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