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
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.
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Barrie, Ontario, Canada
Additional Information
Starting date: January 2005
Last updated: January 13, 2009
|
