Effect of Cosopt Versus Combigan on Retinal Vascular Autoregulation in Primary Open Angle Glaucoma (POAG)

This study is currently recruiting participants.

Verified October 2011 by Massachusetts Eye and Ear Infirmary

First Received on January 16, 2009. Last Updated on October 7, 2011 History of Changes

Sponsor:	Massachusetts Eye and Ear Infirmary
Information provided by (Responsible Party):	Louis Pasquale, MD, Massachusetts Eye and Ear Infirmary
ClinicalTrials.gov Identifier:	NCT00824824

Purpose

We have completed a study in which we examined the response of the retinal circulation to changes in posture from sitting to lying down in patients with primary open angle glaucoma (POAG). This alteration in position produces changes in the local blood pressure at the entrance to the retinal vasculature. In a healthy retina, the vasculature adapts by dilating and constricting in order to maintain a steady blood flow rate. In an eye with POAG, this often does not occur. As a result, there are large fluctuations in blood flow which may produce the retinal neuronal damage associated with glaucoma.

The purpose of this study is to demonstrate that topical anti-glaucoma treatments with agents that have vasoactive as well as IOP-lowering effects can have a beneficial effect on maintaining a steady retinal blood flow rate even when there are changes in local blood pressure.

Condition	Intervention
Glaucoma	Drug: Cosopt Drug: Combigan

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Single Blind (Investigator) Primary Purpose: Basic Science

Resource links provided by NLM:

Genetics Home Reference related topics: early-onset glaucoma

MedlinePlus related topics: Glaucoma

Drug Information available for: Cosopt

U.S. FDA Resources

Further study details as provided by Massachusetts Eye and Ear Infirmary:

Primary Outcome Measures:

Change in retinal blood flow with increase in perfusion pressure due to posture change [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	January 2009
Estimated Study Completion Date:	April 2012
Estimated Primary Completion Date:	April 2012 (Final data collection date for primary outcome measure)

Intervention Details:

2.0% dorzolamide-0.5% timolol BID OU 6 weeks

0.2% brimonidine-0.5% timolol BID OU 6 weeks

Eligibility

Ages Eligible for Study:	40 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

POAG
Age 40 to 80 years
Untreated IOP greater than 21 mm Hg

Exclusion Criteria:

More than two IOP lowering medications
Exfoliation or pigment dispersion syndrome
Diabetic retinopathy
History of ocular surgery

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00824824

Locations

United States, Massachusetts
Massachusetts Eye and Ear Infirmary	Recruiting
Boston, Massachusetts, United States, 02114
Contact: Louis R Pasquale, MD 617-573-4270 Louis_Pasquale@meei.harvard.edu
Principal Investigator: Louis R Pasquale, MD

Sponsors and Collaborators

Massachusetts Eye and Ear Infirmary

More Information

Publications:

Feke GT, Pasquale LR. Retinal blood flow response to posture change in glaucoma patients compared with healthy subjects. Ophthalmology. 2008 Feb;115(2):246-52. Epub 2007 Aug 8.

Responsible Party:	Louis Pasquale, MD, Director, Glaucoma Service Associate Director, Telemedicine, Massachusetts Eye and Ear Infirmary
ClinicalTrials.gov Identifier:	NCT00824824 History of Changes
Other Study ID Numbers:	35797
Study First Received:	January 16, 2009
Last Updated:	October 7, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Massachusetts Eye and Ear Infirmary:

Retinal Vascular Autoregulation

Additional relevant MeSH terms:

Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases

ClinicalTrials.gov processed this record on February 09, 2012