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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

NCT ID: NCT02822729

Last Updated: 2017-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

125 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-01

Study Completion Date

2017-11-09

Brief Summary

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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

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Conditions

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Open Angle Glaucoma or Ocular Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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DE-117 ophthalmic solution (Group1)

Monotherapy

Group Type EXPERIMENTAL

DE-117 ophthalmic solution

Intervention Type DRUG

DE-117 ophthalmic solution (Group2)

Monotherapy

Group Type EXPERIMENTAL

DE-117 ophthalmic solution

Intervention Type DRUG

DE-117 ophthalmic solution + Timolol (Group3)

Concomitant Use

Group Type OTHER

DE-117 ophthalmic solution

Intervention Type DRUG

Timolol ophthalmic solution

Intervention Type DRUG

Interventions

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DE-117 ophthalmic solution

Intervention Type DRUG

Timolol ophthalmic solution

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Santen Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Tokyo, , Japan

Site Status

Countries

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Japan

References

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Aihara M, Lu F, Kawata H, Iwata A, Odani-Kawabata N. Twelve-month efficacy and safety of omidenepag isopropyl, a selective EP2 agonist, in open-angle glaucoma and ocular hypertension: the RENGE study. Jpn J Ophthalmol. 2021 Nov;65(6):810-819. doi: 10.1007/s10384-021-00868-y. Epub 2021 Sep 8.

Reference Type DERIVED
PMID: 34495425 (View on PubMed)

Other Identifiers

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01171504

Identifier Type: -

Identifier Source: org_study_id