Ignite Creation Date:
2025-12-24 @ 2:14 PM
Ignite Modification Date:
2025-12-24 @ 2:14 PM
Study NCT ID:
NCT04357795
Status:
COMPLETED
Last Update Posted:
2024-02-06
First Post:
2020-04-08
Is Possible Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Effect of Cequa™ in Subjects With Dry Eye Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-10-03', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D015352', 'term': 'Dry Eye Syndromes'}, {'id': 'D007638', 'term': 'Keratoconjunctivitis Sicca'}], 'ancestors': [{'id': 'D007766', 'term': 'Lacrimal Apparatus Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D007637', 'term': 'Keratoconjunctivitis'}, {'id': 'D003231', 'term': 'Conjunctivitis'}, {'id': 'D003229', 'term': 'Conjunctival Diseases'}, {'id': 'D007634', 'term': 'Keratitis'}, {'id': 'D003316', 'term': 'Corneal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016572', 'term': 'Cyclosporine'}, {'id': 'D009883', 'term': 'Ophthalmic Solutions'}], 'ancestors': [{'id': 'D003524', 'term': 'Cyclosporins'}, {'id': 'D010456', 'term': 'Peptides, Cyclic'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D019999', 'term': 'Pharmaceutical Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D020313', 'term': 'Specialty Uses of Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinical.trial@sunpharma.com', 'phone': '2266455645', 'title': 'Head-Clinical Development', 'phoneExt': '5689', 'organization': 'Sun Pharmaceutical Industries Limited'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '12 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'CequaTM (Cyclosporine 0.09%) Ophthalmic Solution', 'description': 'CequaTM (Cyclosporine 0.09%) ophthalmic solution: One drop CequaTM (Cyclosporine 0.09%) ophthalmic solution in each eye twice daily, approximately 12 hours apart.', 'otherNumAtRisk': 134, 'deathsNumAtRisk': 134, 'otherNumAffected': 20, 'seriousNumAtRisk': 134, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Instillation Site Irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 134, 'numAffected': 17}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Instillation Site Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 134, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Change in Baseline in Total Corneal Fluoroscein Staining Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CequaTM (Cyclosporine 0.09%) Ophthalmic Solution', 'description': 'CequaTM (Cyclosporine 0.09%) ophthalmic solution: One drop CequaTM (Cyclosporine 0.09%) ophthalmic solution in each eye twice daily, approximately 12 hours apart.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.1', 'spread': '2.88', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'statisticalMethod': 'Paired t-test', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Single group analysis'}], 'paramType': 'MEAN', 'timeFrame': 'Week12', 'description': 'Scale for Corneal Staining as defined by the FDA/NEI: 0-4 (0-no staining, 4-severe staining). The higher number indicates more severe. The lower the number indicates less severe staining on the cornea', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Modified Dry Eye Scoring.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CequaTM (Cyclosporine 0.09%) Ophthalmic Solution', 'description': 'CequaTM (Cyclosporine 0.09%) ophthalmic solution: One drop CequaTM (Cyclosporine 0.09%) ophthalmic solution in each eye twice daily, approximately 12 hours apart.'}], 'classes': [{'categories': [{'measurements': [{'value': '-29.14', 'spread': '26.220', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'statisticalMethod': 'Paired t-test', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Single group analysis'}], 'paramType': 'MEAN', 'timeFrame': 'Week12', 'description': 'Based on questionnaire asked to subjects (sign and symptoms), modified symptom of dry eye score (range 0 to 100) will be assessed. Increase in score will indicate severity in the symptoms.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mean Change in Baseline for Conjunctival Staining Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CequaTM (Cyclosporine 0.09%) Ophthalmic Solution', 'description': 'CequaTM (Cyclosporine 0.09%) ophthalmic solution: One drop CequaTM (Cyclosporine 0.09%) ophthalmic solution in each eye twice daily, approximately 12 hours apart.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.35', 'spread': '2.918', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'statisticalMethod': 'Paired t-test', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Single group analysis'}], 'paramType': 'MEAN', 'timeFrame': 'Week 12', 'description': "Based on Investigator's judgement, 6 areas of the conjunctiva will be evaluated in a low to moderate intensity.\n\nScale for Conjunctival Staining defined: 0-6 (0 no staining, 6-severe staining). The higher the number indicates more severe. The lower the number indicates less severe staining on the conjunctival", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Changes From Baseline in Central Corneal Staining Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CequaTM (Cyclosporine 0.09%) Ophthalmic Solution', 'description': 'CequaTM (Cyclosporine 0.09%) ophthalmic solution: One drop CequaTM (Cyclosporine 0.09%) ophthalmic solution in each eye twice daily, approximately 12 hours apart.