Overview
Comparison of the Fixed Combinations of Brimonidine/Timolol and Dorzolamide/Timolol in Subjects With Open-Angle Glaucoma or Ocular Hypertension
Status:
Completed
Completed
Trial end date:
2006-04-01
2006-04-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
This study compares the efficacy and tolerability/comfort of brimonidine/timolol and dorzolamide/timolol in patients with open-angle glaucoma or ocular hypertension. In an investigator masked randomization process, each subject is allocated to recieve either brimonidine/timolol or dorzolamide/timolol as fixed-combination monotherapy or as an adjuctive to a prostoglandin analogue for a period of 12 weeks. After screening, patient returns at baseline, Month 1, and Month 3 for ophthalmic evaluations.Phase:
Phase 4Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Bp Consulting, IncCollaborator:
AllerganTreatments:
Brimonidine Tartrate
Brimonidine Tartrate, Timolol Maleate Drug Combination
Dorzolamide
Maleic acid
Timolol
Criteria
Inclusion Criteria:- Male or female over 18 yrs.
- Female subjects of childbearing potential must have negative pregnancy test and
provide contraception.
- Subjects must have confirmed diagnosis of primary open-angle glaucoma or ocular
hypertension in both eyes.
- Subjects who are or have been insufficiently responsive to IOP reducing monotherapy
and use of either study medication is deemed appropriate.
- Subjects able to complete questionnaires and provide informed consent.
Exclusion Criteria:
- Female subjects who are pregnant, planning to become pregnant during study period,
breast feeding or not practicing a reliable method of birth control.
- Subjects wherein the study drugs are containdicated.
- Subjects who have had introcular surgery with 6 months (3 months for laser).
- Subjects with known side effects/ allergy or sensitivity to any component of study
treatments.
- Subjects with any uncontrolled systemic disease.