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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2008-12-31

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.

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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.

Conditions

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Glaucoma, Open-Angle Ocular Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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1

OT-730 ophthalmic solution

Group Type EXPERIMENTAL

OT-730 ophthalmic solution

Intervention Type DRUG

one eye drop twice daily

2

timolol maleate ophthalmic solution

Group Type ACTIVE_COMPARATOR

timolol maleate ophthalmic solution

Intervention Type DRUG

one eye drop twice daily

3

placebo eye drops

Group Type PLACEBO_COMPARATOR

OT-730 placebo

Intervention Type DRUG

one eye drop twice daily

Interventions

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OT-730 ophthalmic solution

one eye drop twice daily

Intervention Type DRUG

timolol maleate ophthalmic solution

one eye drop twice daily

Intervention Type DRUG

OT-730 placebo

one eye drop twice daily

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No