Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2026-03-01 @ 12:50 PM
Study NCT ID:
NCT02656394
Status:
COMPLETED
Last Update Posted:
2023-03-24
First Post:
2016-01-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Amelioration of Adverse Ocular Side Effects of Glaucoma Medications in Glaucoma Patients Using Topical GL101
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, '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': 49}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2018-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-23', 'studyFirstSubmitDate': '2016-01-08', 'studyFirstSubmitQcDate': '2016-01-12', 'lastUpdatePostDateStruct': {'date': '2023-03-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-01-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Adverse events', 'timeFrame': 'Day 1 to 4 weeks', 'description': 'Adverse events:\n\n* Visual acuity\n* Slit lamp biomicroscopy\n* Undilated fundoscopy examination\n* Intraocular pressure'}], 'primaryOutcomes': [{'measure': 'Glaucoma medication ocular side effect symptoms', 'timeFrame': 'Day 1 to 4 weeks', 'description': 'Glaucoma medication ocular side effect symptoms:\n\n* Ocular discomfort\n* Burning\n* Stinging\n* Conjunctival redness\n* Itching\n* Dryness\n* Foreign object sensation\n* Grittiness\n* Pain\n* Eyelid swelling\n* Eyelid redness\n* Photophobia\n* Excessive tearing\n* Crusty lids\n* Blurred vision'}], 'secondaryOutcomes': [{'measure': 'Glaucoma medication ocular side effect signs', 'timeFrame': 'Day 1 to 4 weeks', 'description': 'Glaucoma medication ocular side effect signs:\n\n* Tearscope tear film examination\n* Tear meniscus height (TMH)\n* Tear film break up time (NIKBUT)\n* Bulbar redness (BR)\n* Meibography\n* Conjunctival redness (hyperemia)\n* Blepharitis\n* Lid margin vessel inflammation\n* Punctate keratitis\n* Corneal staining\n* Conjunctival staining'}, {'measure': 'Other signs', 'timeFrame': 'Day 1 to 4 weeks', 'description': 'Other signs:\n\n* Visual acuity\n* Intraocular pressure\n* Artificial tear use\n* Glaucoma medication compliance'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['ocular surface disease', 'glaucoma medications'], 'conditions': ['Ocular Surface Disease']}, 'descriptionModule': {'briefSummary': 'To evaluate the safety and efficacy of 0.5% GL101 topical gel administered twice daily for 28 days in ameliorating adverse ocular side effects in patients under ongoing treatment with glaucoma medications.', 'detailedDescription': 'The study is to assess the safety and efficacy of a new treatment for ocular surface disease associated with the use of glaucoma medications.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Male or female of any race, at least 18 years of age at Visit 1 Screening.\n2. Has provided verbal and written informed consent.\n3. Be able and willing to follow instructions, including participation in all study assessments and visits.\n4. Currently being treated for glaucoma using at least two medications, and be willing to continue on the same regime.\n5. Suffers from at least two of the symptoms in the GLIA™ Glaucoma Medication Ocular Side Effect Symptoms Questionnaire at a severity of 2 (moderate) or more.\n6. If a woman of childbearing potential, have a negative urine pregnancy test at Visit 1 and be using an adequate method of birth control throughout the study period.\n\nExclusion Criteria:\n\n1. Comorbidity with other severe or chronic eye conditions that in the judgment of the investigator will interfere with study assessments, such as corneal opacities and scars, dystrophies, epithelial scarring, infections, blood clots, etc.\n2. Best corrected visual acuity (BCVA) at baseline \\<20/200.\n3. Has a condition or history that, in the opinion of the investigator, may interfere significantly with the subject's participation in the study.\n4. A woman who is pregnant, nursing an infant, or planning a pregnancy.\n5. Has a known adverse reaction and/or sensitivity to the study drug or its components.\n6. Routine use (more than twice a week) of a chlorinated swimming pool.\n7. Unwilling or unable to cease using the following medications during the study period: Topical ocular cyclosporine (e.g. Restasis®), anti-histamines, antipsychotics, or eye gels.\n8. Currently enrolled in an investigational drug or device study or have used an investigational drug or device within 30 days prior to Visit 1."}, 'identificationModule': {'nctId': 'NCT02656394', 'briefTitle': 'Amelioration of Adverse Ocular Side Effects of Glaucoma Medications in Glaucoma Patients Using Topical GL101', 'organization': {'class': 'INDUSTRY', 'fullName': 'Glia, LLC'}, 'officialTitle': 'Amelioration of Adverse Ocular Side Effects of Glaucoma Medications in Glaucoma Patients Using Topical GL101 - Proof of Concept, Safety, and Efficacy Study', 'orgStudyIdInfo': {'id': 'GL-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'GL101', 'description': 'GL101 topical gel', 'interventionNames': ['Drug: GL101']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo topical gel', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'GL101', 'type': 'DRUG', 'otherNames': ['Pro-Ocular'], 'description': 'Topical Gel', 'armGroupLabels': ['GL101']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo topical gel', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10003', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York Eye & Ear Infirmary of Mount Sinai', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Robert Ritch, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'New York Eye & Ear Infirmary of Mount Sinai'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Glia, LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}