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 Brazil

• Sponsor: Alcon Research (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT01514734
• Collaborator: (none)
• Enrollment: 9
• Location: 1
• Arm: 1
• Duration (Months): 5
• Patients Per Site Per Month: 1.8

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 patients 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: 9 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 Brazil
• Study Start Date: Mar 1, 2012
• Actual Primary Completion Date: Aug 1, 2012
• Actual Study Completion Date: Aug 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: AZARGA Brinzolamide/timolol maleate fixed combination, one drop self-administered in study eye(s) twice a day for 8 weeks	Drug: Brinzolamide/timolol maleate fixed combination; Commercially marketed topical ocular agent for the treatment of open-angle glaucoma (OAG) or ocular hypertension.; Other Names: AZARGA®

Outcome Measures

Primary Outcome Measures

1. Change in Intraocular Pressure (IOP) at 8 Weeks From Baseline (Prior Therapy). [8 weeks]

   Intraocular pressure was measured by Goldmann applanation tonometry. Data for the worse eye were used for the efficacy analysis. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage).

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• 18 years of age or older.

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

• Be on a stable intraocular pressure (IOP) lowering regimen within 30 days of the Screening Visit.

• IOP considered safe in both eyes in such a way that should 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 not listed in inclusion criteria #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 three 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.

• Use of systemic medications known to affect IOP which have not been on a stable course for 7 days prior to the 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

	Site	City	State	Country	Postal Code
1	Contact Alcon Call Center for Trial Locations	São Paulo		Brazil	11045-140

Sponsors and Collaborators

• Alcon Research

Investigators

• Study Director: Doug Hubatsch, M.Sc., Alcon Research

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alcon Research
• ClinicalTrials.gov Identifier: NCT01514734
• Other Study ID Numbers: RDG-11-191
• First Posted: Jan 23, 2012
• Last Update Posted: Oct 21, 2013
• Last Verified: Aug 1, 2013

• 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

Arm/Group Title	AZARGA
Arm/Group Description	Brinzolamide/timolol maleate fixed combination, one drop self-administered in study eye(s) twice a day for 8 weeks
Period Title: Overall Study
STARTED	9
COMPLETED	9
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	AZARGA
Arm/Group Description	Brinzolamide/timolol maleate fixed combination, one drop self-administered in study eye(s) twice a day for 8 weeks
Overall Participants	9
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	58.56 (15.83)
Sex: Female, Male (Count of Participants)
Female	6 66.7%
Male	3 33.3%
Region of Enrollment (participants) [Number]
Brazil	9 100%

Outcome Measures

1. Primary Outcome

Title	Change in Intraocular Pressure (IOP) at 8 Weeks From Baseline (Prior Therapy).
Description	Intraocular pressure was measured by Goldmann applanation tonometry. Data for the worse eye were used for the efficacy analysis. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage).
Time Frame	8 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	AZARGA
Arm/Group Description	Brinzolamide/timolol maleate fixed combination, one drop self-administered in study eye(s) twice a day for 8 weeks
Measure Participants	9
Mean (Standard Deviation) [millimeters mercury (mmHg)]	-0.89 (4.14)

Adverse Events

Arm/Group Title	AZARGA
Arm/Group Description	Brinzolamide/timolol maleate fixed combination, one 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	0/9 (0%)
Other (Not Including Serious) Adverse Events
	AZARGA
	Affected / at Risk (%)	# Events
Total	0/9 (0%)

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.