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

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

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.

Study Overview

• Status: Completed
• Conditions: Ocular Hypertension; Glaucoma Open-Angle Primary
• Intervention / Treatment: Drug: H-1337 0.6%; Drug: H-1337 1.0%; Drug: H-1337 Placebo; Drug: Timolol 0.5%

• Study Type: Interventional
• Enrollment (Actual): 201
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Glendale, California, United States, 91204
      • Global Research Management
  • Colorado
    • Colorado Springs, Colorado, United States, 80907
      • Skyline Vision Clinic and Laser Center
  • Florida
    • Lakeland, Florida, United States, 33805
      • Central Florida Eye Associates
    • Largo, Florida, United States, 33773
      • Shettle Eye Research, Inc.
  • Georgia
    • Albany, Georgia, United States, 31701
      • Dixon Eye Care
    • Roswell, Georgia, United States, 30076
      • Coastal Research Associates, LLC
  • New York
    • Rochester, New York, United States, 14618
      • Rochester Ophthalmological Group, PC
  • Tennessee
    • Maryville, Tennessee, United States, 37803
      • University Eye Specialists
  • Virginia
    • Roanoke, Virginia, United States, 24011
      • Vistar Eye Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: H-1337 0.6% Ophthalmic Solution b.i.d.; One drop H-1337 twice daily in the study eye for 28 days	Drug: H-1337 0.6%; ophthalmic solution
Experimental: H-1337 1.0% Ophthalmic Solution b.i.d.; One drop H-1337 twice daily in the study eye for 28 days	Drug: H-1337 1.0%; ophthalmic solution
Experimental: H-1337 1.0% Ophthalmic Solution q.a.m. and H-1337 Placebo q.p.m.; One drop H-1337 every morning and matching placebo every evening in the study eye for 28 days	Drug: H-1337 1.0%; ophthalmic solution; Drug: H-1337 Placebo; ophthalmic solution
Active Comparator: Timolol 0.5% Ophthalmic Solution b.i.d.; One drop Timolol twice daily in the study eye for 28 days	Drug: Timolol 0.5%; ophthalmic solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy as Assessed by Change in Intraocular Pressure	Mean change in intraocular pressure from baseline on Day 28 compared to timolol	Day 28

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy as Assessed by Intraocular Pressure	Percentage of subjects reaching target intraocular pressure (≤18 mmHg) at each time point	Day 0, Day 1, Day 7, Day 14, and Day 28
Safety as Assessed by Adverse Event Reporting	Percentage of participants with ocular and systemic adverse events	Screening through Day 28

Collaborators and Investigators

• Sponsor: D. Western Therapeutics Institute, Inc.
• Investigators: Principal Investigator: El-Roy Dixon, MD, Dixon Eye Care

Study record dates

Study Major Dates

• Study Start (Actual): August 28, 2023
• Primary Completion (Actual): August 29, 2024
• Study Completion (Actual): August 29, 2024

Study Registration Dates

• First Submitted: June 12, 2023
• First Submitted That Met QC Criteria: June 12, 2023
• First Posted (Actual): June 22, 2023

Study Record Updates

• Last Update Posted (Estimated): August 27, 2025
• Last Update Submitted That Met QC Criteria: August 26, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Physiological Effects of Drugs; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Antihypertensive Agents; Timolol
• Other Study ID Numbers: H1337-CS202

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No