Phase 1-2 Evaluation of OT-730 Eye Drops in Reducing the Intraocular Pressure in Patients With Ocular Hypertension or Open-Angle Glaucoma

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety and potential efficacy of a new drug, OT-730 ophthalmic solution (eye drops), in reducing intraocular pressure in the eyes of patients with open angle glaucoma or ocular hypertension. It will be compared with commercial timolol and placebo eye drops.

Detailed Description
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Glaucoma is a group of diseases of the eye that can result in irreversible vision loss due to damage to the optic nerve. Elevated intraocular pressure (IOP) is one factor associated with glaucoma. Currently-available medication used to lower IOP includes beta-blocking agents, which can have undesirable side effects on the cardiac and respiratory systems. The OT-730 ophthalmic solution contains OT-730, a prodrug that, when applied as an eyedrop, metabolizes to OT-705, an active beta blocker. The OT-730 ophthalmic solution is being studied to see how well it lowers IOP in patients with a diagnosis of open angle glaucoma or ocular hypertension. It will be compared with a well known beta blocker, timolol maleate ophthalmic solution, and with a placebo eye drop, in order to assess its ability to lower IOP without the typical side effects of other beta blockers.

Official Title
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A Randomized, Parallel-Group, Multi-Center, Investigator-Masked, Active-and Placebo-Controlled, Phase 1-2 Evaluation of the Safety and Efficacy of OT-730 Ophthalmic Solution in Reducing the Intraocular Pressure in Subjects With Ocular Hypertension or Open-Angle Glaucoma

Conditions
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Glaucoma, Open-Angle, Ocular Hypertension

Intervention / Treatment
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* Drug: OT-730 ophthalmic solution
* Drug: timolol maleate ophthalmic solution
* Drug: OT-730 placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: healthy subjects, 18 to 80 years of age, any gender diagnosis of primary open angle, pseudoexfoliative or pigmentary glaucoma or ocular hypertension Exclusion Criteria: have VA worse than 20/200, cataract that compromises visualization of fundus, history of lack of response to ocular beta blocker therapy, uncontrolled intraocular pressure, angle closure glaucoma or occludable angles, retinal detachment, macular hole, progressive vision loss, any progressive retinal disease or neurologic disease other than glaucoma that is likely to worsen visual field or acuity during the course of the study, a history of, or any current condition contraindicated with use of a beta blocker (e.g., chronic obstructive pulmonary disease, bronchial asthma, congestive heart failure, myasthenia gravis, hypoglycemia, bradycardia, etc), chronic use of steroids, any disease that, in the opinion of the investigator, may put the patient at significant risk, taking systemic beta blockers

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: 1<br>OT-730 ophthalmic solution | Drug: OT-730 ophthalmic solution<br>* one eye drop twice daily<br>|
| Active Comparator: 2<br>timolol maleate ophthalmic solution | Drug: timolol maleate ophthalmic solution<br>* one eye drop twice daily<br>|
| Placebo Comparator: 3<br>placebo eye drops | Drug: OT-730 placebo<br>* one eye drop twice daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the safety profile of OT-730 |  | 8 days | 
| Change from baseline in intraocular pressure |  | Day 6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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glaucoma, open angle, ocular hypertension, beta blocker, beta adrenergic, intraocular pressure