NCT00348400CompletedPhase 4
Brimonidine Purite 0.15% Versus Dorzolamide 2% Used as Adjunctive Therapy to Latanoprost
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Innovative Medical
- Locations
- 2
Study Overview
Brief Summary
Evaluate the relative efficacy and tolerability of Alphagan P compared to Trusopt as adjunctive therapy
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Masking
- Single
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •· Male or female > 18 years of age
- •Diagnosis of open-angle glaucoma or ocular hypertension
- •IOP > 16 mm Hg in each eye at the latanoprost -treated baseline evaluation
- •Presently on latanoprost monotherapy for at least 6 weeks
- •Ability to provide informed consent and likely to complete all study visits
Exclusion Criteria
- •· Known contraindication or allergy to brimonidine or any of its components
- •Subjects must be naive to brimonidine 0.2% or brimonidine Purite 0.15% and dorzolamide 2%
- •Uncontrolled systemic disease
- •Active ocular disease other than glaucoma or ocular hypertension (e.g. uveitis, ocular infections, or severe dry eye). Patients with chronic mild blepharitis, cataract, age-related macular degeneration, or background diabetic retinopathy may be enrolled at the discretion of the investigator.
- •Required use of ocular medications other than the study medications during the study (intermittent use of artificial tear product is allowed).
- •Corneal abnormalities
- •History of intraocular surgery within the last 3 months
- •Female patients of childbearing potential who are pregnant, lactating, planning a pregnancy, or not using a reliable form of birth control
- •Visual field loss, which in the opinion of the investigator, is functionally significant, or evidence of progressive visual field loss within the last year.
Investigators
Study Sites (2)
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