Phase 4
Completed N=148
An Evaluation of the Fixed Combination Brimonidine Tartrate 0.2%/ Timolol Maleate 0.5% to Latanoprost 0.005% in Glaucoma or Ocular Hypertension Subjects
Source: ClinicalTrials.gov NCT00811564 ↗Enrolled (actual)
148
Serious AEs
0.7%
Results posted
Sep 2011
Primary outcomePrimary: Intraocular Pressure (IOP) at Week 12 — 17.75; 17.90 Millimeters of mercury (mm Hg)
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Intraocular Pressure (IOP) at Week 12 |
17.75; 17.90 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00811564). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.