Text Size

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
  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:

U.S. FDA Resources

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 May 16, 2013