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

Primary Purpose

Glaucoma, Open-Angle, Ocular Hypertension

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

OT-730 ophthalmic solution

timolol maleate ophthalmic solution

OT-730 placebo

About this trial

This is an interventional treatment trial for Glaucoma, Open-Angle focused on measuring glaucoma, open angle, ocular hypertension, beta blocker, beta adrenergic, intraocular pressure

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Arm Description

OT-730 ophthalmic solution

timolol maleate ophthalmic solution

placebo eye drops

Outcomes

Primary Outcome Measures

Assess the safety profile of OT-730

Change from baseline in intraocular pressure

Secondary Outcome Measures

Full Information

NCT ID

NCT00753168

First Posted

September 8, 2008

Last Updated

January 6, 2009

Sponsor

Othera Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT00753168

Brief Title

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

2. Study Status

Record Verification Date

January 2009

Overall Recruitment Status

Completed

Study Start Date

September 2008 (undefined)

Primary Completion Date

December 2008 (Actual)

Study Completion Date

December 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Othera Pharmaceuticals

4. Oversight

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Glaucoma, Open-Angle, Ocular Hypertension

Keywords

glaucoma, open angle, ocular hypertension, beta blocker, beta adrenergic, intraocular pressure

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

InvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

OT-730 ophthalmic solution

Arm Title

Arm Type

Active Comparator

Arm Description

timolol maleate ophthalmic solution

Arm Title

Arm Type

Placebo Comparator

Arm Description

placebo eye drops

Intervention Type

Drug

Intervention Name(s)

OT-730 ophthalmic solution

Intervention Description

one eye drop twice daily

Intervention Type

Drug

Intervention Name(s)

timolol maleate ophthalmic solution

Intervention Description

one eye drop twice daily

Intervention Type

Drug

Intervention Name(s)

OT-730 placebo

Intervention Description

one eye drop twice daily

Primary Outcome Measure Information:

Title

Assess the safety profile of OT-730

Time Frame

8 days

Title

Change from baseline in intraocular pressure

Time Frame

Day 6

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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

Facility Information:

City

Artesia

State/Province

California

Country

United States

City

Roswell

State/Province

Georgia

Country

United States

City

Charlotte

State/Province

North Carolina

Country

United States

City

High Point

State/Province

North Carolina

Country

United States

City

Mount Pleasant

State/Province

South Carolina

Country

United States

12. IPD Sharing Statement

Links:

URL

http://www.othera.com

Description

Othera Pharmaceuticals, Inc. website

Learn more about this trial

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

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