Efficacy and Tolerability of AZARGA® as Replacement Therapy in Patients on COMBIGAN® Therapy in Canada

Glaucoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01415401
• Other study ID #: RDG-11-199
• Status: Completed
• Phase: Phase 4
• First received: August 10, 2011
• Last updated: May 30, 2014
• Start date: September 2011
• Est. completion date: June 2013

Study information

• Verified date: May 2014
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Ocular Hypertension
• Open-angle Glaucoma

Intervention

Drug:
• Brinzolamide 1% / timolol 0.5% maleate fixed combination

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in IOP at the Final Visit From Prior Brimonidine 0.2%/Timolol 0.5% Fixed Combination (COMBIGAN®) Therapy (i.e. From Baseline)	IOP (fluid pressure inside the eye) was assessed by Goldmann applanation tonometry and measured in millimeters of mercury (mmHg). A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates a greater amount of improvement. One eye was chosen as the study eye, and only data from the study eye were used for the efficacy analysis.	Baseline, Week 8	No
Secondary	Percentage of Subjects Who Reach Target IOP (= 18 mmHg)	IOP (fluid pressure inside the eye) was assessed by Goldmann applanation tonometry and measured in mmHg. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye was chosen as the study eye, and only data from the study eye were used for the efficacy analysis.	Week 8	No