drugset / Trial / NCT00596492

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

NCT00596492 ↗

Phase 3 Terminated 200 enrolled Aqumen Biopharmaceuticals, N.A.
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2008-05
Primary completion
2008-09
Completion
2008-12

Outcome

Outcome not reported

Stopped: “Terminated due to reasons unrelated to safety”

Drugs

EvaluationDrugModalityDoseRoute
Comparator BRILLIANT BLUE G FREE ACID Small molecule 0.05 mg/ml —
Comparator BRILLIANT BLUE G FREE ACID Small molecule 0.25 mg/ml —

Indications