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Clinical Comparison of Two Multifocal Contact Lenses Made of Silicone Hydrogel Materials

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ClinicalTrials.gov Identifier: NCT01371539
Recruitment Status : Completed
First Posted : June 13, 2011
Results First Posted : August 3, 2012
Last Update Posted : August 3, 2012
Sponsor:
Information provided by (Responsible Party):
Alcon Research ( CIBA VISION )

Brief Summary:
The purpose of this study was to compare visual performance measures between two multifocal contact lenses on presbyopic wearers.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 109 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Clinical Comparison of Two Multifocal Contact Lenses Made of Silicone Hydrogel Materials
Study Start Date : June 2011
Actual Primary Completion Date : August 2011
Actual Study Completion Date : August 2011

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 contact lenses worn first, with comfilcon A contact lenses worn second. Both products worn bilaterally on a daily wear basis for one week each.
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 (France), silicone hydrogel, multifocal contact lens for daily wear use.
Other Name: Biofinity Multifocal
Comfilcon A / Lotrafilcon B
Comfilcon A contact lenses worn first, with lotrafilcon B contact lenses worn second. Both products worn bilaterally on a daily wear basis for one week each.
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 (France), silicone hydrogel, multifocal contact lens for daily wear use.
Other Name: Biofinity Multifocal



Primary Outcome Measures :
  1. Corrected Distance Binocular Visual Measurement in Normal Illumination Reported as Binocular Distance Visual Acuity [ Time Frame: 1 week ]
    The participant read a Snellen chart at a 20-foot equivalent distance with both eyes together while wearing study lenses. The Snellen acuity was converted into logMAR units (logarithm of the minimum angle of resolution). A 20/20 Snellen acuity equated to a logMAR acuity of 0.0 and was considered normal distance eyesight. A positive logMAR value indicated poorer vision, and a negative value denoted better visual acuity.

  2. Corrected Near Binocular Visual Measurement in Normal Illumination Reported as Binocular Near Visual Acuity [ Time Frame: 1 week ]
    The participant read a Snellen chart at 40 centimeters with both eyes together while wearing study lenses. The Snellen acuity was converted into logMAR units (logarithm of the minimum angle of resolution). A 20/20 Snellen acuity equated to a logMAR acuity of 0.0 and was considered normal near eyesight. A positive logMAR value indicated poorer vision, and a negative value denoted better visual acuity.



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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.
  • Spectacle add of +0.50 to +2.50 diopters (inclusive).
  • Currently wearing soft contact lenses at least 5 days per week and at least 8 hours per day.
  • Able to be fit in both eyes with soft multifocal lenses in available powers.
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Eye injury or surgery within 12 weeks of enrollment in trial.
  • Currently enrolled in any clinical trial.
  • Astigmatism of 1.00 diopter or more.
  • Currently wearing excluded brands of multifocal lenses, as specified by protocol.
  • Other protocol-defined exclusion criteria may apply.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01371539


Sponsors and Collaborators
CIBA VISION
Investigators
Study Director: Stacie Cummings, O.D. Alcon Research

Responsible Party: CIBA VISION
ClinicalTrials.gov Identifier: NCT01371539     History of Changes
Other Study ID Numbers: P-319-C-021
First Posted: June 13, 2011    Key Record Dates
Results First Posted: August 3, 2012
Last Update Posted: August 3, 2012
Last Verified: June 2012

Keywords provided by Alcon Research ( CIBA VISION ):
Myopia
Presbyopia

Additional relevant MeSH terms:
Myopia
Presbyopia
Refractive Errors
Eye Diseases