A Long-term Study of DE-117 Ophthalmic Solution Monotherapy and Concomitant Use of DE-117 Ophthalmic Solution With Timolol Ophthalmic Solution in Patients With OAG or OH: RENGE Study

Santen Pharmaceutical Co., Ltd.125 enrolled

Overview

The purposes of this study are to evaluate the long-term safety and intraocular pressure-lowering efficacy of DE-117 ophthalmic solution monotherapy and concomitant use of DE-117 ophthalmic solution with timolol ophthalmic solution 0.5% in patients with open angle glaucoma or ocular hypertension.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

125

Conditions

Open Angle Glaucoma or Ocular Hypertension

Interventions

DE-117 ophthalmic solutionDRUG

Timolol ophthalmic solutionDRUG

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients with 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, Japan

Outcomes

Primary Outcomes

Evaluation of adverse events

Time frame: Week 52

Data from ClinicalTrials.gov

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