drugset / Trial / NCT01189032

Late Phase II Confirmatory Study of DE-089 Ophthalmic Solution in Patients With Dry Eye

NCT01189032 ↗

Phase 2 Completed 320 enrolled Santen Pharmaceutical Co., Ltd.

Summary

Dose response related to efficacy and safety of DE-089 ophthalmic solution are examined in patients with dry eye, using a multicenter, randomized, double-blind, parallel group comparison study, and the optimal concentration is determined.

Timeline

Start
—
Primary completion
2006-07
Completion
—

Outcome

Met primary endpoint

registry p = 0.004; maximum contrast method; note: It's the p-value of linear trend. NCT01189032 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Diquafosol tetrasodium Oligonucleotide (other) — —

Indications