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

• Status: Completed
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Othera Pharmaceuticals
• Treatments: Maleic acid; Ophthalmic Solutions; Pharmaceutical Solutions; Tetrahydrozoline; Timolol

Criteria

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