Clinical trial NCT01415401: Efficacy and Tolerability of AZARGA® as Replacement Therapy in Patients on COMBIGAN® Therapy in Canada
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Glaucoma
Ocular Hypertension
Open-angle Glaucoma
Keywords: Glaucoma
Ocular hypertension
Intraocular pressure (IOP)
Open angle glaucoma
Pigment dispersion glaucoma
Pigmentary
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2011-08-12
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 glaucoma or ocular hypertension and uncontrolled intraocular pressure (IOP).


Eligibility 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.

Primary outcomes:
measure: Change in IOP at the Final Visit From Prior Brimonidine 0.2%/Timolol 0.5% Fixed Combination (COMBIGAN®) Therapy (i.e. From Baseline)
timeFrame: Baseline, Week 8
Secondary outcomes:
measure: Percentage of Subjects Who Reach Target IOP (≤ 18 mmHg)
timeFrame: Week 8
Other outcomes:
Locations:
Study officials:
affiliation: Alcon Research
name: Danyel C. Carr, MS, CCRA
role: STUDY_DIRECTOR
References: