An Evaluation of the Fixed Combination Brimonidine Tartrate 0.2%/ Timolol Maleate 0.5% to Latanoprost 0.005% in Glaucoma or Ocular Hypertension Subjects
Information source: Allergan
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Glaucoma; Ocular Hypertension
Intervention: fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% ophthalmic solution (Drug); latanoprost 0.005% (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Allergan Official(s) and/or principal investigator(s):
Medical Director, Study Director, Affiliation: Allergan
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
Clinical Details
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
Primary outcome: Intraocular Pressure (IOP) at Week 12
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Slingerlands, New York, United States
Additional Information
Starting date: December 2008
Last updated: August 17, 2011
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