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Sponsored by: |
Aqumen Biopharmaceuticals, N.A. |
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Information provided by: | Aqumen Biopharmaceuticals, N.A. |
ClinicalTrials.gov Identifier: | NCT00596492 |
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.
Condition | Intervention | Phase |
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Mature Cataracts |
Drug: DYME |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
Official Title: | 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 |
Estimated Enrollment: | 200 |
Study Start Date: | May 2008 |
Estimated Study Completion Date: | December 2008 |
Estimated Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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High Dose: Active Comparator |
Drug: DYME
2ml of 0.25 mg/ml BBG 250 in sterile ophthalmic solution
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Low Dose: Active Comparator |
Drug: DYME
2ml of 0.05 mg/ml BBG 250 in sterile ophthalmic solution
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
Peace Laser Eye Center | |
Inglewood, California, United States, 90301 | |
United States, Florida | |
Center for Excellence in Eye Care | |
Miami, Florida, United States, 33176 | |
Center for Excellence in Eye Care | |
Miami, Florida, United States, 33176 | |
United States, Missouri | |
St. John's Clinic Eye Specialists | |
Springfield, Missouri, United States, 65804 | |
Ballas Surgery Center | |
St. Louis, Missouri, United States, 63141 | |
Silverstein Eye Centers | |
Kansas City, Missouri, United States, 64133 | |
Ophthalmology Consultants, Ltd. | |
Des Peres, Missouri, United States, 63131 | |
United States, New Jersey | |
Brar-Parekh Eye Associates | |
West Paterson, New Jersey, United States, 07424 | |
United States, New York | |
Island Eye Surgicenter | |
Carle Place, New York, United States, 11514 | |
Island Eye Surgicenter | |
Carle Place, New York, United States, 11514 | |
United States, Pennsylvania | |
Eye Care Specialists | |
Kingston, Pennsylvania, United States, 18704 | |
India, Andhra Pradesh | |
LV Prasad Eye Institute | |
Hyderabaad, Andhra Pradesh, India, 500034 | |
India, Karnataka | |
Narayana Nethralaya | |
Bangalore, Karnataka, India, 560020 | |
Bhagwan Mahaveer Jain Hospital | |
Bangalore, Karnataka, India, 560052 | |
Narayana Nethralaya | |
Bangalore, Karnataka, India, 560099 | |
India, Maharashtra | |
Bombay City Eye Institute & Research Centre | |
Mumbai, Maharashtra, India, 400 007 | |
India, Tamilnadu | |
Sankara Nethralaya | |
Chennai, Tamilnadu, India, 600006 |
Study Director: | Hardy Kagimoto, M.D. | Aqumen Biopharmaceuticals, N.A. |
Responsible Party: | Aqumen Biopharmaceuticals, N.A. ( Hardy Kagimoto, M.D. / C.E.O. ) |
Study ID Numbers: | AQNA-DY002, US IND 75,735 |
Study First Received: | January 9, 2008 |
Last Updated: | February 27, 2009 |
ClinicalTrials.gov Identifier: | NCT00596492 History of Changes |
Health Authority: | United States: Food and Drug Administration; India: Drugs Controller General of India |
Eye Diseases Cataract Lens Diseases |
Eye Diseases Cataract Lens Diseases |