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

• Glaucoma
• Ocular Hypertension

• Drug: fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% ophthalmic solution
  1 drop of study medication taken approximately 12 hours apart, dosed 2 times a day
  Other Name: Combigan™
• Drug: latanoprost 0.005%
  1 drop of study medication taken once daily
  Other Name: Xalatan™

• Active Comparator: 1
  Fixed combination of brimonidine tartrate 0.2%/timolol maleate 0.5% ophthalmic solution
  Intervention: Drug: fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% ophthalmic solution
• Active Comparator: 2
  Latanoprost 0.005% ophthalmic solution
  Intervention: Drug: latanoprost 0.005%

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