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NCT05913232 · ClinicalTrials.gov registry record · Phase 2
Study of Safety and Efficacy of H-1337 in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension
A Phase 2 study of Ocular Hypertension and Glaucoma Open-Angle Primary, sponsored by D. Western Therapeutics Institute.
- Completed
- Registry status
- Phase 2
- Development phase
- 201
- Enrollment target
- 9
- Study locations
NCT05913232 is a Phase 2 study of Ocular Hypertension and Glaucoma Open-Angle Primary that has completed, run by D. Western Therapeutics Institute. The registered enrollment target is 201 participants, below the 274-participant average among 54 other Ocular Hypertension trials with a reported enrollment target (27% lower). The trial reports 9 study locations across 7 states.
The verdict
NCT05913232, a Phase 2 study of Ocular Hypertension and Glaucoma Open-Angle Primary, has completed, sponsored by D. Western Therapeutics Institute.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 201 participants
- Enrollment target
- 9
- Study locations
Study 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 Studied
Interventions
- DRUG Timolol 0.5%
- DRUG H-1337 0.6%
- DRUG H-1337 1.0%
- DRUG H-1337 Placebo
Study Locations (9)
Florida
- Central Florida Eye Associates - Lakeland
- Shettle Eye Research, Inc. - Largo
Georgia
- Dixon Eye Care - Albany
- Coastal Research Associates, LLC - Roswell
California
- Global Research Management - Glendale
Colorado
- Skyline Vision Clinic and Laser Center - Colorado Springs
New York
- Rochester Ophthalmological Group, PC - Rochester
Tennessee
- University Eye Specialists - Maryville
Virginia
- Vistar Eye Center - Roanoke
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 201 participants |
| Start Date | 2023-08-28 |
| Est. Completion | 2024-08-29 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05913232
The ClinicalTrials.gov registry entry for NCT05913232 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 201 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 274-participant average among 54 other Ocular Hypertension trials with a reported enrollment target (27% lower). The listed sponsor is D. Western Therapeutics Institute, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Ocular Hypertension appearing as the primary indexed condition, and to 4 interventions - of which Timolol 0.5% is the first listed.
NCT05913232 reports 9 study locations spanning 7 distinct geographic areas - top geographies include Florida, Georgia, California.
Frequently Asked Questions
What is clinical trial NCT05913232 about?
NCT05913232 is a clinical study titled "Study of Safety and Efficacy of H-1337 in Subjects With Primary Open Angle Glaucoma 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.
What is the current status of trial NCT05913232?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 201 participants. The study started on 2023-08-28. Estimated completion is 2024-08-29.
What conditions does trial NCT05913232 study?
This clinical trial studies the following conditions: Ocular Hypertension, Glaucoma Open-Angle Primary.
What interventions are being tested in trial NCT05913232?
The interventions under investigation include: Timolol 0.5% (DRUG), H-1337 0.6% (DRUG), H-1337 1.0% (DRUG), H-1337 Placebo (DRUG).
Who is sponsoring clinical trial NCT05913232?
This trial is sponsored by D. Western Therapeutics Institute, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05913232 being conducted?
This trial has 9 study locations across California, Colorado, Florida, Georgia, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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