A Long-term Safety Study of Once-daily Travatan

This study has been completed.

Study NCT00051168 Information provided by Alcon Research

First Received on January 3, 2003. Last Updated on October 2, 2011 History of Changes

Results First Received: March 22, 2010

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Conditions:	Glaucoma, Open-angle Ocular Hypertension
Intervention:	Drug: Travatan

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
Patients were recruited in ophthalmic clinics, academic and civil hospitals from September 24, 2002. Last patient completed the study on March 23, 2009.

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
Travatan	Travoprost (0.004%)

Participant Flow: Overall Study

	Travatan
STARTED	502
COMPLETED	367
NOT COMPLETED	135

Baseline Characteristics

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Reporting Groups

	Description
Travatan	Travoprost (0.004%)

Baseline Measures

	Travatan
Number of Participants [units: participants]	502
Age [units: participants]
<=18 years	0
Between 18 and 65 years	237
>=65 years	265
Gender [units: participants]
Female	281
Male	221

Outcome Measures

1. Primary:

Mean Intraocular Pressure [ Time Frame: At 5 years. ]

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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.

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: Alcon Clinical
Organization: Alcon Research, Ltd.
phone: 888.451.3937; 817.568.6725
e-mail: medinfo@alconlabs.com

No publications provided

Responsible Party:	Alcon Research
ClinicalTrials.gov Identifier:	NCT00051168 History of Changes
Other Study ID Numbers:	C-02-20
Study First Received:	January 3, 2003
Results First Received:	March 22, 2010
Last Updated:	October 2, 2011
Health Authority:	United States: Food and Drug Administration