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NCT05913232 Clinical Trial

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

Ocular Hypertension Clinical Trial

Official title:
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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05913232
Other study ID # H1337-CS202
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date August 28, 2023
Est. completion date December 2025

Study information
Verified date April 2024
Source D. Western Therapeutics Institute, Inc.
Contact DWTI CTA
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 200
Est. completion date December 2025
Est. primary completion date December 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• H-1337 0.6%
ophthalmic solution
• H-1337 1.0%
ophthalmic solution
• H-1337 Placebo
ophthalmic solution
• Timolol 0.5%
ophthalmic solution

Locations
Country Name City State
United States Dixon Eye Care Albany Georgia
United States Skyline Vision Clinic and Laser Center Colorado Springs Colorado
United States Global Research Management Glendale California
United States Central Florida Eye Associates Lakeland Florida
United States Shettle Eye Research, Inc. Largo Florida
United States University Eye Specialists Maryville Tennessee
United States Vistar Eye Center Roanoke Virginia
United States Rochester Ophthalmological Group, PC Rochester New York
United States Coastal Research Associates, LLC Roswell Georgia

Sponsors (1)
Lead Sponsor Collaborator
D. Western Therapeutics Institute, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Efficacy as Assessed by Change in Intraocular Pressure Change from baseline in intraocular pressure using Goldmann tonometry for each group compared to timolol Day 28
Secondary Efficacy as Assessed by Intraocular Pressure Mean intraocular pressure using Goldmann tonometry for each group compared to timolol Day 28
Secondary Safety as Assessed by Adverse Event Reporting Incidence of ocular and systemic adverse events Screening through Day 28
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