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An Evaluation of Marketed Contact Lens Disinfectant Systems on Eyelid Tissues (ID11-56)

Primary Purpose

Myopia

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
AOSEPT® Plus contact lens solution
ReNu MultiPlus® contact lens solution
Etafilcon A contact lenses
Lotrafilcon B contact lenses
COMPLETE® MPS Easy Rub® Formula contact lens solution
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 CLEAR CARE®, AOSEPT® Plus, ReNu MultiPlus®, silicone hydrogel, hydrogel, ACUVUE® 2®, AIR OPTIX® AQUA, eyelid response, wettability, contamination, contact lenses

Eligibility Criteria

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

Inclusion Criteria:

  • Read and understand the Participant Information Sheet;
  • Read, sign, and date an Informed Consent;
  • Successfully wearing a frequent replacement hydrogel or silicone hydrogel contact lens brand under a frequent replacement (biweekly or monthly) daily wear modality;
  • Classified as symptomatic according to protocol-specified criteria;
  • Agree to wear study contact lenses as directed for the duration of the study;
  • Best corrected visual acuity (BCVA) of 6/9 or better in each eye;
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Any known sensitivity or intolerance to any of the contact lenses or contact lens care products to be used;
  • Monocular vision (only one eye with functional vision or only one eye fitted with contact lenses);
  • History of seasonal allergies, which may have an adverse impact on contact lens wear, or data and information obtained in this study;
  • Systemic disease or use of medication which might interfere with contact lens wear or produce dry eye side effects;
  • Ocular allergies or ocular disease which might interfere with contact lens wear or data and information obtained in this study;
  • Active ocular infection;
  • Use of any concomitant topical ocular medications during the study period;
  • Significant ocular anomaly;
  • Previous ocular surgery;
  • History of recent, significant changes in visual acuity;
  • Any medical condition that might be prejudicial to the study;
  • Pregnant, planning to be become pregnant, or lactating at time of enrollment;
  • Any infectious disease (e.g. hepatitis, tuberculosis), immunosuppressive disease (e.g. HIV), or diabetes;
  • Participation in an investigational drug or device study within 30 days of entering study;
  • Other protocol-defined exclusion criteria may apply.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Active Comparator

    Other

    Arm Label

    AOSEPT Plus

    ReNu MultiPlus

    Complete MPS Easy Rub

    Arm Description

    AOSEPT® Plus contact lens solution used with etafilcon A contact lenses or lotrafilcon B contact lenses for 3 months (Investigational Phase)

    ReNu MultiPlus® contact lens solution used with etafilcon A contact lenses or lotrafilcon B contact lenses for 3 months (Investigational Phase)

    COMPLETE® MPS Easy Rub® Formula contact lens solution used with etafilcon A contact lenses (14 days) or lotrafilcon B contact lenses (30 days), Screening Phase

    Outcomes

    Primary Outcome Measures

    Maximum Papillae
    Eyelid papillae (bumps on the inner eyelid) were recorded separately for three zones of the upper lid and overall for the lower lid on a 5-point forced choice scale: 0 = None; 1 = Slight (diffuse papillae); 2 = Mild (diffuse & tufts papillae); 3 = Moderate (moderate & tufts papillae); 4 = Severe (giant papillae). The maximum value represents the worse grade in any zone. Both eyes were included in the model for analysis. Contact lenses were not worn for this assessment.
    Maximum Eyelid Hyperaemia
    Eyelid hyperaemia (redness) was recorded separately for three zones of the upper lid and overall for the lower lid on a 5-point forced choice scale: 0 = Clear; 1 = Slight redness; 2 = Mild redness; 3 = Moderate redness; 4 = Severe redness). The maximum value represents the worst grade in any zone. Both eyes were included in the model for analysis. Contact lenses were not worn for this assessment.
    Mean Upper Eyelid Redness
    The contact lenses were removed and upper eyelid redness was objectively measured through digital images. The coverage of the palpebral surface by blood vessels is expressed as percentage of the total surface measured. Both eyes were included in the model for analysis. Contact lenses were not worn for this assessment.
    Mean Upper Eyelid Margin Staining
    The contact lens was removed and ophthalmic dye was instilled. Upper eyelid margin staining was objectively measured through digital images. The extent of true staining (i.e., the total area of lid margin covered by staining) was recorded. Both eyes were included in the model for analysis. Contact lenses were not worn for this assessment.

