Effect of Cosopt Versus Combigan on Retinal Vascular Autoregulation in Primary Open Angle Glaucoma (POAG)
Primary Purpose
Glaucoma
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dorzolamide 2%-timolol 0.5%
Brimonidine 0.2%-0.5% timolol 0.5
Sponsored by
About this trial
This is an interventional basic science trial for Glaucoma focused on measuring Retinal Vascular Autoregulation
Eligibility 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
Sites / Locations
- Massachusetts Eye and Ear Infirmary
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Brimonidine 0.2%-timolol 0.5% arm
Dorzolamide 2%-timolol 0.5% arm
Arm Description
Patients using timolol were switched to brimonidine tartrate / timolol maleate 0.2%/05% 1 get BID OU for six weeks.
Patients using timolol were switched ti dorzolamide hydrochloride / timolol 0.5% 2%/0.5% bid OU for six weeks
Outcomes
Primary Outcome Measures
Presence of Retinal Vascular Dysregulation (RVD)
We determined whether RVD was present in the following way. The difference between the retinal blood flow measured while reclining for 30 minutes and the baseline retinal blood flow measured while seated was calculated. In a previous study, we found that among healthy subjects the change in the blood flow while reclining compared to baseline was +6.5% ± 12%. For this study, we defined the normal range of blood flow autoregulation as ± 2 standard deviations about the mean percentage change found in the control group in the initial study (6.5% ± 24.0%); that is, as -17.5% to +30.5%. Participants with a change in retinal blood flow induced by posture change outside this range were randomized to either dorzolamide-timolol fixed combination BID OU or brimonidine-timolol fixed combination BID OU for 6 weeks.
Secondary Outcome Measures
Full Information
NCT ID
NCT00824824
First Posted
January 16, 2009
Last Updated
March 31, 2017
Sponsor
Massachusetts Eye and Ear Infirmary
1. Study Identification
Unique Protocol Identification Number
NCT00824824
Brief Title
Effect of Cosopt Versus Combigan on Retinal Vascular Autoregulation in Primary Open Angle Glaucoma (POAG)
Official Title
Effect of Cosopt Versus Combigan on Retinal Vascular Autoregulation in Primary Open Angle Glaucoma (POAG)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts Eye and Ear Infirmary
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma
Keywords
Retinal Vascular Autoregulation
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Brimonidine 0.2%-timolol 0.5% arm
Arm Type
Experimental
Arm Description
Patients using timolol were switched to brimonidine tartrate / timolol maleate 0.2%/05% 1 get BID OU for six weeks.
Arm Title
Dorzolamide 2%-timolol 0.5% arm
Arm Type
Active Comparator
Arm Description
Patients using timolol were switched ti dorzolamide hydrochloride / timolol 0.5% 2%/0.5% bid OU for six weeks
Intervention Type
Drug
Intervention Name(s)
Dorzolamide 2%-timolol 0.5%
Other Intervention Name(s)
Cosopt, RVD intervention after run-in on timolol 0.5% bid OU
Intervention Description
BID OU for 6 weeks
Intervention Type
Drug
Intervention Name(s)
Brimonidine 0.2%-0.5% timolol 0.5
Other Intervention Name(s)
Combigan, RVD intervention after run-in on timolol 0.5% bid OU
Intervention Description
BID OU for 6 weeks
Primary Outcome Measure Information:
Title
Presence of Retinal Vascular Dysregulation (RVD)
Description
We determined whether RVD was present in the following way. The difference between the retinal blood flow measured while reclining for 30 minutes and the baseline retinal blood flow measured while seated was calculated. In a previous study, we found that among healthy subjects the change in the blood flow while reclining compared to baseline was +6.5% ± 12%. For this study, we defined the normal range of blood flow autoregulation as ± 2 standard deviations about the mean percentage change found in the control group in the initial study (6.5% ± 24.0%); that is, as -17.5% to +30.5%. Participants with a change in retinal blood flow induced by posture change outside this range were randomized to either dorzolamide-timolol fixed combination BID OU or brimonidine-timolol fixed combination BID OU for 6 weeks.
Time Frame
6 weeks post treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Louis Pasquale
Organizational Affiliation
Mass Eye and Ear Infirmary
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts Eye and Ear Infirmary
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
17689612
Citation
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. doi: 10.1016/j.ophtha.2007.04.055. Epub 2007 Aug 8.
Results Reference
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Effect of Cosopt Versus Combigan on Retinal Vascular Autoregulation in Primary Open Angle Glaucoma (POAG)
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