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

Phase 1

Completed

• Conditions: Glaucoma, Open-Angle; Ocular Hypertension
• Interventions: Drug: OT-730 ophthalmic solution; Drug: timolol maleate ophthalmic solution; Drug: OT-730 placebo

• Registration Number: NCT00753168
• Lead Sponsor: Othera Pharmaceuticals

Brief Summary

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

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.

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2008-09-08
• Study First Submitted QC: 2008-09-15
• Study First Posted: 2008-09-16
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Status Verified: 2009-01
• Last Update Submitted: 2009-01-06
• Last Update Posted: 2009-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	OT-730 ophthalmic solution	OT-730 ophthalmic solution
2	timolol maleate ophthalmic solution	timolol maleate ophthalmic solution
3	OT-730 placebo	placebo eye drops

Primary Outcome Measures

Name	Time	Method
Assess the safety profile of OT-730	8 days
Change from baseline in intraocular pressure	Day 6