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Evaluation of Two Daily Disposable Contact Lenses for Wearers With Astigmatism

Primary Purpose

Astigmatism, Myopia

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Nelfilcon A investigational contact lens
Nelfilcon A commercial contact lens
Sponsored by
CIBA VISION
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Astigmatism

Eligibility Criteria

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

Inclusion Criteria:

  • Currently wearing soft contact lenses with astigmatism correction
  • Other protocol inclusion criteria may apply

Exclusion Criteria:

  • Eye injury or surgery within twelve weeks prior to enrollment
  • Currently enrolled in an ophthalmic clinical trial
  • Strabismus
  • Any use of medications for which contact lens wear could be contraindicated as determined by the investigator
  • Other protocol exclusion criteria may apply

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Other

    Arm Label

    Nelfilcon A invest'l / nelfilconA comm'l

    Nelfilcon A comm'l / nelfilconA invest'l

    Arm Description

    Nelfilcon A investigational toric contact lenses worn first, with nelfilcon A commercial toric contact lenses worn second. Each product worn bilaterally on a daily disposable basis for one week.

    Nelfilcon A commercial toric contact lenses worn first, with nelfilcon A investigational toric contact lenses worn second. Each product worn bilaterally on a daily disposable basis for one week.

    Outcomes

    Primary Outcome Measures

    Quality of Vision (Crisp and Clear)
    Quality of vision (crisp and clear), as interpreted and reported by the participant by eye on a questionnaire as a single, retrospective evaluation of one week's wear time. Quality of vision was assessed on a 10-point scale, with 1 being poor and 10 being excellent.

    Secondary Outcome Measures

    Full Information

    First Posted
    September 21, 2010
    Last Updated
    June 27, 2012
    Sponsor
    CIBA VISION
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01207466
    Brief Title
    Evaluation of Two Daily Disposable Contact Lenses for Wearers With Astigmatism
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2010 (undefined)
    Primary Completion Date
    October 2010 (Actual)
    Study Completion Date
    October 2010 (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 trial is to compare the performance of two contact lenses for contact lens wearers with astigmatism.

    6. Conditions and Keywords

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

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Nelfilcon A invest'l / nelfilconA comm'l
    Arm Type
    Other
    Arm Description
    Nelfilcon A investigational toric contact lenses worn first, with nelfilcon A commercial toric contact lenses worn second. Each product worn bilaterally on a daily disposable basis for one week.
    Arm Title
    Nelfilcon A comm'l / nelfilconA invest'l
    Arm Type
    Other
    Arm Description
    Nelfilcon A commercial toric contact lenses worn first, with nelfilcon A investigational toric contact lenses worn second. Each product worn bilaterally on a daily disposable basis for one week.
    Intervention Type
    Device
    Intervention Name(s)
    Nelfilcon A investigational contact lens
    Intervention Description
    Investigational, soft contact lens for astigmatism worn on a daily disposable basis.
    Intervention Type
    Device
    Intervention Name(s)
    Nelfilcon A commercial contact lens
    Other Intervention Name(s)
    Focus DAILIES Toric
    Intervention Description
    Commercially marketed, soft contact lens for astigmatism worn on a daily disposable basis.
    Primary Outcome Measure Information:
    Title
    Quality of Vision (Crisp and Clear)
    Description
    Quality of vision (crisp and clear), as interpreted and reported by the participant by eye on a questionnaire as a single, retrospective evaluation of one week's wear time. Quality of vision was assessed on a 10-point scale, with 1 being poor and 10 being excellent.
    Time Frame
    1 week of wear

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Currently wearing soft contact lenses with astigmatism correction Other protocol inclusion criteria may apply Exclusion Criteria: Eye injury or surgery within twelve weeks prior to enrollment Currently enrolled in an ophthalmic clinical trial Strabismus Any use of medications for which contact lens wear could be contraindicated as determined by the investigator Other protocol exclusion criteria may apply

    12. IPD Sharing Statement

    Learn more about this trial

    Evaluation of Two Daily Disposable Contact Lenses for Wearers With Astigmatism

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