A Investigator Masked Parallel Comparison of Tolerability of Combigan and Cosopt

A 12- Week Investigator Masked, Parallel Comparison of Tolerability of Combigan and Cosopt in the Treatment of Open Angle Glaucoma or Ocular Hypertension

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00621335

Acronym

CICOM1010

Enrollment

Registered

2008-02-22

Start date

2007-03-31

Completion date

2008-02-29

Last updated

2013-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ocular Hypertension, Open Angle Glaucoma

Keywords

Open angle glaucoma, Ocular hypertension, Parallel comparison, Combigan, Cosopt

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.

Interventions

None listed

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

40 Years to 90 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Comparison of the tolerability and effectiveness of Combigan and Cosopt in the treatment of open angle glaucoma or ocular hypertension	12 weeks

Countries

Canada

Outcome results