Phase 2
N=201
Study of Safety and Efficacy of H-1337 in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension
Glaucoma Open-Angle Primary · Ocular Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT05913232 ↗Enrolled (actual)
201
Serious AEs
0.0%
Results posted
Aug 2025
Primary outcome: Primary: Efficacy as Assessed by Change in Intraocular Pressure — -6.3; -6.3; -5.9; -7.0 mmHg
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- H-1337 0.6% (Drug); H-1337 1.0% (Drug); H-1337 Placebo (Drug); Timolol 0.5% (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- D. Western Therapeutics Institute, Inc.
- Primary completion
- Aug 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Efficacy as Assessed by Change in Intraocular Pressure |
-6.3; -6.3; -5.9; -7.0; -7.3; -7.2 | — |
| SECONDARY Efficacy as Assessed by Intraocular Pressure |
0.0; 2.0; 0.0; 0.0; 0.0; 3.9 | — |
| SECONDARY Safety as Assessed by Adverse Event Reporting |
43.1; 60.8; 64.0; 18.4; 3.9; 7.8 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT05913232). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.