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OpenTrials
Completed

NCT Number: NCT01426867

A Comfort Study of Brinzolamide 1% / Brimonidine 0.2% Fixed Combination, Brinzolamide 1% and Brimonidine 0.2%

The purpose of this study was to describe the ocular discomfort immediately upon instillation of Brinzolamide 1%/Brimonidine 0.2% Tartrate Ophthalmic Suspension, Brinzolamide 1% Ophthalmic Suspension, and Brimonidine Tartrate 0.2% Ophthalmic Solution in subjects with open-angle glaucoma and/or ocular hypertension.

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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 2

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Sign Informed Consent document.
  • Diagnosis of open-angle glaucoma or ocular hypertension
  • Other protocol-specified inclusion criteria may apply.

Exclusion criteria

  • Females of childbearing potential if pregnant, lactating, or not using highly effective birth control measures.
  • Severe central vision loss in either eye.
  • Any chronic or recurrent inflammatory eye disease.
  • Ocular trauma within the preceding 6 months.
  • Ocular infection or ocular inflammation within the preceding 3 months.
  • Best-corrected visual acuity score worse than 55 letters using the Early Treatment Diabetic Retinopathy Study chart.
  • Any intraocular surgery within the preceding 6 months.
  • Any ocular laser surgery within the preceding 3 months.
  • History or current evidence of severe illness or any other conditions which would make the subject, in the opinion of the Investigator, unsuitable for the study.
  • Other protocol-defined exclusion criteria may apply.

Treatment and study plan

Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension

Drug

Brinzolamide ophthalmic suspension, 1%

Drug

Brimonidine tartrate ophthalmic solution, 0.2%

Drug

Primary outcomes

  1. Mean Ocular Discomfort Score

    Time frame: Week 1

    Ocular discomfort was assessed by the subject immediately following the 8 AM instillation of study drug and rated on a 5-point scale: 0 (none), 1 (mild), 2 (moderate), 3 (severe), and 4 (very severe).

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Official study title

A Descriptive Comfort Study of Brinzolamide 1% / Brimonidine Tartrate 0.2% Fixed Combination Ophthalmic Suspension, Brinzolamide 1% Ophthalmic Suspension and Brimonidine Tartrate 0.2% Ophthalmic Solution in Patients With Open-Angle Glaucoma or Ocular Hypertension

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Sep 1, 2011
Registry last updated
Jul 8, 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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