medical device, tear substitute with 0.18% sodium hyaluronate'}], 'classes': [{'title': 'Change from Baseline in NAsal Conjunctival Fluorescein Staining Score at Day 28 (Visit 4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.6', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '0.1', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline in Nasal Conjunctival Fluorescein Staining Score at day 90 (Visit 5)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.9', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '-0.6', 'spread': '0.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '>0.05', 'groupIds': ['OG000'], 'pValueComment': 'Significance level 0.05', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjustment for baseline'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Day 0), Visit 4 (Day 28) and Visit 5 (Day 90)', 'description': 'Mean change from baseline (CFB) in the study eye in Nasal Conjunctival Fluorescein Staining scored according to the Oxford Scheme.\n\nThe Oxford Scheme is a validated scale consisting of a series of panels labelled A to E in order of increasing severity. Grade 0 corresponds to panel A increasing to Grade 5 corresponding to more than Panel E, with punctate dots representing staining. The Nasal conjunctival region is graded separately from 0 (best outcome) to 5 (worst outcome).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Two participants of the per-protocol population, one in each group withdrew before Day 90 (Visit 5)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Temporal Conjunctival Fluorescein Staining Score at Day 28 (Visit 4) and at Day 90 (Visit 5)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CBL-102 Eye Drops', 'description': 'Participants received CBL-102 Eye Drops, 3 to 6 times daily for 3 months in both eyes.\n\nCBL-102 Eye Drops: CE-marked medical device, tear substitute wit 0.24% sodium hyaluronate, carbomer and triglycerides'}, {'id': 'OG001', 'title': 'Vismed Multi Eye Drops', 'description': 'Participants received Vismed ® Multi eye drops, 3 to 6 times daily for 3 months in both eyes.\n\nVismed ® Multi: CE marked medical device, tear substitute with 0.18% sodium hyaluronate'}], 'classes': [{'title': 'Change From Baseline in temporal Conjunctival Staining Score at Day 28 (Visit 4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.8', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '0.1', 'groupId': 'OG001'}]}]}, {'title': 'Change From BAseline in Temporal Conjunctival Staining Score at Day 90 (Visit 5)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.2', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '-0.9', 'spread': '0.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '>0.05', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Significance level of 0.05', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjustment for baseline'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Day 0), Visit 4 (Day 28), Visit 5 (Day 90)', 'description': 'Mean change from baseline (CFB) in the study eye in Temporal Conjunctival Fluorescein Staining scored according to the Oxford Scheme.\n\nThe Oxford Scheme is a validated scale consisting of a series of panels labelled A to E in order of increasing severity. Grade 0 corresponds to panel A increasing to Grade 5 corresponding to more than Panel E, with punctate dots representing staining. The Temporal Conjunctival region is graded separately from 0 (best outcome) to 5 (worst outcome).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Two participants of the per-protocol population, on in each group withdrew before Day 90 (Visit 5)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Global Sum Score of Dry Eye Symptoms at Day 28 (Visit 4) and at Day 90 (Visit 5)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CBL-102 Eye Drops', 'description': 'Participants received CBL-102 Eye Drops, 3 to 6 times daily for 3 months in both eyes.\n\nCBL-102 Eye Drops: CE-marked medical device, tear substitute wit 0.24% sodium hyaluronate, carbomer and triglycerides'}, {'id': 'OG001', 'title': 'Vismed Multi Eye Drops', 'description': 'Participants received Vismed ® Multi eye drops, 3 to 6 times daily for 3 months in both eyes.\n\nVismed ® Multi: CE marked medical device, tear substitute with 0.18% sodium hyaluronate'}], 'classes': [{'title': 'Change From Baseline in Global Sum Score of Dry Eye Symptoms at Day (Visit 4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.9', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '-2.1', 'spread': '0.5', 'groupId': 'OG001'}]}]}, {'title': 'Change From Baseline in Global Sum Score of Dry Eye Symptoms at Day 90 (Visit 5)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-6.3', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '-3.9', 'spread': '0.