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Sponsors and Collaborators: |
DBYAN Medicine Professional Corporation Allergan |
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Information provided by: | DBYAN Medicine Professional Corporation |
ClinicalTrials.gov Identifier: | NCT00621335 |
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 angle glaucoma or ocular hypertension.
Condition |
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Open Angle Glaucoma Ocular Hypertension |
Study Type: | Observational |
Study Design: | Cohort, Cross-Sectional |
Official Title: | A 12- Week Investigator Masked, Parallel Comparison of Tolerability of Combigan and Cosopt in the Treatment of Open Angle Glaucoma or Ocular Hypertension |
Estimated Enrollment: | 50 |
Study Start Date: | March 2007 |
Estimated Study Completion Date: | November 2008 |
Estimated Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
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 glaucomatous optic disk cupping and/or glaucomatous visual field loss, who have been recieving a stable treatment regime for at least 4 weeks prior to the study initiation, with a Cosopt mono or a Prostaglandin + Cosopt combination are to be included in the study.Patients must have an IOP between 16 and 32 mmHg, with no readings above 35 mmHg at baseline.
Patients with any other form of glaucoma other than primary open angle glaucoma, with a gonioscopy measured angle grade of less than 2, with a visual field defect not of glaucomatous origen and previous cyclodestructive procedures will be excluded.The use of ocular non steroidal and anti-inflammatory topical agents which inhibit cyclooxygenase and prostaglandin analog synthesis,the use of glucocorticoid therapy, and hypersensitivity to any of the study components also precludes involvement in the study. Any ocular laser therapy within the past three months, ocular inflammation or infection in the past three months or any history of trauma in the last six months will also exclude enrollment in the study.
Ages Eligible for Study: | 40 Years to 90 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Community sample
Inclusion Criteria:
Exclusion Criteria:
Canada, Ontario | |
Ophthalmic Consultants Centres | Recruiting |
Mississauga, Ontario, Canada, L4W 1W9 | |
Contact: Jacqueline Freudenthal, M.D. 647-521-4758 | |
Principal Investigator: David Yan, M.D. | |
Sub-Investigator: Jacqueline Freudenthal, M.D. |
Principal Investigator: | David Yan, M.D. | University of Toronto |
Responsible Party: | Ophthalmic Consultants Centres ( David Yan, Principal Investigator ) |
Study ID Numbers: | CICOM 1010 |
Study First Received: | February 13, 2008 |
Last Updated: | February 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00621335 |
Health Authority: | Canada: Health Canada |
Open angle glaucoma Ocular hypertension Parallel comparison Combigan Cosopt |
Glaucoma Eye Diseases Glaucoma, Open-Angle |
Vascular Diseases Hypertension Ocular Hypertension |
Cardiovascular Diseases |