ClinicalTrials.gov
ClinicalTrials.gov Menu

Comparison of Two Multifocal Contact Lenses

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01250054
Recruitment Status : Completed
First Posted : November 30, 2010
Results First Posted : August 12, 2011
Last Update Posted : June 29, 2012
Sponsor:
Information provided by (Responsible Party):
Alcon Research ( CIBA VISION )

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

Condition or disease Intervention/treatment Phase
Presbyopia Device: Lotrafilcon B contact lens Device: Comfilcon A contact lens Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Study Start Date : October 2010
Actual Primary Completion Date : October 2010
Actual Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Overall Vision [ Time Frame: One week of wear ]
    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.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   35 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Responsible Party: CIBA VISION
ClinicalTrials.gov Identifier: NCT01250054     History of Changes
Other Study ID Numbers: P-319-C-018
First Posted: November 30, 2010    Key Record Dates
Results First Posted: August 12, 2011
Last Update Posted: June 29, 2012
Last Verified: July 2011

Additional relevant MeSH terms:
Presbyopia
Refractive Errors
Eye Diseases