Clinical Assessment of a Multifocal Contact Lens for People Who Use Reading Glasses Only

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Alcon Research ( CIBA VISION )

ClinicalTrials.gov Identifier:

NCT01268501

First received: December 29, 2010

Last updated: June 26, 2012

Last verified: February 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	December 29, 2010
Last Updated Date	June 26, 2012
Start Date ^ICMJE	December 2010
Primary Completion Date	February 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: February 6, 2012)	Overall Convenience With Contact Lenses [ Time Frame: 3 weeks of wear ] [ Designated as safety issue: No ] Overall convenience with contact lenses, as interpreted by the participant and reported on a questionnaire as a single, retrospective evaluation of 3 weeks of wear time. Overall convenience is measured on a 4-point scale: 1=very satisfied; 2=satisfied; 3=dissatisfied; 4=very dissatisfied. Results were reported as a percentage of participants who responded, "very satisfied" or "satisfied."
Original Primary Outcome Measures ^ICMJE (submitted: December 29, 2010)	Overall Convenience with Contact Lenses [ Time Frame: 3 weeks of wear ] [ Designated as safety issue: No ] Overall convenience with contact lenses, as interpreted by the participant and reported on a questionnaire as a single, retrospective evaluation of 3-weeks' wear time. Overall convenience is measured on a 4-point scale, with 1 being Very Satisfied and 4 being Very Dissatisfied.
Change History	Complete list of historical versions of study NCT01268501 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	Clinical Assessment of a Multifocal Contact Lens for People Who Use Reading Glasses Only
Official Title ^ICMJE	Clinical Assessment of a New Multifocal Contact Lens With Emmetropic Presbyopes
Brief Summary	The purpose of this trial is to evaluate the use of multifocal contact lenses in people who use reading glasses only.
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	Presbyopia
Intervention ^ICMJE	Device: Lotrafilcon B multifocal contact lens Commercially marketed, silicone hydrogel, multifocal, soft contact lenses FDA-approved for up to 4 weeks recommended replacement schedule and up to 6 nights of extended (overnight) wear. Other Name: AIR OPTIX® AQUA MULTIFOCAL
Study Arm (s)	Experimental: Lotrafilcon B multifocal Lotrafilcon B multifocal contact lenses worn bilaterally for 3 weeks on a daily wear basis Intervention: Device: Lotrafilcon B multifocal 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	103
Completion Date	February 2011
Primary Completion Date	February 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Is between 40 and 48 years of age (inclusive). Has read and signed the Informed Consent. Is willing and able to follow instructions and maintain the appointment schedule. Wears reading spectacles for close work. Other protocol-defined inclusion/exclusion criteria may apply. Exclusion Criteria: Eye injury or surgery within twelve weeks of enrollment. Evidence of systemic or ocular abnormality, infection, or disease likely to affect successful wear of contact lenses or use of accessory solutions. Currently enrolled in a clinical trial. Has worn contact lenses previously. Other protocol-defined inclusion/exclusion criteria may apply.
Gender	Both
Ages	40 Years to 48 Years
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	NCT01268501
Other Study ID Numbers ^ICMJE	P-319-C-019
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	February 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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