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Safety and Efficacy Evaluation of a New Contact Lens Disinfecting Solution in Soft Contact Lens Wearers

Primary Purpose

Myopia, Astigmatism, Hyperopia

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
FID 120947A contact lens disinfecting solution
renu fresh multi-purpose solution
Soft contact lenses
Sponsored by
Alcon Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Myopia focused on measuring contact lenses, contact lens solution, soft contact lenses

Eligibility Criteria

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

Inclusion Criteria:

  • Normal eyes (other than correction for visual acuity);
  • Successful history of silicone hydrogel or soft contact lens wear in both eyes in one of the following brands: Soflens® 38, Proclear DW, Frequency 55, Acuvue® Oasys™, Air Optix Aqua, O2 OPTIX, Air Optix for Astigmatism, Air Optix Aqua Multifocal, Biofinity®, PureVision®, PureVision®2;
  • Best spectacle corrected distance visual acuity greater than or equal to 20/25 in each eye;
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Any ocular or systemic medical condition that may, in the opinion of the investigator, preclude safe administration of the investigational products or affect the results of this study;
  • Need to wear contact lenses on an extended wear basis (ie, overnight) during the study;
  • Use of a daily cleaner and/or an enzyme cleaner to care for lenses at least 7 days prior to Visit 1;
  • History of intolerance or hypersensitivity to any component of the investigational products;
  • Use of all over-the-counter (OTC) or prescribed topical ocular medications within 7 days prior to Visit 1;
  • Moderate, severe, abnormal, or other ocular findings;
  • Current or history of ocular infection, severe inflammation, or disease within 6 months prior to Visit 1;
  • Any systemic disease at Visit 1 (including allergies, respiratory infections or colds) that may affect the eye or be exacerbated by use of contact lenses or contact lens solutions;
  • Use of systemic medications that may contribute to adverse ocular effects unless on a stable dosing regimen;
  • Ocular surgery within the last 12 months;
  • Other protocol-defined exclusion criteria may apply.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    FID 120947A

    renu fresh

    Arm Description

    FID 120947A contact lens disinfecting solution used with soft contact lenses (study lenses) on a daily basis for 90 days

    Renu fresh multi-purpose solution used with soft contact lenses (study lenses) on a daily basis for 90 days

