Status:
COMPLETED
Phase 1-2 Evaluation of OT-730 Eye Drops in Reducing the Intraocular Pressure in Patients With Ocular Hypertension or Open-Angle Glaucoma
Lead Sponsor:
Othera Pharmaceuticals
Conditions:
Glaucoma, Open-Angle
Ocular Hypertension
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
PHASE2
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 ang...
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. Cur...
Eligibility Criteria
Inclusion
- healthy subjects, 18 to 80 years of age, any gender
- diagnosis of primary open angle, pseudoexfoliative or pigmentary glaucoma or ocular hypertension
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2008
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00753168
Start Date
September 1 2008
End Date
December 1 2008
Last Update
January 7 2009
Active Locations (5)
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1
Artesia, California, United States
2
Roswell, Georgia, United States
3
Charlotte, North Carolina, United States
4
High Point, North Carolina, United States