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

Sponsor

Santen Pharmaceutical Co., Ltd. (Industry)

Overall Status

Completed

CT.gov ID

NCT02981446

Collaborator

(none)

370

Enrollment

Location

Arms

Duration (Months)

14.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Open Angle Glaucoma or Ocular Hypertension	Drug: DE-117 Drug: Latanoprost ophthalmic solution	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

370 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Investigator)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Nov 1, 2016

Actual Primary Completion Date :

Jan 1, 2019

Actual Study Completion Date :

Jan 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: DE-117 ophthalmic solution	Drug: DE-117 DE-117 ophthalmic solution will be taken one drop, once daily for 3 months in both eyes.
Active Comparator: Latanoprost ophthalmic solution 0.005%	Drug: Latanoprost ophthalmic solution Latanoprost ophthalmic solution will be taken one drop, once daily for 3 months in both eyes. Other Names: Xalatan

Arm

Intervention/Treatment

Experimental: DE-117 ophthalmic solution

Drug: DE-117

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

Active Comparator: Latanoprost ophthalmic solution 0.005%

Drug: Latanoprost ophthalmic solution

Latanoprost ophthalmic solution will be taken one drop, once daily for 3 months in both eyes.

Other Names:

Xalatan

Outcome Measures

Primary Outcome Measures

Mean diurnal intraocular pressure [Month 3]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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