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

November 16, 2017 updated by: Santen Pharmaceutical Co., Ltd.

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

125

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: DE-117 ophthalmic solution (Group1)
Monotherapy
Drug: DE-117 ophthalmic solution
EXPERIMENTAL: DE-117 ophthalmic solution (Group2)
Monotherapy
Drug: DE-117 ophthalmic solution
OTHER: DE-117 ophthalmic solution + Timolol (Group3)
Concomitant Use
Drug: DE-117 ophthalmic solution
Drug: Timolol ophthalmic solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evaluation of adverse events
Time Frame: Week 52
Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Santen Pharmaceutical Co., Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 1, 2016

Primary Completion (ACTUAL)

November 9, 2017

Study Completion (ACTUAL)

November 9, 2017

Study Registration Dates

First Submitted

June 30, 2016

First Submitted That Met QC Criteria

July 1, 2016

First Posted (ESTIMATE)

July 4, 2016

Study Record Updates

Last Update Posted (ACTUAL)

November 20, 2017

Last Update Submitted That Met QC Criteria

November 16, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01171504

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Open Angle Glaucoma or Ocular Hypertension

Clinical Trials on DE-117 ophthalmic solution

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Denmark

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe