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

D. Western Therapeutics Institute

Status and phase: Active, not recruiting; Phase 2

Conditions: Glaucoma Open-Angle Primary; Ocular Hypertension

Treatments: Drug: Timolol 0.5%; Drug: H-1337 Placebo; Drug: H-1337 1.0%; Drug: H-1337 0.6%

Study type: Interventional

Funder types: Industry

Identifiers

NCT05913232

H1337-CS202

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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200 participants in 4 patient groups

H-1337 0.6% Ophthalmic Solution b.i.d.

Experimental group

Description:

One drop H-1337 twice daily in the study eye for 28 days

Treatment:

Drug: H-1337 0.6%

H-1337 1.0% Ophthalmic Solution b.i.d.

Experimental group

Description:

One drop H-1337 twice daily in the study eye for 28 days

Treatment:

Drug: H-1337 1.0%

H-1337 1.0% Ophthalmic Solution q.a.m. and H-1337 Placebo q.p.m.

Experimental group

Description:

One drop H-1337 every morning and matching placebo every evening in the study eye for 28 days

Treatment:

Drug: H-1337 1.0%

Drug: H-1337 Placebo

Timolol 0.5% Ophthalmic Solution b.i.d.

Active Comparator group

Description:

One drop Timolol twice daily in the study eye for 28 days

Treatment:

Drug: Timolol 0.5%