Ignite Creation Date:
2025-12-24 @ 2:43 PM
Ignite Modification Date:
2026-01-31 @ 5:52 AM
Study NCT ID:
NCT02235259
Status:
COMPLETED
Last Update Posted:
2016-07-18
First Post:
2014-09-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of XG-104 for the Treatment of Dry Eye
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 260}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'dispFirstSubmitDate': '2016-07-15', 'completionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-07-15', 'studyFirstSubmitDate': '2014-09-05', 'dispFirstSubmitQcDate': '2016-07-15', 'studyFirstSubmitQcDate': '2014-09-05', 'dispFirstPostDateStruct': {'date': '2016-07-18', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2016-07-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-09-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Visual Acuity (ETDRS) (Pre-CAESM)', 'timeFrame': 'Day -7'}, {'measure': 'Visual Acuity (ETDRS) (Pre-CAESM)', 'timeFrame': 'Day 1'}, {'measure': 'Visual Acuity (ETDRS) (Pre-CAESM)', 'timeFrame': 'Day 15'}, {'measure': 'Visual Acuity (ETDRS) (Pre-CAESM)', 'timeFrame': 'Day 29'}, {'measure': 'Slit-Lamp Biomicroscopy (Pre- and Post-CAESM)', 'timeFrame': 'Day -7'}, {'measure': 'Slit-Lamp Biomicroscopy (Pre- and Post-CAESM)', 'timeFrame': 'Day 1'}, {'measure': 'Slit-Lamp Biomicroscopy (Pre- and Post-CAESM)', 'timeFrame': 'Day 15'}, {'measure': 'Slit-Lamp Biomicroscopy (Pre- and Post-CAESM)', 'timeFrame': 'Day 29'}, {'measure': 'Adverse event query', 'timeFrame': 'up to Day 29'}, {'measure': 'Dilated Fundoscopy Biomicroscopy', 'timeFrame': 'Day -7'}, {'measure': 'Dilated Fundoscopy Biomicroscopy', 'timeFrame': 'Day 29'}, {'measure': 'Intraocular Pressure', 'timeFrame': 'Day -7'}, {'measure': 'Intraocular Pressure', 'timeFrame': 'Day 29'}], 'primaryOutcomes': [{'measure': 'Corneal Fluorescein Staining: in the inferior region change from Pre-CAESM to Post- CAESM, as measured by the Ora CalibraTM Scale', 'timeFrame': 'Day 29'}, {'measure': 'Worst Dry Eye Symptom', 'timeFrame': 'From D22 to Day 28'}], 'secondaryOutcomes': [{'measure': 'Fluorescein Staining using Ora Calibra™ Scale and NEI Scale (all régions) Pre- and Post-CAESM', 'timeFrame': 'Day 15'}, {'measure': 'Fluorescein Staining using Ora Calibra™ Scale and NEI Scale (all régions) Pre- and Post-CAESM', 'timeFrame': 'Day 29'}, {'measure': 'Lissamine Green Staining using Ora Calibra™ Scale and NEI Scale (all regions) (Pre- and Post-CAESM and change from Pre- to Post-CAESM', 'timeFrame': 'Day 15'}, {'measure': 'Lissamine Green Staining using Ora Calibra™ Scale and NEI Scale (all regions) (Pre- and Post-CAESM and change from Pre- to Post-CAESM', 'timeFrame': 'Day 29'}, {'measure': 'Tear Film Break-up Time (Pre- and Post-CAESM)', 'timeFrame': 'Day 15'}, {'measure': 'Tear Film Break-up Time (Pre- and Post-CAESM)', 'timeFrame': 'Day 29'}, {'measure': 'Conjunctival Redness using Ora Calibra™ Scale (Pre- and Post-CAESM)', 'timeFrame': 'Day 15'}, {'measure': 'Conjunctival Redness using Ora Calibra™ Scale (Pre- and Post-CAESM)', 'timeFrame': 'Day 29'}, {'measure': 'Lid Margin Redness using Ora Calibra scale (Pre- and Post-CAESM)', 'timeFrame': 'Day 15'}, {'measure': 'Lid Margin Redness using Ora Calibra scale (Pre- and Post-CAESM)', 'timeFrame': 'Day 29'}, {'measure': 'Tear Osmolarity (Post-CAESM)', 'timeFrame': 'Day 1'}, {'measure': 'Tear Osmolarity (Post-CAESM)', 'timeFrame': 'Day 29'}, {'measure': 'Blink Rate (Pre-CAESM ) using Ora Calibra™ Methodology', 'timeFrame': 'Day 15'}, {'measure': 'Blink Rate (Pre-CAESM ) using Ora Calibra™ Methodology', 'timeFrame': 'Day 29'}, {'measure': 'Ocular Protection Index (OPI 2.0) (Pre-CAESM ) using Ora Calibra™ Methodology', 'timeFrame': 'Day 15'}, {'measure': 'Ocular Protection Index (OPI 2.0) (Pre-CAESM ) using Ora Calibra™ Methodology', 'timeFrame': 'Day 29'}, {'measure': "Unanesthetized Schirmer's Test (Pre-CAESM)", 'timeFrame': 'Day 15'}, {'measure': "Unanesthetized Schirmer's Test (Pre-CAESM)", 'timeFrame': 'Day 29'}, {'measure': 'Drop Comfort and Symptom Assessment using Ora Calibra™ Scales', 'timeFrame': 'Day 1'}, {'measure': 'Drop Comfort and Symptom Assessment using Ora Calibra™ Scales', 