Comparison of Two Multifocal Contact Lenses Worn on a Daily Disposable Basis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research ( CIBA VISION )
ClinicalTrials.gov Identifier:
NCT01254760
First received: December 3, 2010
Last updated: June 26, 2012
Last verified: January 2012
  Purpose

The purpose of this trial is to evaluate and compare the clinical performance of two multifocal contact lenses.


Condition Intervention
Presbyopia
Myopia
Device: Nelfilcon A multifocal contact lens, investigational
Device: Nelfilcon A multifocal contact lens, commercial

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • End of Day Comfort [ Time Frame: 5 days of wear, lenses replaced daily ] [ Designated as safety issue: No ]
    End of day comfort was interpreted and reported by the participant on a questionnaire as a single, retrospective evaluation of 5 days of wear. End of day comfort was measured on a 10-point scale, with 1 being poor and 10 being excellent.

  • End of Day Dryness [ Time Frame: 5 days of wear, lenses replaced daily ] [ Designated as safety issue: No ]
    End of day dryness was interpreted and reported by the participant on a questionnaire as a single, retrospective evaluation of 5 days of wear. End of day dryness was measured on a 10-point scale, with 1 being very dry and 10 being not dry.

  • Handling at Removal [ Time Frame: 5 days of wear, lenses replaced daily ] [ Designated as safety issue: No ]
    Handling at removal was interpreted and reported by the participant on a questionnaire as a single, retrospective evaluation of 5 days of wear. Handling at removal was measured on a 10-point scale, with 1 being poor/difficult and 10 being excellent/easy.

  • Overall Vision [ Time Frame: 5 days of wear, lenses replaced daily ] [ Designated as safety issue: No ]
    Overall vision was interpreted and reported by the participant on a questionnaire as a single, retrospective evaluation of 5 days of wear. Overall vision was measured on a 10-point scale, with 1 being poor and 10 being excellent.


Secondary Outcome Measures:
  • Overall Fit [ Time Frame: Day 5, lenses replaced daily ] [ Designated as safety issue: No ]
    Overall lens fit was assessed by the investigator at study visit using a biomicroscope, which magnifies the appearance of the contact lens on the participant's eye. Lens fit was assessed by eye and graded on a 5-point scale, with 2=unacceptably loose, 1= acceptably loose, 0=optimal, -1=acceptably tight, and -2=unacceptably tight


Enrollment: 79
Study Start Date: December 2010
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Investigational multifocal / Commercial multifocal
Investigational multifocal contact lenses worn first, with commercial multifocal contact lenses worn second. Each product worn bilaterally on a daily wear, daily disposable basis for 5 days.
Device: Nelfilcon A multifocal contact lens, investigational
Investigational, soft, multifocal contact lens for daily wear, daily disposable use.
Device: Nelfilcon A multifocal contact lens, commercial
Commercially marketed, soft, multifocal contact lens FDA-approved for daily wear, daily disposable use.
Other Name: Focus® DAILIES® Progressive
Commercial multifocal / Investigational multifocal
Commercial multifocal contact lenses worn first, with investigational multifocal contact lenses worn second. Each product worn bilaterally on a daily wear, daily disposable basis for 5 days.
Device: Nelfilcon A multifocal contact lens, investigational
Investigational, soft, multifocal contact lens for daily wear, daily disposable use.
Device: Nelfilcon A multifocal contact lens, commercial
Commercially marketed, soft, multifocal contact lens FDA-approved for daily wear, daily disposable use.
Other Name: Focus® DAILIES® Progressive

  Eligibility

Ages Eligible for Study:   41 Years to 68 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 41 to 68 (inclusive).
  • Spectacle add between +0.75 and +2.75D (inclusive).
  • Habitual spectacle prescription ≤ 1.00DC (cyl).
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Eye injury or surgery within twelve weeks of enrollment.
  • Pre-existing ocular irritation that would preclude contact lens fitting.
  • Currently enrolled in a clinical trial.
  • Prior refractive surgery.
  • Other protocol-defined 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: NCT01254760     History of Changes
Other Study ID Numbers: P-416-C-001 Sub 04
Study First Received: December 3, 2010
Results First Received: January 17, 2012
Last Updated: June 26, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Myopia
Presbyopia
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on April 14, 2014