    Outcomes

    Primary Outcome Measures

    Percentage of Subjects With Visibly Clean Lenses
    Worn study lenses were removed and evaluated for deposits. Deposits found on the lenses were defined using a 3-part classification system consisting of general visibility, the specific appearance and area covered. A lens was considered visibly clean if it had nondetectable films or deposits. One eye (study eye) contributed to the analysis.
    Percentage of Subjects With Crystalline Deposits by Type
    Worn study lenses were removed and evaluated for deposits. Deposits found on the lenses were defined using a 3-part classification system consisting of general visibility, the specific appearance and area covered: Type II = films or deposits visible only under special conditions, such as special illumination using an eyepiece of 7-10 times magnification, Type III = films or deposits readily visible on a dry lens under room lighting, with unaided eye, and Type IV = films or deposits obvious under room lighting, with unaided eye, when the lens is wet or dry. One eye (study eye) contributed to the analysis.
    Percentage of Subjects With Film Deposits by Type
    Worn study lenses were removed and evaluated for deposits. Deposits found on the lenses were defined using a 3-part classification system consisting of general visibility, the specific appearance and area covered: Type II = films or deposits visible only under special conditions, such as special illumination using an eyepiece of 7-10 times magnification, Type III = films or deposits readily visible on a dry lens under room lighting, with unaided eye, and Type IV = films or deposits obvious under room lighting, with unaided eye, when the lens is wet or dry. One eye (study eye) contributed to the analysis.
    Average Residual Lens Lysozyme
    Worn study lenses were removed and analyzed by high performance liquid chromatography (HPLC) for residual lens lysozyme (protein). Values reported as lower than the limit of quantitation or none detected were imputed as 0.5 μg or 0 μg, respectively. A lower value indicates less lysozyme deposition. One eye (study eye) contributed to the analysis.
    Percentage of Subjects With Change From Baseline in Contact Lens-Corrected Distance Visual Acuity (CLCDVA) by Line Change
    Distance VA was assessed for each eye individually while reading a chart distant to the participant in dimmed room illumination. VA was measured using a Snellen chart, with 20/20 Snellen acuity considered normal distance-eyesight. A line increase indicates an improvement in VA. One eye (study eye) contributed to the analysis.
    Average Lens Wear Time
    Subject recorded a response to the question, "Averaging over the last 3 days, how many hours per day did you wear your contact lenses?" Lens wear time was measured in hours.
    Number of Unscheduled Lens Replacements by Reason
    A fresh pair of lenses was dispensed on Day 0, Day 30, and Day 60. Lenses replaced at other times were considered unscheduled. The counts in the table represent the total number of unscheduled lenses replaced by reason for any eye, any subject.
    Likert Item - "When I Use This Solution, my Lenses Are Comfortable All Day."
    Lens comfort was assessed by the subject as a single response on a 5-point Likert scale (Strongly Agree, Agree, Undecided, Disagree, Strongly Disagree) to best describe their lens wearing experience over the last 3 days. Responses were summarized by agreement category and presented as percentage of subjects.
    Likert Item - "When I Use This Solution, at the End of the Lens Wearing Day my Vision is Clear."
    Clear vision was assessed by the subject as a single response on a 5-point Likert scale (Strongly Agree, Agree, Undecided, Disagree, Strongly Disagree) to best describe their lens wearing experience over the last 3 days. Responses were summarized by agreement category and presented as percentage of subjects.
    Likert Item - "When I Use This Solution, I Like the Way This Product Feels During Handling."
    Product handling was assessed by the subject as a single response on a 5-point Likert scale (Strongly Agree, Agree, Undecided, Disagree, Strongly Disagree) to best describe their lens wearing experience over the last 3 days. Responses were summarized by agreement category and presented as percentage of subjects.
    Crystalline Deposit Area Covered
    Worn study lenses were removed and evaluated for deposits. Deposits found on the lenses were defined using a 3-part classification system consisting of general visibility, the specific appearance and area covered. Values were reported as a percentage of lens area covered. One eye (study eye) contributed to the analysis.
    Film Deposit Area Covered
    Worn study lenses were removed and evaluated for deposits. Deposits found on the lenses were defined using a 3-part classification system consisting of general visibility, the specific appearance and area covered. Values were reported as a percentage of lens area covered. One eye (study eye) contributed to the analysis.

    Secondary Outcome Measures

    Full Information

    First Posted
    July 29, 2013
    Last Updated
    June 10, 2015
    Sponsor
    Alcon Research
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01912768
    Brief Title
    Safety and Efficacy Evaluation of a New Contact Lens Disinfecting Solution in Soft Contact Lens Wearers
    Official Title
    Clinical Evaluation of the Safety and Efficacy of FID 120947A Compared to a Marketed Lens Care Solution
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2013 (undefined)
    Primary Completion Date
    May 2014 (Actual)
    Study Completion Date
    May 2014 (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 demonstrate substantial equivalence of an investigational contact lens disinfecting solution to a commercially available contact lens solution in silicone hydrogel and soft contact lens wearers.
    Detailed Description
    Subjects with normal eyes (other than correction for refractive error) successfully wearing soft contact lenses were randomized 2:1 to receive either the investigational or commercial contact lens solution for daily use throughout the study (90 days).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Myopia, Astigmatism, Hyperopia, Refractive Error
    Keywords
    contact lenses, contact lens solution, soft contact lenses

