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

Phase 3

Completed

• Conditions: Open Angle Glaucoma or Ocular Hypertension
• Interventions: Drug: DE-117 ophthalmic solution; Drug: Timolol ophthalmic solution

• Registration Number: NCT02822729
• Lead Sponsor: Santen Pharmaceutical Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-06-30
• Study Start: 2016-07-01
• Study First Submitted QC: 2016-07-01
• Study First Posted: 2016-07-04
• Status Verified: 2017-11
• Primary Completion: 2017-11-09
• Study Completion: 2017-11-09
• Last Update Submitted: 2017-11-16
• Last Update Posted: 2017-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 125

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DE-117 ophthalmic solution (Group2)	DE-117 ophthalmic solution	Monotherapy
DE-117 ophthalmic solution + Timolol (Group3)	DE-117 ophthalmic solution	Concomitant Use
DE-117 ophthalmic solution + Timolol (Group3)	Timolol ophthalmic solution	Concomitant Use
DE-117 ophthalmic solution (Group1)	DE-117 ophthalmic solution	Monotherapy

Primary Outcome Measures

Name	Time	Method
Evaluation of adverse events	Week 52