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.5', 'spread': '0.87', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'statisticalMethod': 'Paired t-test', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Single group analysis'}], 'paramType': 'MEAN', 'timeFrame': 'Week 12', 'description': 'Five areas of cornea will be evaluated on a 0 to 4 scale and value from 0 (absent) to 4 (severe) to each section will be allotted based on NEI grading scale', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mean Change in Baseline for Tear Osmolarity Score for Both Eyes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CequaTM (Cyclosporine 0.09%) Ophthalmic Solution', 'description': 'CequaTM (Cyclosporine 0.09%) ophthalmic solution: One drop CequaTM (Cyclosporine 0.09%) ophthalmic solution in each eye twice daily, approximately 12 hours apart.'}], 'classes': [{'title': 'OD- Right eye', 'categories': [{'measurements': [{'value': '-4.0', 'spread': '19.44', 'groupId': 'OG000'}]}]}, {'title': 'OS- left eye', 'categories': [{'measurements': [{'value': '-11.7', 'spread': '18.54', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.0323', 'groupIds': ['OG000'], 'statisticalMethod': 'Paired t-test', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'OD- Right eye p value', 'nonInferiorityComment': 'Single group analysis'}, {'pValue': '0.3447', 'groupIds': ['OG000'], 'pValueComment': 'OS: P-Value', 'statisticalMethod': 'Paired t-test', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Single group analysis'}], 'paramType': 'MEAN', 'timeFrame': 'Week 12', 'description': 'Tear osmolarity of both the eyes will be assessed and score (mOsm/L) will be allotted to each eye. Higher score will indicate severity of the disease (dry eye).\n\nTear osmolarity OU was assessed using the TearLab Osmolarity System Test by collecting nanoliter volumes of tear fluid at each visit from each eyelid margin using the Osmolarity Test Pen and Test Card. Results were interpreted according to the provided instructions and scores (mOsm/L) for each eye were recorded. Normal, mild/moderate, and severe dry eyes had average tear osmolarity values of approximately 302+/-8 mOsm/L, 315+/-10 mOsm/L and 336+/022 mOsm/L, respectively.', 'unitOfMeasure': 'mOsm/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Frequency of Artificial Tear Product Use.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CequaTM (Cyclosporine 0.09%) Ophthalmic Solution', 'description': 'CequaTM (Cyclosporine 0.09%) ophthalmic solution: One drop CequaTM (Cyclosporine 0.09%) ophthalmic solution in each eye twice daily, approximately 12 hours apart.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.5', 'spread': '2.39', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'statisticalMethod': 'Paired t-test', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Single group analysis'}], 'paramType': 'MEAN', 'timeFrame': 'Week 12', 'description': 'Based on entries in the subject diaries, frequency of artificial tear product use will be assessed.\n\nFrequency for artificial tear: This is number of times per day recorded in a daily diary log assessed at baseline and week 12. The higher the number the worse the outcome. The lower the number the better the outcome', 'unitOfMeasure': 'times product used/day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': "Schirmer's Test Score", 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CequaTM (Cyclosporine 0.09%) Ophthalmic Solution', 'description': 'CequaTM (Cyclosporine 0.09%) ophthalmic solution: One drop CequaTM (Cyclosporine 0.09%) ophthalmic solution in each eye twice daily, approximately 12 hours apart.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.4', 'spread': '8.61', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.0029', 'groupIds': ['OG000'], 'statisticalMethod': 'Paired t-test', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Single group analysis'}], 'paramType': 'MEAN', 'timeFrame': 'Week 12', 'description': "An unanesthetized Schirmer's test was performed in each eye at least 5 minutes after the lissamine green conjunctival staining to allow for any reflex tearing to subside. At each visit, strips were placed OU at the same time and timed for 5 min. Strips were removed after 5 min and the amount of wetting was recorded in mm and also marked with a line on the strip. The Investigator recorded a score for each eye. A score of greater than 10 mm in 5 minutes is accepted as normal. A score of less than 5 mm in 5 minutes indicates a tear deficiency. A score less than 10 mm in 5 minutes indicates a change from normal in tear production.", 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects Who Prefer Study Treatments Over Prior Treatment.