Ignite Creation Date:
2025-12-24 @ 3:55 PM
Ignite Modification Date:
2026-02-22 @ 9:04 AM
Study NCT ID:
NCT00596492
Status:
TERMINATED
Last Update Posted:
2009-03-02
First Post:
2008-01-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
DY002: Safety and Effectiveness of DYME as an Agent for Selective Staining of the Anterior Capsule During Cataract Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'whyStopped': 'Terminated due to reasons unrelated to safety', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2008-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-02', 'completionDateStruct': {'date': '2008-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-02-27', 'studyFirstSubmitDate': '2008-01-09', 'studyFirstSubmitQcDate': '2008-01-09', 'lastUpdatePostDateStruct': {'date': '2009-03-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-01-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Optimal curvilinear capsulorrhexis with a single dose, as assessed by the surgeon based on the tissue dyed and subsequently removed.', 'timeFrame': 'During surgery'}, {'measure': 'Uncomplicated discharge', 'timeFrame': 'Three months post-op'}], 'secondaryOutcomes': [{'measure': 'Quality of stain', 'timeFrame': 'during surgery'}, {'measure': 'Intra-ocular safety of DYME as measured by best corrected visual acuity, corneal endothelial cell count, intraocular pressure, presence/absence of retained dye, duration of surgery, and the absence of dye related adverse events', 'timeFrame': '1-day and 1-week post-op'}, {'measure': 'Intra-ocular safety of DYME as measured by corneal endothelial cell count', 'timeFrame': 'Three months post-op'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Mature Cataracts']}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to test the hypothesis that DYME is safe and effective as a drug to facilitate continuous curvilinear capsulorhexis (CCC) by selectively staining the anterior capsule. Secondary objectives are to compare the safety and effectiveness of DYME to that of a smaller dose of the same API.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Have a cataract sufficiently opaque/mature/brunescent that, in the surgeon's assessment,a dye could facilitate surgery;\n* Be aged at least 18 years old at the time of enrollment;\n* Be in a medical condition suitable for cataract surgery;\n* Able and willing to participate in study examinations and visit schedule; and\n* Understand and freely consent to participate in the study.\n\nExclusion Criteria:\n\n* In either eye, ocular infection or inflammation within the past 3 months;\n* Known allergy to BBG 250;\n* Uncontrolled intercurrent diseases including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia;\n* Active treatment for cancer or systemic infection within the past month;\n* Active treatment with systemic corticosteroids within the past month;\n* Previous participation in this Study for the contralateral eye;\n* Participation in another clinical trial involving an investigational therapeutic during the past 30 days or 5.5 half-lives (if applicable), whichever is longer;\n* Unwillingness to participate in the study or inability to give informed consent; or\n* Any medical condition that in the opinion of the Investigator may compromise the research subject's safety or ability to participate in the study."}, 'identificationModule': {'nctId': 'NCT00596492', 'acronym': 'AQNA-DY002', 'briefTitle': 'DY002: Safety and Effectiveness of DYME as an Agent for Selective Staining of the Anterior Capsule During Cataract Surgery', 'organization': {'class': 'INDUSTRY', 'fullName': 'Aqumen Biopharmaceuticals, N.A.'}, 'officialTitle': 'AQNA-DY002: A Double-Masked, Randomized Study of the Safety and Effectiveness of DYME as an Agent for Selective Staining of the Anterior Capsule During Cataract Surgery', 'orgStudyIdInfo': {'id': 'AQNA-DY002'}, 'secondaryIdInfos': [{'id': 'US IND 75,735'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'High Dose', 'interventionNames': ['Drug: DYME']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Low Dose', 'interventionNames': ['Drug: DYME']}], 'interventions': [{'name': 'DYME', 'type': 'DRUG', 'description': '2ml of 0.05 mg/ml BBG 250 in sterile ophthalmic solution', 'armGroupLabels': ['Low Dose']}, {'name': 'DYME', 'type': 'DRUG', 'description': '2ml of 0.25 mg/ml BBG 250 in sterile ophthalmic solution', 'armGroupLabels': ['High Dose']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90301', 'city': 'Inglewood', 'state': 'California', 'country': 'United States', 'facility': 'Peace Laser Eye Center', 'geoPoint': {'lat': 33.96168, 'lon': -118.35313}}, {'zip': '33176', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Center for Excellence in Eye Care', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '63131', 'city': 'Des Peres', 'state': 'Missouri', 'country': 'United States', 'facility': 'Ophthalmology Consultants, Ltd.', 'geoPoint': {'lat': 38.60089, 'lon': -90.4329}}, {'zip': '64133', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': 'Silverstein Eye Centers', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '65804', 'city': 'Springfield', 'state': 'Missouri', 'country': 'United States', 'facility': "St. John's Clinic Eye Specialists", 'geoPoint': {'lat': 37.21533, 'lon': -93.29824}}, {'zip': '63141', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Ballas Surgery Center', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '07424', 'city': 'Woodland Park', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Brar-Parekh Eye Associates', 'geoPoint': {'lat': 40.88982, 'lon': -74.19487}}, {'zip': '11514', 'city': 'Carle Place', 'state': 'New York', 'country': 'United States', 'facility': 'Island Eye Surgicenter', 'geoPoint': {'lat': 40.7526, 'lon': -73.61041}}, {'zip': '18704', 'city': 'Kingston', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Eye Care Specialists', 'geoPoint': {'lat': 41.26175, 'lon': -75.89686}}, {'zip': '500034', 'city': 'Hyderabaad', 'state': 'Andhra Pradesh', 'country': 'India', 'facility': 'LV Prasad Eye Institute'}, {'zip': '560020', 'city': 'Bangalore', 'state': 'Karnataka', 'country': 'India', 'facility': 'Narayana Nethralaya', 'geoPoint': {'lat': 12.97194, 'lon': 77.59369}}, {'zip': '560052', 'city': 'Bangalore', 'state': 'Karnataka', 'country': 'India', 'facility': 'Bhagwan Mahaveer Jain Hospital', 'geoPoint': {'lat': 12.97194, 'lon': 77.59369}}, {'zip': '560099', 'city': 'Bangalore', 'state': 'Karnataka', 'country': 'India', 'facility': 'Narayana Nethralaya', 'geoPoint': {'lat': 12.97194, 'lon': 77.59369}}, {'zip': '400 007', 'city': 'Mumbai', 'state': 'Maharashtra', 'country': 'India', 'facility': 'Bombay City Eye Institute & Research Centre', 'geoPoint': {'lat': 19.07283, 'lon': 72.88261}}, {'zip': '600006', 'city': 'Chennai', 'state': 'Tamil Nadu', 'country': 'India', 'facility': 'Sankara Nethralaya', 'geoPoint': {'lat': 13.08784, 'lon': 80.27847}}], 'overallOfficials': [{'name': 'Hardy Kagimoto, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Aqumen Biopharmaceuticals, N.A.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aqumen Biopharmaceuticals, N.A.', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Hardy Kagimoto, M.D. / C.E.O.', 'oldOrganization': 'Aqumen Biopharmaceuticals, N.A.'}}}}