Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2025-12-25 @ 9:54 PM
Study NCT ID:
NCT00223951
Status:
COMPLETED
Last Update Posted:
2015-02-20
First Post:
2005-09-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety Study of Ophthalmic Solution in Healthy, Normal Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003233', 'term': 'Conjunctivitis, Allergic'}], 'ancestors': [{'id': 'D003231', 'term': 'Conjunctivitis'}, {'id': 'D003229', 'term': 'Conjunctival Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 900}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-02', 'lastUpdateSubmitDate': '2015-02-19', 'studyFirstSubmitDate': '2005-09-20', 'studyFirstSubmitQcDate': '2005-09-20', 'lastUpdatePostDateStruct': {'date': '2015-02-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse events; biomicroscopy and visual acuity at baseline and Days 7, 21, and 42; ophthalmoscopy and intraocular pressure at baseline and Day 42; physical examination'}], 'secondaryOutcomes': [{'measure': 'No additional endpoints'}]}, 'conditionsModule': {'keywords': ['Healthy volunteers, safety, ocular, allergic conjunctivitis, ophthalmic'], 'conditions': ['Healthy Volunteers Eligible for Study; Drug Being Developed for Allergic Conjunctivitis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety of R89674 0.25% ophthalmic solution in healthy normal volunteers'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '3 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nhealthy normal volunteers age \\>=3 years with normal ocular health and a best-corrected logMAR score of 0.3 or better\n\n\\-\n\nExclusion Criteria:\n\nintraocular surgery and/or ocular surgical intervention within last 3 months, refractive surgery within last 6 months, active ocular disorder other than refractive disorders, breastfeeding women, pregnant female \\< 18 years of age -'}, 'identificationModule': {'nctId': 'NCT00223951', 'briefTitle': 'Safety Study of Ophthalmic Solution in Healthy, Normal Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Vistakon Pharmaceuticals'}, 'officialTitle': 'A Multi-Center, Randomized, Double-Masked, Vehicle-Controlled, Parallel-Group Study Evaluating the Safety of R89674 0.25% Ophthalmic Solution in Healthy, Normal Volunteers', 'orgStudyIdInfo': {'id': '05-003-10'}}, 'armsInterventionsModule': {'interventions': [{'name': 'R89674 (generic name not yet established)', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '85032', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '21014', 'city': 'Bel Air', 'state': 'Maryland', 'country': 'United States', 'geoPoint': {'lat': 39.53594, 'lon': -76.34829}}, {'zip': '01845', 'city': 'North Andover', 'state': 'Massachusetts', 'country': 'United States', 'geoPoint': {'lat': 42.6987, 'lon': -71.13506}}, {'zip': '89102', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '28204', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '19148', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Jack V Greiner, OD, DO, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ophthalmic Research Associates, North Andover, MA'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vistakon Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}