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A Phase 2b Randomized, Double-masked, Active-controlled, Dose-response Study of the Safety and Efficacy of H-1337 in Subjects With Primary Open Angle Glaucoma (POAG) or Ocular Hypertension
The trial will evaluate the safety and efficacy of 3 dose regimens of H-1337 \[0.6% twice daily (b.i.d.), 1.0% b.i.d. and 1.0% once in the morning (q.a.m.), and timolol maleate (0.5%, b.i.d.) in both eyes for 28 days.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Global Research Management
Glendale, California, United States
Skyline Vision Clinic and Laser Center
Colorado Springs, Colorado, United States
Central Florida Eye Associates
Lakeland, Florida, United States
Shettle Eye Research, Inc.
Largo, Florida, United States
Dixon Eye Care
Albany, Georgia, United States
Coastal Research Associates, LLC
Roswell, Georgia, United States
Rochester Ophthalmological Group, PC
Rochester, New York, United States
University Eye Specialists
Maryville, Tennessee, United States
Vistar Eye Center
Roanoke, Virginia, United States
Start Date
August 28, 2023
Primary Completion Date
August 29, 2024
Completion Date
August 29, 2024
Last Updated
August 27, 2025
201
ACTUAL participants
H-1337 0.6%
DRUG
H-1337 1.0%
DRUG
H-1337 Placebo
DRUG
Timolol 0.5%
DRUG
Lead Sponsor
D. Western Therapeutics Institute, 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.
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