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

Phase 4

Completed

• Conditions: Glaucoma; Ocular Hypertension
• Interventions: Drug: fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% ophthalmic solution; Drug: latanoprost 0.005%

• Registration Number: NCT00811564
• Lead Sponsor: Allergan

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 glaucoma or ocular hypertension subjects

Detailed Description

Not available

Study Timeline

• Study Start: 2008-12
• Study First Submitted: 2008-12-17
• Study First Submitted QC: 2008-12-17
• Study First Posted: 2008-12-19
• Primary Completion: 2010-01
• Study Completion: 2010-01
• Status Verified: 2011-08
• Results First Submitted: 2011-08-17
• Results First Submitted QC: 2011-08-17
• Last Update Submitted: 2011-08-17
• Results First Posted: 2011-09-21
• Last Update Posted: 2011-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 148

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% ophthalmic solution	Fixed combination of brimonidine tartrate 0.2%/timolol maleate 0.5% ophthalmic solution
2	latanoprost 0.005%	Latanoprost 0.005% ophthalmic solution

Primary Outcome Measures

Name	Time	Method
Intraocular Pressure (IOP) at Week 12	Week 12	Mean IOP at week 12. IOP is a measurement of the fluid pressure inside the eye.