A Investigator Masked Parallel Comparison of Tolerability of Combigan and Cosopt

NCT ID: NCT00621335

Last Updated: 2013-02-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 64 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-03-31
• Study Completion Date: 2008-02-29

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 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 receiving 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.

Conditions

Open Angle Glaucoma; Ocular Hypertension

Study Design

• Study Time Perspective: PROSPECTIVE

Eligibility 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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Allergan

INDUSTRY

Sponsor Role: collaborator

DBYAN Medicine Professional Corporation

OTHER

Sponsor Role: lead

Responsible Party

Dr. David Yan

Dr. David Yan M.D, F.R.C.S (c)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David Yan, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Toronto

Locations

Ophthalmic Consultants Centres

Mississauga, Ontario, Canada

Countries

Canada

Other Identifiers

CICOM 1010

Identifier Type: -

Identifier Source: org_study_id