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    362 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    FID 120947A
    Arm Type
    Experimental
    Arm Description
    FID 120947A contact lens disinfecting solution used with soft contact lenses (study lenses) on a daily basis for 90 days
    Arm Title
    renu fresh
    Arm Type
    Active Comparator
    Arm Description
    Renu fresh multi-purpose solution used with soft contact lenses (study lenses) on a daily basis for 90 days
    Intervention Type
    Device
    Intervention Name(s)
    FID 120947A contact lens disinfecting solution
    Other Intervention Name(s)
    Clear Care® Plus
    Intervention Description
    Investigational 3% hydrogen peroxide solution intended for simultaneous cleaning, protein removal, disinfecting and storage of silicone hydrogel and soft contact lenses
    Intervention Type
    Device
    Intervention Name(s)
    renu fresh multi-purpose solution
    Intervention Description
    Commercially available solution indicated for cleaning, removing protein deposits, rinsing, chemical disinfection, and storage of soft contact lenses
    Intervention Type
    Device
    Intervention Name(s)
    Soft contact lenses
    Intervention Description
    Commercially available soft contact lenses worn a minimum of 8 hours each day on a daily wear basis for the duration of the study (90 days). A fresh pair will be dispensed on Day 0, Day 30, and Day 60.
    Primary Outcome Measure Information:
    Title
    Percentage of Subjects With Visibly Clean Lenses
    Description
    Worn study lenses were removed and evaluated for deposits. Deposits found on the lenses were defined using a 3-part classification system consisting of general visibility, the specific appearance and area covered. A lens was considered visibly clean if it had nondetectable films or deposits. One eye (study eye) contributed to the analysis.
    Time Frame
    Day 7, Day 30, Day 60, Day 90
    Title
    Percentage of Subjects With Crystalline Deposits by Type
    Description
    Worn study lenses were removed and evaluated for deposits. Deposits found on the lenses were defined using a 3-part classification system consisting of general visibility, the specific appearance and area covered: Type II = films or deposits visible only under special conditions, such as special illumination using an eyepiece of 7-10 times magnification, Type III = films or deposits readily visible on a dry lens under room lighting, with unaided eye, and Type IV = films or deposits obvious under room lighting, with unaided eye, when the lens is wet or dry. One eye (study eye) contributed to the analysis.
    Time Frame
    Day 7, Day 30, Day 60, Day 90
    Title
    Percentage of Subjects With Film Deposits by Type
    Description
    Worn study lenses were removed and evaluated for deposits. Deposits found on the lenses were defined using a 3-part classification system consisting of general visibility, the specific appearance and area covered: Type II = films or deposits visible only under special conditions, such as special illumination using an eyepiece of 7-10 times magnification, Type III = films or deposits readily visible on a dry lens under room lighting, with unaided eye, and Type IV = films or deposits obvious under room lighting, with unaided eye, when the lens is wet or dry. One eye (study eye) contributed to the analysis.
    Time Frame
    Day 7, Day 30, Day 60, Day 90
    Title
    Average Residual Lens Lysozyme
    Description
    Worn study lenses were removed and analyzed by high performance liquid chromatography (HPLC) for residual lens lysozyme (protein). Values reported as lower than the limit of quantitation or none detected were imputed as 0.5 μg or 0 μg, respectively. A lower value indicates less lysozyme deposition. One eye (study eye) contributed to the analysis.
    Time Frame
    Day 30/Early Exit
    Title
    Percentage of Subjects With Change From Baseline in Contact Lens-Corrected Distance Visual Acuity (CLCDVA) by Line Change
    Description
    Distance VA was assessed for each eye individually while reading a chart distant to the participant in dimmed room illumination. VA was measured using a Snellen chart, with 20/20 Snellen acuity considered normal distance-eyesight. A line increase indicates an improvement in VA. One eye (study eye) contributed to the analysis.
    Time Frame
    Baseline (Day 0), Day 7, Day 30, Day 60, Day 90
    Title
    Average Lens Wear Time
    Description
    Subject recorded a response to the question, "Averaging over the last 3 days, how many hours per day did you wear your contact lenses?" Lens wear time was measured in hours.
    Time Frame
    Day 7, Day 30, Day 60, Day 90
    Title
    Number of Unscheduled Lens Replacements by Reason
    Description
    A fresh pair of lenses was dispensed on Day 0, Day 30, and Day 60. Lenses replaced at other times were considered unscheduled. The counts in the table represent the total number of unscheduled lenses replaced by reason for any eye, any subject.
    Time Frame
    Up to Day 90
    Title
    Likert Item - "When I Use This Solution, my Lenses Are Comfortable All Day."
    Description
    Lens comfort was assessed by the subject as a single response on a 5-point Likert scale (Strongly Agree, Agree, Undecided, Disagree, Strongly Disagree) to best describe their lens wearing experience over the last 3 days. Responses were summarized by agreement category and presented as percentage of subjects.
    Time Frame
    Day 7, Day 30, Day 60, Day 90
    Title
    Likert Item - "When I Use This Solution, at the End of the Lens Wearing Day my Vision is Clear."
    Description
    Clear vision was assessed by the subject as a single response on a 5-point Likert scale (Strongly Agree, Agree, Undecided, Disagree, Strongly Disagree) to best describe their lens wearing experience over the last 3 days. Responses were summarized by agreement category and presented as percentage of subjects.
    Time Frame
    Day 7, Day 30, Day 60, Day 90
    Title
    Likert Item - "When I Use This Solution, I Like the Way This Product Feels During Handling."
    Description
    Product handling was assessed by the subject as a single response on a 5-point Likert scale (Strongly Agree, Agree, Undecided, Disagree, Strongly Disagree) to best describe their lens wearing experience over the last 3 days. Responses were summarized by agreement category and presented as percentage of subjects.
    Time Frame
    Day 7, Day 30, Day 60, Day 90
    Title
    Crystalline Deposit Area Covered
    Description
    Worn study lenses were removed and evaluated for deposits. Deposits found on the lenses were defined using a 3-part classification system consisting of general visibility, the specific appearance and area covered. Values were reported as a percentage of lens area covered. One eye (study eye) contributed to the analysis.
    Time Frame
    Day 7, Day 30, Day 60, Day 90
    Title
    Film Deposit Area Covered
    Description
    Worn study lenses were removed and evaluated for deposits. Deposits found on the lenses were defined using a 3-part classification system consisting of general visibility, the specific appearance and area covered. Values were reported as a percentage of lens area covered. One eye (study eye) contributed to the analysis.
    Time Frame
    Day 7, Day 30, Day 60, Day 90