'timeFrame': 'Day 15'}, {'measure': 'Ocular Surface Disease Index (OSDI) (Pre-CAESM)', 'timeFrame': 'Day 15'}, {'measure': 'Ocular Surface Disease Index (OSDI) (Pre-CAESM)', 'timeFrame': 'Day 29'}, {'measure': 'Ocular Discomfort using Ora Calibra™ Scale (Pre and Post-CAESM)', 'timeFrame': 'Day 15'}, {'measure': 'Ocular Discomfort using Ora Calibra™ Scale (Pre and Post-CAESM)', 'timeFrame': 'Day 29'}, {'measure': 'Ocular Discomfort using Ora Calibra™ Discomfort and 4-Symptom Questionnaire (Pre and Post-CAESM)', 'timeFrame': 'Day 15'}, {'measure': 'Ocular Discomfort using Ora Calibra™ Discomfort and 4-Symptom Questionnaire (Pre and Post-CAESM)', 'timeFrame': 'Day 29'}, {'measure': 'Ocular Discomfort using Ora Calibra™ Scale (during CAESM exposure)', 'timeFrame': 'Day 15'}, {'measure': 'Ocular Discomfort using Ora Calibra™ Scale (during CAESM exposure)', 'timeFrame': 'Day 29'}, {'measure': 'Daily diary', 'timeFrame': 'up to Day 29'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Dry Eye']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to assess the safety and efficacy of XG-104 Ophthalmic Solution compared to placebo for the treatment of the signs and symptoms of dry eye after a 4 week Three Times a Day (TID) treatment period'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Be at least 18 years of age\n* Provide written informed consent\n* Have a subject reported history of dry eye\n* Have a history of use or desire to use eye drops\n\nExclusion Criteria:\n\n* Have any clinically significant eye findings that require therapeutic treatment, and/or in the opinion of the Investigator may interfere with study parameters;\n* Have worn contact lenses within 7 days of Visit 1 or anticipate using contact lenses during the study;\n* Have previously had laser-assisted in situ keratomileusis (LASIK) surgery within the last 12 months;\n* Have used Restasis® within 30 days of Visit 1;\n* Have any planned ocular and/or lid surgeries over the study period;\n* Be a woman who is pregnant, nursing or planning a pregnancy;\n* Be unwilling to submit a urine pregnancy test at Visit 1 and Visit 4 (or early termination visit) if of childbearing potential.\n* Have a known allergy and/or sensitivity to the study drug or its components\n* Have a condition or be in a situation which the Investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study;\n* Be currently enrolled in an investigational drug or device study or have used an investigational drug or device within 30 days of Visit 1;\n* Be unable or unwilling to follow instructions, including participation in all study assessments and visits"}, 'identificationModule': {'nctId': 'NCT02235259', 'briefTitle': 'Efficacy and Safety of XG-104 for the Treatment of Dry Eye', 'organization': {'class': 'INDUSTRY', 'fullName': 'Xigen SA'}, 'officialTitle': 'A Phase II, Multi-Center, Randomized, Double Masked, Placebo Controlled Clinical Study to Assess the Safety and Efficacy of XG-104 Ophthalmic Solutions in the Environment, and During Challenge in the Controlled Adverse Environmental (CAESM ) Model for the Treatment of Dry Eye', 'orgStudyIdInfo': {'id': 'SDD-1004-059'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'XG-104 low dose', 'interventionNames': ['Drug: XG-104']}, {'type': 'EXPERIMENTAL', 'label': 'XG-104 intermediate dose', 'interventionNames': ['Drug: XG-104']}, {'type': 'EXPERIMENTAL', 'label': 'XG-104 high dose', 'interventionNames': ['Drug: XG-104']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'XG-104', 'type': 'DRUG', 'description': 'Comparison of XG-104 (3 concentrations) versus placebo eye drops efficacy', 'armGroupLabels': ['XG-104 high dose', 'XG-104 intermediate dose', 'XG-104 low dose']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01810', 'city': 'Andover', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Andover Eye Associates', 'geoPoint': {'lat': 42.65843, 'lon': -71.137}}], 'overallOfficials': [{'name': 'Gail Torkildsen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Andover Eye Associates'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xigen SA', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}