NCT02981446

A Phase III Study Assessing the Safety and Efficacy of DE-117 Ophthalmic Solution Compared With Latanoprost Ophthalmic Solution in Subjects With OAG or OHT

A Phase III, Randomized, Observer-Masked, Active-Controlled, Parallel-Group, Multinational and Multicenter Study Assessing the Safety and Efficacy of DE-117 Ophthalmic Solution 0.002% Compared With Latanoprost Ophthalmic Solution 0.005% in Subjects With Open-Angle Glaucoma or Ocular Hypertension- PEONY Study

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 370 (actual)
• Sponsor: Santen Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to investigate the intraocular pressure-lowering effect and the safety of DE-117 ophthalmic solution compared with Latanoprost ophthalmic solution in subjects with open angle glaucoma or ocular hypertension.

Conditions

• Open Angle Glaucoma or Ocular Hypertension

Interventions

Type	Name	Description
DRUG	DE-117	DE-117 ophthalmic solution will be taken one drop, once daily for 3 months in both eyes.
DRUG	Latanoprost ophthalmic solution	Latanoprost ophthalmic solution will be taken one drop, once daily for 3 months in both eyes.

Timeline

• Start date: 2017-01-01
• Primary completion: 2019-01-01
• Completion: 2019-01-01
• First posted: 2016-12-05
• Last updated: 2024-03-15
• Results posted: 2024-03-15

Locations

1 site across 1 country: Singapore