Efficacy and Tolerability of AZARGA® as Replacement Therapy in Patients on COMBIGAN® Therapy in Canada
Information source: Alcon Research
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Glaucoma; Ocular Hypertension; Open-angle Glaucoma
Intervention: Brinzolamide 1% / timolol 0.5% maleate fixed combination (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Alcon Research Official(s) and/or principal investigator(s):
Danyel C. Carr, MS, CCRA, Study Director, Affiliation: Alcon Research
Summary
The purpose of this study was to assess the efficacy and tolerability of changing to AZARGA®
from prior brimonidine 0. 2%/timolol 0. 5% fixed combination (COMBIGAN®) therapy in patients
with open-angle glaucoma or ocular hypertension and uncontrolled intraocular pressure (IOP).
Clinical Details
Official title: Assessing the Efficacy and Tolerability of AZARGA® (Brinzolamide 1%/Timolol 0.5% Fixed Combination) as Replacement Therapy in Patients on COMBIGAN® (Brimonidine 0.2%/Timolol 0.5% Fixed Combination) Therapy in Canada
Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Change in IOP at the Final Visit From Prior Brimonidine 0.2%/Timolol 0.5% Fixed Combination (COMBIGAN®) Therapy (i.e. From Baseline)
Secondary outcome: Percentage of Subjects Who Reach Target IOP (≤ 18 mmHg)
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Willing to sign an Informed Consent form.
- Clinical diagnosis of ocular hypertension, exfoliative open-angle or pigment
dispersion glaucoma in at least one eye (study eye).
- Be on a stable IOP lowering regimen within 30 days of Screening Visit.
- IOP considered to be safe, in both eyes, in such a way that should assure clinical
stability of vision and the optic nerve throughout the study period.
- Willing to discontinue the use of COMBIGAN® prior to receiving the study drug at
Visit 1.
- IOP of between 19 and 35 mmHg in at least one eye (which would be the study eye)
while on brimonidine/timolol fixed combination therapy.
- Best corrected visual acuity of 6/60 (20/200 Snellen, 1. 0 logMAR) or better in each
eye.
- Willing to follow instructions and able to attend required study visits.
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
- Known history of hypersensitivity to any component of the preparations used in this
study.
- Presence of primary or secondary glaucoma not listed in inclusion criterion #2.
- History of ocular herpes simplex.
- Abnormality preventing reliable applanation tonometry.
- Corneal dystrophies.
- Concurrent infectious/noninfectious conjunctivitis, keratitis or uveitis in either
eye. Blepharitis or non-clinically significant conjunctival injection is allowed.
- Intraocular conventional surgery or laser surgery in study eye(s) less than 3 months
prior to the Screening Visit.
- Risk of visual field or visual acuity worsening as a consequence of participation in
the study, in the investigator's best judgment.
- Progressive retinal or optic nerve disease from any cause.
- Women of childbearing potential not using reliable means of birth control for at
least 1 month prior to the Screening/Baseline Visit.
- Pregnant or lactating.
- Other protocol-defined exclusion criteria may apply.
Locations and Contacts
Additional Information
Starting date: September 2011
Last updated: May 30, 2014
|
