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Evaluation of the Effectiveness of Two Marketed Multi-Purpose Solutions for Silicone Hydrogel Contact Lenses - Study 1

Primary Purpose

Myopia, Hyperopia, Contact Lens Comfort

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Opti-Free® PureMoist® MPDS
Biotrue™ MPS
Habitual 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 multi-purpose solution, silicone hydrogel, contact lenses, comfort, Opti-Free, Biotrue

Eligibility Criteria

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

Inclusion Criteria:

  • Wear single vision sphere silicone hydrogel contact lenses (CooperVision™ Biofinity®, Alcon® Air Optix® Aqua, Bausch+Lomb® PureVision™ or ACUVUE® Oasys™) on a daily wear basis (a minimum of 8 hours per day, 5 days a week) for at least one month prior to Visit 1;
  • Willing to wear lenses on a daily wear basis (a minimum of 8 hours per day, 5 days a week) for the duration of the study, and wear lenses for 16 hours on two days during the study;
  • Must have habitually used a Biguanide preserved multi-purpose solution (other than Biotrue) for at least 30 days prior to Visit 1;
  • Vision correctable to 20/30 Snellen (feet) or better in each eye at distance with pre-study contact lenses at Visit 1;
  • Have access, capability and willingness to review and answer text messages;
  • Read, sign, and date IRB/IEC approved informed consent and privacy document before enrollment;
  • Willing to follow the study procedures and visit schedule;
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Need to wear lenses on an extended wear (i.e. overnight) basis during the study;
  • Known sensitivity or intolerance to Biguanide, polyquaternium-1 (POLYQUAD), or ALDOX preserved lens care products;
  • Monocular (only one eye with functional vision) or fit with only one lens;
  • Wearing toric or multifocal contact lenses or fit with monovision;
  • Use of additional lens care products other than a Biguanide preserved multipurpose solution such as daily or enzyme cleaners within the one week prior to Visit 1;
  • Use of topical ocular over-the-counter (OTC) or prescribed topical ocular medications, with the exception of rewetting drops, within 7 days prior to Visit 1;
  • Abnormal ocular condition observed during the Visit 1 slit-lamp examination;
  • Current or history of ocular infections or severe inflammation within 6 months prior to Visit 1;
  • Ocular surgery within the 12 months prior to Visit 1;
  • Participation in any other clinical trial within 30 days of enrollment;
  • Other protocol-defined exclusion criteria may apply.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Other

    Arm Label

    PureMoist - Biotrue

    Biotrue - PureMoist

    Arm Description

    Opti-Free® PureMoist® MPDS used first, followed by Biotrue™ MPS. Each product used as indicated for 30 days with participant's habitual contact lenses.

    Biotrue™ MPS used first, followed by Opti-Free® PureMoist® MPDS. Each product used as indicated for 30 days with participant's habitual contact lenses.

    Outcomes

    Primary Outcome Measures

    Corneal Staining
    Corneal staining in both eyes was assessed during slit lamp examination using flourescein dye. Each of five corneal regions (central, nasal, temporal, inferior, and superior) was graded on a scale from 0 (none) to 4 (patch). The corneal fluorescein staining score was calculated as the total of the five regions. The score ranged from 0 (no staining in any region) to 20 (patch staining in all five regions). The corneal staining of the worse eye was analyzed.
    Change From Baseline in Corneal Staining at Day 30
    Corneal staining in both eyes was assessed during slit lamp examination using flourescein dye. Each of five corneal regions (central, nasal, temporal, inferior, and superior) was graded on a scale from 0 (none) to 4 (patch). The corneal fluorescein staining score was calculated as the total of the five regions. The score ranged from 0 (no staining in any region) to 20 (patch staining in all five regions). The corneal staining of the worse eye was analyzed.

    Secondary Outcome Measures

    Full Information

    First Posted
    September 10, 2012
    Last Updated
    March 12, 2014
    Sponsor
    Alcon Research
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01684033
    Brief Title
    Evaluation of the Effectiveness of Two Marketed Multi-Purpose Solutions for Silicone Hydrogel Contact Lenses - Study 1
    Official Title
    Evaluation of the Effectiveness of Two Marketed Multi-Purpose Solutions for Silicone Hydrogel Contact Lenses - Study 1
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2012 (undefined)
    Primary Completion Date
    March 2013 (Actual)
    Study Completion Date
    March 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 evaluate the performance of Opti-Free® PureMoist® Multi-Purpose Disinfecting Solution (MPDS) compared to Biotrue™ Multipurpose Solution (MPS) in silicone hydrogel contact lens wearers.
    Detailed Description
    In this 2-period crossover study, eligible participants were randomized to either Opti-Free® PureMoist® Multi-Purpose Disinfecting Solution or Biotrue™ Multipurpose Solution in Period 1 for use with their habitual contact lenses, after which they switched to the alternate solution in Period 2. Each period was 30 days in length. A 2-day washout period during which participants refrained from using a multi-purpose contact lens solution preceded Period 1 and Period 2.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Myopia, Hyperopia, Contact Lens Comfort
    Keywords
    multi-purpose solution, silicone hydrogel, contact lenses, comfort, Opti-Free, Biotrue

