drugset / Trial / NCT00234078

Dose-response Study of OPC-12759 Ophthalmic Suspension

NCT00234078 ↗

Phase 2 Completed 290 enrolled Otsuka Pharmaceutical Co., Ltd.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to evaluate the dose-response of OPC-12759 ophthalmic suspension in dry eye patients.

Timeline

Start
2005-01
Primary completion
2006-04
Completion
2007-03

Outcome

Missed primary endpoint

registry analysis (superiority or other test); 0.5% OPC-12759 vs 1% OPC-12759 vs 2% OPC-12759 vs Placebo; p = 0.385; t-test, 2 sided; note: versus placebo NCT00234078 ↗

registry analysis (superiority or other test); 0.5% OPC-12759 vs 1% OPC-12759 vs 2% OPC-12759 vs Placebo; p = 0.601; t-test, 2 sided; note: versus placebo NCT00234078 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Rebamipide Small molecule 0.5 % —
Subject Rebamipide Small molecule 1 % —
Subject Rebamipide Small molecule 2 % —

Indications