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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Alcon Research

ClinicalTrials.gov Identifier:

NCT01415401

First received: August 10, 2011

Last updated: May 30, 2014

Last verified: May 2014

History of Changes

Results First Received: May 30, 2014

Study Type:	Interventional
Study Design:	Endpoint Classification: Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Conditions:	Glaucoma Ocular Hypertension Open-angle Glaucoma
Intervention:	Drug: Brinzolamide 1% / timolol 0.5% maleate fixed combination

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were recruited from 8 study centers located in Canada.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of the 57 enrolled, 3 participants were exited as screen failures. This reporting group includes all participants who received study medication (54).

Reporting Groups

	Description
AZARGA	Brinzolamide 1% / timolol 0.5% maleate fixed combination, 1 drop self-administered in study eye(s) twice daily for 8 weeks (8AM and 8PM)

Participant Flow: Overall Study

	AZARGA
STARTED	54
COMPLETED	47
NOT COMPLETED	7
Adverse Event	5
DId not meet inclusion/exclusion criteri	1
Terminated by Sponsor	1

Baseline Characteristics

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Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
This analysis population includes all participants who received study medication.

Reporting Groups

	Description
AZARGA	Brinzolamide 1% / timolol 0.5% maleate fixed combination, 1 drop self-administered in study eye(s) twice daily for 8 weeks (8AM and 8PM)

Baseline Measures

	AZARGA
Number of Participants [units: participants]	54
Age [units: years] Mean (Standard Deviation)	69.6 (10.37)
Gender [units: participants]
Female	28
Male	26

Outcome Measures

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1. Primary:

Change in IOP at the Final Visit From Prior Brimonidine 0.2%/Timolol 0.5% Fixed Combination (COMBIGAN®) Therapy (i.e. From Baseline) [ Time Frame: Baseline, Week 8 ]

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2. Secondary:

Percentage of Subjects Who Reach Target IOP (≤ 18 mmHg) [ Time Frame: Week 8 ]

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Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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More Information

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Certain Agreements:

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

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Sponsor reserves the right of prior review of any publication or presentation of information related to the study.

Results Point of Contact:

Name/Title: Doug Hubatsch, Global Brand Leader
Organization: Alcon Research, Ltd.
phone: 1-888-451-3937
e-mail: alcon.medinfo@alcon.com

Responsible Party:	Alcon Research
ClinicalTrials.gov Identifier:	NCT01415401 History of Changes
Other Study ID Numbers:	RDG-11-199
Study First Received:	August 10, 2011
Results First Received:	May 30, 2014
Last Updated:	May 30, 2014
Health Authority:	Canada: Ethics Review Committee

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