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

Study Overview
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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.

Official Title
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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

Conditions
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Glaucoma Open-Angle Primary, Ocular Hypertension

Intervention / Treatment
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* Drug: H-1337 0.6%
* Drug: H-1337 1.0%
* Drug: H-1337 Placebo
* Drug: Timolol 0.5%


Participation Criteria
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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 Note: Other inclusion/exclusion criteria apply.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy as Assessed by Change in Intraocular Pressure | Change from baseline in intraocular pressure using Goldmann tonometry for each group compared to timolol | Day 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy as Assessed by Intraocular Pressure | Mean intraocular pressure using Goldmann tonometry for each group compared to timolol | Day 28 | 
| Safety as Assessed by Adverse Event Reporting | Incidence of ocular and systemic adverse events | Screening through Day 28 |