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OpenTrials
Completed

NCT Number: NCT05913232

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.

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Key information

Conditions

Glaucoma Open-Angle Primary Eye Diseases Glaucoma Glaucoma, Open-Angle Ocular Hypertension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Global Research Management, Glendale, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

H-1337 0.6%

Drug

ophthalmic solution

H-1337 1.0%

Drug

ophthalmic solution

H-1337 Placebo

Drug

ophthalmic solution

Timolol 0.5%

Drug

ophthalmic solution

Primary outcomes

  1. Efficacy as Assessed by Change in Intraocular Pressure

    Time frame: Day 28

    Mean change in intraocular pressure from baseline on Day 28 compared to timolol

Secondary outcomes

  1. Efficacy as Assessed by Intraocular Pressure

    Time frame: Day 0, Day 1, Day 7, Day 14, and Day 28

    Percentage of subjects reaching target intraocular pressure (≤18 mmHg) at each time point

  2. Safety as Assessed by Adverse Event Reporting

    Time frame: Screening through Day 28

    Percentage of participants with ocular and systemic adverse events

Sponsors and collaborators

Lead sponsor

D. Western Therapeutics Institute, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 22, 2023
Registry last updated
Aug 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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