Non-dispense Comfort Comparison of Two Silicone Hydrogel Lenses

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Alcon Research ( CIBA VISION )

ClinicalTrials.gov Identifier:

NCT00808834

First received: December 11, 2008

Last updated: June 26, 2012

Last verified: January 2012

History of Changes

Results First Received: June 18, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment
Condition:	Myopia
Interventions:	Device: Lotrafilcon A contact lens Device: Senofilcon 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
Senofilcon A / Lotrafilcon A	Senofilcon A, followed by Lotrafilcon A
Lotrafilcon A / Senofilcon A	Lotrafilcon A, followed by Senofilcon A

Participant Flow for 2 periods

Period 1: Period 1

	Senofilcon A / Lotrafilcon A	Lotrafilcon A / Senofilcon A
STARTED	97	99
COMPLETED	97	99
NOT COMPLETED	0	0

Period 2: Period 2

	Senofilcon A / Lotrafilcon A	Lotrafilcon A / Senofilcon A
STARTED	97	99
COMPLETED	97	99
NOT COMPLETED	0	0

Baseline Characteristics

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Reporting Groups

	Description
Overall	This reporting group includes all enrolled and exposed subjects.

Baseline Measures

	Overall
Number of Participants [units: participants]	196
Age [units: years] Mean ± Standard Deviation	30.7 ± 12.9
Gender [units: participants]
Female	141
Male	55
Region of Enrollment [units: participants]
United States	196

Outcome Measures

1. Primary:

Comfort After Insertion [ Time Frame: 30-60 seconds after initial insertion ]

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Measure Type	Primary
Measure Title	Comfort After Insertion
Measure Description	Evaluated by the subject and measured on a 10-point scale, with 1 being poor and 10 being excellent.
Time Frame	30-60 seconds after initial insertion
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Per protocol

Reporting Groups

	Description
Senofilcon A	Commercially marketed, silicone hydrogel, spherical, soft contact lens
Lotrafilcon A	Investigational, silicone hydrogel, spherical, soft contact lens

Measured Values

	Senofilcon A	Lotrafilcon A
Number of Participants Analyzed [units: participants]	193	193
Comfort After Insertion [units: Scale 1-10] Mean ± Standard Deviation	8.7 ± 1.5	7.7 ± 2.4

No statistical analysis provided for Comfort After Insertion

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:	NCT00808834 History of Changes
Other Study ID Numbers:	P-335-C-008
Study First Received:	December 11, 2008
Results First Received:	June 18, 2010
Last Updated:	June 26, 2012
Health Authority:	United States: Institutional Review Board

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