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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%.
Age
20 - No limit years
Sex
ALL
Healthy Volunteers
No
Tokyo, Osaka, Japan
Start Date
December 6, 2015
Primary Completion Date
February 10, 2017
Completion Date
February 10, 2017
Last Updated
November 20, 2017
253
ACTUAL participants
Placebo ophthalmic solution
DRUG
DE-117 ophthalmic solution low
DRUG
DE-117 ophthalmic solution high
DRUG
Latanoprost ophthalmic solution 0.005%
DRUG
Lead Sponsor
Santen Pharmaceutical Co., Ltd.
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07218796