Study of Safety and Efficacy of H-1337 in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension

Phase 2

Active, not recruiting

• Conditions: Ocular Hypertension; Glaucoma Open-Angle Primary
• Interventions: Drug: H-1337 0.6%; Drug: H-1337 1.0%; Drug: Timolol 0.5%; Drug: H-1337 Placebo

• 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

Study Timeline

• Study First Submitted: 2023-06-12
• Study First Submitted QC: 2023-06-12
• Study First Posted: 2023-06-22
• Study Start: 2023-08-28
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-15
• Last Update Posted: 2024-08-16
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Diagnosis of bilateral primary open angle glaucoma or ocular hypertension

Exclusion Criteria

• 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	Change from baseline in intraocular pressure using Goldmann tonometry for each group compared to timolol

Secondary Outcome Measures

Name	Time	Method
Efficacy as Assessed by Intraocular Pressure	Day 28	Mean intraocular pressure using Goldmann tonometry for each group compared to timolol
Safety as Assessed by Adverse Event Reporting	Screening through Day 28	Incidence of ocular and systemic adverse events

Trial Locations

Locations (9)

Global Research Management; 🇺🇸 Glendale, California, 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

Skyline Vision Clinic and Laser Center; 🇺🇸 Colorado Springs, Colorado, United States

University Eye Specialists; 🇺🇸 Maryville, Tennessee, United States

Vistar Eye Center; 🇺🇸 Roanoke, Virginia, United States

Coastal Research Associates, LLC; 🇺🇸 Roswell, Georgia, United States

Rochester Ophthalmological Group, PC; 🇺🇸 Rochester, New York, United States