Phase 1-2 Evaluation of OT-730 Eye Drops in Reducing the Intraocular Pressure in Patients With Ocular Hypertension or Open-Angle Glaucoma
Completed · Phase 1/Phase 2 · Has a placebo group
Conditions studied: Glaucoma, Open-Angle, Ocular Hypertension
In brief
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.
Key facts
- Study ID
- NCT00753168
- Run by
- Othera Pharmaceuticals
- People needed
- 48
- Starts
- 2008-09-01
- Expected to finish
- 2008-12-01
- Last updated by the study team
- 2009-01-07
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- healthy subjects, 18 to 80 years of age, any gender
- diagnosis of primary open angle, pseudoexfoliative or pigmentary glaucoma or ocular hypertension
You may not qualify if…
- 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
Where it is running
- Study site — Artesia, California, United States
- Study site — Roswell, Georgia, United States
- Study site — Charlotte, North Carolina, United States
- Study site — High Point, North Carolina, United States
- Study site — Mt. Pleasant, South Carolina, United States
Full record on ClinicalTrials.gov
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