A Study Assessing the Efficacy and Safety of DE-117 Ophthalmic Solution in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension -AYAME Study-

Phase 2

Completed

• Conditions: Primary Open Angle Glaucoma; Ocular Hypertension
• Interventions: Drug: DE-117 ophthalmic solution low; Drug: Latanoprost ophthalmic solution 0.005%; Drug: Placebo ophthalmic solution; Drug: DE-117 ophthalmic solution high

• Registration Number: NCT02623738
• Lead Sponsor: Santen Pharmaceutical Co., Ltd.

Brief Summary

The purposes of this study are to determine the optimal concentration of DE-117 ophthalmic solution compared to the placebo ophthalmic solution and to determine if intraocular pressure reduction after 4 weeks of treatment with DE-117 ophthalmic solution is non-inferior to latanoprost ophthalmic solution 0.005%.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-12-03
• Study Start: 2015-12-06
• Study First Submitted QC: 2015-12-07
• Study First Posted: 2015-12-08
• Primary Completion: 2017-02-10
• Study Completion: 2017-02-10
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-16
• Last Update Posted: 2017-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 253

Inclusion Criteria

• Primary open angle glaucoma or ocular hypertension

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DE-117 ophthalmic solution low	DE-117 ophthalmic solution low	Eyedrop
Latanoprost ophthalmic solution 0.005%	Latanoprost ophthalmic solution 0.005%	Eyedrop
Placebo ophthalmic solution	Placebo ophthalmic solution	Eyedrop
DE-117 ophthalmic solution high	DE-117 ophthalmic solution high	Eyedrop

Primary Outcome Measures

Name	Time	Method
Intraocular pressure	Week 4