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Completed

NCT Number: NCT00811564

An Evaluation of the Fixed Combination Brimonidine Tartrate 0.2%/ Timolol Maleate 0.5% to Latanoprost 0.005% in Glaucoma or Ocular Hypertension Subjects

A three-month evaluation comparing the safety and efficacy of a fixed combination of 0.2% brimonidine tartrate/0.5% timolol maleate with that of latanoprost 0.005%, a prostaglandin analogue in glaucoma or ocular hypertension subjects

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Key information

Conditions

Glaucoma Eye Diseases Ocular Hypertension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Slingerlands, New York, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Be at least 18 years of age;
  • Give written informed consent;
  • Be in good general health as determined by your doctor;
  • Have a diagnosis of unilateral or bilateral glaucoma or ocular hypertension;
  • If you are a female of child bearing potential, you must be willing to practice effective contraception for the duration of the study (i.e., abstinence, spermicide, condoms, or birth control pills);
  • Understand the study instructions, and be able to follow the study instructions; and
  • Be likely to complete the entire study period (12 weeks), including all regularly scheduled study visits.

Exclusion criteria

  • Have any active ocular disease other than glaucoma or ocular hypertension that would interfere with study interpretation;
  • Any systemic disease or clinical evidence of any condition which would make the subject, in the opinion of the investigator, unsuitable for the study or could potentially confound the study results; and
  • Concurrent participation or prior participation in any investigational drug or device study within the last 30 days prior to the Screening Visit

Treatment and study plan

fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% ophthalmic solution

Drug

1 drop of study medication taken approximately 12 hours apart, dosed 2 times a day

Other names: Combigan™

Latanoprost 0.005%

Drug

1 drop of study medication taken once daily

Other names: Xalatan™

Primary outcomes

  1. Intraocular Pressure (IOP) at Week 12

    Time frame: Week 12

    Mean IOP at week 12. IOP is a measurement of the fluid pressure inside the eye.

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Dec 19, 2008
Registry last updated
Sep 21, 2011

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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