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| Sponsored by: |
Aqumen Biopharmaceuticals, N.A. |
|---|---|
| Information provided by: | Aqumen Biopharmaceuticals, N.A. |
| ClinicalTrials.gov Identifier: | NCT00596583 |
Purpose
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 |
|---|---|---|
|
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-DY001: 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: | 300 |
| Study Start Date: | April 2007 |
| Study Completion Date: | May 2008 |
| Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| High Dose: Active Comparator |
Drug: DYME
2ml of 0.25 mg/ml BBG 250 in sterile ophthalmic solution
|
| Low Dose: Active Comparator |
Drug: DYME
2ml of 0.05 mg/ml BBG 250 in sterile ophthalmic solution
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Arkansas | |
| McDonald Eye Associates | |
| Fayetteville, Arkansas, United States, 72703 | |
| United States, California | |
| Capitol City Surgery Center | |
| Sacramento, California, United States, 95815 | |
| Peace Laser Eye Center | |
| Inglewood, California, United States, 90301 | |
| United States, Florida | |
| Center for Excellence in Eye Care | |
| Miami, Florida, United States, 33176 | |
| The Eye Institute of West Florida | |
| Largo, Florida, United States, 33770 | |
| United States, Indiana | |
| Eye Surgeons of Indiana | |
| Indianapolis, Indiana, United States, 46256 | |
| United States, Missouri | |
| Ballas Surgery Center | |
| St. Louis, Missouri, United States, 63141 | |
| St. John's Clinic Eye Specialists | |
| Springfield, Missouri, United States, 65804 | |
| Silverstein Eye Centers | |
| Kansas City, Missouri, United States, 64133 | |
| United States, New Jersey | |
| Wills Eye Surgery Center | |
| Cherry Hill, New Jersey, United States, 08002 | |
| 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 | |
| Island Eye Surgicenter | |
| Carle Place, New York, United States, 11514 | |
| United States, Ohio | |
| The Ohio State University Hospital | |
| Columbus, Ohio, United States, 43210 | |
| United States, Pennsylvania | |
| Wills Surgery Center | |
| Philadelphia, Pennsylvania, United States, 19145 | |
| Wills Eye Surgery Center | |
| Philadelphia, Pennsylvania, United States, 19107 | |
| Eye Care Specialists | |
| Kingston, Pennsylvania, United States, 18704 | |
| United States, Wisconsin | |
| SMDV Surgery Center | |
| Madison, Wisconsin, United States, 53715 | |
| 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 | |
| The Mehta International Eye Institute & Colaba Eye Hospital | |
| Mumbai, Maharashtra, India, 400 005 | |
| Study Director: | Hardy Kagimoto, M.D. | Aqumen Biopharmaceuticals, N.A. |
More Information
| Responsible Party: | Aqumen Biopharmaceuticals, N.A. ( Hardy Kagimoto, M.D. / C.E.O. ) |
| Study ID Numbers: | AQNA-DY001, US IND 75,735 |
| Study First Received: | January 9, 2008 |
| Last Updated: | February 27, 2009 |
| ClinicalTrials.gov Identifier: | NCT00596583 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 |