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CequaTM (Cyclosporine 0.09%) Ophthalmic Solution', 'description': 'CequaTM (Cyclosporine 0.09%) ophthalmic solution: One drop CequaTM (Cyclosporine 0.09%) ophthalmic solution in each eye twice daily, approximately 12 hours apart.'}], 'classes': [{'title': 'Prefer prior treatment', 'categories': [{'measurements': [{'value': '21.8', 'groupId': 'OG000'}]}]}, {'title': 'Prefer study treatment', 'categories': [{'measurements': [{'value': '69.4', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12', 'description': 'Subjects will be asked, which treatment they prefer for the management of the dry eye (prior treatment or study treatment).\n\nNote- For this outcome measure, participants were provided the option to not choose either treatment as the preferred treatment.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'CequaTM (Cyclosporine 0.09%) Ophthalmic Solution', 'description': 'CequaTM (Cyclosporine 0.09%) ophthalmic solution: One drop CequaTM (Cyclosporine 0.09%) ophthalmic solution in each eye twice daily, approximately 12 hours apart.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '134'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '115'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'CequaTM (Cyclosporine 0.09%) Ophthalmic Solution', 'description': 'CequaTM (Cyclosporine 0.09%) ophthalmic solution: One drop CequaTM (Cyclosporine 0.09%) ophthalmic solution in each eye twice daily, approximately 12 hours apart.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '65.5', 'groupId': 'BG000', 'lowerLimit': '23', 'upperLimit': '90'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '110', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '18', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '107', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-12-11', 'size': 571365, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-09-04T02:43', 'hasProtocol': True}, {'date': '2023-01-25', 'size': 182787, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-09-04T02:46', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 135}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2022-06-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-16', 'studyFirstSubmitDate': '2020-04-08', 'resultsFirstSubmitDate': '2023-09-05', 'studyFirstSubmitQcDate': '2020-04-20', 'lastUpdatePostDateStruct': {'date': '2024-02-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-01-16', 'studyFirstPostDateStruct': {'date': '2020-04-22', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-02-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Change in Baseline in Total Corneal Fluoroscein Staining Score', 'timeFrame': 'Week12', 'description': 'Scale for Corneal Staining as defined by the FDA/NEI: 0-4 (0-no staining, 4-severe staining). The higher number indicates more severe. The lower the number indicates less severe staining on the cornea'}, {'measure': 'Change From Baseline in Modified Dry Eye Scoring.', 'timeFrame': 'Week12', 'description': 'Based on questionnaire asked to subjects (sign and symptoms), modified symptom of dry eye score (range 0 to 100) will be assessed. Increase in score will indicate severity in the symptoms.'}], 'secondaryOutcomes': [{'measure': 'Mean Change in Baseline for Conjunctival Staining Assessment', 'timeFrame': 'Week 12', 'description': "Based on Investigator's judgement, 6 areas of the conjunctiva will be evaluated in a low to moderate intensity.\n\nScale for Conjunctival Staining defined: 0-6 (0 no staining, 6-severe staining). The higher the number indicates more severe. The lower the number indicates less severe staining on the conjunctival"}, {'measure': 'Changes From Baseline in Central Corneal Staining Score', 'timeFrame': 'Week 12', 'description': 'Five areas of cornea will be evaluated on a 0 to 4 scale and value from 0 (absent) to 4 (severe) to each section will be allotted based on NEI grading scale'}, {'measure': 'Mean Change in Baseline for Tear Osmolarity Score for Both Eyes', 'timeFrame': 'Week 12', 'description': 'Tear osmolarity of both the eyes will be assessed and score (mOsm/L) will be allotted to each eye. Higher score will indicate severity of the disease (dry eye).\n\nTear osmolarity OU was assessed using the TearLab Osmolarity System Test by collecting nanoliter volumes of tear fluid at each visit from each eyelid margin using the Osmolarity Test Pen and Test Card. Results were interpreted according to the provided instructions and scores (mOsm/L) for each eye were recorded. Normal, mild/moderate, and severe dry eyes had average tear osmolarity values of approximately 302+/-8 mOsm/L, 315+/-10 mOsm/L and 336+/022 mOsm/L, respectively.'}, {'measure': 'Mean Change From Baseline in Frequency of Artificial Tear Product Use.', 'timeFrame': 'Week 12', 'description': 'Based on entries in the subject diaries, frequency of artificial tear product use will be assessed.