DY002: Safety and Effectiveness of DYME as an Agent for Selective Staining of the Anterior Capsule During Cataract Surgery

• Status: Terminated
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Aqumen Biopharmaceuticals, N.A.
• Treatments: Ophthalmic Solutions

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 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.