A Investigator Masked Parallel Comparison of Tolerability of Combigan and Cosopt
Information source: DBYAN Medicine Professional Corporation
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Open Angle Glaucoma; Ocular Hypertension
Phase: N/A
Status: Recruiting
Sponsored by: DBYAN Medicine Professional Corporation Official(s) and/or principal investigator(s):
David Yan, M.D., Principal Investigator, Affiliation: University of Toronto
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 angle glaucoma or ocular hypertension.
Clinical Details
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
Study design: Cohort, Cross-Sectional
Primary outcome: Comparison of the tolerability and effectiveness of Combigan and Cosopt in the treatment of open angle glaucoma or ocular hypertension
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 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.
Eligibility
Minimum age: 40 Years.
Maximum age: 90 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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 Criteria:
- 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
Locations and Contacts
Ophthalmic Consultants Centres, Mississauga, Ontario L4W 1W9, Canada; Recruiting
Jacqueline Freudenthal, M.D., Phone: 647-521-4758
David Yan, M.D., Principal Investigator
Jacqueline Freudenthal, M.D., Sub-Investigator
Additional Information
Starting date: March 2007
Ending date: November 2008
Last updated: February 13, 2008
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