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0176', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Significance level 0.05', 'groupDescription': 'Change from Baseline in Global Sum Score of Dry Eye Symptoms at Day 28 (Visit 4)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0010', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Significance level 0.05', 'groupDescription': 'Change from Baseline in Global Sum Score of Dry Eye Symptoms at Day 90 (Visit 5)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjustment to baseline'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Day 0), Visit 4 (Day 28) and Visit 5 (Day 90)', 'description': 'The global sum score (scale 0-28) of dry eye symptoms assessed 7 items: sensation of dryness, foreign body, burning, stinging, itching, blurred vision, sensitivity to light, each graded from 0 (absent) to 4 (severe and/or disabling and constant).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Two participants of the per-protocol population, one in each group withdrew before the Day 90 visit.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Ocular Surface Disease-Quality of Life (OSD-QoL®) at Day 90 (Visit 5)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CBL-102 Eye Drops', 'description': 'Participants received CBL-102 Eye Drops, 3 to 6 times daily for 3 months in both eyes.\n\nCBL-102 Eye Drops: CE-marked medical device, tear substitute wit 0.24% sodium hyaluronate, carbomer and triglycerides'}, {'id': 'OG001', 'title': 'Vismed Multi Eye Drops', 'description': 'Participants received Vismed ® Multi eye drops, 3 to 6 times daily for 3 months in both eyes.\n\nVismed ® Multi: CE marked medical device, tear substitute with 0.18% sodium hyaluronate'}], 'classes': [{'title': 'Daily activities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11.3', 'spread': '1.9', 'groupId': 'OG000'}, {'value': '4.8', 'spread': '2.1', 'groupId': 'OG001'}]}]}, {'title': 'Difficulties with work and handicap', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.8', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '1.6', 'spread': '1.9', 'groupId': 'OG001'}]}]}, {'title': 'Giving up makeup', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14.1', 'spread': '3.9', 'groupId': 'OG000'}, {'value': '7.1', 'spread': '3.7', 'groupId': 'OG001'}]}]}, {'title': 'acknowledgement of the disease', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.1', 'spread': '2.7', 'groupId': 'OG000'}, {'value': '-3.3', 'spread': '3.0', 'groupId': 'OG001'}]}]}, {'title': 'acceptance of the disease', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.7', 'spread': '3.4', 'groupId': 'OG000'}, {'value': '-1.8', 'spread': '3.9', 'groupId': 'OG001'}]}]}, {'title': 'Fear for the future', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.8', 'spread': '2.1', 'groupId': 'OG000'}, {'value': '4.6', 'spread': '2.4', 'groupId': 'OG001'}]}]}, {'title': 'Emotional well-beig', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.5', 'spread': '2.0', 'groupId': 'OG000'}, {'value': '4.4', 'spread': '2.2', 'groupId': 'OG001'}]}]}, {'title': 'Global Question', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17.6', 'spread': '2.4', 'groupId': 'OG000'}, {'value': '9.5', 'spread': '2.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0251', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Significance level 0.05', 'groupDescription': 'Ocular Surface Disease-Quality of Life (OSD-QoL®) dimension:\n\nDaily Activities', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjustment for baseline'}, {'pValue': '0.0015', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Significance level of 0.05', 'groupDescription': 'Ocular Surface Disease-Quality of Life (OSD-QoL®) dimension:\n\nDifficulties with work and handicap', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjustment for baseline'}, {'pValue': '0.2024', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Significance level 0.05', 'groupDescription': 'Ocular Surface Disease-Quality if Life (OSD-QoL®) dimension:\n\nGiving up makeup', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjustment for baseline'}, {'pValue': '0.0421', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Significance level 0.05', 'groupDescription': 'Ocular Surface Disease-Quality if Life (OSD-QoL®) dimension:\n\nAcknowledgement of the Disease', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjustment for baseline'}, {'pValue': '0.3945', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Significance level 0.05', 'groupDescription': 'Ocular Surface Disease-Quality if Life (OSD-QoL®) dimension:\n\nAcceptance of the disease', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjustment for baseline'}, {'pValue': '0.0536', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Significance level of 0.05', 'groupDescription': 'Ocular Surface Disease-Quality if Life (OSD-QoL®) dimension:\n\nFear for the Future', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjustment for baseline'}, {'pValue': '0.1998', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Significance level of 0.05', 'groupDescription': 'Ocular Surface Disease-Quality if Life (OSD-QoL®) dimension:\n\nEmotional well-being', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjustment for baseline'}, {'pValue': '0.0306', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Significance level of 0.05', 'groupDescription': 'Ocular Surface Disease-Quality of Life (OSD-QoL®) questions:\n\nGlobal Question', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjustment for baseline'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Day 0), Visit 5 (Day 90)', 'description': 'The OSD-QoL® questionnaire is a validated instrument for measuring dry eye severity and impairment. It includes 28 items divided into 7 dimensions: Daily activities, Difficulties with work and handicap, Giving up makeup, Acknowledgement of the disease, Acceptance of the disease, Fear for the future, and Emotional well-being. A Global Question: "How do you feel when considering your eye problems?" (included in the Fear for the future dimension) is also evaluated separately. The converted score for each dimension ranges from 0 to 100, with a higher score reflecting a better quality of life.