Evaluation of Two Silicone Hydrogel Lenses Over a One Month Period

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Alcon Research ( CIBA VISION )

ClinicalTrials.gov Identifier:

NCT00810511

First received: December 17, 2008

Last updated: June 26, 2012

Last verified: January 2012

History of Changes

Results First Received: July 23, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment
Condition:	Myopia
Interventions:	Device: Lotrafilcon A contact lens Device: Comfilcon 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, spherical, silicone hydrogel contact lenses
Comfilcon A	Commercially marketed, spherical, silicone hydrogel contact lenses

Participant Flow: Overall Study

	Lotrafilcon A	Comfilcon A
STARTED	107	106
COMPLETED	97	102
NOT COMPLETED	10	4
Protocol Violation	0	1
Lack of Efficacy	9	1
death in the family	0	1
Lost to Follow-up	1	0
deposits on contact lens	0	1

Baseline Characteristics

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Reporting Groups

	Description
Lotrafilcon A	Investigational, spherical, silicone hydrogel contact lenses
Comfilcon A	Commercially marketed, spherical, silicone hydrogel contact lenses
Total	Total of all reporting groups

Baseline Measures

	Lotrafilcon A	Comfilcon A	Total
Number of Participants [units: participants]	107	106	213
Age [units: participants]
<=18 years	11	10	21
Between 18 and 65 years	96	96	192
>=65 years	0	0	0
Age [units: years] Mean ± Standard Deviation	30.6 ± 9.8	31.8 ± 11.0	31.2 ± 10.4
Gender [units: participants]
Female	84	84	168
Male	23	22	45
Region of Enrollment [units: participants]
United States	107	106	213

Outcome Measures

1. Primary:

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

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Measure Type	Primary
Measure Title	Comfort at End of Day
Measure Description	Evaluated by the subject as a single, retrospective evaluation of 4-week wear time. Measured on a 10-point scale, with 1 being poor and 10 being excellent.
Time Frame	After 4 weeks of wear
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.
One subject in the Lotrafilcon A arm was excluded from efficacy analysis due to a protocol deviation.

Reporting Groups

	Description
Lotrafilcon A	Investigational, spherical, silicone hydrogel contact lenses
Comfilcon A	Commercially marketed, spherical, silicone hydrogel contact lenses

Measured Values

	Lotrafilcon A	Comfilcon A
Number of Participants Analyzed [units: participants]	96	102
Comfort at End of Day [units: Scale of 1-10] Mean ± Standard Deviation	6.5 ± 2.4	6.9 ± 2.4

No statistical analysis provided for Comfort at End of Day

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:	NCT00810511 History of Changes
Other Study ID Numbers:	P-335-C-007
Study First Received:	December 17, 2008
Results First Received:	July 23, 2010
Last Updated:	June 26, 2012
Health Authority:	United States: Institutional Review Board

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