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NCT05913232 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Ocular Hypertension and Glaucoma Open-Angle Primary, sponsored by D. Western Therapeutics Institute.

Completed
Registry status
Phase 2
Development phase
201
Enrollment target
9
Study locations

NCT05913232: Completed Phase 2 study of Ocular Hypertension and Glaucoma Open-Angle Primary, sponsored by D. Western Therapeutics Institute.

NCT05913232 is a Phase 2 study of Ocular Hypertension and Glaucoma Open-Angle Primary that has completed, run by D. Western Therapeutics Institute. The registered enrollment target is 201 participants, below the 274-participant average among 54 other Ocular Hypertension trials with a reported enrollment target (27% lower). The trial reports 9 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05913232, a Phase 2 study of Ocular Hypertension and Glaucoma Open-Angle Primary, has completed, sponsored by D. Western Therapeutics Institute.

COMPLETED
Registry status
Phase 2
Development phase
201 participants
Enrollment target
9
Study locations

Study 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.

Primary Outcome

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

Interventions

  • DRUG Timolol 0.5%
  • DRUG H-1337 0.6%
  • DRUG H-1337 1.0%
  • DRUG H-1337 Placebo

Study Locations (9)

Florida

  • Central Florida Eye Associates - Lakeland
  • Shettle Eye Research, Inc. - Largo

Georgia

  • Dixon Eye Care - Albany
  • Coastal Research Associates, LLC - Roswell

California

  • Global Research Management - Glendale

Colorado

  • Skyline Vision Clinic and Laser Center - Colorado Springs

New York

  • Rochester Ophthalmological Group, PC - Rochester

Tennessee

  • University Eye Specialists - Maryville

Virginia

  • Vistar Eye Center - Roanoke

Trial Details

FieldValue
Enrollment Target 201 participants
Start Date 2023-08-28
Est. Completion 2024-08-29
Phase Phase 2

What the finished NCT05913232 record still lists

NCT05913232 is an interventional study that assigns participants to a tested intervention. The registered 201 participants enrollment target is mid-sized for trials with a published cap, below the 274-participant average among 54 other Ocular Hypertension trials with a reported enrollment target (27% lower).

The record links to 2 conditions, with Ocular Hypertension appearing as the primary indexed condition, and to 4 interventions - of which Timolol 0.5% is the first listed.

NCT05913232 lists 9 locations in 7 states (Florida, Georgia, California).

Frequently Asked Questions

What is clinical trial NCT05913232 about?

NCT05913232 is a clinical study titled "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.

What is the current status of trial NCT05913232?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 201 participants. The study started on 2023-08-28. Estimated completion is 2024-08-29.

What conditions does trial NCT05913232 study?

This clinical trial studies the following conditions: Ocular Hypertension, Glaucoma Open-Angle Primary.

What interventions are being tested in trial NCT05913232?

The interventions under investigation include: Timolol 0.5% (DRUG), H-1337 0.6% (DRUG), H-1337 1.0% (DRUG), H-1337 Placebo (DRUG).

Who is sponsoring clinical trial NCT05913232?

This trial is sponsored by D. Western Therapeutics Institute, which has 2 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05913232 being conducted?

This trial has 9 study locations across California, Colorado, Florida, Georgia, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Ocular Hypertension

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT05913232's enrollment target sits among peer trials

201 22nd of 54 higher than 32 of 54 other Ocular Hypertension trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Ocular Hypertension trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05913232, the US trial registry maintained by the National Library of Medicine. NCT05913232 (mid enrollment · multi site footprint · completed) retrieved and formatted by PlainTrial, see methodology.