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included participants in the per-protocol population with evaluable Questionnaire dimension or Global question on both Day 0 and Day 90.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Tear Film Break Up Time (TFBUT) at Day 28 (Visit 4) and at Day 90 (Visit 5)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CBL-102 Eye Drops', 'description': 'Participants received CBL-102 Eye Drops, 3 to 6 times daily for 3 months in both eyes.\n\nCBL-102 Eye Drops: CE-marked medical device, tear substitute wit 0.24% sodium hyaluronate, carbomer and triglycerides'}, {'id': 'OG001', 'title': 'Vismed Multi Eye Drops', 'description': 'Participants received Vismed ® Multi eye drops, 3 to 6 times daily for 3 months in both eyes.\n\nVismed ® Multi: CE marked medical device, tear substitute with 0.18% sodium hyaluronate'}], 'classes': [{'title': 'Change From Baseline Tear Film Break Up Time (TFBUT) at day 28 (Visit 4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.2', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '0.3', 'groupId': 'OG001'}]}]}, {'title': 'Change From Baseline in Tear Film Break Up Time (TFBUT) at Day 90 (Visit 5)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.3', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '0.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '>0.05', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Significance level of 0.05', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjustment for baseline'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Day 0), Visit 4 (Day 28), Visit 5 (Day 90)', 'description': 'The Tear Film Break Up Time (TFBUT) after fluorescein instillation, measured the time between the last blink and the first appearance of a dry spot or disruption of the tear film. The TFBUT was measured in tenth of seconds with a stopwatch provided to the sites. It was conducted 3 times and the means was calculated.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-protocol population. Two participants of the per-protocol population, one in each group, withdrew before the Day 90 (Visit 5).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Schirmer Test at Day 28 (Visit 4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CBL-102 Eye Drops', 'description': 'Participants received CBL-102 Eye Drops, 3 to 6 times daily for 3 months in both eyes.\n\nCBL-102 Eye Drops: CE-marked medical device, tear substitute with 0.24% sodium hyaluronate, carbomer and triglycerides'}, {'id': 'OG001', 'title': 'Vismed® Multi Eye Drops', 'description': 'Participants received Vismed® Multi eye drops, 3 to 6 times daily for 3 months in both eyes.\n\nVismed® Multi: CE-marked medical device, tear substitute with 0.18% sodium hyaluronate'}], 'classes': [{'categories': [{'measurements': [{'value': '1.2', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '0.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '>0.05', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Significance level 0.05', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjustment for baseline'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Day 0), Visit 4 (Day 28)', 'description': 'Tear fluid secretion was assessed by the un-anaesthetized Schirmer test in the study eye with graduated strips in millimeters.\n\nSchirmer paper test strips were carefully inserted over the lower eyelid margin. The strips were removed after 5 minutes and the amount of tear fluid secretion ready to the nearest mm from the graduated strip margins.', 'unitOfMeasure': 'mm/5 min', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Per -protocol population'}, {'type': 'SECONDARY', 'title': 'Frequency of Eye Drop Instillation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CBL-102 Eye Drops', 'description': 'Participants received CBL-102 Eye Drops, 3 to 6 times daily for 3 months in both eyes.\n\nCBL-102 Eye Drops: CE-marked medical device, tear substitute with 0.24% sodium hyaluronate, carbomer and triglycerides'}, {'id': 'OG001', 'title': 'Vismed® Multi Eye Drops', 'description': 'Participants received Vismed® Multi eye drops, 3 to 6 times daily for 3 months in both eyes.\n\nVismed® Multi: CE-marked medical device, tear substitute with 0.18% sodium hyaluronate'}], 'classes': [{'categories': [{'measurements': [{'value': '3.4', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '4.0', 'spread': '1.