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
Sponsor:
Information provided by (Responsible Party):
Massachusetts Eye and Ear Infirmary
ClinicalTrials.gov Identifier:
NCT00824824
First received: January 16, 2009
Last updated: April 19, 2012
Last verified: April 2012

January 16, 2009
April 19, 2012
January 2009
April 2012   (final data collection date for primary outcome measure)
Change in retinal blood flow with increase in perfusion pressure due to posture change [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00824824 on ClinicalTrials.gov Archive Site
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Effect of Cosopt Versus Combigan on Retinal Vascular Autoregulation in Primary Open Angle Glaucoma (POAG)
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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.

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Interventional
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Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Basic Science
Glaucoma
  • Drug: Cosopt
    2.0% dorzolamide-0.5% timolol BID OU 6 weeks
  • Drug: Combigan
    0.2% brimonidine-0.5% timolol BID OU 6 weeks
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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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
April 2012
April 2012   (final data collection date for primary outcome measure)

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
Both
40 Years to 80 Years
No
United States
 
NCT00824824
08-12-057
No
Massachusetts Eye and Ear Infirmary
Massachusetts Eye and Ear Infirmary
Not Provided
Not Provided
Massachusetts Eye and Ear Infirmary
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP