Clinical Performance of a Silicone Hydrogel Lens With Use of FID 114675A

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Alcon Research

ClinicalTrials.gov Identifier:

NCT01240135

First received: November 10, 2010

Last updated: June 8, 2012

Last verified: June 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	November 10, 2010
Last Updated Date	June 8, 2012
Start Date ^ICMJE	October 2010
Primary Completion Date	February 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: June 8, 2012)	Lens Fit [ Time Frame: Day 14 of lens wear ] [ Designated as safety issue: No ] As assessed by the investigator using a composite score based on three lens fit measures: static, push-up, and centration. Static and pushup were assessed on a 5-point scale, where -2=reduced movement unacceptable, -1=reduced movement acceptable, 0=optimal movement, 1=excessive movement acceptable, 2=excessive movement unacceptable. Centration was assessed on a 3-point scale, where 0=optimal lens centration, 1=acceptable decentration, 2=unacceptable decentration. A subject with an assessment of optimal or acceptable for each measure was considered acceptable on all measurements.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01240135 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: June 8, 2012)	Mean Change From Baseline for Circumlimbal Conjunctival Staining Sum Score [ Time Frame: Day 14 of lens wear ] [ Designated as safety issue: No ] The bulbar conjunctiva was assessed by the investigator at baseline and Day 14 utilizing a slit-lamp and ophthalmic dye. Staining coverage was scored separately in each of four regions (nasal, temporal, inferior, and superior) using a 5-point photographic reference scale, where 0=0.00% coverage and 4=10% or greater coverage. The scores for the four regions were summed, with a sum score range of 0-16.
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE
Original Other Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Clinical Performance of a Silicone Hydrogel Lens With Use of FID 114675A
Official Title ^ICMJE	Clinical Performance of a Marketed Silicone Hydrogel Contact Lens When Used With Silicone Hydrogel MPDS FID 114675A
Brief Summary	The purpose of this study is to evaluate the clinical performance of a silicone hydrogel contact lens when used with an investigational multi-purpose disinfecting solution (MPDS).
Detailed Description
Study Type ^ICMJE	Interventional
Study Phase
Study Design ^ICMJE	Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Supportive Care
Condition ^ICMJE	Contact Lens Fit Myopia
Intervention ^ICMJE	Device: FID 114675A multi-purpose disinfecting solution (MPDS) Daily regimen, 14 days: Thoroughly wet and rub each side of study contact lens for 10 seconds, rinse each side of the lens for 10 seconds, and soak contact lens for at least 6 hours. Other Name: Alcon Multi-Purpose Disinfecting Solution (MPDS) Device: renu fresh Multi-Purpose Solution (MPS) Daily regimen, 14 days: Wet study contact lens with 3 drops and rub each side of the lens for 20 seconds, rinse each side of the lens for 5 seconds, and soak contact lens for at least 4 hours. Other Name: Bausch + Lomb renu® fresh™ Multi-Purpose Solution Device: Galyfilcon A contact lenses (Acuvue Advance) A fresh pair of contact lenses matching subject's pre-study lenses, including parameters, dispensed at the beginning of each period for daily wear, minimum 8 hours per day, 14 days. Other Name: Acuvue® Advance®
Study Arm (s)	FID 114576A / renu fresh FID 114675A used for contact lens care per protocol-specified instructions for 14 days, followed by a minimum 1-day washout period, after which renu fresh used for contact lens care for an additional 14 days. Interventions: Device: FID 114675A multi-purpose disinfecting solution (MPDS) Device: renu fresh Multi-Purpose Solution (MPS) Device: Galyfilcon A contact lenses (Acuvue Advance) renu fresh / FID 114675A Renu fresh used for contact lens care per protocol-specified instructions for 14 days, followed by a minimum 1-day washout period, after FID 114675A used for contact lens care for an additional 14 days. Interventions: Device: FID 114675A multi-purpose disinfecting solution (MPDS) Device: renu fresh Multi-Purpose Solution (MPS) Device: Galyfilcon A contact lenses (Acuvue Advance)
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	89
Completion Date	February 2011
Primary Completion Date	February 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: 18 years of age or older. History of at least 5 days successful daily wear (minimum 8 hours per day) of spherical, single power Acuvue® Advance® SiH contact lenses prior to Visit 1. Wear contact lenses a minimum of 8 hours per day prior to Visit 1. Vision correctable to 20/30 (Snellen) or better in each eye at distance with study lenses at Visit 1. Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Need to wear contact lenses on an extended wear basis (i.e., overnight) during the study. Use of products other than a multi-purpose solution to care for lenses at least 7 days prior to Visit 1. Pre-study use of rewetting drops is acceptable. History of intolerance or known sensitivity to any component of the treatments. Use of over-the-counter (OTC) or prescribed topical ocular medications within 7 days prior to Visit 1. Other protocol-defined exclusion criteria may apply.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE

Administrative Information
NCT Number ^ICMJE	NCT01240135
Other Study ID Numbers ^ICMJE	C-10-030
Has Data Monitoring Committee	No
Responsible Party	Alcon Research
Study Sponsor ^ICMJE	Alcon Research
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Alcon Research
Verification Date	June 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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