Ocular Hypertension, Open-Angle Glaucoma
Conditions
Brief 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.
Interventions
1 drop BID in each eye
DRUGdorzolamide hcl 2%/ timolol maleate 0.5% fixed combination
1 drop BID in each eye
DRUGbrimonidine tartrate 0.2%/timolol maleate 0.5% fixed combination as adjunctive to current prostaglandin therapy.
1 drop BID in each eye
DRUGdorzolamide hcl 2%/timolol maleate 0.5% fixed combinatin as adjunctive to current prostaglandin therapy.
1 drop BID in each eye
Sponsors
Allergan
Bp Consulting, Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in mean IOP. | 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Patient tolerability/comfort measured by Likert scale. | Month 1 |
Countries
Canada
Outcome results
None listed