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Prospective Study of Lens Performance of a Monthly Replacement Lens at Two Weeks and Four Weeks

Primary Purpose

Myopia, Astigmatism, Presbyopia

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
lotrafilcon B contact lens
Sponsored by
CIBA VISION
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myopia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Habitual and successful wearers of contact lenses made of lotrafilcon B material for at least 4 weeks prior to enrollment.
  • Good general health.
  • Sphere requirement in the range +6.00 to -10.00 with astigmatism or multifocal correction or no astigmatism or multifocal correction.
  • Ability to comply with all protocol-mandated procedures and to attend all scheduled office visits.
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Anterior segment abnormalities (i.e., cataracts, opacities, etc.) or active anterior segment disease.
  • Administration of any investigational drug or device within 14 days of study initiation.
  • Use of any eye drops with a pharmacological effect within 7 days of Visit 1.
  • Known local or systemic hypersensitivity to contact lens cleaning and disinfecting solutions.
  • Post-refractive surgery.
  • Currently pregnant or lactating by case history.
  • Other protocol-defined exclusion criteria may apply.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Lotrafilcon B

    Arm Description

    Outcomes

    Primary Outcome Measures

    Overall Comfort
    Overall comfort was assessed and reported by the participant on a questionnaire as a single, retrospective evaluation of 2 weeks of wear. Overall comfort was measured on a 10-point scale, with 1 being poor and 10 being excellent.
    Overall Comfort
    Overall comfort was assessed and reported by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Overall comfort was measured on a 10-point scale, with 1 being poor and 10 being excellent.
    End of Day Dryness
    End of day dryness was assessed and reported by the participant on a questionnaire as a single, retrospective evaluation of 2 weeks of wear. End of day dryness was measured on a 10-point scale, with 1 being very dry and 10 being not dry.
    End of Day Dryness
    End of day dryness was assessed and reported by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. End of day dryness was measured on a 10-point scale, with 1 being very dry and 10 being not dry.
    Ocular Redness
    Ocular redness was assessed and reported by the participant on a questionnaire as a single, retrospective evaluation of 2 weeks of wear. Ocular redness was measured on a 10-point scale, with 1 being very red and 10 being not red.
    Ocular Redness
    Ocular redness was assessed and reported by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Ocular redness was measured on a 10-point scale, with 1 being very red and 10 being not red.
    Visual Clarity
    Visual clarity was assessed and reported by the participant on a questionnaire as a single, retrospective evaluation of 2 weeks of wear. Visual clarity was measured on a 10-point scale, with 1 being poor and 10 being excellent.
    Visual Clarity
    Visual clarity was assessed and reported by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Visual clarity was measured on a 10-point scale, with 1 being poor and 10 being excellent.
    Lens Deposits
    Protein and lipid deposits on the contact lens surface were assessed for each eye by the investigator using a biomicroscope, which magnifies the appearance of the contact lens on the wearer's eye. Deposits were graded on a scale of 0 to 4, with 0 being none and 4 being severe.
    Lens Deposits
    Protein and lipid deposits on the contact lens surface were assessed for each eye by the investigator using a biomicroscope, which magnifies the appearance of the contact lens on the wearer's eye. Deposits were graded on a scale of 0 to 4, with 0 being none and 4 being severe.
    Corrected Visual Acuity
    Each eye was tested individually while the participant read distant charts in normal lighting. Corrected visual acuity was measured using a Snellen chart, which was converted into logMAR units (logarithm of the minimum angle of resolution). A 20/20 Snellen acuity equates to a logMAR acuity of 0.0 and is considered normal distance eyesight. Positive logMAR values indicate poorer vision, and negative values denote better visual acuity.
    Corrected Visual Acuity
    Each eye was tested individually while the participant read distant charts in normal lighting. Corrected visual acuity was measured using a Snellen chart, which was converted into logMAR units (logarithm of the minimum angle of resolution). A 20/20 Snellen acuity equates to a logMAR acuity of 0.0 and is considered normal distance eyesight. Positive logMAR values indicate poorer vision, and negative values denote better visual acuity.

    Secondary Outcome Measures

    Full Information

    First Posted
    February 9, 2011
    Last Updated
    June 26, 2012
    Sponsor
    CIBA VISION
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01293240
    Brief Title
    Prospective Study of Lens Performance of a Monthly Replacement Lens at Two Weeks and Four Weeks
    Official Title
    Prospective Study of Lens Performance of a Monthly Replacement Lens at Two Weeks and Four Weeks
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2010 (undefined)
    Primary Completion Date
    April 2011 (Actual)
    Study Completion Date
    April 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    CIBA VISION

