Safety and Efficacy of a Glaucoma Drug Delivery System

This study is currently recruiting participants.

Verified by Vistakon Pharmaceuticals, February 2009

First Received: January 9, 2009 Last Updated: February 25, 2009 History of Changes

Sponsored by:	Vistakon Pharmaceuticals
Information provided by:	Vistakon Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00824720

Purpose

The purpose of this study is to evaluate the ocular safety and efficacy of a glaucoma drug delivery system in open-angle glaucoma or ocular hypertension.

Condition	Intervention	Phase
Glaucoma, Open-Angle Ocular Hypertension	Drug: bimatoprost Device: punctal plug	Phase II

Genetics Home Reference related topics: early-onset glaucoma

MedlinePlus related topics: Glaucoma High Blood Pressure

Drug Information available for: Bimatoprost

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Parallel Assignment

Further study details as provided by Vistakon Pharmaceuticals:

Primary Outcome Measures:

ETDRS Visual Acuity [ Time Frame: baseline, 1 day, 1 week, 2 weeks ] [ Designated as safety issue: Yes ]
Visual Field Assessment [ Time Frame: baseline, 2 weeks ] [ Designated as safety issue: Yes ]
Slit Lamp Biomicroscopy [ Time Frame: baseline, 1 day, 1 week, 2 weeks ] [ Designated as safety issue: Yes ]
Fundus Examination [ Time Frame: baseline, 2 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Intraocular Pressure [ Time Frame: baseline, 1 day, 1 week, 2 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	December 2008
Estimated Study Completion Date:	May 2009
Estimated Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental punctal plug with bimatoprost, high dose	Drug: bimatoprost high dose Device: punctal plug punctal plug
2: Experimental punctal plug with bimatoprost, low dose	Drug: bimatoprost low dose Device: punctal plug punctal plug
3: Placebo Comparator punctal plug without bimatoprost	Device: punctal plug punctal plug

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Man or woman 21 years of age or greater
must have open angle glaucoma or ocular hypertension.
Corrected visual acuity in each eye of 20/200 or better.

Exclusion Criteria:

Previous glaucoma intraocular surgery or refractive surgery.
Planned contact lens use during the study.
Clinically significant ocular or systemic disease that might interfere with the study.
Use of chronic corticosteroids by any route.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00824720

Contacts

Contact: Brian Schwam, MD

904-443-1482

bschwam@its.jnj.com

Locations

United States, California
	Recruiting
Artesia, California, United States
United States, Kentucky
	Recruiting
Louisville, Kentucky, United States
United States, Maryland
	Recruiting
Baltimore, Maryland, United States, USA
United States, South Carolina
	Recruiting
Mount Pleasant, South Carolina, United States

Sponsors and Collaborators

Vistakon Pharmaceuticals

More Information

No publications provided

Responsible Party:	Vistakon ( Brian Schwam, MD/Director Medical Affairs and Ocular Sciences )
Study ID Numbers:	CR-1630
Study First Received:	January 9, 2009
Last Updated:	February 25, 2009
ClinicalTrials.gov Identifier:	NCT00824720 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Bimatoprost
Glaucoma
Eye Diseases
Glaucoma, Open-Angle
Vascular Diseases

Cardiovascular Agents
Antihypertensive Agents
Hypertension
Ocular Hypertension

Additional relevant MeSH terms:

Bimatoprost
Glaucoma
Therapeutic Uses
Eye Diseases
Glaucoma, Open-Angle
Vascular Diseases

Cardiovascular Diseases
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions
Ocular Hypertension
Hypertension

ClinicalTrials.gov processed this record on May 07, 2009