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OpenTrials
Completed

NCT Number: NCT00822055

Comparison of the Fixed Combinations of Brimonidine/Timolol and Dorzolamide/Timolol in Subjects With Open-Angle Glaucoma or Ocular Hypertension

This study compares the efficacy and tolerability/comfort of brimonidine/timolol and dorzolamide/timolol in patients with open-angle glaucoma or ocular hypertension. In an investigator masked randomisation process, each subject is allocated to received either brimonidine/timolol or dorzolamide/timolol as fixed-combination monotherapy or as an adjunctive to a prostaglandin analogue for a period of 12 weeks. After screening, patient returns at baseline, Month 1 and Month 3 for ophthalmic evaluations.

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Key information

Conditions

Open-angle Glaucoma Eye Diseases Glaucoma Glaucoma, Open-Angle Ocular Hypertension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Barrie, Ontario, Canada

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male or female over 18 years
  • Female subjects of childbearing potential must have negative pregnancy test and practice contraception
  • Subjects must have confirmed diagnosis of primary open-angle glaucoma or ocular hypertension in both eyes
  • Subjects who are or have been insufficiently responsive to IOP reducing monotherapy and use of either study medication is deemed appropriate
  • Subjects able to complete questionnaires and provide informed consent

Exclusion criteria

  • Female subjects who are pregnant, planning to become pregnant during study period, breast feeding or not practicing a reliable method of birth control
  • Subjects wherein the study drugs are contraindicated
  • Subjects who have had intraocular surgery with 6 months (3 months for laser)
  • Subjects with known side effects/allergy or sensitivity to any component of study treatments
  • Subjects with any uncontrolled systemic disease

Treatment and study plan

brimonidine tartrate 0.2%/timolol maleate 0.5% fixed combination

Drug

1 drop BID in each eye

Other names: Combigan®

dorzolamide hcl 2%/timolol maleate 0.5% fixed combination

Drug

1 drop BID in each eye

Other names: Cosopt®

brimonidine tartrate 0.2%/timolol maleate 0.5% fixed combination as adjunctive to current prostaglandin therapy

Drug

1 drop BID in each eye

Other names: Combigan®

dorzolamide hcl 2%/timolol maleate 0.5% fixed combination as adjunctive to current prostaglandin therapy

Drug

1 drop BID in each eye

Other names: Cosopt®

Primary outcomes

  1. Change from baseline in mean IOP

    Time frame: 12 weeks

Secondary outcomes

  1. Patient tolerability/comfort measured by Likert scale

    Time frame: Month 1

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Jan 14, 2009
Registry last updated
Jan 14, 2009

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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