| January 9, 2008 |
| February 27, 2009 |
| May 2008 |
| September 2008 (final data collection date for primary outcome measure) |
- 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: Three months post-op ] [ Designated as safety issue: Yes ]
|
| Same as current |
| Complete list of historical versions of study NCT00596492 on ClinicalTrials.gov Archive Site |
- 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 ]
- Intra-ocular safety of DYME as measured by corneal endothelial cell count [ Time Frame: Three months post-op ] [ Designated as safety issue: Yes ]
|
| Same as current |
| |
| DY002: Safety and Effectiveness of DYME as an Agent for Selective Staining of the Anterior Capsule During Cataract Surgery |
| 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 |
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. |
| |
| Phase III |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
| Mature Cataracts |
| Drug: DYME |
| |
| |
| |
| Terminated |
| 200 |
| December 2008 |
| September 2008 (final data collection date for primary outcome measure) |
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 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.
|
| Both |
| 18 Years and older |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| United States, India |
| |
| NCT00596492 |
| Hardy Kagimoto, M.D. / C.E.O., Aqumen Biopharmaceuticals, N.A. |
| AQNA-DY002, US IND 75,735 |
| Aqumen Biopharmaceuticals, N.A. |
|
| Study Director: |
Hardy Kagimoto, M.D. |
Aqumen Biopharmaceuticals, N.A. |
|
|
| Aqumen Biopharmaceuticals, N.A. |
| February 2009 |