Clinical trial NCT00753168: Phase 1-2 Evaluation of OT-730 Eye Drops in Reducing the Intraocular Pressure in Patients With Ocular Hypertension or Open-Angle Glaucoma
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Glaucoma, Open-Angle
Ocular Hypertension
Keywords: glaucoma, open angle, ocular hypertension, beta blocker, beta adrenergic, intraocular pressure
Lead sponsor: Othera Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2008-09-16
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 angle glaucoma or ocular hypertension. It will be compared with commercial timolol and placebo eye drops.

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. 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.

Eligibility 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

Primary outcomes:
measure: Assess the safety profile of OT-730
timeFrame: 8 days
measure: Change from baseline in intraocular pressure
timeFrame: Day 6
Secondary outcomes:
Other outcomes:
Locations:
city: Artesia
country: United States
state: California
city: Roswell
country: United States
state: Georgia
city: Charlotte
country: United States
state: North Carolina
city: High Point
country: United States
state: North Carolina
city: Mount Pleasant
country: United States
state: South Carolina
Study officials:
References: