Status:
COMPLETED
Efficacy and Tolerability of AZARGA® as Replacement Therapy in Patients on COMBIGAN® Therapy in Canada
Lead Sponsor:
Alcon Research
Conditions:
Glaucoma
Ocular Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT01415401
Start Date
September 1 2011
End Date
June 1 2013
Last Update
July 1 2014
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