Study of Safety and Efficacy of H-1337 in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension
NCT05913232 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 201
Last updated 2025-08-27
Summary
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.
Conditions
- Glaucoma Open-Angle Primary
- Ocular Hypertension
Interventions
- DRUG
-
H-1337 0.6%
ophthalmic solution
- DRUG
-
H-1337 1.0%
ophthalmic solution
- DRUG
-
H-1337 Placebo
ophthalmic solution
- DRUG
-
Timolol 0.5%
ophthalmic solution
Sponsors & Collaborators
-
D. Western Therapeutics Institute, Inc.
lead INDUSTRY
Principal Investigators
-
El-Roy Dixon, MD · Dixon Eye Care
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-08-28
- Primary Completion
- 2024-08-29
- Completion
- 2024-08-29
- FDA Drug
- Yes
Countries
- United States
Study Locations
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