Prospective Study of Lens Performance of a Monthly Replacement Lens at Two Weeks and Four Weeks

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Alcon Research ( CIBA VISION )

ClinicalTrials.gov Identifier:

NCT01293240

First received: February 9, 2011

Last updated: June 26, 2012

Last verified: May 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	February 9, 2011
Last Updated Date	June 26, 2012
Start Date ^ICMJE	December 2010
Primary Completion Date	April 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: May 1, 2012)	Overall Comfort [ Time Frame: 2 weeks ] [ Designated as safety issue: No ] Overall comfort was assessed and reported by the participant on a questionnaire as a single, retrospective evaluation of 2 weeks of wear. Overall comfort was measured on a 10-point scale, with 1 being poor and 10 being excellent. Overall Comfort [ Time Frame: 4 weeks ] [ Designated as safety issue: No ] Overall comfort was assessed and reported by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Overall comfort was measured on a 10-point scale, with 1 being poor and 10 being excellent. End of Day Dryness [ Time Frame: 2 weeks ] [ Designated as safety issue: No ] End of day dryness was assessed and reported by the participant on a questionnaire as a single, retrospective evaluation of 2 weeks of wear. End of day dryness was measured on a 10-point scale, with 1 being very dry and 10 being not dry. End of Day Dryness [ Time Frame: 4 weeks ] [ Designated as safety issue: No ] End of day dryness was assessed and reported by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. End of day dryness was measured on a 10-point scale, with 1 being very dry and 10 being not dry. Ocular Redness [ Time Frame: 2 weeks ] [ Designated as safety issue: No ] Ocular redness was assessed and reported by the participant on a questionnaire as a single, retrospective evaluation of 2 weeks of wear. Ocular redness was measured on a 10-point scale, with 1 being very red and 10 being not red. Ocular Redness [ Time Frame: 4 weeks ] [ Designated as safety issue: No ] Ocular redness was assessed and reported by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Ocular redness was measured on a 10-point scale, with 1 being very red and 10 being not red. Visual Clarity [ Time Frame: 2 weeks ] [ Designated as safety issue: No ] Visual clarity was assessed and reported by the participant on a questionnaire as a single, retrospective evaluation of 2 weeks of wear. Visual clarity was measured on a 10-point scale, with 1 being poor and 10 being excellent. Visual Clarity [ Time Frame: 4 weeks ] [ Designated as safety issue: No ] Visual clarity was assessed and reported by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Visual clarity was measured on a 10-point scale, with 1 being poor and 10 being excellent. Lens Deposits [ Time Frame: 2 weeks ] [ Designated as safety issue: No ] Protein and lipid deposits on the contact lens surface were assessed for each eye by the investigator using a biomicroscope, which magnifies the appearance of the contact lens on the wearer's eye. Deposits were graded on a scale of 0 to 4, with 0 being none and 4 being severe. Lens Deposits [ Time Frame: 4 weeks ] [ Designated as safety issue: No ] Protein and lipid deposits on the contact lens surface were assessed for each eye by the investigator using a biomicroscope, which magnifies the appearance of the contact lens on the wearer's eye. Deposits were graded on a scale of 0 to 4, with 0 being none and 4 being severe. Corrected Visual Acuity [ Time Frame: 2 weeks ] [ Designated as safety issue: No ] Each eye was tested individually while the participant read distant charts in normal lighting. Corrected visual acuity was measured using a Snellen chart, which was converted into logMAR units (logarithm of the minimum angle of resolution). A 20/20 Snellen acuity equates to a logMAR acuity of 0.0 and is considered normal distance eyesight. Positive logMAR values indicate poorer vision, and negative values denote better visual acuity. Corrected Visual Acuity [ Time Frame: 4 weeks ] [ Designated as safety issue: No ] Each eye was tested individually while the participant read distant charts in normal lighting. Corrected visual acuity was measured using a Snellen chart, which was converted into logMAR units (logarithm of the minimum angle of resolution). A 20/20 Snellen acuity equates to a logMAR acuity of 0.0 and is considered normal distance eyesight. Positive logMAR values indicate poorer vision, and negative values denote better visual acuity.
Original Primary Outcome Measures ^ICMJE (submitted: February 9, 2011)	Objective Visual Acuity [ Time Frame: 2 weeks of wear and 4 weeks of wear ] [ Designated as safety issue: No ] Visual acuity, as measured using the distance Snellen charts.
Change History	Complete list of historical versions of study NCT01293240 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Prospective Study of Lens Performance of a Monthly Replacement Lens at Two Weeks and Four Weeks
Official Title ^ICMJE	Prospective Study of Lens Performance of a Monthly Replacement Lens at Two Weeks and Four Weeks
Brief Summary	The purpose of this study is to compare the overall performance of a monthly replacement contact lens when worn for one month and when worn for two weeks.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Myopia Astigmatism Presbyopia
Intervention ^ICMJE	Device: lotrafilcon B contact lens Commercially marketed, silicone hydrogel contact lens worn bilaterally on a daily wear basis for up to 30 days with a two week and four week evaluation visit. Other Name: AIR OPTIX® AQUA, AIR OPTIX® for ASTIGMATISM, AIR OPTIX® AQUA MULTIFOCAL
Study Arm (s)	Experimental: Lotrafilcon B Intervention: Device: lotrafilcon B contact lens
Publications *	Not Provided
* 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	117
Completion Date	April 2011
Primary Completion Date	April 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Habitual and successful wearers of contact lenses made of lotrafilcon B material for at least 4 weeks prior to enrollment. Good general health. Sphere requirement in the range +6.00 to -10.00 with astigmatism or multifocal correction or no astigmatism or multifocal correction. Ability to comply with all protocol-mandated procedures and to attend all scheduled office visits. Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Anterior segment abnormalities (i.e., cataracts, opacities, etc.) or active anterior segment disease. Administration of any investigational drug or device within 14 days of study initiation. Use of any eye drops with a pharmacological effect within 7 days of Visit 1. Known local or systemic hypersensitivity to contact lens cleaning and disinfecting solutions. Post-refractive surgery. Currently pregnant or lactating by case history. 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	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT01293240
Other Study ID Numbers ^ICMJE	P-368-C-400
Has Data Monitoring Committee	No
Responsible Party	Alcon Research ( CIBA VISION )
Study Sponsor ^ICMJE	CIBA VISION
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Alcon Research
Verification Date	May 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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