drugset / Trial / NCT01493180

Exploratory Study of OPC-12759 Ophthalmic Suspension

NCT01493180 ↗

Phase 2 Completed 102 enrolled Otsuka Pharmaceutical Co., Ltd.
RandomizedParallel-groupSingle-blindTreatment

Summary

The purpose of this study is to evaluate the efficacy of OPC-12759 ophthalmic suspension for patients with keratoconjunctival epithelial disorder compared with sodium hyaluronate. Also, safety of OPC-12759 is to be assessed.

Timeline

Start
2011-12
Primary completion
2012-11
Completion
2012-12

Outcome

Missed primary endpoint

registry analysis (superiority or other test); OPC-12759 Ophthalmic Suspension vs Sodium Hyaluronate Ophthalmic Solution; p = 0.576; t-test, 2 sided NCT01493180 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Rebamipide Small molecule 2 % —
Comparator Sodium Hyaluronate Other / unclassified 0.1 % —

Indications