drugset / Trial / NCT03822559

A Study of DE-111A on the Treatment of Open Angle Glaucoma or Ocular Hypertension

NCT03822559

Phase 3 Completed 219 enrolled Santen Pharmaceutical Co., Ltd.
RandomizedParallel-groupTriple-blindTreatment

Summary

The objective of this study is to investigate whether the IOP (intraocular pressure) -lowering effect of DE-111A (preservative-free fixed dose combination of 0.0015% tafluprost and 0.5% timolol eye drops, administered one drop a time, once daily for 3 months) is superior to the monotherapy of tafluprost 0.0015% eye drops administered one drop a time, once daily for 3 months) in subjects with open-angle glaucoma or ocular hypertension in China as well as comparison of safety.

Timeline

Start
2019-01-20
Primary completion
2023-04-04
Completion
2023-04-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Tafluprost Other / unclassified 0.015 mg/ml Other
Subject Timolol Other / unclassified 5 mg/ml Other

Indications