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OpenTrials
Completed

NCT Number: NCT00735449

Comparing Efficacy and Safety of Combigan With Timolol Adjunctive to Xalatan in Glaucoma or Ocular Hypertension Subjects

Efficacy and safety evaluation of Combigan with timolol when each is used as adjunctive therapy to Xalatan in subjects with glaucoma or ocular hypertension.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Montreal, Quebec, Canada

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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
  • History of severe renal or hepatic impairment
  • Subjects with severe cardiovascular disease should not be enrolled unless their disease is controlled and clearance has been obtained from the subject's primary care physician and/or cardiologist
  • Contraindications to beta-adrenoceptor antagonist therapy such as chronic obstructive pulmonary disease, bronchial asthma, sinus bradycardia, second and third degree atrioventricular block, overt cardiac failure and cardiogenic shock or uncontrolled congestive heart failure
  • 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%

Drug

1 drop of fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% taken approximately 12 hours apart, up to 2 times a day.

Other names: Combigan®

timolol maleate 0.5%

Drug

1 drop of timolol maleate 0.5% taken approximately 12 hours apart, up to 2 times a day.

Other names: Timpoptic®, Timoptol®

Latanoprost 0.005%

Drug

1 drop of latanoprost 0.005% once nightly.

Other names: Xalatan®

Primary outcomes

  1. Mean Intraocular Pressure (IOP) at 10 AM at Week 12

    Time frame: Week 12

    Mean IOP at 10 AM at week 12. IOP is a measurement of the fluid pressure in the eye.

Secondary outcomes

  1. Mean Intraocular Pressure (IOP) at 10 AM at Week 6

    Time frame: Week 6

    Mean IOP at 10 AM at week 6. IOP is a measurement of the fluid pressure inside the eye.

  2. Mean Intraocular Pressure (IOP) at 8 AM at Week 12

    Time frame: Week 12

    Mean IOP at 8 AM at week 12. IOP is a measurement of the fluid pressure inside the eye.

  3. Mean Intraocular Pressure (IOP) at 8 AM at Week 6

    Time frame: Week 6

    Mean IOP at 8 AM at week 6. IOP is a measurement of the fluid pressure inside the eye.

  4. Number of Subjects With Adverse Events

    Time frame: Week 12

    Number of subjects with adverse events, defined as any untoward medical occurrence in a subject, during the study (reported through the week 12 visit).

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Aug 15, 2008
Registry last updated
Apr 23, 2019

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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