Assessing the Performance of Lotrafilcon A Lenses During a Three Month Period

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Alcon Research ( CIBA VISION )

ClinicalTrials.gov Identifier:

NCT00933166

First received: July 2, 2009

Last updated: June 26, 2012

Last verified: January 2012

History of Changes

Results First Received: December 2, 2010

Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Myopia
Intervention:	Device: Lotrafilcon A contact lens

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
Lotrafilcon A	Investigational contact lens worn in both eyes for three months

Participant Flow: Overall Study

	Lotrafilcon A
STARTED	169
COMPLETED	151
NOT COMPLETED	18
Lost to Follow-up	4
Lack of Efficacy	9
Unavailable	4
Withdrawal by Subject	1

Baseline Characteristics

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Reporting Groups

	Description
Lotrafilcon A	Investigational contact lens worn in both eyes for three months

Baseline Measures

	Lotrafilcon A
Number of Participants [units: participants]	169
Age [units: years] Mean ± Standard Deviation	37.3 ± 12.1
Gender [units: participants]
Female	115
Male	54

Outcome Measures

1. Primary:

Comfort After Insertion [ Time Frame: 3 months ]

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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: For a period of 10 years, the clinical investigator must hold all trial-related information and documents confidential and must agree to obtain sponsor’s written consent before discussing, presenting, publicizing, or otherwise disclosing any preclinical and/or clinical data or impressions from this trial.

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: Priya Janakiraman, OD, FAAO / Head, Global Clinical Affairs
Organization: CIBA VISION
phone: 1-800-241-7629
e-mail: priya.janakiraman@cibavision.com

No publications provided

Responsible Party:	Alcon Research ( CIBA VISION )
ClinicalTrials.gov Identifier:	NCT00933166 History of Changes
Other Study ID Numbers:	P-335-C-014v2
Study First Received:	July 2, 2009
Results First Received:	December 2, 2010
Last Updated:	June 26, 2012
Health Authority:	United States: Institutional Review Board

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