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

Completed · Phase 2 · Has a placebo group

Conditions studied: Glaucoma Open-Angle Primary, Ocular Hypertension

In brief

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.

Key facts

Study ID

NCT05913232

Run by

D. Western Therapeutics Institute, Inc.

People needed

201

Starts

2023-08-28

Expected to finish

2024-08-29

Last updated by the study team

2025-08-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of bilateral primary open angle glaucoma or ocular hypertension

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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