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

Santen Pharmaceutical Co., Ltd.253 enrolled

Overview

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%.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

253

Conditions

Primary Open Angle Glaucoma Ocular Hypertension

Interventions

Placebo ophthalmic solutionDRUG

DE-117 ophthalmic solution lowDRUG

DE-117 ophthalmic solution highDRUG

Latanoprost ophthalmic solution 0.005%

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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

Locations (1)

Unnamed facility

Tokyo, Osaka, Japan

Outcomes

Primary Outcomes

Intraocular pressure

Time frame: Week 4

Data from ClinicalTrials.gov

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