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0017', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Significance level of 0.05', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'From Day 0 to Day 90, an average of 3 months', 'description': "Mean daily frequency of investigational eye drop instillations as reported in participant's diary", 'unitOfMeasure': 'drops per day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Two participants of the per-protocol population, one in each group withdrew before the Day 90 (Visit 5).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'CBL-102 Eye Drops', 'description': 'Participants received CBL-102 Eye Drops, 3 to 6 times daily for 3 months in both eyes.\n\nCBL-102 Eye Drops: CE-marked medical device, tear substitute with 0.24% sodium hyaluronate, carbomer and triglycerides'}, {'id': 'FG001', 'title': 'Vismed® Multi Eye Drops', 'description': 'Participants received Vismed® Multi eye drops, 3 to 6 times daily for 3 months in both eyes.\n\nVismed® Multi: CE-marked medical device, tear substitute with 0.18% sodium hyaluronate'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'One participant never took the assigned product and withdrew consent.', 'groupId': 'FG000', 'numSubjects': '48'}, {'comment': 'One participant did not have the Day 28 performance assessments and was withdrawn from the Intention-to-treat population according to the protocol. The participant was included in the Safety population.', 'groupId': 'FG001', 'numSubjects': '39'}]}, {'type': 'Safety Population', 'achievements': [{'groupId': 'FG000', 'numSubjects': '47'}, {'groupId': 'FG001', 'numSubjects': '39'}]}, {'type': 'Intention-to-treat- Population', 'achievements': [{'groupId': 'FG000', 'numSubjects': '47'}, {'groupId': 'FG001', 'numSubjects': '38'}]}, {'type': 'Per Protocol Population Day 28', 'achievements': [{'groupId': 'FG000', 'numSubjects': '45'}, {'groupId': 'FG001', 'numSubjects': '34'}]}, {'type': 'Per Protocol Population Day 90', 'achievements': [{'groupId': 'FG000', 'numSubjects': '44'}, {'groupId': 'FG001', 'numSubjects': '33'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '45'}, {'groupId': 'FG001', 'numSubjects': '37'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Participants were recruited from 16 sites in France', 'preAssignmentDetails': '92 enrolled participants underwent a washout period of 2 weeks with povidone 2% eye drops in both eyes. Following completion of the washout period, 87 participants met inclusion criteria and were randomized either to CBL-202 or Vismed Multi treatment group. Both eyes of each participant were treated with assigned eye drops.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '85', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'CBL-102 Eye Drops', 'description': 'Participants received CBL-102 Eye Drops, 3 to 6 times daily for 3 months in both eyes.\n\nCBL-102 Eye Drops: CE-marked medical device, tear substitute with 0.24% sodium hyaluronate, carbomer and triglycerides'}, {'id': 'BG001', 'title': 'Vismed® Multi Eye Drops', 'description': 'Participants received Vismed® Multi eye drops, 3 to 6 times daily for 3 months in both eyes.\n\nVismed® Multi: CE-marked medical device, tear substitute with 0.18% sodium hyaluronate'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '85', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '62.6', 'spread': '14.3', 'groupId': 'BG000'}, {'value': '64.8', 'spread': '14.7', 'groupId': 'BG001'}, {'value': '63.6', 'spread': '14.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '85', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'France', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '85', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '85', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Ocular surface fluorescein staining', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '85', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '5.7', 'spread': '1.2', 'groupId': 'BG000'}, {'value': '5.9', 'spread': '1.3', 'groupId': 'BG001'}, {'value': '5.8', 'spread': '1.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The Ocular Surface Fluorescein Score (OSFS) was scored according to scale (Oxford Scheme) with total score ranging from a minimum of 0 (best outcome) to a maximum of 15 (worst outcome).\n\nThe total OSFS total score is the sum of 3 sub-scores (corneal, nasal and temporal regions).\n\nEach sub-score ranges from a minimum of 0 (best outcome) to a maximum of 5 (worst outcome).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Corneal fluorescein staining score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '85', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1.9', 'spread': '0.8', 'groupId': 'BG000'}, {'value': '1.9', 'spread': '0.9', 'groupId': 'BG001'}, {'value': '1.9', 'spread': '0.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The Corneal fluorescein staining score was measured according to a scale (Oxford Scheme) ranging from 0 (best outcome) to 5 (worst outcome).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Nasal conjunctival fluorescein staining score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '85', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1.9', 'spread': '0.6', 'groupId': 'BG000'}, {'value': '1.9', 'spread': '0.7', 'groupId': 'BG001'}, {'value': '1.9', 'spread': '0.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The Nasal fluorescein staining score was measured according to a scale (Oxford Scheme) ranging from 0 (best outcome) to 5 (worst outcome).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Temporal conjunctival fluorescein staining score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '85', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1.9', 'spread': '0.6', 'groupId': 'BG000'}, {'value': '2.1', 'spread': '0.6', 'groupId': 'BG001'}, {'value': '2.0', 'spread': '0.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The Temporal fluorescein staining score was measured according to a scale (Oxford Scheme) ranging from 0 (best outcome) to 5 (worst outcome).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Global dry eye symptoms score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '85', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '11.0', 'spread': '3.8', 'groupId': 'BG000'}, {'value': '9.0', 'spread': '3.8', 'groupId': 'BG001'}, {'value': '10.1', 'spread': '3.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The Global dry eye symptom score was the sum score (scale 0-28) of dry eye symptoms assessing 7 items: sensation of dryness, foreign body, burning, stinging, itching, blurred vision, sensitivity to light), each graded individually from 0 (absence) to 4 (severe and/or disabling and constant).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Ocular surface disease-Quality of life (OSD-QoL®)', 'classes': [{'title': 'Daily activities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '65.9', 'spread': '19.6', 'groupId': 'BG000'}, {'value': '64.7', 'spread': '24.5', 'groupId': 'BG001'}, {'value': '65.4', 'spread': '21.8', 'groupId': 'BG002'}]}]}, {'title': 'Difficulties with work and handicap', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '75.1', 'spread': '17.7', 'groupId': 'BG000'}, {'value': '74.9', 'spread': '22.4', 'groupId': 'BG001'}, {'value': '75.0', 'spread': '19.8', 'groupId': 'BG002'}]}]}, {'title': 'Giving up makeup', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '63.0', 'spread': '33.2', 'groupId': 'BG000'}, {'value': '54.2', 'spread': '35.1', 'groupId': 'BG001'}, {'value': '58.7', 'spread': '34.1', 'groupId': 'BG002'}]}]}, {'title': 'Acknowledgement of the disease', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '34.9', 'spread': '19.9', 'groupId': 'BG000'}, {'value': '31.3', 'spread': '19.2', 'groupId': 'BG001'}, {'value': '33.3', 'spread': '19.6', 'groupId': 'BG002'}]}]}, {'title': 'Acceptance of the disease', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '76.7', 'spread': '24.4', 'groupId': 'BG000'}, {'value': '61.8', 'spread': '35.6', 'groupId': 'BG001'}, {'value': '70.0', 'spread': '30.7', 'groupId': 'BG002'}]}]}, {'title': 'Fear for the future', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '79', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '59.2', 'spread': '16.9', 'groupId': 'BG000'}, {'value': '55.1', 'spread': '19.9', 'groupId': 'BG001'}, {'value': '57.3', 'spread': '18.3', 'groupId': 'BG002'}]}]}, {'title': 'Emotional well-being', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '79', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '82.7', 'spread': '19.3', 'groupId': 'BG000'}, {'value': '80.0', 'spread': '20.6', 'groupId': 'BG001'}, {'value': '81.5', 'spread': '19.8', 'groupId': 'BG002'}]}]}, {'title': 'Global Question', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '50.6', 'spread': '19.8', 'groupId': 'BG000'}, {'value': '50.0', 'spread': '23.1', 'groupId': 'BG001'}, {'value': '50.3', 'spread': '21.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The OSD-QoL® questionnaire is a validated instrument for measuring dry eye severity and impairment. It includes 28 items divided into 7 dimensions: Daily activities, Difficulties with work and handicap, Giving up makeup, Acknowledgement of the disease, Acceptance of the disease, Fear for the future, and Emotional well-being.\n\nA Global Question: "How do you feel when considering your eye problems?" (included in the Fear for the future dimension) is also evaluated separately. The converted score for each dimension ranges from 0-100, with a higher score reflecting a better quality of life.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Some of the Quality-of-Life questionnaires could not be analyzed due to incomplete data.\n\nGiving up makeup dimension was only completed by women.'}, {'title': 'Tear film break-up time (TFBUT)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '85', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '5.9', 'spread': '1.7', 'groupId': 'BG000'}, {'value': '5.4', 'spread': '1.9', 'groupId': 'BG001'}, {'value': '5.7', 'spread': '1.