NCT05913232

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 201 (actual)
• Sponsor: D. Western Therapeutics Institute, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

• Glaucoma Open-Angle Primary
• Ocular Hypertension

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-08-28
• Primary completion: 2024-08-29
• Completion: 2024-08-29
• First posted: 2023-06-22
• Last updated: 2025-08-27
• Results posted: 2025-08-27

Locations

9 sites across 1 country: United States

Regulatory

• FDA-regulated drug study