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Amethyst: Multipurpose Disinfecting Solution Compatibility With a Silicone Hydrogel Contact Lens

Sponsor
University of Waterloo (Other)
Overall Status
Completed
CT.gov ID
NCT00520689
Collaborator
Menicon Co., Ltd. (Industry)
25
Enrollment
1
Location
4
Arms
3
Duration (Months)
8.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to verify the compatibility of a silicone hydrogel lens when used with four multipurpose disinfecting solutions (OPTI-FREE® RepleniSH®, ReNu MultiPlus®, Solo-Care Aqua™ and MeniCareTM Soft).

Condition or Disease Intervention/Treatment Phase
  • Device: Silicone Hydrogel Contact Lens
 Phase 3

Detailed Description

The purpose of this study is to verify the compatibility of a silicone hydrogel lens when used with four multipurpose disinfecting solutions (OPTI-FREE® RepleniSH®, ReNu MultiPlus®, Solo-Care Aqua™ and MeniCareTM Soft) by observing changes within the cornea.

Study Design

Study Type:
Interventional
Actual Enrollment :
25 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Single (Investigator)
Primary Purpose:
Treatment
Official Title:
Multipurpose Solution Compatibility With a Silicone Hydrogel Lens
Study Start Date :
Sep 1, 2007
Actual Primary Completion Date :
Dec 1, 2007
Actual Study Completion Date :
Dec 1, 2007

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 1

Device: Silicone Hydrogel Contact Lens
use of lens over 2 days
Other Names:
  • Premio

    		•
    Active Comparator: 2

    Device: Silicone Hydrogel Contact Lens
    use of lens over 2 days
    Other Names:
  • Premio

    		•
    Active Comparator: 3

    Device: Silicone Hydrogel Contact Lens
    use of lens over 2 days
    Other Names:
  • Premio

    		•
    Active Comparator: 4

    Device: Silicone Hydrogel Contact Lens
    use of lens over 2 days
    Other Names:
  • Premio

    		•

    Outcome Measures

    Primary Outcome Measures

    1. To see if there are any effects on the cornea when using each contact lens/solution combination. [Over 2 days]

    Secondary Outcome Measures

    1. To quantify comfort and vision ratings with each lens/solution combination. [over 2 days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    17 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    A person is eligible for inclusion in the study if he/she:

    1. Is at least 17 years old and has full legal capacity to volunteer

    2. