Comparison of Two Multifocal Contact Lenses

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research ( CIBA VISION )
ClinicalTrials.gov Identifier:
NCT01250054
First received: November 29, 2010
Last updated: June 26, 2012
Last verified: July 2011
  Purpose

The purpose of this study is to compare two multifocal contact lenses in presbyopic wearers.


Condition Intervention
Presbyopia
Device: Lotrafilcon B contact lens
Device: Comfilcon A contact lens

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:
  • Overall Vision [ Time Frame: One week of wear ] [ Designated as safety issue: No ]
    Overall vision, as interpreted by the participant and recorded by the investigator as a single, retrospective evaluation of one week's wear time. Overall vision was measured on a 10-point scale, with 1 being worst and 10 being best.


Enrollment: 17
Study Start Date: October 2010
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Lotrafilcon B / Comfilcon A
Lotrafilcon B multifocal contact lenses worn first, with comfilcon A multifocal contact lenses worn second. Each product worn bilaterally on a daily wear basis for one week.
Device: Lotrafilcon B contact lens
Commercially marketed, silicone hydrogel, multifocal contact lens for daily wear use
Other Name: AIR OPTIX AQUA MULTIFOCAL
Device: Comfilcon A contact lens
Commercially marketed (Europe), silicone hydrogel, multifocal contact lens for daily wear use
Other Name: BIOFINITY MULTIFOCAL
Comfilcon A /Lotrafilcon B
Comfilcon A multifocal contact lenses worn first, with lotrafilcon B multifocal contact lenses worn second. Each product worn bilaterally on a daily wear basis for one week.
Device: Lotrafilcon B contact lens
Commercially marketed, silicone hydrogel, multifocal contact lens for daily wear use
Other Name: AIR OPTIX AQUA MULTIFOCAL
Device: Comfilcon A contact lens
Commercially marketed (Europe), silicone hydrogel, multifocal contact lens for daily wear use
Other Name: BIOFINITY MULTIFOCAL

  Eligibility

Ages Eligible for Study:   35 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • At least 35 years of age.
  • Sign written Informed Consent
  • Spectacle add of +0.50 to +2.50D.
  • Best corrected visual acuity of at least 20.30 in both eyes.
  • Currently wearing soft contact lenses at least 5 days per week.
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Eye injury or surgery within twelve weeks of enrollment.
  • Currently enrolled in any clinical trial.
  • Astigmatism > 1.00D.
  • Strabismus/amblyopia.
  • 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: NCT01250054     History of Changes
Other Study ID Numbers: P-319-C-018
Study First Received: November 29, 2010
Results First Received: July 19, 2011
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 16, 2014