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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

201 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-28

Study Completion Date

2024-08-29

Brief Summary

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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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Detailed Description

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Conditions

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Glaucoma Open-Angle Primary Ocular Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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

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

Group Type EXPERIMENTAL

H-1337 0.6%

Intervention Type DRUG

ophthalmic solution

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

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

Group Type EXPERIMENTAL

H-1337 1.0%

Intervention Type DRUG

ophthalmic solution

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

Group Type EXPERIMENTAL

H-1337 1.0%

Intervention Type DRUG

ophthalmic solution

H-1337 Placebo

Intervention Type DRUG

ophthalmic solution

Timolol 0.5% Ophthalmic Solution b.i.d.

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

Group Type ACTIVE_COMPARATOR

Timolol 0.5%

Intervention Type DRUG

ophthalmic solution

Interventions

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H-1337 0.6%

ophthalmic solution

Intervention Type DRUG

H-1337 1.0%

ophthalmic solution

Intervention Type DRUG

H-1337 Placebo

ophthalmic solution

Intervention Type DRUG

Timolol 0.5%

ophthalmic solution

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No