A Study Assessing the Efficacy and Safety of DE-117 Ophthalmic Solution in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension -AYAME Study-

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

A Phase II/III Randomized, Double-masked, Controlled, Parallel Group, Multicenter Study Assessing the Efficacy and Safety of DE-117 Ophthalmic Solution in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension -AYAME Study-

The purposes of this study are to determine the optimal concentration of DE-117 ophthalmic solution compared to the placebo ophthalmic solution and to determine if intraocular pressure reduction after 4 weeks of treatment with DE-117 ophthalmic solution is non-inferior to latanoprost ophthalmic solution 0.005%.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

253

Phase

  • Phase 2
  • 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

  • Japan
      • Tokyo, Osaka, Japan

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:

  • Primary 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 Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo ophthalmic solution
Eyedrop
Drug: Placebo ophthalmic solution
Experimental: DE-117 ophthalmic solution low
Eyedrop
Drug: DE-117 ophthalmic solution low
Experimental: DE-117 ophthalmic solution high
Eyedrop
Drug: DE-117 ophthalmic solution high
Active Comparator: Latanoprost ophthalmic solution 0.005%
Eyedrop
Drug: Latanoprost ophthalmic solution 0.005%
Other Names:
  • Latanoprost

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Intraocular pressure
Time Frame: Week 4
Week 4

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)

December 6, 2015

Primary Completion (Actual)

February 10, 2017

Study Completion (Actual)

February 10, 2017

Study Registration Dates

First Submitted

December 3, 2015

First Submitted That Met QC Criteria

December 7, 2015

First Posted (Estimate)

December 8, 2015

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

  • 01171503

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.

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