Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by Massachusetts Eye and Ear Infirmary.
Recruitment status was  Recruiting
Information provided by (Responsible Party):
Massachusetts Eye and Ear Infirmary Identifier:
First received: January 16, 2009
Last updated: April 19, 2012
Last verified: April 2012

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
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:

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:
    Drug: Cosopt
    2.0% dorzolamide-0.5% timolol BID OU 6 weeks
    Drug: Combigan
    0.2% brimonidine-0.5% timolol BID OU 6 weeks

Ages Eligible for Study:   40 Years to 80 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00824824

United States, Massachusetts
Massachusetts Eye and Ear Infirmary Recruiting
Boston, Massachusetts, United States, 02114
Contact: Louis R Pasquale, MD    617-573-4270   
Principal Investigator: Louis R Pasquale, MD         
Sponsors and Collaborators
Massachusetts Eye and Ear Infirmary
  More Information

Responsible Party: Massachusetts Eye and Ear Infirmary Identifier: NCT00824824     History of Changes
Other Study ID Numbers: 08-12-057 
Study First Received: January 16, 2009
Last Updated: April 19, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts Eye and Ear Infirmary:
Retinal Vascular Autoregulation

Additional relevant MeSH terms:
Ocular Hypertension
Eye Diseases
Brimonidine Tartrate, Timolol Maleate Drug Combination
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists processed this record on October 21, 2016