Safety and Efficacy of Brimonidine Tartrate/Timolol Fixed Combination in Patients With Glaucoma or Ocular Hypertension

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Allergan

ClinicalTrials.gov Identifier:

NCT01229462

First received: October 26, 2010

Last updated: August 15, 2012

Last verified: August 2012

History of Changes

Results First Received: August 15, 2012

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment
Conditions:	Glaucoma Ocular Hypertension
Interventions:	Drug: brimonidine tartrate/timolol fixed combination ophthalmic solution Drug: brimonidine tartrate ophthalmic solution Drug: timolol ophthalmic solution Other: fixed combination vehicle

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®	One drop of brimonidine tartrate/timolol fixed combination ophthalmic solution (Combigan®) and one drop of brimonidine tartrate/timolol fixed combination vehicle administered to the affected eye(s) twice daily (morning and evening) for four weeks.
Alphagan® and Timolol Concurrent	One drop of brimonidine tartrate ophthalmic solution (Alphagan®) and one drop of timolol ophthalmic solution administered to the affected eye(s) twice daily (morning and evening) for four weeks.

Participant Flow: Overall Study

	Combigan®	Alphagan® and Timolol Concurrent
STARTED	120	118
COMPLETED	115	109
NOT COMPLETED	5	9

Baseline Characteristics

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Reporting Groups

	Description
Combigan®	One drop of brimonidine tartrate/timolol fixed combination ophthalmic solution (Combigan®) and one drop of brimonidine tartrate/timolol fixed combination vehicle administered to the affected eye(s) twice daily (morning and evening) for four weeks.
Alphagan® and Timolol Concurrent	One drop of brimonidine tartrate ophthalmic solution (Alphagan®) and one drop of timolol ophthalmic solution administered to the affected eye(s) twice daily (morning and evening) for four weeks.
Total	Total of all reporting groups

Baseline Measures

	Combigan®	Alphagan® and Timolol Concurrent	Total
Number of Participants [units: participants]	120	118	238
Age [units: Years] Mean ± Standard Deviation	46.2 ± 15.18	48.2 ± 15.57	47.2 ± 15.38
Gender [units: Participants]
Female	48	55	103
Male	72	63	135

Outcome Measures

1. Primary:

Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) in the Study Eye at Week 4 [ Time Frame: Baseline, Week 4 ]

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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 NOT 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.

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: Therapeutic Area Head,
Organization: Allergan, Inc
phone: 714-246-4500
e-mail: clinicaltrials@allergan.com

No publications provided

Responsible Party:	Allergan
ClinicalTrials.gov Identifier:	NCT01229462 History of Changes
Other Study ID Numbers:	190342-035
Study First Received:	October 26, 2010
Results First Received:	August 15, 2012
Last Updated:	August 15, 2012
Health Authority:	China: State Food and Drug Administration P.R. China (SFDA)

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