\n\nFrequency for artificial tear: This is number of times per day recorded in a daily diary log assessed at baseline and week 12. The higher the number the worse the outcome. The lower the number the better the outcome'}, {'measure': "Schirmer's Test Score", 'timeFrame': 'Week 12', 'description': "An unanesthetized Schirmer's test was performed in each eye at least 5 minutes after the lissamine green conjunctival staining to allow for any reflex tearing to subside. At each visit, strips were placed OU at the same time and timed for 5 min. Strips were removed after 5 min and the amount of wetting was recorded in mm and also marked with a line on the strip. The Investigator recorded a score for each eye. A score of greater than 10 mm in 5 minutes is accepted as normal. A score of less than 5 mm in 5 minutes indicates a tear deficiency. A score less than 10 mm in 5 minutes indicates a change from normal in tear production."}, {'measure': 'Percentage of Subjects Who Prefer Study Treatments Over Prior Treatment.', 'timeFrame': 'Week 12', 'description': 'Subjects will be asked, which treatment they prefer for the management of the dry eye (prior treatment or study treatment).\n\nNote- For this outcome measure, participants were provided the option to not choose either treatment as the preferred treatment.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Keratoconjunctivitis Sicca', 'KCS', 'Dry eye'], 'conditions': ['Dry Eye Disease']}, 'descriptionModule': {'briefSummary': 'This is a Phase 4, multicenter, single arm, 12 week study in subjects with dry eye disease, which is inadequately controlled by cyclosporine 0.05% ophthalmic emulsion.', 'detailedDescription': 'This is a phase 4, multicenter, open-label, single-arm, 12-week study of subjects with dry eye disease that is inadequately controlled by cyclosporine (CsA) 0.05% ophthalmic emulsion. Subject enrollment will be classified by evidence of dry eye disease (ie, signs, symptoms, or both signs and symptoms). Treatment will be one drop of CsA 0.09% ophthalmic solution (Cequa) in each eye twice daily (BID) for 12 weeks. The study hypothesis is that CsA 0.09% ophthalmic solution will show improved clinical benefit in subjects whose dry eye signs and/or symptoms are inadequately controlled while on CsA.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or female subjects with a history of bilateral dry eye disease for a period of at least 3 months.\n2. Aged of at least 18 years.\n3. Subjects with total corneal fluorescein staining ≥6 or corneal fluorescein staining in an individual zone ≥2 as per National Eye Institute Grading Scale.\n4. Subjects with modified symptom assessment in dry eye global symptom score, ≥40 using visual analogue scale.\n5. Subjects with best-corrected visual acuity 20/200 or better in both eyes at the Screening/Baseline visit\n\nExclusion Criteria:\n\n1. Subjects who have used cyclosporin 0.05% ophthalmic emulsion in both eyes for less than 3 months prior to the Screening/Baseline visit.\n2. Subjects with history of treatment failure with cyclosporin 0.05% ophthalmic emulsion.\n3. Subjects who have active seasonal and/or perennial allergic conjunctivitis in either eye.\n4. Subjects who had already Use initiated any systemic or topical ocular medication.'}, 'identificationModule': {'nctId': 'NCT04357795', 'briefTitle': 'Effect of Cequa™ in Subjects With Dry Eye Disease', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sun Pharmaceutical Industries Limited'}, 'officialTitle': 'Effect of Cequa™ in Subjects With Dry Eye Disease That Is Currently Inadequately Controlled While on Cyclosporine 0.05% Ophthalmic Emulsion', 'orgStudyIdInfo': {'id': 'OTX101-2019-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CequaTM (Cyclosporine 0.09%) ophthalmic solution', 'interventionNames': ['Drug: CequaTM (Cyclosporine 0.09%) ophthalmic solution']}], 'interventions': [{'name': 'CequaTM (Cyclosporine 0.09%) ophthalmic solution', 'type': 'DRUG', 'description': 'One drop CequaTM (Cyclosporine 0.09%) ophthalmic solution in each eye twice daily, approximately 12 hours apart.', 'armGroupLabels': ['CequaTM (Cyclosporine 0.09%) ophthalmic solution']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33901', 'city': 'Fort Myers', 'state': 'Florida', 'country': 'United States', 'facility': 'Eye Associates of Fort Myers, 4225 Evans Ave.', 'geoPoint': {'lat': 26.62168, 'lon': -81.84059}}, {'zip': '32256', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Bowden Eye and Associates, 7205 Bonneval Road', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '32405', 'city': 'Panama City', 'state': 'Florida', 'country': 'United States', 'facility': 'Eye Center of N Florida, 2500 Martin Luther King Jr Blvd', 'geoPoint': {'lat': 30.15946, 'lon': -85.65983}}, {'zip': '66762', 'city': 'Pittsburg', 'state': 'Kansas', 'country': 'United States', 'facility': 'Kannarr Eye Care, 2521 N Broadway', 'geoPoint': {'lat': 37.41088, 'lon': -94.70496}}, {'zip': '76054', 'city': 'Hurst', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Eye and Laser Center, 1872 Norwood Dr. #200', 'geoPoint': {'lat': 32.82346, 'lon': -97.17057}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Pharmaceutical Industries Limited', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}