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

Ocular Hypertension Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00753168
Study type Interventional
Source Othera Pharmaceuticals
Contact
Status Completed
Phase Phase 1/Phase 2
Start date September 2008
Completion date December 2008
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