Clinical trial

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

Name

H1337-CS202

Description

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.

Trial arms

Trial start

2023-08-28

Estimated PCD

2025-12-01

Trial end

2025-12-01

Status

Recruiting

Phase

Early phase I

Treatment

H-1337 0.6%

ophthalmic solution

Arms:

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

H-1337 1.0%

ophthalmic solution

Arms:

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.

H-1337 Placebo

ophthalmic solution

Arms:

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

Timolol 0.5%

ophthalmic solution

Arms:

Timolol 0.5% Ophthalmic Solution b.i.d.

Size

200

Primary endpoint

Efficacy as Assessed by Change in Intraocular Pressure

Day 28

Eligibility criteria

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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 200, 'type': 'ESTIMATED'}}

Updated at

2024-04-02

1 organization

2 products

2 indications

Product

H-1337

Indication

Glaucoma

Indication

ocular hypertension

Organization

D. Western Therapeutics Institute

Product

Timolol