DY001: Safety and Effectiveness of DYME as an Agent for Selective Staining of the Anterior Capsule During Cataract Surgery
This study has been completed.
Sponsor:
Aqumen Biopharmaceuticals, N.A.
Information provided by:
Aqumen Biopharmaceuticals, N.A.
ClinicalTrials.gov Identifier:
NCT00596583
First received: January 9, 2008
Last updated: February 27, 2009
Last verified: February 2009
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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 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Aqumen Biopharmaceuticals, N.A.:
Primary Outcome Measures:
- Optimal curvilinear capsulorrhexis with a single dose, as assessed by the surgeon based on the tissue dyed and subsequently removed. [ Time Frame: During surgery ] [ Designated as safety issue: No ]
- Uncomplicated discharge [ Time Frame: one week post-op ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Quality of stain [ Time Frame: during surgery ] [ Designated as safety issue: No ]
- 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 [ Time Frame: 1-day and 1-week post-op ] [ Designated as safety issue: Yes ]
| 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 |
|---|---|
| Active Comparator: High Dose |
Drug: DYME
2ml of 0.25 mg/ml BBG 250 in sterile ophthalmic solution
|
| Active Comparator: Low Dose |
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 |
Criteria
Inclusion Criteria:
- Have a cataract sufficiently opaque/mature/brunescent that, in the surgeon's assessment,a dye could facilitate surgery;
- Be aged at least 18 years old at the time of enrollment;
- Be able to tolerate a surgical procedure for up to 3 hours;
- Be in a medical condition suitable for cataract surgery;
- Able and willing to participate in study examinations and visit schedule; and
- Understand and freely consent to participate in the study.
Exclusion Criteria:
- In either eye, ocular infection or inflammation within the past 3 months;
- Known allergy to BBG 250;
- Uncontrolled intercurrent diseases including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia;
- Active treatment for cancer or systemic infection within the past month;
- Active treatment with systemic corticosteroids within the past month;
- Previous participation in this Study for the contralateral eye;
- Participation in another clinical trial involving an investigational therapeutic during the past 30 days or 5.5 half-lives (if applicable), whichever is longer;
- Unwillingness to participate in the study or inability to give informed consent; or
- Any medical condition that in the opinion of the Investigator may compromise the research subject's safety or ability to participate in the study.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00596583
Locations
| United States, Arkansas | |
| McDonald Eye Associates | |
| Fayetteville, Arkansas, United States, 72703 | |
| United States, California | |
| Peace Laser Eye Center | |
| Inglewood, California, United States, 90301 | |
| Capitol City Surgery Center | |
| Sacramento, California, United States, 95815 | |
| United States, Florida | |
| The Eye Institute of West Florida | |
| Largo, Florida, United States, 33770 | |
| Center for Excellence in Eye Care | |
| Miami, Florida, United States, 33176 | |
| United States, Indiana | |
| Eye Surgeons of Indiana | |
| Indianapolis, Indiana, United States, 46256 | |
| United States, Missouri | |
| Silverstein Eye Centers | |
| Kansas City, Missouri, United States, 64133 | |
| St. John's Clinic Eye Specialists | |
| Springfield, Missouri, United States, 65804 | |
| Ballas Surgery Center | |
| St. Louis, Missouri, United States, 63141 | |
| 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 | |
| United States, Ohio | |
| The Ohio State University Hospital | |
| Columbus, Ohio, United States, 43210 | |
| United States, Pennsylvania | |
| Eye Care Specialists | |
| Kingston, Pennsylvania, United States, 18704 | |
| Wills Surgery Center | |
| Philadelphia, Pennsylvania, United States, 19145 | |
| Wills Eye Surgery Center | |
| Philadelphia, Pennsylvania, United States, 19107 | |
| United States, Wisconsin | |
| SMDV Surgery Center | |
| Madison, Wisconsin, United States, 53715 | |
| India | |
| Narayana Nethralaya | |
| Bangalore, Karnataka, India, 560020 | |
| Bhagwan Mahaveer Jain Hospital | |
| Bangalore, Karnataka, India, 560052 | |
| Narayana Nethralaya | |
| Bangalore, Karnataka, India, 560099 | |
| Bombay City Eye Institute & Research Centre | |
| Mumbai, Maharashtra, India, 400 007 | |
| The Mehta International Eye Institute & Colaba Eye Hospital | |
| Mumbai, Maharashtra, India, 400 005 | |
Sponsors and Collaborators
Aqumen Biopharmaceuticals, N.A.
Investigators
| Study Director: | Hardy Kagimoto, M.D. | Aqumen Biopharmaceuticals, N.A. |
More Information
No publications provided
| Responsible Party: | Hardy Kagimoto, M.D. / C.E.O., Aqumen Biopharmaceuticals, N.A. |
| ClinicalTrials.gov Identifier: | NCT00596583 History of Changes |
| Other Study ID Numbers: | AQNA-DY001, US IND 75,735 |
| Study First Received: | January 9, 2008 |
| Last Updated: | February 27, 2009 |
| Health Authority: | United States: Food and Drug Administration India: Drugs Controller General of India |
Additional relevant MeSH terms:
|
Cataract Lens Diseases Eye Diseases |
ClinicalTrials.gov processed this record on May 21, 2013