drugset / Trial / NCT00430092

Study of Difluprednate in the Treatment of Inflammation Following Ocular Surgery (ST-601A-002b)

NCT00430092 ↗

Phase 3 Completed 219 enrolled Sirion Therapeutics, Inc.
RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this phase III study is to determine the efficacy of difluprednate in the treatment of inflammation following ocular surgery.

Timeline

Start
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Primary completion
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Completion
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Outcome

Met primary endpoint

registry analysis (superiority or other test); Difluprednate 0.05% QID vs Placebo; p <0.0001; Mantel Haenszel NCT00430092 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Difluprednate Small molecule 0.05 % Topical

Indications

No indication recorded.