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

NCT ID: NCT00824824

Last Updated: 2017-04-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2012-08-31

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.

Conditions

Glaucoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

Brimonidine 0.2%-timolol 0.5% arm

Patients using timolol were switched to brimonidine tartrate / timolol maleate 0.2%/05% 1 get BID OU for six weeks.

Group Type: EXPERIMENTAL

Brimonidine 0.2%-0.5% timolol 0.5

Intervention Type: DRUG

BID OU for 6 weeks

Dorzolamide 2%-timolol 0.5% arm

Patients using timolol were switched ti dorzolamide hydrochloride / timolol 0.5% 2%/0.5% bid OU for six weeks

Group Type: ACTIVE_COMPARATOR

Dorzolamide 2%-timolol 0.5%

Intervention Type: DRUG

BID OU for 6 weeks

Interventions

Dorzolamide 2%-timolol 0.5%

BID OU for 6 weeks

Intervention Type: DRUG

Brimonidine 0.2%-0.5% timolol 0.5

BID OU for 6 weeks

Intervention Type: DRUG

Other Intervention Names

Cosopt; RVD intervention after run-in on timolol 0.5% bid OU; Combigan; RVD intervention after run-in on timolol 0.5% bid OU

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Massachusetts Eye and Ear Infirmary

OTHER

Sponsor Role: lead

Responsible Party

Louis Pasquale, MD

Director, Glaucoma Service Associate Director, Telemedicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Louis Pasquale

Role: PRINCIPAL_INVESTIGATOR

Mass Eye and Ear Infirmary

Locations

Massachusetts Eye and Ear Infirmary

Boston, Massachusetts, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 17689612 (View on PubMed)

Other Identifiers

08-12-057

Identifier Type: -

Identifier Source: org_study_id