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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Page 1 of 2 (5 locations)

1

Artesia, California, United States

2

Roswell, Georgia, United States

3

Charlotte, North Carolina, United States

4

High Point, North Carolina, United States