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

NCT05913232 — Phase 2, Completed, 201 participants, D. Western Therapeutics Institute, Inc.

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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

Registry	NCT05913232
Status	Completed
Phase	Phase 2
Study type	Interventional; randomized, parallel, masking: double, treatment
Enrollment	201 (Actual)
Sponsor	D. Western Therapeutics Institute, Inc. (Industry)
Conditions	Glaucoma Open-Angle Primary, Ocular Hypertension
Interventions	H-1337 0.6%, H-1337 1.0%, H-1337 Placebo, Timolol 0.5% (Drug)
Dates	start 2023-08-28, primary completion 2024-08-29, completion 2024-08-29, first posted 2023-06-22, last updated 2025-08-27
Locations	9 sites in United States

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
H-1337 0.6% Ophthalmic Solution b.i.d.	Experimental	Drug: H-1337 0.6%	One drop H-1337 twice daily in the study eye for 28 days
H-1337 1.0% Ophthalmic Solution b.i.d.	Experimental	Drug: H-1337 1.0%	One drop H-1337 twice daily in the study eye for 28 days
H-1337 1.0% Ophthalmic Solution q.a.m. and H-1337 Placebo q.p.m.	Experimental	Drug: H-1337 1.0%; Drug: H-1337 Placebo	One drop H-1337 every morning and matching placebo every evening in the study eye for 28 days
Timolol 0.5% Ophthalmic Solution b.i.d.	Active comparator	Drug: Timolol 0.5%	One drop Timolol twice daily in the study eye for 28 days

H-1337 0.6% (Drug): ophthalmic solution
H-1337 1.0% (Drug): ophthalmic solution
H-1337 Placebo (Drug): ophthalmic solution
Timolol 0.5% (Drug): ophthalmic solution

+Outcome measures

Primary outcomes

Efficacy as Assessed by Change in Intraocular Pressure [Day 28]: Mean change in intraocular pressure from baseline on Day 28 compared to timolol

Secondary outcomes

Efficacy as Assessed by Intraocular Pressure [Day 0, Day 1, Day 7, Day 14, and Day 28]: Percentage of subjects reaching target intraocular pressure (≤18 mmHg) at each time point
Safety as Assessed by Adverse Event Reporting [Screening through Day 28]: Percentage of participants with ocular and systemic adverse events

+Eligibility

Sex: All, ages: 18 Years to any

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.

+Posted results

Participant flow

Milestone	H-1337 0.6% Ophthalmic Solution b.i.d.	H-1337 1.0% Ophthalmic Solution b.i.d.	H-1337 1.0% Ophthalmic Solution q.a.m. and H-1337 Placebo q.p.m.	Timolol 0.5% Ophthalmic Solution b.i.d.
Started	51	51	50	49
Completed	51	49	49	48
Not completed	0	2	1	1

Outcome results

Efficacy as Assessed by Change in Intraocular Pressure (Primary), Mean, mmHg: H-1337 0.6% Ophthalmic Solution b.i.d. -6.3 +/- 3.27; H-1337 1.0% Ophthalmic Solution b.i.d. -6.3 +/- 3.15; H-1337 1.0% Ophthalmic Solution q.a.m. and H-1337 Placebo q.p.m. -5.9 +/- 3.45; Timolol 0.5% Ophthalmic Solution b.i.d. -7.0 +/- 3.26
Efficacy as Assessed by Intraocular Pressure (Secondary), Number, percentage of subjects: H-1337 0.6% Ophthalmic Solution b.i.d. 0.0 (0.0 to 7.0); H-1337 1.0% Ophthalmic Solution b.i.d. 2.0 (0.0 to 10.4); H-1337 1.0% Ophthalmic Solution q.a.m. and H-1337 Placebo q.p.m. 0.0 (0.0 to 7.1); Timolol 0.5% Ophthalmic Solution b.i.d. 0.0 (0.0 to 7.3)
Safety as Assessed by Adverse Event Reporting (Secondary), Number, percentage of subjects: H-1337 0.6% Ophthalmic Solution b.i.d. 43.1 (29.3 to 57.8); H-1337 1.0% Ophthalmic Solution b.i.d. 60.8 (46.1 to 74.2); H-1337 1.0% Ophthalmic Solution q.a.m. and H-1337 Placebo q.p.m. 64.0 (49.2 to 77.1); Timolol 0.5% Ophthalmic Solution b.i.d. 18.4 (8.8 to 32.0)

Adverse events

Time frame: 28 days

Arm	Deaths	Serious adverse events	Other adverse events
H-1337 0.6% Ophthalmic Solution b.i.d.	0/51 (0.0%)	0/51 (0.0%)	19/51 (37.3%)
H-1337 1.0% Ophthalmic Solution b.i.d.	0/51 (0.0%)	0/51 (0.0%)	28/51 (54.9%)
H-1337 1.0% Ophthalmic Solution q.a.m. and H-1337 Placebo q.p.m.	0/50 (0.0%)	0/50 (0.0%)	29/50 (58.0%)
Timolol 0.5% Ophthalmic Solution b.i.d.	0/49 (0.0%)	0/49 (0.0%)	8/49 (16.3%)

Other adverse events by term

Term	Organ system	H-1337 0.6% Ophthalmic Solution b.i.d.	H-1337 1.0% Ophthalmic Solution b.i.d.	H-1337 1.0% Ophthalmic Solution q.a.m. and H-1337 Placebo q.p.m.	Timolol 0.5% Ophthalmic Solution b.i.d.
Conjunctival hyperaemia	Eye disorders	16/51	19/51	26/50	5/49
Instillation site irritation	General disorders	7/51	11/51	7/50	3/49

Limitations and caveats: No significant limitations or caveats were reported for the study.

+Locations (9)

Facility	City	Country
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

+Study documents

Study Protocol (PDF, 2024-01-19)
Statistical Analysis Plan (PDF, 2024-01-30)

+Investigators

El-Roy Dixon, MD, Principal investigator, Dixon Eye Care

My Notes

Public

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