One Month Performance Comparison Between Two Commercially Available Silicone Hydrogel Lenses

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Alcon Research ( CIBA VISION )

ClinicalTrials.gov Identifier:

NCT01300741

First received: February 18, 2011

Last updated: June 26, 2012

Last verified: April 2012

History of Changes

Results First Received: April 11, 2012

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Single Group Assignment; Masking: Single Blind (Subject); Primary Purpose: Treatment
Condition:	Myopia
Interventions:	Device: Lotrafilcon B contact lens (AIR OPTIX® AQUA) Device: Galyfilcon A contact lens (ACUVUE® ADVANCE® Plus) Device: Contact lens solution (Clear Care®)

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
Participants were recruited from 5 US study centers.

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 B / Galyfilcon A	Lotrafilcon B commercially marketed contact lens randomly assigned to one eye, with galyfilcon A commercially marketed contact lens in the fellow eye for contralateral wear. Lenses were worn in a daily wear (DW) modality for approximately 5 days or more per week, at least 10 hours per day, for up to 4 weeks.

Participant Flow: Overall Study

	Lotrafilcon B / Galyfilcon A
STARTED	75
COMPLETED	72
NOT COMPLETED	3
Lens deposits	1
Lost to Follow-up	1
Discomfort	1

Baseline Characteristics

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Reporting Groups

	Description
Lotrafilcon B / Galyfilcon A	Lotrafilcon B commercially marketed contact lens randomly assigned to one eye, with galyfilcon A commercially marketed contact lens in the fellow eye for contralateral wear. Lenses were worn in a daily wear (DW) modality for approximately 5 days or more per week, at least 10 hours per day, for up to 4 weeks.

Baseline Measures

	Lotrafilcon B / Galyfilcon A
Number of Participants [units: participants]	75
Age [units: years] Mean ± Standard Deviation	30.9 ± 9.2
Gender [units: participants]
Female	53
Male	22

Outcome Measures

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1. Primary:

Comfort on Insertion [ Time Frame: 4 weeks ]

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2. Primary:

Comfort During the Day [ Time Frame: 4 weeks ]

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3. Primary:

Comfort at End of Day [ Time Frame: 4 weeks ]

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Measure Type	Primary
Measure Title	Comfort at End of Day
Measure Description	As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Comfort at end of day was graded on a 10-point scale, with 1 being poor and 10 being excellent.
Time Frame	4 weeks
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.
Analysis conducted per protocol, with exclusions due to reasons such as, major protocol deviations as determined by masked review; discontinuations; and/or missing responses.

Reporting Groups

	Description
Lotrafilcon B	Lotrafilcon B commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality.
Galyfilcon A	Galyfilcon A commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality, with a replacement lens issued at 2 weeks.

Measured Values

	Lotrafilcon B	Galyfilcon A
Number of Participants Analyzed [units: participants]	69	69
Comfort at End of Day [units: Units on a Scale] Mean ± Standard Deviation	7.8 ± 1.9	7.7 ± 2.0

No statistical analysis provided for Comfort at End of Day

4. Primary:

Overall Comfort [ Time Frame: 4 weeks ]

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5. Primary:

Daytime Vision [ Time Frame: 4 weeks ]

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6. Primary:

Low Light Vision [ Time Frame: 4 weeks ]

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7. Primary:

Handling on Insertion [ Time Frame: 4 weeks ]

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8. Primary:

Handling at Removal [ Time Frame: 4 weeks ]

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9. Primary:

Delivers a Healthy, Natural Feeling [ Time Frame: 4 weeks ]

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10. Primary:

Lens Awareness [ Time Frame: 4 weeks ]

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11. Primary:

Overall Satisfaction [ Time Frame: 4 weeks ]

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12. Primary:

Purchase Intent [ Time Frame: 4 weeks ]

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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
No text entered.

Results Point of Contact:

Name/Title: Director of Clinical Trials
Organization: Alcon Research
phone: 1-800-241-7629

No publications provided

Responsible Party:	Alcon Research ( CIBA VISION )
ClinicalTrials.gov Identifier:	NCT01300741 History of Changes
Other Study ID Numbers:	P-336-C-018
Study First Received:	February 18, 2011
Results First Received:	April 11, 2012
Last Updated:	June 26, 2012
Health Authority:	United States: Institutional Review Board

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