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

Santen Pharmaceutical Co., Ltd.0 sites370 target enrollmentJanuary 2017

ConditionsOpen Angle Glaucoma or Ocular Hypertension

InterventionsDE-117 Latanoprost ophthalmic solution

DrugsDE-117 Latanoprost ophthalmic solution

Overview

Phase: Phase 3
Intervention: DE-117
Conditions: Open Angle Glaucoma or Ocular Hypertension
Sponsor: Santen Pharmaceutical Co., Ltd.
Enrollment: 370
Primary Endpoint: Mean Diurnal IOP at Month 3
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

January 2017

End Date

January 2019

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Santen Pharmaceutical Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patients with open angle glaucoma or ocular hypertension in both eyes

Exclusion Criteria

•Patients at risk of progression of visual field loss
•Patients with severe visual field defect
•Patients with any diseases that preclude participation in this study for safety reasons

Arms & Interventions

DE-117 ophthalmic solution

Intervention: DE-117

Latanoprost ophthalmic solution 0.005%

Intervention: Latanoprost ophthalmic solution

Outcomes

Primary Outcomes

Mean Diurnal IOP at Month 3

Time Frame: Month 3 (average of IOP at 3 time points: 09:00, 13:00, 17:00)

The IOP (mmHg) measured in the study eye (identified at Day 1 \[baseline\]) was the efficacy measure for this study. The IOP was measured using a calibrated Goldmann applanation tonometer preferably by the same Investigator (operator) and the same authorized study staff (recorder) during the study for each subject.

Secondary Outcomes

IOP at 9 Timepoints (First Key Secondary Efficacy Endpoint)(09:00, 13:00, and 17:00 at Week 1, Week 6, and Month 3.)
Mean Diurnal IOP at Week 1 (Second Key Secondary Endpoint)(Week 1)