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CLEAR CARE® PLUS for Presbyopic Contact Lens Wearers

Primary Purpose

Presbyopia

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
3% hydrogen peroxide solution with HydraGlyde® Moisture Matrix
Habitual Multi-Purpose Contact Lens Solution
Habitual Contact Lenses
Sponsored by
Alcon, a Novartis Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Presbyopia focused on measuring Contact lens induced dryness

Eligibility Criteria

45 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Must sign an informed consent document;
  • Current adapted two-week/monthly replacement soft contact lens wearers (at least 2 months) with symptoms of contact lens induced dryness;
  • Near spectacle add of +0.50 or greater;
  • Best corrected visual acuity (BCVA) to 20/30 or better in each eye at distance;
  • Willing to wear lenses for a minimum of 5 days per week, 6 hours per day, and attend all study visits;
  • Currently (at least 2 months) using a non-HYDRAGLYDE® containing multi-purpose solution (OPTI-FREE® PureMoist® is excluded) to care for lenses;
  • Use of digital devices (eg, smart phone, tablet, laptop computer, or desktop computer) for 20 consecutive minutes at least twice a week and willing to continue the same pattern for the duration of the study;
  • Other protocol-specific inclusion criteria may apply.

Exclusion Criteria:

  • Extended wear contact lens wearer (sleeps in lenses 1 or more nights per week);
  • Any anterior segment infection, inflammation, disease, or abnormality that contraindicates contact lens wear as determined by the investigator;
  • Any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the investigator, including use of any topical ocular medications that would require instillation during contact lens wear;
  • Monocular (only 1 eye with functional vision) or fit with only 1 lens;
  • Known sensitivity to any ingredients in CLEAR CARE® PLUS (CCP);
  • Prior refractive surgery;
  • History of herpetic keratitis, ocular surgery, or irregular cornea;
  • Pathological dry eye that precludes contact lens wear;
  • Use of mechanical eyelid therapy or eyelid scrubs within 14 days before Visit 1 and not willing to discontinue during the study;
  • Participation in any clinical study within 30 days of Visit 1;
  • Currently using or have not discontinued Restasis®, Xiidra® or a topical steroid within the past 7 days;
  • Other protocol-specific exclusion criteria may apply.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Other

    Arm Label

    CCP, then HMPS

    HMPS, then CCP

    Arm Description

    3% hydrogen peroxide solution with HydraGlyde® Moisture Matrix contact lens solution in Period 1, followed by subject's habitual multi-purpose contact lens solution (HMPS) in Period 2. Each product used daily per packaging instructions with subject's habitual contact lenses for approximately 30 cleaning and disinfection cycles.

    Subject's habitual multi-purpose contact lens solution in Period 1, followed by 3% hydrogen peroxide solution with HydraGlyde® Moisture Matrix contact lens solution in Period 2. Each product used daily per packaging instructions with subject's habitual contact lenses for approximately 30 cleaning and disinfection cycles.

    Outcomes

    Primary Outcome Measures

    Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) Score at Day 30
    CLDEQ-8 score (assessment of contact lens discomfort) was obtained by adding the numerical responses to each of 8 items. Individual scales ranged from 0-4, 0-5, and 1-6, with a resultant overall score from 1 minimum to 37 maximum. A lower CLDEQ-8 score indicates less frequent or less intense symptoms.

    Secondary Outcome Measures

    Full Information

    First Posted
    November 15, 2016
    Last Updated
    June 14, 2018
    Sponsor
    Alcon, a Novartis Company
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02965833
    Brief Title
    CLEAR CARE® PLUS for Presbyopic Contact Lens Wearers
    Official Title
    Clinical Study of CLEAR CARE® PLUS for Presbyopic Contact Lens Wearers
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    December 13, 2016 (Actual)
    Primary Completion Date
    March 24, 2017 (Actual)
    Study Completion Date
    March 24, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Alcon, a Novartis Company

