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

Sponsor

D. Western Therapeutics Institute, Inc. (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05913232

Collaborator

(none)

200

Enrollment

Location

Arms

Anticipated Duration (Months)

7.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Glaucoma Open-Angle Primary Ocular Hypertension	Drug: H-1337 0.6% Drug: H-1337 1.0% Drug: H-1337 Placebo Drug: Timolol 0.5%	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Sep 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2025

Anticipated Study Completion Date :

Dec 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: H-1337 0.6% Ophthalmic Solution b.i.d. One drop H-1337 twice daily in the study eye for 28 days	Drug: H-1337 0.6% ophthalmic solution
Experimental: H-1337 1.0% Ophthalmic Solution b.i.d. One drop H-1337 twice daily in the study eye for 28 days	Drug: H-1337 1.0% ophthalmic solution
Experimental: H-1337 1.0% Ophthalmic Solution q.a.m. and H-1337 Placebo q.p.m. One drop H-1337 every morning and matching placebo every evening in the study eye for 28 days	Drug: H-1337 1.0% ophthalmic solution Drug: H-1337 Placebo ophthalmic solution
Active Comparator: Timolol 0.5% Ophthalmic Solution b.i.d. One drop Timolol twice daily in the study eye for 28 days	Drug: Timolol 0.5% ophthalmic solution

Outcome Measures

Primary Outcome Measures

Efficacy as Assessed by Change in Intraocular Pressure [Day 28]
Change from baseline in intraocular pressure using Goldmann tonometry for each group compared to timolol

Secondary Outcome Measures

Efficacy as Assessed by Intraocular Pressure [Day 28]
Mean intraocular pressure using Goldmann tonometry for each group compared to timolol
Safety as Assessed by Adverse Event Reporting [Screening through Day 28]
Incidence of ocular and systemic adverse events

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dixon Eye Care	Albany	Georgia	United States	31701

Sponsors and Collaborators

D. Western Therapeutics Institute, Inc.

Investigators

Principal Investigator: El-Roy Dixon, MD, Dixon Eye Care

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

D. Western Therapeutics Institute, Inc.

ClinicalTrials.gov Identifier:

NCT05913232

Other Study ID Numbers:

H1337-CS202

First Posted:

Jun 22, 2023

Last Update Posted:

Jun 22, 2023

Last Verified:

Jun 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 22, 2023