drugset / Trial / NCT01660256

Confirmatory Study of OPC-12759 Ophthalmic Solution

NCT01660256 ↗

Phase 3 Completed 209 enrolled Otsuka Pharmaceutical Co., Ltd.
RandomizedParallel-groupSingle-blindTreatment

Summary

The purpose of this study is to verify whether OPC-12759 ophthalmic solution is effective compared with placebo in dry eye patients. OPC-12759 ophthalmic suspension will be used as a reference drug.

Timeline

Start
2012-08
Primary completion
2013-03
Completion
2013-05

Outcome

Met primary endpoint

registry OPC-12759 Solution vs Placebo; p <0.001; Mean Difference (Final Values) -1.3; t-test, 2 sided NCT01660256 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Rebamipide Small molecule — Other

Indications