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to evaluate CLEAR CARE® PLUS (CCP) compared to non-HYDRAGLYDE® multi-purpose contact lens solutions in presbyopes currently wearing soft contact lenses and experiencing symptoms of dryness.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Presbyopia
    Keywords
    Contact lens induced dryness

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    126 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    CCP, then HMPS
    Arm Type
    Other
    Arm Description
    3% hydrogen peroxide solution with HydraGlyde® Moisture Matrix contact lens solution in Period 1, followed by subject's habitual multi-purpose contact lens solution (HMPS) in Period 2. Each product used daily per packaging instructions with subject's habitual contact lenses for approximately 30 cleaning and disinfection cycles.
    Arm Title
    HMPS, then CCP
    Arm Type
    Other
    Arm Description
    Subject's habitual multi-purpose contact lens solution in Period 1, followed by 3% hydrogen peroxide solution with HydraGlyde® Moisture Matrix contact lens solution in Period 2. Each product used daily per packaging instructions with subject's habitual contact lenses for approximately 30 cleaning and disinfection cycles.
    Intervention Type
    Device
    Intervention Name(s)
    3% hydrogen peroxide solution with HydraGlyde® Moisture Matrix
    Other Intervention Name(s)
    CLEAR CARE® PLUS
    Intervention Description
    For cleaning, disinfection and overnight storage of contact lenses
    Intervention Type
    Device
    Intervention Name(s)
    Habitual Multi-Purpose Contact Lens Solution
    Intervention Type
    Device
    Intervention Name(s)
    Habitual Contact Lenses
    Intervention Description
    Participant's habitual contact lens brand worn in a daily wear modality for 30 days.
    Primary Outcome Measure Information:
    Title
    Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) Score at Day 30
    Description
    CLDEQ-8 score (assessment of contact lens discomfort) was obtained by adding the numerical responses to each of 8 items. Individual scales ranged from 0-4, 0-5, and 1-6, with a resultant overall score from 1 minimum to 37 maximum. A lower CLDEQ-8 score indicates less frequent or less intense symptoms.
    Time Frame
    Day 30, each product

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    45 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Must sign an informed consent document; Current adapted two-week/monthly replacement soft contact lens wearers (at least 2 months) with symptoms of contact lens induced dryness; Near spectacle add of +0.50 or greater; Best corrected visual acuity (BCVA) to 20/30 or better in each eye at distance; Willing to wear lenses for a minimum of 5 days per week, 6 hours per day, and attend all study visits; Currently (at least 2 months) using a non-HYDRAGLYDE® containing multi-purpose solution (OPTI-FREE® PureMoist® is excluded) to care for lenses; Use of digital devices (eg, smart phone, tablet, laptop computer, or desktop computer) for 20 consecutive minutes at least twice a week and willing to continue the same pattern for the duration of the study; Other protocol-specific inclusion criteria may apply. Exclusion Criteria: Extended wear contact lens wearer (sleeps in lenses 1 or more nights per week); Any anterior segment infection, inflammation, disease, or abnormality that contraindicates contact lens wear as determined by the investigator; Any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the investigator, including use of any topical ocular medications that would require instillation during contact lens wear; Monocular (only 1 eye with functional vision) or fit with only 1 lens; Known sensitivity to any ingredients in CLEAR CARE® PLUS (CCP); Prior refractive surgery; History of herpetic keratitis, ocular surgery, or irregular cornea; Pathological dry eye that precludes contact lens wear; Use of mechanical eyelid therapy or eyelid scrubs within 14 days before Visit 1 and not willing to discontinue during the study; Participation in any clinical study within 30 days of Visit 1; Currently using or have not discontinued Restasis®, Xiidra® or a topical steroid within the past 7 days; Other protocol-specific exclusion criteria may apply.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Clinical Project Manager, CPM
    Organizational Affiliation
    Alcon, A Novartis Division
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    CLEAR CARE® PLUS for Presbyopic Contact Lens Wearers

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