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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 28, 2014