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Completed

NCT Number: NCT00621335

A Investigator Masked Parallel Comparison of Tolerability of Combigan and Cosopt

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.

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Key information

Age range

40 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ophthalmic Consultants Centres

Mississauga, Ontario, L4W 1W9, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Comparison of the tolerability and effectiveness of Combigan and Cosopt in the treatment of open angle glaucoma or ocular hypertension

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

DBYAN Medicine Professional Corporation

Other

Collaborators

  • Allergan

Registry information

Official study title

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

Acronym: CICOM1010

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Feb 22, 2008
Registry last updated
Feb 25, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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