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Visual Performance Investigation of Two Toric Soft Contact Lenses (CARDINAL)

Primary Purpose

Refractive Error, Astigmatism, Myopia

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Lotrafilcon B toric contact lens
Comfilcon A toric contact lens
Sponsored by
Alcon Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Refractive Error focused on measuring myopia, hyperopia, astigmatism, contact lenses

Eligibility Criteria

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

Inclusion Criteria:

  • Sign informed consent;
  • Wears toric soft contact lenses;
  • Can be successfully fit with study lenses within the power ranges available;
  • Has cylinder of ≥ -0.75 diopter in both eyes;
  • Has correctable vision of at least 0.1 (logMAR) or better in each eye at distance with both study lenses;
  • Willing and able to wear study lenses on a daily wear basis for at least 5 days a week, minimum 8 hours per day, and attend all study visits;
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Any ocular condition that would contraindicate contact lens wear;
  • Use of medications for which contact lens wear could be contraindicated;
  • Monocular (only 1 eye with functional vision) or fit with 1 lens;
  • History of herpetic keratitis, ocular surgery, or irregular cornea;
  • Known sensitivity to the diagnostic pharmaceuticals to be used in the study;
  • Requires presbyopic correction;
  • Use of rewetting/lubricating eye-drops more than twice a day;
  • Other protocol-defined exclusion criteria may apply.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Other

    Arm Label

    AO for Astig / Biofinity Toric

    Biofinity Toric / AO for Astig

    Arm Description

    Lotrafilcon B toric contact lenses worn in Period 1, followed by comfilcon A toric contact lenses in Period 2, as randomized. Each product will be worn bilaterally on a daily wear basis for 30 days, removed nightly. A minimum 1-day washout of no contact lens wear will precede each wear period.

    Comfilcon A toric contact lenses worn in Period 1, followed by lotrafilcon B toric contact lenses in Period 2, as randomized. Each product will be worn bilaterally on a daily wear basis for 30 days, removed nightly. A minimum 1-day washout of no contact lens wear will precede each wear period.

    Outcomes

    Primary Outcome Measures

    Mean Ocular Coma Score at 5mm Pupil at Day 30
    Ocular coma is a type of optical aberration or a distortion in image formation occurring when a bundle of light rays enters an optical system (eye) that is not parallel to the optic axis. Ocular coma will be measured in micrometers using a Ladarwave aberrometer. A lower number indicates less coma/less image distortion. One eye (right eye) contributed to the mean.

    Secondary Outcome Measures

    Full Information

    First Posted
    May 17, 2013
    Last Updated
    October 17, 2014
    Sponsor
    Alcon Research
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01858701
    Brief Title
    Visual Performance Investigation of Two Toric Soft Contact Lenses
    Acronym
    CARDINAL
    Official Title
    Visual Performance Investigation of Two Toric Soft Contact Lenses
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2013 (undefined)
    Primary Completion Date
    October 2013 (Actual)
    Study Completion Date
    October 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Alcon Research

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to compare the amount of coma as measured by aberrometry induced by two silicone hydrogel toric lenses in astigmatic participants.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Refractive Error, Astigmatism, Myopia, Hyperopia
    Keywords
    myopia, hyperopia, astigmatism, contact lenses

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    49 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    AO for Astig / Biofinity Toric
    Arm Type
    Other
    Arm Description
    Lotrafilcon B toric contact lenses worn in Period 1, followed by comfilcon A toric contact lenses in Period 2, as randomized. Each product will be worn bilaterally on a daily wear basis for 30 days, removed nightly. A minimum 1-day washout of no contact lens wear will precede each wear period.
    Arm Title
    Biofinity Toric / AO for Astig
    Arm Type
    Other
    Arm Description
    Comfilcon A toric contact lenses worn in Period 1, followed by lotrafilcon B toric contact lenses in Period 2, as randomized. Each product will be worn bilaterally on a daily wear basis for 30 days, removed nightly. A minimum 1-day washout of no contact lens wear will precede each wear period.
    Intervention Type
    Device
    Intervention Name(s)
    Lotrafilcon B toric contact lens
    Other Intervention Name(s)
    AIR OPTIX® for ASTIGMATISM
    Intervention Description
    Commercially available, silicone hydrogel contact lens for correction of astigmatism
    Intervention Type
    Device
    Intervention Name(s)
    Comfilcon A toric contact lens
    Other Intervention Name(s)
    Biofinity® Toric
    Intervention Description
    Commercially available, silicone hydrogel contact lens for correction of astigmatism
    Primary Outcome Measure Information:
    Title
    Mean Ocular Coma Score at 5mm Pupil at Day 30
    Description
    Ocular coma is a type of optical aberration or a distortion in image formation occurring when a bundle of light rays enters an optical system (eye) that is not parallel to the optic axis. Ocular coma will be measured in micrometers using a Ladarwave aberrometer. A lower number indicates less coma/less image distortion. One eye (right eye) contributed to the mean.
    Time Frame
    Day 30

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Sign informed consent; Wears toric soft contact lenses; Can be successfully fit with study lenses within the power ranges available; Has cylinder of ≥ -0.75 diopter in both eyes; Has correctable vision of at least 0.1 (logMAR) or better in each eye at distance with both study lenses; Willing and able to wear study lenses on a daily wear basis for at least 5 days a week, minimum 8 hours per day, and attend all study visits; Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Any ocular condition that would contraindicate contact lens wear; Use of medications for which contact lens wear could be contraindicated; Monocular (only 1 eye with functional vision) or fit with 1 lens; History of herpetic keratitis, ocular surgery, or irregular cornea; Known sensitivity to the diagnostic pharmaceuticals to be used in the study; Requires presbyopic correction; Use of rewetting/lubricating eye-drops more than twice a day; Other protocol-defined exclusion criteria may apply.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jessie Lemp, MS
    Organizational Affiliation
    Alcon Research
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Lyndon Jones, PhD
    Organizational Affiliation
    School of Optometry and Vision Science
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Visual Performance Investigation of Two Toric Soft Contact Lenses

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