Safety and Efficacy of Bimatoprost/Timolol Fixed Combination Versus Latanoprost in Patients With Open-Angle Glaucoma Who Have Never Been Treated

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Allergan

ClinicalTrials.gov Identifier:

NCT01243567

First received: November 17, 2010

Last updated: January 22, 2013

Last verified: January 2013

History of Changes

Results First Received: January 22, 2013

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Single Blind (Investigator); Primary Purpose: Treatment
Condition:	Glaucoma, Open-Angle
Interventions:	Drug: bimatoprost 0.03%/timolol 0.5% combination ophthalmic solution Drug: latanoprost 0.005% ophthalmic solution

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
Bimatoprost 0.03%/Timolol 0.5% Combination Ophthalmic Solution	Bimatoprost 0.03%/timolol 0.5% combination ophthalmic solution (GANfort®) administered to each eye requiring treatment, once daily in the evening for 3 months.
Latanoprost 0.005% Ophthalmic Solution	Latanoprost 0.005% ophthalmic solution (Xalatan®) administered to each eye requiring treatment, once daily in the evening for 3 months.

Participant Flow: Overall Study

	Bimatoprost 0.03%/Timolol 0.5% Combination Ophthalmic Solution	Latanoprost 0.005% Ophthalmic Solution
STARTED	43	38
COMPLETED	42	38
NOT COMPLETED	1	0

Baseline Characteristics

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Reporting Groups

	Description
Bimatoprost 0.03%/Timolol 0.5% Combination Ophthalmic Solution	Bimatoprost 0.03%/timolol 0.5% combination ophthalmic solution (GANfort®) administered to each eye requiring treatment, once daily in the evening for 3 months.
Latanoprost 0.005% Ophthalmic Solution	Latanoprost 0.005% ophthalmic solution (Xalatan®) administered to each eye requiring treatment, once daily in the evening for 3 months.
Total	Total of all reporting groups

Baseline Measures

	Bimatoprost 0.03%/Timolol 0.5% Combination Ophthalmic Solution	Latanoprost 0.005% Ophthalmic Solution	Total
Number of Participants [units: participants]	43	38	81
Age [units: Years] Mean ± Standard Deviation	65.9 ± 10.24	63.1 ± 13.72	64.6 ± 12.01
Gender [units: Participants]
Female	20	18	38
Male	23	20	43

Outcome Measures

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1. Primary:

Change From Baseline in Average Intraocular Pressure (IOP) [ Time Frame: Baseline, Month 3 ]

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2. Secondary:

Change From Baseline IOP [ Time Frame: Baseline, Month 3 ]

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3. Secondary:

Percentage of Patients Reaching a Predefined Target Pressure Threshold [ Time Frame: Baseline, Month 3 ]

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4. Secondary:

Absolute Difference Between Patient's Highest IOP Reading at Baseline (Day 0) and the Corresponding IOP Reading [ Time Frame: Baseline, Month 3 ]

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5. Secondary:

Absolute Difference Between Patient's Lowest IOP Reading at Baseline (Day 0) and the Corresponding IOP Reading [ Time Frame: Baseline, Month 3 ]

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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:	NCT01243567 History of Changes
Other Study ID Numbers:	MAF-AGN-OPH-GLA-010, 2009-012799-28
Study First Received:	November 17, 2010
Results First Received:	January 22, 2013
Last Updated:	January 22, 2013
Health Authority:	Spain: Agency for Medicines and Medical Devices (AEMPS) Portugal: National Authority for Medicines and Health Products (INFARMED)

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