Ignite Creation Date:
2025-12-25 @ 2:04 AM
Ignite Modification Date:
2025-12-31 @ 9:53 PM
Study NCT ID:
NCT00333060
Status:
TERMINATED
Last Update Posted:
2008-04-02
First Post:
2006-05-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of OT-551 Eye Drops to Prevent or Delay Progression of Nuclear Cataracts Following Vitreous Removal
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019773', 'term': 'Epiretinal Membrane'}, {'id': 'D012167', 'term': 'Retinal Perforations'}], 'ancestors': [{'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 164}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2005-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-03', 'completionDateStruct': {'date': '2008-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2008-03-31', 'studyFirstSubmitDate': '2006-05-31', 'studyFirstSubmitQcDate': '2006-05-31', 'lastUpdatePostDateStruct': {'date': '2008-04-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-06-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change in visual acuity'}, {'measure': 'change in lens opacity'}]}, 'conditionsModule': {'conditions': ['Epiretinal Membrane', 'Macular Hole']}, 'descriptionModule': {'briefSummary': 'The purpose of this trial is to compare the ability of two doses of OT-551 ophthalmic solution and drug-free solution to safely and effectively prevent or delay the progression of nuclear cataracts that frequently develop as a result of vitrectomy (surgery for retina repair), thereby avoiding the need for a second surgery (cataract removal). Victrectomies involve removal of the jelly-like substance (vitreous) that is located in a cavity behind the lens.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Imminent vitrectomy to repair macular holes or puckers\n* Ability to be screened for eligibility and begin dosing 7-10 days in advance of the surgery\n* Best corrected ETDRS visual acuity equivalent to Snellen 20/400 or better in the surgical eye and 20/100 or better in the fellow eye\n\nExclusion Criteria:\n\n* Artificial lens or no lens in the surgical eye\n* Cataract (greater than slight opacity or thickness) in the surgical eye\n* Any other retinal abnormality which may be vision-threatening\n* Serious heart, kidney, or liver disease\n* Recent ophthalmic surgery (within 6 months) or ocular infection (within 30 days)\n* Poorly controlled diabetes or unstable glaucoma'}, 'identificationModule': {'nctId': 'NCT00333060', 'briefTitle': 'Study of OT-551 Eye Drops to Prevent or Delay Progression of Nuclear Cataracts Following Vitreous Removal', 'organization': {'class': 'INDUSTRY', 'fullName': 'Othera Pharmaceuticals'}, 'officialTitle': 'Phase 2 Study of OT-551 Ophthalmic Solution to Prevent or Delay Progression of Nuclear Cataract Formation In Post-Vitrectomy Patients', 'orgStudyIdInfo': {'id': 'OT-551-002'}}, 'armsInterventionsModule': {'interventions': [{'name': 'OT-551 ophthalmic solution', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Peoria', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.5806, 'lon': -112.23738}}, {'city': 'Beverly Hills', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.07362, 'lon': -118.40036}}, {'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'city': 'Tallahassee', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 30.43826, 'lon': -84.28073}}, {'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'city': 'Joliet', 'state': 'Illinois', 'country': 'United States', 'geoPoint': {'lat': 41.52519, 'lon': -88.0834}}, {'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'city': 'Cherry Hill', 'state': 'New Jersey', 'country': 'United States', 'geoPoint': {'lat': 39.93484, 'lon': -75.03073}}, {'city': 'Forrest Hills', 'state': 'New Jersey', 'country': 'United States'}, {'city': 'New York', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'city': 'Bala-Cynwyd', 'state': 'Pennsylvania', 'country': 'United States', 'geoPoint': {'lat': 40.00761, 'lon': -75.23407}}, {'city': 'West Chester', 'state': 'Pennsylvania', 'country': 'United States', 'geoPoint': {'lat': 39.96097, 'lon': -75.60804}}, {'city': 'Abilene', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 32.44874, 'lon': -99.73314}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Othera Pharmaceuticals', 'class': 'INDUSTRY'}}}}