Assessing the Efficacy and Tolerability of AZARGA® (Brinzolamide 1%/Timolol 0.5% Fixed Combination) as Replacement Therapy in Patients on Brimonidine 0.2%/Timolol 0.5% Fixed Combination Therapy (COMBIGAN®) in Latin America

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 Brimonidine 0.2%/Timolol 0.5% Fixed Combination Therapy (COMBIGAN®) in Latin America

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01518244
• Other study ID #: RDG-11-198
• Status: Completed
• Phase: Phase 4
• First received: January 23, 2012
• Last updated: July 17, 2015
• Start date: December 2011
• Est. completion date: February 2013

Study information

• Verified date: February 2014
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Ethics CommitteeArgentina: Human Research Bioethics CommitteeChile: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study was to assess the efficacy and tolerability of changing to AZARGA® from prior COMBIGAN® pharmacotherapy in participants with open-angle glaucoma or ocular hypertension.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Clinical diagnosis of ocular hypertension, exfoliative open-angle glaucoma, or pigment dispersion glaucoma in at least one eye (study eye).

• On a stable IOP (intra-ocular pressure) lowering regimen within 30 days of Screening Visit.

• IOP considered safe in both eyes in order to assure clinical stability of vision and optic nerve throughout the study period.

• Best corrected visual acuity of 6/60 (20/200 Snellen; 1.0 LogMAR) or better in each eye.

• IOP between 19 and 35 mmHG in at least one eye (which would be the study eye) while on brimonidine/timolol fixed combination therapy.

• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Presence of other primary or secondary glaucoma.

• History of ocular herpes simplex.

• Any 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 three months prior to Screening Visit.

• Risk of visual field or visual acuity worsening as a consequence of participation in the study, in the opinion of the investigator.

• Progressive retinal or optic nerve disease from any cause.

• Use of systemic medications known to affect IOP which have not been on a stable course for 7 days prior to Screening Visit or an anticipated change in the dosage during the course of the study.

• Pregnant or lactating.

• Other protocol-defined exclusion criteria may apply.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glaucoma

Intervention

Drug:
• Brinzolamide/timolol 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	Mean Change in Intraocular Pressure (IOP) From Baseline (Prior Therapy) at Week 8	IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. 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) at Week 8	IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. 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