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

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ClinicalTrials.gov Identifier: NCT01268501
Recruitment Status : Completed
First Posted : December 31, 2010
Results First Posted : February 9, 2012
Last Update Posted : June 29, 2012
Sponsor:
Information provided by (Responsible Party):
Alcon Research ( CIBA VISION )

Brief Summary:
The purpose of this trial is to evaluate the use of multifocal contact lenses in people who use reading glasses only.

Condition or disease Intervention/treatment Phase
Presbyopia Device: Lotrafilcon B multifocal contact lens Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 103 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Assessment of a New Multifocal Contact Lens With Emmetropic Presbyopes
Study Start Date : December 2010
Actual Primary Completion Date : February 2011
Actual Study Completion Date : February 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear

Arm Intervention/treatment
Experimental: Lotrafilcon B multifocal
Lotrafilcon B multifocal contact lenses worn bilaterally for 3 weeks on a daily wear basis
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




Primary Outcome Measures :
  1. Overall Convenience With Contact Lenses [ Time Frame: 3 weeks of wear ]
    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."



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Ages Eligible for Study:   40 Years to 48 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Responsible Party: CIBA VISION
ClinicalTrials.gov Identifier: NCT01268501     History of Changes
Other Study ID Numbers: P-319-C-019
First Posted: December 31, 2010    Key Record Dates
Results First Posted: February 9, 2012
Last Update Posted: June 29, 2012
Last Verified: February 2012

Additional relevant MeSH terms:
Presbyopia
Refractive Errors
Eye Diseases