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Comparison of Two Multifocal Contact Lenses

Sponsor
CIBA VISION (Industry)
Overall Status
Completed
CT.gov ID
NCT01250054
Collaborator
(none)
17
Enrollment
2
Arms

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: Lotrafilcon B contact lens
  • Device: Comfilcon A contact lens
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
17 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Study Start Date :
Oct 1, 2010
Actual Primary Completion Date :
Oct 1, 2010
Actual Study Completion Date :
Oct 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Other: 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 Names:
  • AIR OPTIX AQUA MULTIFOCAL

    • Device: Comfilcon A contact lens
    Commercially marketed (Europe), silicone hydrogel, multifocal contact lens for daily wear use
    Other Names:
  • BIOFINITY MULTIFOCAL

    		•
    Other: 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 Names:
  • AIR OPTIX AQUA MULTIFOCAL

    • Device: Comfilcon A contact lens
    Commercially marketed (Europe), silicone hydrogel, multifocal contact lens for daily wear use
    Other Names:
  • BIOFINITY MULTIFOCAL

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Overall Vision [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    35 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    No locations specified.

    Sponsors and Collaborators

    • CIBA VISION

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    CIBA VISION
    ClinicalTrials.gov Identifier:
    NCT01250054
    Other Study ID Numbers:
    • P-319-C-018
    First Posted:
    Nov 30, 2010
    Last Update Posted:
    Jun 29, 2012
    Last Verified:
    Jul 1, 2011
    Additional relevant MeSH terms:
    Presbyopia

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail This reporting group includes all enrolled and dispensed participants.
    Arm/Group Title Lotrafilcon B / Comfilcon A Comfilcon A /Lotrafilcon B
    Arm/Group Description 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. 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.
    Period Title: Period 1, One Week of Wear
    STARTED 8 8
    COMPLETED 8 8
    NOT COMPLETED 0 0
    Period Title: Period 1, One Week of Wear
    STARTED 7 8
    COMPLETED 6 8
    NOT COMPLETED 1 0

    Baseline Characteristics

    Arm/Group Title Overall
    Arm/Group Description This reporting group includes all enrolled and dispensed subjects.
    Overall Participants 17
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    48.6
    (4.9)
    Sex: Female, Male (Count of Participants)
    Female
    11
    64.7%
    Male
    6
    35.3%

    Outcome Measures

    1. Primary Outcome
    Title Overall Vision
    Description 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.
    Time Frame One week of wear

    Outcome Measure Data

    Analysis Population Description
    Analysis conducted per protocol, with exclusions due to reasons such as: major protocol deviations as determined by masked review; discontinuations; and/or missing responses.
    Arm/Group Title Lotrafilcon B Comfilcon A
    Arm/Group Description Commercially marketed, silicone hydrogel, multifocal contact lenses for daily wear use worn bilaterally for one week. Commercially marketed (Europe), silicone hydrogel, multifocal contact lenses for daily wear use worn bilaterally for one week.
    Measure Participants 16 13
    Mean (Standard Deviation) [units on a scale]
    8.5
    (1.2)
    8.3
    (1.1)

    Adverse Events

    Time Frame Adverse event data were collected for the duration of the trial: 19 days.
    Adverse Event Reporting Description This reporting group includes all enrolled and exposed participants.
    Arm/Group Title Lotrafilcon B Comfilcon A
    Arm/Group Description Commercially marketed, silicone hydrogel, multifocal contact lenses for daily wear use worn bilaterally for one week. Commercially marketed (Europe), silicone hydrogel, multifocal contact lenses for daily wear use worn bilaterally for one week.
    All Cause Mortality
    Lotrafilcon B Comfilcon A
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN)
    Serious Adverse Events
    Lotrafilcon B Comfilcon A
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/16 (0%) 0/17 (0%)
    Other (Not Including Serious) Adverse Events
    Lotrafilcon B Comfilcon A
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/16 (0%) 0/17 (0%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    All Principal Investigators ARE employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Joe Rappon, OD, MS, FAAO / Head, Clinical Trial Management
    Organization CIBA VISION
    Phone 1-678-415-3343
    Email Joseph.Rappon@cibavision.com
    Responsible Party:
    CIBA VISION
    ClinicalTrials.gov Identifier:
    NCT01250054
    Other Study ID Numbers:
    • P-319-C-018
    First Posted:
    Nov 30, 2010
    Last Update Posted:
    Jun 29, 2012
    Last Verified:
    Jul 1, 2011