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to compare the overall performance of a monthly replacement contact lens when worn for one month and when worn for two weeks.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Myopia, Astigmatism, Presbyopia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    117 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Lotrafilcon B
    Arm Type
    Experimental
    Intervention Type
    Device
    Intervention Name(s)
    lotrafilcon B contact lens
    Other Intervention Name(s)
    AIR OPTIX® AQUA, AIR OPTIX® for ASTIGMATISM, AIR OPTIX® AQUA MULTIFOCAL
    Intervention Description
    Commercially marketed, silicone hydrogel contact lens worn bilaterally on a daily wear basis for up to 30 days with a two week and four week evaluation visit.
    Primary Outcome Measure Information:
    Title
    Overall Comfort
    Description
    Overall comfort was assessed and reported by the participant on a questionnaire as a single, retrospective evaluation of 2 weeks of wear. Overall comfort was measured on a 10-point scale, with 1 being poor and 10 being excellent.
    Time Frame
    2 weeks
    Title
    Overall Comfort
    Description
    Overall comfort was assessed and reported by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Overall comfort was measured on a 10-point scale, with 1 being poor and 10 being excellent.
    Time Frame
    4 weeks
    Title
    End of Day Dryness
    Description
    End of day dryness was assessed and reported by the participant on a questionnaire as a single, retrospective evaluation of 2 weeks of wear. End of day dryness was measured on a 10-point scale, with 1 being very dry and 10 being not dry.
    Time Frame
    2 weeks
    Title
    End of Day Dryness
    Description
    End of day dryness was assessed and reported by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. End of day dryness was measured on a 10-point scale, with 1 being very dry and 10 being not dry.
    Time Frame
    4 weeks
    Title
    Ocular Redness
    Description
    Ocular redness was assessed and reported by the participant on a questionnaire as a single, retrospective evaluation of 2 weeks of wear. Ocular redness was measured on a 10-point scale, with 1 being very red and 10 being not red.
    Time Frame
    2 weeks
    Title
    Ocular Redness
    Description
    Ocular redness was assessed and reported by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Ocular redness was measured on a 10-point scale, with 1 being very red and 10 being not red.
    Time Frame
    4 weeks
    Title
    Visual Clarity
    Description
    Visual clarity was assessed and reported by the participant on a questionnaire as a single, retrospective evaluation of 2 weeks of wear. Visual clarity was measured on a 10-point scale, with 1 being poor and 10 being excellent.
    Time Frame
    2 weeks
    Title
    Visual Clarity
    Description
    Visual clarity was assessed and reported by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Visual clarity was measured on a 10-point scale, with 1 being poor and 10 being excellent.
    Time Frame
    4 weeks
    Title
    Lens Deposits
    Description
    Protein and lipid deposits on the contact lens surface were assessed for each eye by the investigator using a biomicroscope, which magnifies the appearance of the contact lens on the wearer's eye. Deposits were graded on a scale of 0 to 4, with 0 being none and 4 being severe.
    Time Frame
    2 weeks
    Title
    Lens Deposits
    Description
    Protein and lipid deposits on the contact lens surface were assessed for each eye by the investigator using a biomicroscope, which magnifies the appearance of the contact lens on the wearer's eye. Deposits were graded on a scale of 0 to 4, with 0 being none and 4 being severe.
    Time Frame
    4 weeks
    Title
    Corrected Visual Acuity
    Description
    Each eye was tested individually while the participant read distant charts in normal lighting. Corrected visual acuity was measured using a Snellen chart, which was converted into logMAR units (logarithm of the minimum angle of resolution). A 20/20 Snellen acuity equates to a logMAR acuity of 0.0 and is considered normal distance eyesight. Positive logMAR values indicate poorer vision, and negative values denote better visual acuity.
    Time Frame
    2 weeks
    Title
    Corrected Visual Acuity
    Description
    Each eye was tested individually while the participant read distant charts in normal lighting. Corrected visual acuity was measured using a Snellen chart, which was converted into logMAR units (logarithm of the minimum angle of resolution). A 20/20 Snellen acuity equates to a logMAR acuity of 0.0 and is considered normal distance eyesight. Positive logMAR values indicate poorer vision, and negative values denote better visual acuity.
    Time Frame
    4 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Habitual and successful wearers of contact lenses made of lotrafilcon B material for at least 4 weeks prior to enrollment. Good general health. Sphere requirement in the range +6.00 to -10.00 with astigmatism or multifocal correction or no astigmatism or multifocal correction. Ability to comply with all protocol-mandated procedures and to attend all scheduled office visits. Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Anterior segment abnormalities (i.e., cataracts, opacities, etc.) or active anterior segment disease. Administration of any investigational drug or device within 14 days of study initiation. Use of any eye drops with a pharmacological effect within 7 days of Visit 1. Known local or systemic hypersensitivity to contact lens cleaning and disinfecting solutions. Post-refractive surgery. Currently pregnant or lactating by case history. Other protocol-defined exclusion criteria may apply.

    12. IPD Sharing Statement

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    Prospective Study of Lens Performance of a Monthly Replacement Lens at Two Weeks and Four Weeks

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