Overview

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

Status:
Completed
Trial end date:
2010-01-01
Target enrollment:
0
Participant gender:
All
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 glaucoma or ocular hypertension subjects
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Allergan
Treatments:
Brimonidine Tartrate
Latanoprost
Maleic acid
Ophthalmic Solutions
Pharmaceutical Solutions
Timolol
Criteria
Inclusion Criteria:

1. Be at least 18 years of age;

2. Give written informed consent;

3. Be in good general health as determined by your doctor;

4. Have a diagnosis of unilateral or bilateral glaucoma or ocular hypertension;

5. 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);

6. Understand the study instructions, and be able to follow the study instructions; and

7. Be likely to complete the entire study period (12 weeks), including all regularly
scheduled study visits.

Exclusion Criteria:

1. Have any active ocular disease other than glaucoma or ocular hypertension that would
interfere with study interpretation;

2. 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

3. Concurrent participation or prior participation in any investigational drug or device
study within the last 30 days prior to the Screening Visit