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

A Long-term Open-label Study of DE-117 Ophthalmic Solution Monotherapy and Concomitant Use of DE-117 Ophthalmic Solution With Timolol Ophthalmic Solution in Patients With Open-angle Glaucoma or Ocular Hypertension : RENGE Study

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02822729

Enrollment

125

Registered

2016-07-04

Start date

2016-07-01

Completion date

2017-11-09

Last updated

2017-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Open Angle Glaucoma or Ocular Hypertension

Brief summary

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.

Interventions

DRUGDE-117 ophthalmic solution

DRUGTimolol ophthalmic solution

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Evaluation of adverse events	Week 52

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026