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
  Purpose

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


Condition Intervention
Presbyopia
Device: Lotrafilcon B multifocal contact lens

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Assessment of a New Multifocal Contact Lens With Emmetropic Presbyopes

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • 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."


Enrollment: 103
Study Start Date: December 2010
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   40 Years to 48 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Alcon Research ( CIBA VISION )
ClinicalTrials.gov Identifier: NCT01268501     History of Changes
Other Study ID Numbers: P-319-C-019
Study First Received: December 29, 2010
Results First Received: January 13, 2012
Last Updated: June 26, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Presbyopia
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on April 17, 2014