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The Tear Film Break Up Time (TFBUT) is assessed after fluorescein instillation and is the time measured between the last blink and the first appearance of a dry spot or disruption of the tear film. The TFBUT was measured in tenths of seconds with a stopwatch provided to the sites. It was conducted 3 times and the mean was calculated.', 'unitOfMeasure': 'seconds', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': "Schirmer's test", 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '85', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '7.2', 'spread': '5.0', 'groupId': 'BG000'}, {'value': '7.1', 'spread': '4.8', 'groupId': 'BG001'}, {'value': '7.1', 'spread': '4.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': "Tear fluid secretion was assessed by un-anaesthetised Schirmer's test in the study eye with graduated strips in millimetres.\n\nSchirmer paper test strips were carefully inserted over the lower eyelid margin. The strips were removed after 5 minutes and the amount of tear fluid secretion was read to the nearest mm from the graduated strip margin.", 'unitOfMeasure': 'millimeters', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Baseline data were only collected for Intention-to-treat population. Intention-to-treat-population: all participants with treatment and a post-baseline assessment Each Baseline Participant contributed one study eye.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-07-25', 'size': 973476, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-10-11T10:37', 'hasProtocol': True}, {'date': '2021-03-18', 'size': 3629851, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-10-11T10:37', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 92}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-11-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2020-06-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-29', 'studyFirstSubmitDate': '2017-11-28', 'resultsFirstSubmitDate': '2023-10-12', 'studyFirstSubmitQcDate': '2017-12-08', 'lastUpdatePostDateStruct': {'date': '2025-05-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-04-29', 'studyFirstPostDateStruct': {'date': '2017-12-11', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-05-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Ocular Surface Fluorescein Staining Score at Day 28', 'timeFrame': 'Baseline (Day 0), Visit 4 (Day 28)', 'description': 'Mean change from baseline (CFB) in the study eye in Ocular Surface Fluorescein Staining (OSFS) scored according to the Oxford Scheme.\n\nThe Oxford Scheme is a validated scale consisting of a series of panels labelled A to E in order of increasing severity. Grade 0 corresponds to panel A increasing to Grade 5 corresponding to more than Panel E, with punctate dots representing staining. The 3 regions, cornea, nasal and temporal bulbar conjunctiva are graded separately from 0 (best outcome) to 5 (worst outcome), with the Ocular Surface Fluorescein Score (OSFS) ranging from 0 (best outcome) to 15 (worst outcome). The OSFS is the sum score of the 3 sub-scores (corneal, nasal and temporal regions).\n\nThe study eye was the eligible eye with the highest OSFS score at baseline, which needed to be ≥4 and ≤9 on the 15-grade Oxford Scheme. If both eyes were eligible and had the same OSFS score, the study eye was the right eye.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Ocular Surface Fluorescein Staining Score at Day 90 (Visit 5)', 'timeFrame': 'Baseline (Day 0), Visit 5 (Day 90)', 'description': 'Mean change from baseline (CFB) in the study eye in Ocular Surface Fluorescein Staining (OSFS) scored according to the Oxford Scheme.\n\nThe Oxford Scheme is a validated scale consisting of a series of panels labelled A to E in order of increasing severity. Grade 0 corresponds to panel A increasing to Grade 5 corresponding to more than Panel E, with punctate dots representing staining. The 3 regions, cornea, nasal and temporal bulbar conjunctiva are graded separately from 0 to 5, with the OSFS score ranging from 0 (best outcome) to 15 (worst outcome).\n\nThe study eye was the eligible eye with the highest OSFS score at baseline, which needed to be ≥4 and ≤9 on the 15-grade Oxford Scheme. If both eyes were eligible and had the same OSFS score, the study eye was the right eye.'}, {'measure': 'Change From Baseline in Corneal Fluorescein Staining Score at Day 28 (Visit 4) and at Day 90 (Visit 5)', 'timeFrame': 'Baseline (Day 0), Visit 4 (Day 28) and Visit 5 (Day 90)', 'description': 'Mean change from baseline (CFB) in the study eye in Corneal Fluorescein Staining (OSFS) scored according to the Oxford Scheme.\n\nThe Oxford Scheme is a validated scale consisting of a series of panels labelled A to E in order of increasing severity. Grade 0 corresponds to panel A increasing to Grade 5 corresponding to more than Panel E, with punctate dots representing staining. The Corneal Region is graded separately from 0 (best outcome) to 5 (worst outcome).'}, {'measure': 'Change From Baseline in Nasal Conjunctival Fluorescein Staining Score at Day 28 (Visit 4) and at Day 90 (Visit 5)', 'timeFrame': 'Baseline (Day 0), Visit 4 (Day 28) and Visit 5 (Day 90)', 'description': 'Mean change from baseline (CFB) in the study eye in Nasal Conjunctival Fluorescein Staining scored according to the Oxford Scheme.