Overview

Comparison of the Fixed Combinations of Brimonidine/Timolol and Dorzolamide/Timolol in Subjects With Open-Angle Glaucoma or Ocular Hypertension

Status:
Completed
Trial end date:
2006-04-01
Target enrollment:
0
Participant gender:
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 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Bp Consulting, Inc
Collaborator:
Allergan
Treatments:
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.