Study of Safety and Efficacy of H-1337 in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension
- Conditions
- Ocular HypertensionGlaucoma Open-Angle Primary
- Interventions
- Registration Number
- NCT05913232
- Lead Sponsor
- D. Western Therapeutics Institute, Inc.
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 200
- Diagnosis of bilateral primary open angle glaucoma or ocular hypertension
- Closed or very narrow angles (Grades 0-1) or those the investigator judges as occludable and/or with evidence of peripheral anterior synechiae >/= 180 degrees by gonioscopy within 6 months prior to screening visit in either eye
Note: Other inclusion/exclusion criteria apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description H-1337 0.6% Ophthalmic Solution b.i.d. H-1337 0.6% One drop H-1337 twice daily in the study eye for 28 days H-1337 1.0% Ophthalmic Solution b.i.d. H-1337 1.0% One drop H-1337 twice daily in the study eye for 28 days H-1337 1.0% Ophthalmic Solution q.a.m. and H-1337 Placebo q.p.m. H-1337 Placebo One drop H-1337 every morning and matching placebo every evening in the study eye for 28 days H-1337 1.0% Ophthalmic Solution q.a.m. and H-1337 Placebo q.p.m. H-1337 1.0% One drop H-1337 every morning and matching placebo every evening in the study eye for 28 days Timolol 0.5% Ophthalmic Solution b.i.d. Timolol 0.5% One drop Timolol twice daily in the study eye for 28 days
- Primary Outcome Measures
Name Time Method Efficacy as Assessed by Change in Intraocular Pressure Day 28 Mean change in intraocular pressure from baseline on Day 28 compared to timolol
- Secondary Outcome Measures
Name Time Method Efficacy as Assessed by Intraocular Pressure Day 0, Day 1, Day 7, Day 14, and Day 28 Percentage of subjects reaching target intraocular pressure (≤18 mmHg) at each time point
Safety as Assessed by Adverse Event Reporting Screening through Day 28 Percentage of participants with ocular and systemic adverse events
Trial Locations
- Locations (9)
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
Global Research Management🇺🇸Glendale, California, United States