In-vivo Wettability Grading and Assessment Study - Tabular View

Tracking Information
First Received Date ^ICMJE	November 9, 2009
Last Updated Date	June 26, 2012
Start Date ^ICMJE	October 2009
Primary Completion Date	April 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: May 3, 2011)	On-eye Wettability [ Time Frame: 4 weeks of wear ] [ Designated as safety issue: No ] On-eye wettability, as assessed at the 4-week visit by a masked observer from a video taken of the eye 5 minutes after lens insertion. On-eye wettability was recorded on a 5-point scale, with 0=excellent and 4=very poor.
Original Primary Outcome Measures ^ICMJE (submitted: November 9, 2009)	The primary outcome variable is to test clinical application of a grading system for graded wettability with various silicone hydrogel lens materials over time. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Change History	Complete list of historical versions of study NCT01010555 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE (submitted: November 9, 2009)	visual acuity [ Time Frame: 4 weeks ] [ Designated as safety issue: No ] time to haze [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Current Other Outcome Measures ^ICMJE
Original Other Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	In-vivo Wettability Grading and Assessment Study
Official Title ^ICMJE
Brief Summary	The purpose of this study is to investigate the front surface wettability of soft contact lenses while on eye.
Detailed Description
Study Type ^ICMJE	Interventional
Study Phase
Study Design ^ICMJE	Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Myopia
Intervention ^ICMJE	Device: lotrafilcon B Commercially marketed, silicone hydrogel, spherical contact lens Other Name: Air Optix Device: balafilcon A Commercially marketed, silicone hydrogel, spherical contact lens Other Name: PureVision Device: senofilcon A Commercially marketed, silicone hydrogel, spherical contact lens Other Name: Acuvue OASYS Device: enfilcon A Commercially marketed, silicone hydrogel, spherical contact lens Other Name: Avaira
Study Arms	Active Comparator: lotrafilcon B Lotrafilcon B contact lens randomly assigned to one eye, with balafilcon A contact lens assigned to the fellow eye for contralateral wear. Both products to be worn on a daily wear basis for 4 weeks, after which participant will wear senofilcon A contact lens randomly assigned to one eye and enfilcon A contact lens in the fellow eye for an additional 4 weeks of daily wear. Intervention: Device: lotrafilcon B Active Comparator: balafilcon A Balafilcon A contact lens randomly assigned to one eye, with lotrafilcon B contact lens assigned to the fellow eye for contralateral wear. Both products to be worn on a daily wear basis for 4 weeks, after which participant will wear senofilcon A contact lens randomly assigned to one eye and enfilcon A contact lens in the fellow eye for an additional 4 weeks of daily wear. Intervention: Device: balafilcon A Active Comparator: senofilcon A Senofilcon A contact lens randomly assigned to one eye, with enfilcon A contact lens assigned to the fellow eye for contralateral wear. Both products to be worn on a daily wear basis for 4 weeks, after which participant will wear lotrafilcon B contact lens randomly assigned to one eye and balafilcon A contact lens in the fellow eye for an additional 4 weeks of daily wear. Intervention: Device: senofilcon A Active Comparator: enfilcon A Enfilcon A contact lens randomly assigned to one eye, with senofilcon A contact lens assigned to the fellow eye for contralateral wear. Both products to be worn on a daily wear basis for 4 weeks, after which participant will wear lotrafilcon B contact lens randomly assigned to one eye and balafilcon A contact lens in the fellow eye for an additional 4 weeks of daily wear. Intervention: Device: enfilcon A
Publications *
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	25
Completion Date	April 2010
Primary Completion Date	April 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: is at least 17 years of age has read and signed an information consent letter is a current daily wear contact lens wearer has acceptable fit with the study lenses has had an ocular exam in the last two years other protocol-defined inclusion criteria may apply Exclusion Criteria: has any ocular disease has undergone corneal refractive surgery or is aphakic has any systemic disease affecting ocular health is pregnant or lactating other protocol-defined exclusion criteria may apply
Gender	Both
Ages	17 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Canada

Administrative Information
NCT Number ^ICMJE	NCT01010555
Other Study ID Numbers ^ICMJE	P-368-C-104
Has Data Monitoring Committee	No
Responsible Party	Alcon Research ( CIBA VISION )
Study Sponsor ^ICMJE	CIBA VISION
Collaborators ^ICMJE	University of Waterloo
Investigators ^ICMJE
Information Provided By	Alcon Research
Verification Date	January 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP