Ignite Creation Date:
2025-12-25 @ 12:58 AM
Ignite Modification Date:
2025-12-28 @ 9:30 PM
Study NCT ID:
NCT00767793
Status:
COMPLETED
Last Update Posted:
2015-10-02
First Post:
2008-10-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Placebo-Controlled Study of INS117548 Ophthalmic Solution in Subjects With Glaucoma (P08650)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D005901', 'term': 'Glaucoma'}], 'ancestors': [{'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 84}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-01', 'studyFirstSubmitDate': '2008-10-02', 'studyFirstSubmitQcDate': '2008-10-06', 'lastUpdatePostDateStruct': {'date': '2015-10-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-10-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of adverse events', 'timeFrame': '15'}, {'measure': 'Rate of discontinuation', 'timeFrame': '15'}, {'measure': 'Changes in: >Ophthalmic exam parameters >Corneal thickness >Intraocular pressure >Visual Acuity >Physical exam, vital signs and laboratory parameters', 'timeFrame': '15'}, {'measure': 'Compliance', 'timeFrame': '15'}]}, 'conditionsModule': {'conditions': ['Glaucoma']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety and tolerability of INS117548 ophthalmic solution.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have a diagnosis of bilateral ocular hypertension or early primary open angle glaucoma\n* Have best corrected visual acuity in both eyes of at least +0.5 or better\n\nExclusion Criteria:\n\n* Are diagnosed with closed angle glaucoma, exfoliation syndrome or exfoliation glaucoma, and pigment dispersion or secondary glaucoma\n* Have a history of any type of intraocular surgery, except for cataract surgery\n* Have had cataract surgery within three months'}, 'identificationModule': {'nctId': 'NCT00767793', 'briefTitle': 'A Placebo-Controlled Study of INS117548 Ophthalmic Solution in Subjects With Glaucoma (P08650)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Multi-Center, Double-Masked, Randomized, Placebo-Controlled, Ascending Dose Study of INS117548 Ophthalmic Solution in Subjects With Bilateral Ocular Hypertension or Early Primary Open Angle Glaucoma', 'orgStudyIdInfo': {'id': 'P08650'}, 'secondaryIdInfos': [{'id': '037-101'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Arm 1', 'description': 'One drop in each eye every 12 hours for seven days', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 2', 'description': 'One drop of Concentration #1 in one eye and one drop of placebo in contralateral eye every 12 hours for seven days', 'interventionNames': ['Drug: INS117548']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 3', 'description': 'One drop of Concentration #2 in one eye and one drop of placebo in contralateral eye every 12 hours for seven days', 'interventionNames': ['Drug: INS117548']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 4', 'description': 'One drop of Concentration #3 in one eye and one drop of placebo in contralateral eye every 12 hours for seven days', 'interventionNames': ['Drug: INS117548']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'description': 'One drop in each eye every 12 hours for seven days', 'armGroupLabels': ['Arm 1']}, {'name': 'INS117548', 'type': 'DRUG', 'description': 'One drop of Concentration #1 in one eye and one drop of placebo in contralateral eye every 12 hours for seven days', 'armGroupLabels': ['Arm 2']}, {'name': 'INS117548', 'type': 'DRUG', 'description': 'One drop of Concentration #2 in one eye and one drop of placebo in contralateral eye every 12 hours for seven days', 'armGroupLabels': ['Arm 3']}, {'name': 'INS117548', 'type': 'DRUG', 'description': 'One drop of Concentration #3 in one eye and one drop of placebo in contralateral eye every 12 hours for seven days', 'armGroupLabels': ['Arm 4']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Reza Haque, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Medical Monitor, Inspire'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}