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    PureMoist - Biotrue
    Arm Type
    Other
    Arm Description
    Opti-Free® PureMoist® MPDS used first, followed by Biotrue™ MPS. Each product used as indicated for 30 days with participant's habitual contact lenses.
    Arm Title
    Biotrue - PureMoist
    Arm Type
    Other
    Arm Description
    Biotrue™ MPS used first, followed by Opti-Free® PureMoist® MPDS. Each product used as indicated for 30 days with participant's habitual contact lenses.
    Intervention Type
    Device
    Intervention Name(s)
    Opti-Free® PureMoist® MPDS
    Other Intervention Name(s)
    OPTI-FREE® PureMoist™
    Intervention Type
    Device
    Intervention Name(s)
    Biotrue™ MPS
    Other Intervention Name(s)
    Biotrue™
    Intervention Type
    Device
    Intervention Name(s)
    Habitual contact lenses
    Intervention Description
    Silicone hydrogel contact lenses per participant's habitual brand, prescription, and replacement schedule worn on a daily wear basis for at least 8 hours a day, 5 days a week for the duration of the study. During the washout period, the contact lenses were worn on a daily disposable basis.
    Primary Outcome Measure Information:
    Title
    Corneal Staining
    Description
    Corneal staining in both eyes was assessed during slit lamp examination using flourescein dye. Each of five corneal regions (central, nasal, temporal, inferior, and superior) was graded on a scale from 0 (none) to 4 (patch). The corneal fluorescein staining score was calculated as the total of the five regions. The score ranged from 0 (no staining in any region) to 20 (patch staining in all five regions). The corneal staining of the worse eye was analyzed.
    Time Frame
    Day 30
    Title
    Change From Baseline in Corneal Staining at Day 30
    Description
    Corneal staining in both eyes was assessed during slit lamp examination using flourescein dye. Each of five corneal regions (central, nasal, temporal, inferior, and superior) was graded on a scale from 0 (none) to 4 (patch). The corneal fluorescein staining score was calculated as the total of the five regions. The score ranged from 0 (no staining in any region) to 20 (patch staining in all five regions). The corneal staining of the worse eye was analyzed.
    Time Frame
    Baseline (Day 0), Day 30

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Wear single vision sphere silicone hydrogel contact lenses (CooperVision™ Biofinity®, Alcon® Air Optix® Aqua, Bausch+Lomb® PureVision™ or ACUVUE® Oasys™) on a daily wear basis (a minimum of 8 hours per day, 5 days a week) for at least one month prior to Visit 1; Willing to wear lenses on a daily wear basis (a minimum of 8 hours per day, 5 days a week) for the duration of the study, and wear lenses for 16 hours on two days during the study; Must have habitually used a Biguanide preserved multi-purpose solution (other than Biotrue) for at least 30 days prior to Visit 1; Vision correctable to 20/30 Snellen (feet) or better in each eye at distance with pre-study contact lenses at Visit 1; Have access, capability and willingness to review and answer text messages; Read, sign, and date IRB/IEC approved informed consent and privacy document before enrollment; Willing to follow the study procedures and visit schedule; Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Need to wear lenses on an extended wear (i.e. overnight) basis during the study; Known sensitivity or intolerance to Biguanide, polyquaternium-1 (POLYQUAD), or ALDOX preserved lens care products; Monocular (only one eye with functional vision) or fit with only one lens; Wearing toric or multifocal contact lenses or fit with monovision; Use of additional lens care products other than a Biguanide preserved multipurpose solution such as daily or enzyme cleaners within the one week prior to Visit 1; Use of topical ocular over-the-counter (OTC) or prescribed topical ocular medications, with the exception of rewetting drops, within 7 days prior to Visit 1; Abnormal ocular condition observed during the Visit 1 slit-lamp examination; Current or history of ocular infections or severe inflammation within 6 months prior to Visit 1; Ocular surgery within the 12 months prior to Visit 1; Participation in any other clinical trial within 30 days of enrollment; Other protocol-defined exclusion criteria may apply.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jessie Lemp, MS
    Organizational Affiliation
    Alcon Research
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Evaluation of the Effectiveness of Two Marketed Multi-Purpose Solutions for Silicone Hydrogel Contact Lenses - Study 1

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