Skip to main content
OpenTrials
Completed

NCT Number: NCT02623738

A 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%.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Primary Open Angle Glaucoma Eye Diseases Glaucoma Glaucoma, Open-Angle Ocular Hypertension

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Tokyo, Osaka, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo Ophthalmic Solution

Drug

DE-117 ophthalmic solution low

Drug

DE-117 ophthalmic solution high

Drug

Latanoprost ophthalmic solution 0.005%

Drug

Other names: Latanoprost

Primary outcomes

  1. Intraocular pressure

    Time frame: Week 4

Sponsors and collaborators

Lead sponsor

Santen Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

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-

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Dec 8, 2015
Registry last updated
Nov 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.