Status:
COMPLETED
An Evaluation of the Fixed Combination Brimonidine Tartrate 0.2%/ Timolol Maleate 0.5% to Latanoprost 0.005% in Glaucoma or Ocular Hypertension Subjects
Lead Sponsor:
Allergan
Conditions:
Glaucoma
Ocular Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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 glaucom...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
148 Patients enrolled
Trial Details
Trial ID
NCT00811564
Start Date
December 1 2008
End Date
January 1 2010
Last Update
September 21 2011
Active Locations (1)
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1
Slingerlands, New York, United States