Status:
COMPLETED
A Investigator Masked Parallel Comparison of Tolerability of Combigan and Cosopt
Lead Sponsor:
DBYAN Medicine Professional Corporation
Collaborating Sponsors:
Allergan
Conditions:
Open Angle Glaucoma
Ocular Hypertension
Eligibility:
All Genders
40-90 years
Brief Summary
The objective of this research study is to compare the tolerability and effectiveness of Combigan(brimonidine tartrate/timolol maleate) and Cosopt (dorzolamide hydrochloride)in the treatment of open a...
Detailed Description
Patients between the ages of 40 to 90 years of age, that have been diagnosed with open angle glaucoma or ocular hypertension,including pseudo-exfoliation and pigmentary glaucoma with definitive glauco...
Eligibility Criteria
Inclusion
- open angle glaucoma or ocular hypertension including pseudo-exfoliation and pigmentary glaucoma
- definitive glaucomatous optic disk cupping and/or glaucomatous visual field loss
- a stable treatment regime for at least 4 weeks prior to the study initiation, with a Cosopt mono or a Prostaglandin + Cosopt combination
- an IOP between 16 and 32 mmHg, with no readings above 35 mmHg at baseline
Exclusion
- any other form of glaucoma other than primary open angle glaucoma
- a gonioscopy measured angle grade of less than 2
- a visual field defect not of glaucomatous origen
- previous history of cyclodestructive procedures
- the use of ocular non steroidal and anti-inflammatory topical agent that inhibit cyclooxygenase and prostaglandin analog synthesis
- the use of glucocorticoid therapy
- hypersensitivity to any of the study components
- any ocular laser therapy within the past three months
- ocular inflammation or infection in the past three months
- any history of trauma in the last six months
Key Trial Info
Start Date :
March 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 1 2008
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT00621335
Start Date
March 1 2007
End Date
February 1 2008
Last Update
February 25 2013
Active Locations (1)
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1
Ophthalmic Consultants Centres
Mississauga, Ontario, Canada, L4W 1W9