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

NCT05913232 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 201

Last updated 2025-08-27

Study results available
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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.

Conditions

Interventions

DRUG

H-1337 0.6%

ophthalmic solution

DRUG

H-1337 1.0%

ophthalmic solution

DRUG

H-1337 Placebo

ophthalmic solution

DRUG

Timolol 0.5%

ophthalmic solution

Sponsors & Collaborators

  • D. Western Therapeutics Institute, Inc.

    lead INDUSTRY

Principal Investigators

  • El-Roy Dixon, MD · Dixon Eye Care

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-28
Primary Completion
2024-08-29
Completion
2024-08-29
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05913232 on ClinicalTrials.gov