Comparison of the Fixed Combinations of Brimonidine/Timolol and Dorzolamide/Timolol in Subjects With Open-Angle Glaucoma or Ocular Hypertension
NCT00822055 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 140
Last updated 2009-01-14
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 randomisation process, each subject is allocated to received either brimonidine/timolol or dorzolamide/timolol as fixed-combination monotherapy or as an adjunctive to a prostaglandin analogue for a period of 12 weeks. After screening, patient returns at baseline, Month 1 and Month 3 for ophthalmic evaluations.
Conditions
- Open-Angle Glaucoma
- Ocular Hypertension
Interventions
- DRUG
-
brimonidine tartrate 0.2%/timolol maleate 0.5% fixed combination
1 drop BID in each eye
- DRUG
-
dorzolamide hcl 2%/timolol maleate 0.5% fixed combination
1 drop BID in each eye
- DRUG
-
brimonidine tartrate 0.2%/timolol maleate 0.5% fixed combination as adjunctive to current prostaglandin therapy
1 drop BID in each eye
- DRUG
-
dorzolamide hcl 2%/timolol maleate 0.5% fixed combination as adjunctive to current prostaglandin therapy
1 drop BID in each eye
Sponsors & Collaborators
-
Allergan
lead INDUSTRY
Principal Investigators
-
Medical Director · Allergan
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2005-05-31
- Primary Completion
- 2006-11-30
- Completion
- 2006-11-30
Countries
- Canada
Study Locations
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