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

• Sponsor: Alcon Research (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01518244
• Collaborator: (none)
• Enrollment: 50
• Arm: 1
• Duration (Months): 14.1

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Glaucoma	Drug: Brinzolamide/timolol maleate fixed combination	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Study Start Date: Dec 1, 2011
• Actual Primary Completion Date: Feb 1, 2013
• Actual Study Completion Date: Feb 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: AZARGA® Brinzolamide/timolol maleate fixed combination, 1 drop self-administered in study eye(s) twice a day for 8 weeks	Drug: Brinzolamide/timolol maleate fixed combination; Other Names: AZARGA®

Outcome Measures

Primary Outcome Measures

1. Mean Change in Intraocular Pressure (IOP) From Baseline (Prior Therapy) at Week 8 [Baseline, 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.

Secondary Outcome Measures

1. Percentage of Subjects Who Reach Target IOP (≤18 mmHg) at Week 8 [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Alcon Research

Investigators

• Study Director: Doug Hubatsch, Alcon Research

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alcon Research
• ClinicalTrials.gov Identifier: NCT01518244
• Other Study ID Numbers: RDG-11-198
• First Posted: Jan 25, 2012
• Last Update Posted: Aug 7, 2015
• Last Verified: Feb 1, 2014

• Keywords provided by Alcon Research: Primary open angle-glaucoma; Ocular hypertension; Pigment dispersion glaucoma
• Additional relevant MeSH terms: Glaucoma; Timolol; Brinzolamide

Study Results

Participant Flow

Recruitment Details	Participants were recruited from 6 study centers located in South America: Argentina (3), Chile (1), and Mexico (2).
Pre-assignment Detail	This reporting group includes all participants who received at least one dose of AZARGA®.

Arm/Group Title	AZARGA®
Arm/Group Description	Brinzolamide/timolol maleate fixed combination, 1 drop self-administered in study eye(s) twice a day for 8 weeks
Period Title: Overall Study
STARTED	50
COMPLETED	47
NOT COMPLETED	3

Baseline Characteristics

Arm/Group Title	AZARGA®
Arm/Group Description	Brinzolamide/timolol maleate fixed combination, 1 drop self-administered in study eye(s) twice a day for 8 weeks
Overall Participants	49
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	66.67 (11.51)
Sex: Female, Male (Count of Participants)
Female	30 61.2%
Male	19 38.8%

Outcome Measures

1. Primary Outcome

Title	Mean Change in Intraocular Pressure (IOP) From Baseline (Prior Therapy) at Week 8
Description	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.
Time Frame	Baseline, Week 8

Outcome Measure Data

Analysis Population Description

The analysis population includes all participants who received AZARGA® and with at least 1 on-therapy study visit (V2 or V3).

Arm/Group Title	AZARGA®
Arm/Group Description	Brinzolamide/timolol maleate fixed combination, 1 drop self-administered in study eye(s) twice a day for 8 weeks
Measure Participants	49
Mean (Standard Deviation) [milllimeters mercury (mmHg)]	-3.60 (3.01)

2. Secondary Outcome

Title	Percentage of Subjects Who Reach Target IOP (≤18 mmHg) at Week 8
Description	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.
Time Frame	Week 8

Outcome Measure Data

Analysis Population Description

The analysis population includes all participants who received AZARGA® and with at least 1 on-therapy study visit (V2 or V3).

Arm/Group Title	AZARGA®
Arm/Group Description	Brinzolamide/timolol maleate fixed combination, 1 drop self-administered in study eye(s) twice a day for 8 weeks
Measure Participants	49
Number [percentage of participants]	55.3 112.9%

Adverse Events

Time Frame	Adverse events (AEs) were collected for the duration of the study (December 2011-February 2013). An AE was defined as any untoward medical occurrence in a subject administered the test product, regardless of causal relationship with such product.
Adverse Event Reporting Description	The analysis population includes all participants who received at least one dose of AZARGA®.
Arm/Group Title	AZARGA®
Arm/Group Description	Brinzolamide/timolol maleate fixed combination, 1 drop self-administered in study eye(s) twice a day for 8 weeks
All Cause Mortality
	AZARGA®
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	AZARGA®
	Affected / at Risk (%)	# Events
Total	0/50 (0%)
Other (Not Including Serious) Adverse Events
	AZARGA®
	Affected / at Risk (%)	# Events
Total	4/50 (8%)
Eye disorders
Eye irritation	4/50 (8%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Sponsor reserves the right of prior review of any publication or presentation of information related to the study.