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OpenTrials
Completed

NCT Number: NCT00675207

Comparison of Brimonidine Purite, Dorzolamide, and Brinzolamide as Adjunctive Therapy to Prostaglandin Analogs

The purpose of this study is to compare the efficacy of brimonidine Purite, dorzolamide, and brinzolamide in reducing intraocular pressure when added to prostaglandin analog therapy (bimatoprost, latanoprost, or travoprost) in patients with glaucoma or ocular hypertension.

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Key information

Conditions

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

Age range

41 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Northwestern Ophthalmic Institute S.C.

Glenview, Illinois, 60026, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosis of primary open-angle glaucoma or ocular hypertension.
  • Must be over 40 years of age.
  • Intraocular pressure must be 18 mm Hg or higher after 6 weeks of treatment (run-in) with a prostaglandin analog (bimatoprost, latanoprost, or travoprost).

Exclusion criteria

  • History of angle closure or narrow angle.
  • Previous intraocular surgery.
  • Laser trabeculoplasty within 3 months prior to screening.
  • History of uveitis or intraocular inflammation.
  • Use of medications other than the study medications that are known to affect IOP (e.g., beta-blockers, steroids, or angiotensin II blockers) within 3 months of study entry or during the study.
  • Intolerance of or hypersensitivity to prostaglandin analogs, sulfonamides, alpha-agonists, or the preservative benzalkonium chloride.
  • Women of childbearing age who are pregnant or not using contraception.

Treatment and study plan

Brimonidine purite 0.15%

Drug

A single drop of brimonidine purite 0.15% ophthalmic solution administered topically in the eye 3 times daily.

Other names: Alphagan P 0.15%

Dorzolamide 2%

Drug

A single drop of dorzolamide 2% ophthalmic solution administered topically in the eye 3 times daily.

Other names: Trusopt

Brinzolamide 1%

Drug

A single drop of brinzolamide 1% ophthalmic solution administered topically in the eye 3 times daily.

Other names: Azopt

Primary outcomes

  1. Intraocular pressure

    Time frame: Measurements at peak and trough effect (10 am and 4 pm) at baseline, month 1, and month 4

Sponsors and collaborators

Lead sponsor

Northwestern Ophthalmic Institute S.C.

Other

Collaborators

  • Research to Prevent Blindness

Registry information

Official study title

Comparison of Brimonidine 0.15% Purite, Dorzolamide 2%, and Brinzolamide 1% as Adjunctive Therapy to Prostaglandin Analogs

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
May 8, 2008
Registry last updated
May 8, 2008

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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