Comparing Efficacy and Safety of Combigan With Timolol Adjunctive to Xalatan in Glaucoma or Ocular Hypertension Subjects

This study has been completed.

Study NCT00735449 Information provided by Allergan

First Received on August 13, 2008. Last Updated on October 17, 2011 History of Changes

Results First Received: October 17, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Single Blind (Investigator); Primary Purpose: Treatment
Conditions:	Glaucoma Ocular Hypertension
Interventions:	Drug: Fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5%; latanoprost 0.005% Drug: timolol maleate 0.5%; latanoprost 0.005%

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
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Combigan®	Fixed combination of brimonidine tartrate 0.2%/timolol maleate 0.5% ophthalmic solution
Timolol Maleate 0.5%	Timolol maleate 0.5%

Participant Flow: Overall Study

	Combigan®	Timolol Maleate 0.5%
STARTED	102	102
COMPLETED	95	96
NOT COMPLETED	7	6

Baseline Characteristics

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Reporting Groups

	Description
Combigan®	Fixed combination of brimonidine tartrate 0.2%/timolol maleate 0.5% ophthalmic solution
Timolol Maleate 0.5%	Timolol maleate 0.5%

Baseline Measures

	Combigan®	Timolol Maleate 0.5%	Total
Number of Participants [units: participants]	102	102	204
Age [units: years] Median ( Full Range )	64.5 ( 30.1 to 87.0 )	65.9 ( 29.8 to 88.9 )	65.4 ( 29.8 to 88.9 )
Gender [units: participants]
Female	57	45	102
Male	45	57	102

Outcome Measures

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1. Primary:

Mean Intraocular Pressure (IOP) at 10 AM at Week 6 [ Time Frame: Week 6 ]

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2. Primary:

Mean Intraocular Pressure (IOP) at 10 AM at Week 12 [ Time Frame: Week 12 ]

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3. Secondary:

Mean Intraocular Pressure (IOP) at 8 AM at Week 6 [ Time Frame: Week 6 ]

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4. Secondary:

Mean Intraocular Pressure (IOP) at 8 AM at Week 12 [ Time Frame: Week 12 ]

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5. Secondary:

Number of Subjects With Adverse Events [ Time Frame: Week 12 ]

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Serious Adverse Events

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Other Adverse Events

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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: A 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 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo

Limitations and Caveats

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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Results Point of Contact:

Name/Title: Vice President Medical Affairs
Organization: Allergan, Inc.
phone: 714-246-4500
e-mail: clinicaltrials@allergan.com

No publications provided

Responsible Party:	Allergan
ClinicalTrials.gov Identifier:	NCT00735449 History of Changes
Other Study ID Numbers:	GMA-COM-07-XTC
Study First Received:	August 13, 2008
Results First Received:	October 17, 2011
Last Updated:	October 17, 2011
Health Authority:	United States: Institutional Review Board