\n\nThe Oxford Scheme is a validated scale consisting of a series of panels labelled A to E in order of increasing severity. Grade 0 corresponds to panel A increasing to Grade 5 corresponding to more than Panel E, with punctate dots representing staining. The Nasal conjunctival region is graded separately from 0 (best outcome) to 5 (worst outcome).'}, {'measure': 'Change From Baseline in Temporal Conjunctival Fluorescein Staining Score at Day 28 (Visit 4) and at Day 90 (Visit 5)', 'timeFrame': 'Baseline (Day 0), Visit 4 (Day 28), Visit 5 (Day 90)', 'description': 'Mean change from baseline (CFB) in the study eye in Temporal Conjunctival Fluorescein Staining scored according to the Oxford Scheme.\n\nThe Oxford Scheme is a validated scale consisting of a series of panels labelled A to E in order of increasing severity. Grade 0 corresponds to panel A increasing to Grade 5 corresponding to more than Panel E, with punctate dots representing staining. The Temporal Conjunctival region is graded separately from 0 (best outcome) to 5 (worst outcome).'}, {'measure': 'Change From Baseline in Global Sum Score of Dry Eye Symptoms at Day 28 (Visit 4) and at Day 90 (Visit 5)', 'timeFrame': 'Baseline (Day 0), Visit 4 (Day 28) and Visit 5 (Day 90)', 'description': 'The global sum score (scale 0-28) of dry eye symptoms assessed 7 items: sensation of dryness, foreign body, burning, stinging, itching, blurred vision, sensitivity to light, each graded from 0 (absent) to 4 (severe and/or disabling and constant).'}, {'measure': 'Change From Baseline in the Ocular Surface Disease-Quality of Life (OSD-QoL®) at Day 90 (Visit 5)', 'timeFrame': 'Baseline (Day 0), Visit 5 (Day 90)', 'description': 'The OSD-QoL® questionnaire is a validated instrument for measuring dry eye severity and impairment. It includes 28 items divided into 7 dimensions: Daily activities, Difficulties with work and handicap, Giving up makeup, Acknowledgement of the disease, Acceptance of the disease, Fear for the future, and Emotional well-being. A Global Question: "How do you feel when considering your eye problems?" (included in the Fear for the future dimension) is also evaluated separately. The converted score for each dimension ranges from 0 to 100, with a higher score reflecting a better quality of life.'}, {'measure': 'Change From Baseline in Tear Film Break Up Time (TFBUT) at Day 28 (Visit 4) and at Day 90 (Visit 5)', 'timeFrame': 'Baseline (Day 0), Visit 4 (Day 28), Visit 5 (Day 90)', 'description': 'The Tear Film Break Up Time (TFBUT) after fluorescein instillation, measured the time between the last blink and the first appearance of a dry spot or disruption of the tear film. The TFBUT was measured in tenth of seconds with a stopwatch provided to the sites. It was conducted 3 times and the means was calculated.'}, {'measure': 'Change From Baseline in Schirmer Test at Day 28 (Visit 4)', 'timeFrame': 'Baseline (Day 0), Visit 4 (Day 28)', 'description': 'Tear fluid secretion was assessed by the un-anaesthetized Schirmer test in the study eye with graduated strips in millimeters.\n\nSchirmer paper test strips were carefully inserted over the lower eyelid margin. The strips were removed after 5 minutes and the amount of tear fluid secretion ready to the nearest mm from the graduated strip margins.'}, {'measure': 'Frequency of Eye Drop Instillation', 'timeFrame': 'From Day 0 to Day 90, an average of 3 months', 'description': "Mean daily frequency of investigational eye drop instillations as reported in participant's diary"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['dry eye, tear substitute, ocular lubricant'], 'conditions': ['Dry Eye']}, 'descriptionModule': {'briefSummary': 'The primary objectives of this investigation were to show that the performance of CBL-102 Eye Drops is non-inferior to that of Vismed® Multi eye drops in subjects with moderate to severe keratoconjunctivitis sicca after 28 days, and to assess the safety of CBL-102 Eye Drops during a 90-day period with treatment administered 3 to 6 times per day.', 'detailedDescription': "This was a multicenter, randomized, parallel group, investigator-masked, non-inferiority study. Approximately 84 subjects were planned to be randomized in a 1:1 ratio.\n\nThe primary performance endpoint was the mean change from baseline (CFB) in the study eye at Day 28 in the Ocular surface fluorescein staining score as assessed by the Oxford Scheme.\n\nFollowing a screening visit (Visit 1) and a 2-week washout with povidone 2% artificial tear (ART), participants were randomized on Day 0 (Visit 2) with follow-up visits on Day 28 ±3 (Visit 4) and Day 90 ±10 (Visit 5). A telephone assessment took place on Day 7 ±1 ('Visit 3') for safety and compliance."