drugset / Trial / NCT00596583

DY001: Safety and Effectiveness of DYME as an Agent for Selective Staining of the Anterior Capsule During Cataract Surgery

NCT00596583 ↗

Phase 3 Completed 300 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
2007-04
Primary completion
2008-05
Completion
2008-05

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