Clinical Evaluation of a Silicone Hydrogel Lens

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Alcon Research ( CIBA VISION )

ClinicalTrials.gov Identifier:

NCT01016132

First received: November 17, 2009

Last updated: June 26, 2012

Last verified: September 2011

History of Changes

Results First Received: December 17, 2010

Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment; Masking: Double Blind (Subject, Investigator); 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
All Participants	In this single group study, all participants wore an investigational lotrafilcon A silicone hydrogel, single-vision, soft contact lens in both eyes for a period of four weeks. Participants wore the study lenses at least as often as they wore their habitual lenses, and as prescribed by their eye care practitioners -- ie., on a daily wear, flex wear, or extended wear basis.

Participant Flow: Overall Study

	All Participants
STARTED	152
COMPLETED	151
NOT COMPLETED	1
Discomfort	1

Baseline Characteristics

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Reporting Groups

	Description
All Participants	In this single group study, all participants wore an investigational lotrafilcon A silicone hydrogel, single-vision, soft contact lens in both eyes for a period of four weeks. Participants wore the study lenses at least as often as they wore their habitual lenses, and as prescribed by their eye care practitioners -- ie., on a daily wear, flex wear, or extended wear basis.

Baseline Measures

	All Participants
Number of Participants [units: participants]	152
Age [units: years] Mean ± Standard Deviation	33.5 ± 10.9
Gender [units: participants]
Female	97
Male	55

Outcome Measures

1. Primary:

Overall Preference [ Time Frame: 4 weeks of wear ]

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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:	NCT01016132 History of Changes
Other Study ID Numbers:	P-019-C-055
Study First Received:	November 17, 2009
Results First Received:	December 17, 2010
Last Updated:	June 26, 2012
Health Authority:	United States: Institutional Review Board

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