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age of at least 18 and ability to read, understand, and provide written voluntary informed consent on the Ethics Committee approved Informed Consent Form\n2. Ability and willingness to comply with all treatment and follow-up and study procedures\n3. Use of tear substitutes for at least 2.5 months prior to inclusion, and agreement to use multidose preservative-free ART (Aqualarm® U.P. povidone 2% eye drops in 10 mL bottles) up to 6 times a day for at least 2 weeks immediately prior to randomization\n4. Symptom score ≥ 1 for at least 2 out of the 7 following symptoms (rated 0 to 4): sensation of dryness, foreign body, burning, stinging, itching, blurred vision, sensitivity to light\n5. At least 1 eye with the following signs of keratoconjunctivitis sicca :\n\n * Tear break-up time of 10 sec (mean of 3 measurements) at both screening visit and inclusion visit\n * Total ocular surface staining score ≥ 4 and ≤ 9 at both screening visit and inclusion visit. This assessment combines corneal, nasal and temporal bulbar conjunctival fluorescein staining, each graded 0-5 according to the Oxford Scheme\n6. A decimal visual acuity with habitual correction equal to or better than 0.1 (Monoyer chart) in both eyes\n7. No systemic treatment or who had received stable systemic treatment (unchanged for 1 month or longer)\n8. Female subjects had to be into 1 of the following categories:\n\n * Post-menopausal\n * Surgically sterile\n * Using birth control method throughout the duration of the study\n9. Female of childbearing potential needed a negative urine pregnancy test result at screening\n\nExclusion Criteria:\n\n1. Severe blepharitis\n2. Severe ocular dryness accompanied by 1 of the following:\n\n * Lid abnormality\n * Corneal disease\n * Ocular surface metaplasia\n * Filamentary keratitis\n * Corneal neovascularization\n3. Use of contact lenses at inclusion or within 90 days prior to study start\n4. History of ocular surgery, including laser surgery, in either eye within 180 days prior to study start\n5. History of ocular trauma, non-dry eye ocular inflammation, or ocular infection within 90 days prior to study start\n6. History of ocular allergic disease or ocular herpes within 1 year prior to study start\n7. History of any inflammatory ulcerative keratitis, recurrent corneal erosion, or uveitis\n8. Known hypersensitivity or contraindications to any of the ingredients in the test or comparator products or ART\n9. Initiation of, or changes to, concomitant medication that could affect dry eye within 30 days prior to Visit 1 (Screening) or with planned initiation or changes of such medications during the study\n10. Ocular therapy (either eye) with any ophthalmic medication, except tear substitutes, within 2 weeks prior to study start\n11. Expected use of ocular therapy during the study\n12. Use of topical ocular steroidal or non-steroidal anti-inflammatory medication within 30 days prior to study start\n13. Expected use of ocular therapy with immunosuppressants during the study or use of ocular immunosuppressants within 90 days prior to study start\n14. Use of occlusion therapy with non-resorbable lacrimal or punctum plugs within 90 days prior to study start or use of resorbable plugs\n15. Use or planned use of therapy such as LipiFlow® or BlephEx®\n16. Breastfeeding females\n17. Participation in any drug or device clinical investigation within 30 days prior to entry into study and/or during the period of study participation'}, 'identificationModule': {'nctId': 'NCT03368404', 'acronym': 'RESTA', 'briefTitle': 'A Study to Evaluate the Performance and Safety of CBL-102 Versus Vismed® Multi Eye Drops in the Management of Dry Eye', 'organization': {'class': 'INDUSTRY', 'fullName': 'Laboratoire Chauvin'}, 'officialTitle': 'A Study to Evaluate the Performance and Safety of CBL-102 Versus Vismed® Multi Eye Drops in the Management of Dry Eye', 'orgStudyIdInfo': {'id': 'CBL-2017-01'}, 'secondaryIdInfos': [{'id': '2017-A01099-44', 'type': 'OTHER', 'domain': 'ANSM Registry Office RCB - France'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CBL-102 eye drops', 'description': 'CE marked medical device, tear substitute containing 0.24% hyaluronic acid salt, carbomer and medium chain triglycerides, presented in 10 mL bottles', 'interventionNames': ['Device: CBL-102 eye drops']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Vismed Multi eye drops', 'description': 'CE marked medical device, tear substitute containing 0.18% sodium hyaluronate, presented in 10 mL bottles', 'interventionNames': ['Device: Vismed Multi eye drops']}], 'interventions': [{'name': 'CBL-102 eye drops', 'type': 'DEVICE', 'description': 'CBL-102 eye drops, 3 to 6 times per day for 3 months', 'armGroupLabels': ['CBL-102 eye drops']}, {'name': 'Vismed Multi eye drops', 'type': 'DEVICE', 'description': 'Vismed Multi eye drops, 3 to 6 times per day for 3 months', 'armGroupLabels': ['Vismed Multi eye drops']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94270', 'city': 'Le Kremlin-Bicêtre', 'country': 'France', 'facility': 'Hôpital Kremlin-Bicêtre', 'geoPoint': {'lat': 48.81471, 'lon': 2.36073}}], 'overallOfficials': [{'name': 'Marc Labetoulle, M.D Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hôpital Kremlin-Bicêtre'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Laboratoire Chauvin', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Bausch & Lomb Incorporated', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}