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Normal eyes (other than correction for visual acuity); Successful history of silicone hydrogel or soft contact lens wear in both eyes in one of the following brands: Soflens® 38, Proclear DW, Frequency 55, Acuvue® Oasys™, Air Optix Aqua, O2 OPTIX, Air Optix for Astigmatism, Air Optix Aqua Multifocal, Biofinity®, PureVision®, PureVision®2; Best spectacle corrected distance visual acuity greater than or equal to 20/25 in each eye; Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Any ocular or systemic medical condition that may, in the opinion of the investigator, preclude safe administration of the investigational products or affect the results of this study; Need to wear contact lenses on an extended wear basis (ie, overnight) during the study; Use of a daily cleaner and/or an enzyme cleaner to care for lenses at least 7 days prior to Visit 1; History of intolerance or hypersensitivity to any component of the investigational products; Use of all over-the-counter (OTC) or prescribed topical ocular medications within 7 days prior to Visit 1; Moderate, severe, abnormal, or other ocular findings; Current or history of ocular infection, severe inflammation, or disease within 6 months prior to Visit 1; Any systemic disease at Visit 1 (including allergies, respiratory infections or colds) that may affect the eye or be exacerbated by use of contact lenses or contact lens solutions; Use of systemic medications that may contribute to adverse ocular effects unless on a stable dosing regimen; Ocular surgery within the last 12 months; Other protocol-defined exclusion criteria may apply.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Monica Studzinski, Lead CSM
    Organizational Affiliation
    Alcon Research
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Safety and Efficacy Evaluation of a New Contact Lens Disinfecting Solution in Soft Contact Lens Wearers

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