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

Information source: Bp Consulting, Inc
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Open-Angle Glaucoma; Ocular Hypertension

Intervention: brimonidine tartrate 0.2%/timolol maleate 0.5% fixed combination (Drug); dorzolamide hcl 2%/ timolol maleate 0.5% fixed combination (Drug); brimonidine tartrate 0.2%/timolol maleate 0.5% fixed combination as adjunctive to current prostaglandin therapy. (Drug); dorzolamide hcl 2%/timolol maleate 0.5% fixed combinatin as adjunctive to current prostaglandin therapy. (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Bp Consulting, Inc

Official(s) and/or principal investigator(s):
Medical Director, Study Director, Affiliation: Allergan


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.

Clinical Details

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Primary outcome: Change from baseline in mean IOP.

Secondary outcome: Patient tolerability/comfort measured by Likert scale.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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


- Subjects with any uncontrolled systemic disease.

Locations and Contacts

Barrie, Ontario, Canada
Additional Information

Starting date: January 2005
Last updated: January 13, 2009

Page last updated: August 23, 2015

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