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

Sponsor

Othera Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT00753168

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

9.6

Patients Per Site

3.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Glaucoma, Open-Angle Ocular Hypertension	Drug: OT-730 ophthalmic solution Drug: timolol maleate ophthalmic solution Drug: OT-730 placebo	Phase 1/Phase 2

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

48 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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 Start Date :

Sep 1, 2008

Actual Primary Completion Date :

Dec 1, 2008

Actual Study Completion Date :

Dec 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 OT-730 ophthalmic solution	Drug: OT-730 ophthalmic solution one eye drop twice daily
Active Comparator: 2 timolol maleate ophthalmic solution	Drug: timolol maleate ophthalmic solution one eye drop twice daily
Placebo Comparator: 3 placebo eye drops	Drug: OT-730 placebo one eye drop twice daily

Arm

Intervention/Treatment

Experimental: 1

OT-730 ophthalmic solution

Drug: OT-730 ophthalmic solution

one eye drop twice daily

Active Comparator: 2

timolol maleate ophthalmic solution

Drug: timolol maleate ophthalmic solution

one eye drop twice daily

Placebo Comparator: 3

placebo eye drops

Drug: OT-730 placebo

one eye drop twice daily

Outcome Measures

Primary Outcome Measures

Assess the safety profile of OT-730 [8 days]
Change from baseline in intraocular pressure [Day 6]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	City	State	Country
1	Artesia	California	United States
2	Roswell	Georgia	United States
3	Charlotte	North Carolina	United States
4	High Point	North Carolina	United States
5	Mount Pleasant	South Carolina	United States