    Secondary Outcome Measures

    Median Non-Invasive Pre-Lens Tear Film Break Up Time (PL-NIBUT)
    The pre-lens tear film is the layer of tears located on top of the contact lens (i.e., between the eyelid and the contact lens). The time required for a dry spot to appear on the pre-lens surface after blinking is referred to as the pre-lens tear film break up time. PL-NIBUT was evaluated using a biomicroscope with a diffuse illumination source, i.e., Tearscope. A longer PL-NIBUT indicates a more stable tear film and greater on-eye lens wettability. Three PL-NIBUT measurements were recorded, and the median value was used for analysis. Both eyes were included in the model for analysis. Contact lenses were on-eye for this assessment.

    Full Information

    First Posted
    May 7, 2012
    Last Updated
    June 27, 2014
    Sponsor
    Alcon Research
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01594294
    Brief Title
    An Evaluation of Marketed Contact Lens Disinfectant Systems on Eyelid Tissues
    Acronym
    ID11-56
    Official Title
    EVALUATION OF THE EFFECTS OF CLEAR CARE® / AOSEPT® PLUS HYDROGEN PEROXIDE SOLUTION ON THE EYELID TISSUES - Part III: COMPARATIVE EVALUATION WITH RENU® MPS OVER 3 MONTH OF WEAR - CONTROL EVALUATION WITH AIR OPTIX® AQUA and ACUVUE® 2®
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2012 (undefined)
    Primary Completion Date
    June 2013 (Actual)
    Study Completion Date
    June 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 was to assess and compare the effect of the repeated usage of 2 different care systems (one hydrogen peroxide based cleaning and disinfecting system and one PHMB containing multipurpose system) with ACUVUE® 2® and AIR OPTIX® AQUA contact lenses worn on a daily wear basis for a 3-month period.
    Detailed Description
    This study was divided into 2 periods, a Screening Phase and an Investigational Phase. During the Screening Phase, subjects were fitted and dispensed with either ACUVUE® 2® (for current hydrogel wearers) or AIR OPTIX® AQUA (for current silicone hydrogel wearers) contact lenses and used COMPLETE® MPS Easy Rub® Formula to clean and disinfect their lenses. At the completion of the Screening Phase, the symptomatic status of the subjects was re-assessed. Those subjects who qualified proceeded to the Investigational Phase and were dispensed with new pair of study contact lenses identical to the lenses they wore during the Screening Phase to use in conjunction with the allocated study care product, CLEAR CARE® /AOSEPT® Plus or ReNu MultiPlus®.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Myopia
    Keywords
    CLEAR CARE®, AOSEPT® Plus, ReNu MultiPlus®, silicone hydrogel, hydrogel, ACUVUE® 2®, AIR OPTIX® AQUA, eyelid response, wettability, contamination, contact lenses

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    AOSEPT Plus
    Arm Type
    Experimental
    Arm Description
    AOSEPT® Plus contact lens solution used with etafilcon A contact lenses or lotrafilcon B contact lenses for 3 months (Investigational Phase)
    Arm Title
    ReNu MultiPlus
    Arm Type
    Active Comparator
    Arm Description
    ReNu MultiPlus® contact lens solution used with etafilcon A contact lenses or lotrafilcon B contact lenses for 3 months (Investigational Phase)
    Arm Title
    Complete MPS Easy Rub
    Arm Type
    Other
    Arm Description
    COMPLETE® MPS Easy Rub® Formula contact lens solution used with etafilcon A contact lenses (14 days) or lotrafilcon B contact lenses (30 days), Screening Phase
    Intervention Type
    Device
    Intervention Name(s)
    AOSEPT® Plus contact lens solution
    Other Intervention Name(s)
    CLEAR CARE®
    Intervention Description
    Hydrogen peroxide-based cleaning and disinfection system
    Intervention Type
    Device
    Intervention Name(s)
    ReNu MultiPlus® contact lens solution
    Intervention Description
    Polyaminopropyl biguanide (PHMB) preserved multipurpose solution
    Intervention Type
    Device
    Intervention Name(s)
    Etafilcon A contact lenses
    Other Intervention Name(s)
    ACUVUE® 2®
    Intervention Description
    Hydrogel contact lenses worn on a daily wear basis for 14 days (Screening Phase) and 3 months (Investigational Phase). During the Investigational Phase, the contact lenses lenses were worn a minimum of six hours per day, 5 days per week, with a fresh pair dispensed every 2 weeks.
    Intervention Type
    Device
    Intervention Name(s)
    Lotrafilcon B contact lenses
    Other Intervention Name(s)
    AIR OPTIX® AQUA
    Intervention Description
    Silicone hydrogel contact lenses worn on a daily wear basis for 30 days (Screening Phase) and 3 months (Investigational Phase). During the Investigational Phase, the contact lenses lenses were worn a minimum of six hours per day, 5 days per week, with a fresh pair dispensed monthly.
    Intervention Type
    Device
    Intervention Name(s)
    COMPLETE® MPS Easy Rub® Formula contact lens solution
    Intervention Description
    PHMB 0.0001% and poloxamer 0.05% multipurpose solution
    Primary Outcome Measure Information:
    Title
    Maximum Papillae
    Description
    Eyelid papillae (bumps on the inner eyelid) were recorded separately for three zones of the upper lid and overall for the lower lid on a 5-point forced choice scale: 0 = None; 1 = Slight (diffuse papillae); 2 = Mild (diffuse & tufts papillae); 3 = Moderate (moderate & tufts papillae); 4 = Severe (giant papillae). The maximum value represents the worse grade in any zone. Both eyes were included in the model for analysis. Contact lenses were not worn for this assessment.
    Time Frame
    Baseline (Day 0), Month 3
    Title
    Maximum Eyelid Hyperaemia
    Description
    Eyelid hyperaemia (redness) was recorded separately for three zones of the upper lid and overall for the lower lid on a 5-point forced choice scale: 0 = Clear; 1 = Slight redness; 2 = Mild redness; 3 = Moderate redness; 4 = Severe redness). The maximum value represents the worst grade in any zone. Both eyes were included in the model for analysis. Contact lenses were not worn for this assessment.
    Time Frame
    Baseline (Day 0), Month 3
    Title
    Mean Upper Eyelid Redness
    Description
    The contact lenses were removed and upper eyelid redness was objectively measured through digital images. The coverage of the palpebral surface by blood vessels is expressed as percentage of the total surface measured. Both eyes were included in the model for analysis. Contact lenses were not worn for this assessment.
    Time Frame
    Baseline (Day 0), Month 3
    Title
    Mean Upper Eyelid Margin Staining
    Description
    The contact lens was removed and ophthalmic dye was instilled. Upper eyelid margin staining was objectively measured through digital images. The extent of true staining (i.e., the total area of lid margin covered by staining) was recorded. Both eyes were included in the model for analysis. Contact lenses were not worn for this assessment.
    Time Frame
    Baseline (Day 0), Month 3
    Secondary Outcome Measure Information:
    Title
    Median Non-Invasive Pre-Lens Tear Film Break Up Time (PL-NIBUT)
    Description
    The pre-lens tear film is the layer of tears located on top of the contact lens (i.e., between the eyelid and the contact lens). The time required for a dry spot to appear on the pre-lens surface after blinking is referred to as the pre-lens tear film break up time. PL-NIBUT was evaluated using a biomicroscope with a diffuse illumination source, i.e., Tearscope. A longer PL-NIBUT indicates a more stable tear film and greater on-eye lens wettability. Three PL-NIBUT measurements were recorded, and the median value was used for analysis. Both eyes were included in the model for analysis. Contact lenses were on-eye for this assessment.
    Time Frame
    Month 3

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Read and understand the Participant Information Sheet; Read, sign, and date an Informed Consent; Successfully wearing a frequent replacement hydrogel or silicone hydrogel contact lens brand under a frequent replacement (biweekly or monthly) daily wear modality; Classified as symptomatic according to protocol-specified criteria; Agree to wear study contact lenses as directed for the duration of the study; Best corrected visual acuity (BCVA) of 6/9 or better in each eye; Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Any known sensitivity or intolerance to any of the contact lenses or contact lens care products to be used; Monocular vision (only one eye with functional vision or only one eye fitted with contact lenses); History of seasonal allergies, which may have an adverse impact on contact lens wear, or data and information obtained in this study; Systemic disease or use of medication which might interfere with contact lens wear or produce dry eye side effects; Ocular allergies or ocular disease which might interfere with contact lens wear or data and information obtained in this study; Active ocular infection; Use of any concomitant topical ocular medications during the study period; Significant ocular anomaly; Previous ocular surgery; History of recent, significant changes in visual acuity; Any medical condition that might be prejudicial to the study; Pregnant, planning to be become pregnant, or lactating at time of enrollment; Any infectious disease (e.g. hepatitis, tuberculosis), immunosuppressive disease (e.g. HIV), or diabetes; Participation in an investigational drug or device study within 30 days of entering study; Other protocol-defined exclusion criteria may apply.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Renee Garofalo, OD, FAAO
    Organizational Affiliation
    Alcon Research
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    An Evaluation of Marketed Contact Lens Disinfectant Systems on Eyelid Tissues

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