search
Back to results

Clinical Validation of the New Print on Focus DAILIES Toric

Primary Purpose

Myopia

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
nelfilcon A contact lens, modified inversion indicator
nelfilcon A contact lens, no inversion indicator
nelfilcon A contact lens, inversion indicator
Sponsored by
CIBA VISION
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myopia

Eligibility Criteria

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

Inclusion Criteria:

  • Be of legal age and sign written Informed Consent Document. If under legal age, parent or guardian must sign Informed Consent Document and subjects ages 12 through 17 must sign Informed Assent.
  • Willing and able to wear study lenses in both eyes in the available parameters.
  • Light-eyed subjects.
  • Able to achieve 20/40 or better distance visual acuity (VA) in each eye at time of dispensing.
  • Optimal or acceptable fit in each eye at time of dispensing.
  • Willing to wear the study lenses at least 8 hours a day, 5 days a week.
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Eye injury or surgery within twelve weeks prior to enrollment for this trial.
  • Pre-existing ocular irritation that would preclude contact lens fitting.
  • Currently enrolled in an ophthalmic clinical trial.
  • Evidence of systemic or ocular abnormality, infection or disease which is likely to affect successful wear of contact lenses or use of their accessory solutions as determined by the investigator.
  • Any use of medications for which contact lens wear could be contraindicated as determined by the investigator.
  • RGP contact lens wearer.
  • Other protocol-defined exclusion criteria may apply.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Active Comparator

    Arm Label

    nelfilcon A, modified inversion indicator

    nelfilcon A, no inversion indicator

    nelfilcon A, inversion indicator

    Arm Description

    Nelfilcon A investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for one week

    Nelfilcon A investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for one week

    Nelfilcon A commercially marketed contact lenses worn in both eyes on a daily wear, daily disposable basis for one week.

    Outcomes

    Primary Outcome Measures

    Visibility of the Inversion Indicator on Lens When Lens Was on Participant's Finger, for Example, During Lens Insertion.
    As assessed by the participant retrospectively after one week of wear and recorded on a questionnaire as a yes or no response to the question, "Did you notice an OK mark on the study lens while it was on your finger, for example, during lens insertion?" The positive "yes" responses are reported.

    Secondary Outcome Measures

    Full Information

    First Posted
    March 31, 2010
    Last Updated
    June 26, 2012
    Sponsor
    CIBA VISION
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT01097863
    Brief Title
    Clinical Validation of the New Print on Focus DAILIES Toric
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2010 (undefined)
    Primary Completion Date
    May 2010 (Actual)
    Study Completion Date
    May 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 study is to validate the improvements to the inversion indicator.
    Detailed Description
    This study was conducted in three countries under three separate protocols: P-346-C-009 sub 02 (UK), P-346-C-009 sub 03 (Germany), and P-346-C-010 (USA). The data reported represents pooled data from the three protocols.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    280 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    nelfilcon A, modified inversion indicator
    Arm Type
    Experimental
    Arm Description
    Nelfilcon A investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for one week
    Arm Title
    nelfilcon A, no inversion indicator
    Arm Type
    Experimental
    Arm Description
    Nelfilcon A investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for one week
    Arm Title
    nelfilcon A, inversion indicator
    Arm Type
    Active Comparator
    Arm Description
    Nelfilcon A commercially marketed contact lenses worn in both eyes on a daily wear, daily disposable basis for one week.
    Intervention Type
    Device
    Intervention Name(s)
    nelfilcon A contact lens, modified inversion indicator
    Intervention Description
    Investigational, nelfilcon A, toric, soft contact lens for daily disposable wear, with modified inversion indicator
    Intervention Type
    Device
    Intervention Name(s)
    nelfilcon A contact lens, no inversion indicator
    Intervention Description
    Investigational, nelfilcon A, toric, soft contact lens for daily disposable wear, with no inversion indicator
    Intervention Type
    Device
    Intervention Name(s)
    nelfilcon A contact lens, inversion indicator
    Other Intervention Name(s)
    Focus DAILIES Toric
    Intervention Description
    Commercially marketed, nelfilcon A, toric, soft contact lens for daily disposable wear, with inversion indicator
    Primary Outcome Measure Information:
    Title
    Visibility of the Inversion Indicator on Lens When Lens Was on Participant's Finger, for Example, During Lens Insertion.
    Description
    As assessed by the participant retrospectively after one week of wear and recorded on a questionnaire as a yes or no response to the question, "Did you notice an OK mark on the study lens while it was on your finger, for example, during lens insertion?" The positive "yes" responses are reported.
    Time Frame
    1 week

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Be of legal age and sign written Informed Consent Document. If under legal age, parent or guardian must sign Informed Consent Document and subjects ages 12 through 17 must sign Informed Assent. Willing and able to wear study lenses in both eyes in the available parameters. Light-eyed subjects. Able to achieve 20/40 or better distance visual acuity (VA) in each eye at time of dispensing. Optimal or acceptable fit in each eye at time of dispensing. Willing to wear the study lenses at least 8 hours a day, 5 days a week. Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Eye injury or surgery within twelve weeks prior to enrollment for this trial. Pre-existing ocular irritation that would preclude contact lens fitting. Currently enrolled in an ophthalmic clinical trial. Evidence of systemic or ocular abnormality, infection or disease which is likely to affect successful wear of contact lenses or use of their accessory solutions as determined by the investigator. Any use of medications for which contact lens wear could be contraindicated as determined by the investigator. RGP contact lens wearer. Other protocol-defined exclusion criteria may apply.

    12. IPD Sharing Statement

    Learn more about this trial

    Clinical Validation of the New Print on Focus DAILIES Toric

    We'll reach out to this number within 24 hrs