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A Randomized, Double-Masked, Parallel-Group, Multicenter Study Assessing the Safety and Efficacy of DE-117 Ophthalmic Solution 0.002% Once Daily and Twice Daily in Subjects With Primary Open-Angle Glaucoma or Ocular Hypertension SPECTRUM 6 Study.
This is a randomized, double-masked, parallel-group, multi-center study. Subjects diagnosed with POAG or OHT who meet eligibility criteria at Visit 1 (Screening) will wash out their current topical IOP lowering medication(s), if any. After completing the required washout period, subjects will return for Visit 2 (Baseline, Day 1). Subjects who meet all eligibility criteria at Visit 2 (Baseline, Day 1) will be randomized to receive study medication for up to 6 weeks. Approximately 100 subjects with POAG or OHT will be randomized in a 1:1 ratio to either: * DE-117 ophthalmic solution 0.002% QD (Once Daily) * DE-117 ophthalmic solution 0.002% BID (Twice Daily) This study will consist of a screening period of up to 35 days including a washout period of up to 28 days (+ 7 days window), and a 6-week double-masked treatment period.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
East West Eye Institute
Los Angeles, California, United States
Danbury Eye Specialist
Danbury, Connecticut, United States
Hernando Eye Institute
Brooksville, Florida, United States
Levenson Eye Associates
Jacksonville, Florida, United States
Seidenberg Protzko Eye Associates
Havre de Grace, Maryland, United States
Tekwani Vision Center
St Louis, Missouri, United States
Eye Associates/SurgiCenter of Vineland
Vineland, New Jersey, United States
Ophthalmic Consultants of Long Island
Lynbrook, New York, United States
Apex Eye Clinical Research, LLC
Cincinnati, Ohio, United States
Abrams Eye Center
Cleveland, Ohio, United States
Start Date
January 28, 2019
Primary Completion Date
June 20, 2019
Completion Date
June 20, 2019
Last Updated
August 4, 2020
98
ACTUAL participants
DE-117 Ophthalmic Solution QD
DRUG
DE-117 Ophthalmic Solution BID
DRUG
Lead Sponsor
Santen Inc.
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.
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