Ignite Creation Date:
2025-12-25 @ 4:19 AM
Ignite Modification Date:
2025-12-31 @ 11:50 PM
Study NCT ID:
NCT05119920
Status:
COMPLETED
Last Update Posted:
2023-07-12
First Post:
2021-11-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of Pilocarpine Ophthalmic Topical Cream for the Treatment of Dry Eye Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015352', 'term': 'Dry Eye Syndromes'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D003316', 'term': 'Corneal Diseases'}, {'id': 'D007637', 'term': 'Keratoconjunctivitis'}], 'ancestors': [{'id': 'D007766', 'term': 'Lacrimal Apparatus Diseases'}, {'id': 'D003231', 'term': 'Conjunctivitis'}, {'id': 'D003229', 'term': 'Conjunctival Diseases'}, {'id': 'D007634', 'term': 'Keratitis'}]}}, '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': 226}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'dispFirstSubmitDate': '2023-07-06', 'completionDateStruct': {'date': '2022-07-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-06', 'studyFirstSubmitDate': '2021-11-03', 'studyFirstSubmitQcDate': '2021-11-03', 'dispFirstPostDateStruct': {'date': '2023-07-12', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2023-07-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean change from baseline in the VAS score at Day 28 visit.', 'timeFrame': 'Baseline and Day 28', 'description': 'Mean change from baseline in the VAS score at Day 28 visit.\n\nVisual Analogue Scale from 0 (no discomfort) to 100 (maximal discomfort)'}, {'measure': 'Mean change from baseline in Fluorescein Staining at the Day 28 visit.', 'timeFrame': 'Baseline and Day 28', 'description': 'Mean change from baseline in Fluorescein Staining at the Day 28 visit.'}], 'secondaryOutcomes': [{'measure': 'Mean change from baseline in the VAS score at the Day 4, 8, and 14 visits', 'timeFrame': 'Baseline and Days 4, 8, and 14', 'description': 'Mean change from baseline in the VAS score at the Day 4, 8, and 14 visits\n\nVisual Analogue Scale from 0 (no discomfort) to 100 (maximal discomfort)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Dry eye syndromes', 'Eye diseases', 'Corneal diseases', 'Keratoconjunctivitis', 'Pilocarpine'], 'conditions': ['Dry Eye Disease', 'Kerato Conjunctivitis Sicca']}, 'descriptionModule': {'briefSummary': 'This is a Multicenter, Randomized, Double-Masked, Placebo-Controlled, Parallel Group Phase 2 Trial Evaluating the Safety and Efficacy of Pilocarpine Ophthalmic Topical Cream for the Treatment of Signs and Symptoms of Dry Eye Disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female, 18 years of age or older at the Screening Visit\n* Willing and able to provide written informed consent on the IRB/IEC-approved informed consent form\n* Diagnosis of dry eye\n\nExclusion Criteria:\n\n* Sensitivity or known allergy to pilocarpine or any of the other excipients of the formulation\n* History of eczema, dermatitis or skin sensitivity to over-the-counter personal care products such as lotions, creams, makeup, soaps, etc.\n* History of, or active iritis or uveitis in either eye\n* Pre-existing retinal disease in either eye that may predispose subjects to retinal detachment'}, 'identificationModule': {'nctId': 'NCT05119920', 'briefTitle': 'Safety and Efficacy of Pilocarpine Ophthalmic Topical Cream for the Treatment of Dry Eye Disease', 'organization': {'class': 'INDUSTRY', 'fullName': 'Glaukos Corporation'}, 'officialTitle': 'Multicenter, Randomized, Double-Masked, Placebo-Controlled, Parallel Group Phase 2 Trial Evaluating the Safety and Efficacy of Pilocarpine Ophthalmic Topical Cream BID for the Treatment of Signs and Symptoms of Dry Eye Disease', 'orgStudyIdInfo': {'id': 'ILUT-401-DED'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pilocarpine Ophthalmic Topical Cream, Dose 1', 'description': 'Pilocarpine Ophthalmic Topical Cream, Dose 1', 'interventionNames': ['Drug: Pilocarpine Ophthalmic Topical Cream, Dose 1']}, {'type': 'EXPERIMENTAL', 'label': 'Pilocarpine Ophthalmic Topical Cream, Dose 2', 'description': 'Pilocarpine Ophthalmic Topical Cream, Dose 2', 'interventionNames': ['Drug: Pilocarpine Ophthalmic Topical Cream, Dose 2']}, {'type': 'EXPERIMENTAL', 'label': 'Pilocarpine Ophthalmic Topical Cream, Dose 3', 'description': 'Pilocarpine Ophthalmic Topical Cream, Dose 3', 'interventionNames': ['Drug: Pilocarpine Ophthalmic Topical Cream, Dose 3']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Ophthalmic Topical Cream', 'description': 'Placebo Ophthalmic Topical Cream', 'interventionNames': ['Drug: Placebo Ophthalmic Topical Cream']}], 'interventions': [{'name': 'Pilocarpine Ophthalmic Topical Cream, Dose 1', 'type': 'DRUG', 'otherNames': ['GLK-301'], 'description': 'Pilocarpine Ophthalmic Topical Cream, Dose 1', 'armGroupLabels': ['Pilocarpine Ophthalmic Topical Cream, Dose 1']}, {'name': 'Pilocarpine Ophthalmic Topical Cream, Dose 2', 'type': 'DRUG', 'otherNames': ['GLK-301'], 'description': 'Pilocarpine Ophthalmic Topical Cream, Dose 2', 'armGroupLabels': ['Pilocarpine Ophthalmic Topical Cream, Dose 2']}, {'name': 'Pilocarpine Ophthalmic Topical Cream, Dose 3', 'type': 'DRUG', 'otherNames': ['GLK-301'], 'description': 'Pilocarpine Ophthalmic Topical Cream, Dose 3', 'armGroupLabels': ['Pilocarpine Ophthalmic Topical Cream, Dose 3']}, {'name': 'Placebo Ophthalmic Topical Cream', 'type': 'DRUG', 'otherNames': ['Placebo'], 'description': 'Placebo Ophthalmic Topical Cream', 'armGroupLabels': ['Placebo Ophthalmic Topical Cream']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85224', 'city': 'Chandler', 'state': 'Arizona', 'country': 'United States', 'facility': 'Glaukos Investigator', 'geoPoint': {'lat': 33.30616, 'lon': -111.84125}}, {'zip': '85351', 'city': 'Sun City', 'state': 'Arizona', 'country': 'United States', 'facility': 'Glaukos Investigator', 'geoPoint': {'lat': 33.59754, 'lon': -112.27182}}, {'zip': '91204', 'city': 'Glendale', 'state': 'California', 'country': 'United States', 'facility': 'Glaukos Investigator', 'geoPoint': {'lat': 34.14251, 'lon': -118.25508}}, {'zip': '91345', 'city': 'Mission Hills', 'state': 'California', 'country': 'United States', 'facility': 'Glaukos Investigator', 'geoPoint': {'lat': 34.68609, 'lon': -120.43683}}, {'zip': '92663', 'city': 'Newport Beach', 'state': 'California', 'country': 'United States', 'facility': 'Glaukos Investigator', 'geoPoint': {'lat': 33.61891, 'lon': -117.92895}}, {'zip': '94954', 'city': 'Petaluma', 'state': 'California', 'country': 'United States', 'facility': 'Glaukos Investigator', 'geoPoint': {'lat': 38.23242, 'lon': -122.63665}}, {'zip': '95670', 'city': 'Rancho Cordova', 'state': 'California', 'country': 'United States', 'facility': 'Glaukos Investigator', 'geoPoint': {'lat': 38.58907, 'lon': -121.30273}}, {'zip': '81501', 'city': 'Grand Junction', 'state': 'Colorado', 'country': 'United States', 'facility': 'Glaukos Investigator', 'geoPoint': {'lat': 39.06387, 'lon': -108.55065}}, {'zip': '33901', 'city': 'Fort Myers', 'state': 'Florida', 'country': 'United States', 'facility': 'Glaukos Investigator', 'geoPoint': {'lat': 26.62168, 'lon': -81.84059}}, {'zip': '30076', 'city': 'Roswell', 'state': 'Georgia', 'country': 'United States', 'facility': 'Glaukos Investigator', 'geoPoint': {'lat': 34.02316, 'lon': -84.36159}}, {'zip': '63131', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Glaukos Investigator', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '89052', 'city': 'Henderson', 'state': 'Nevada', 'country': 'United States', 'facility': 'Glaukos Investigator', 'geoPoint': {'lat': 36.0397, 'lon': -114.98194}}, {'zip': '14618', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'Glaukos Investigator', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '16066', 'city': 'Cranberry Township', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Glaukos Investigator', 'geoPoint': {'lat': 40.68496, 'lon': -80.10714}}, {'zip': '38119', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Glaukos Investigator', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '37215', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Glaukos Investigator', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '77025', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Glaukos Investigator', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Glaukos Investigator', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '24502', 'city': 'Lynchburg', 'state': 'Virginia', 'country': 'United States', 'facility': 'Glaukos Investigator', 'geoPoint': {'lat': 37.41375, 'lon': -79.14225}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Glaukos Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}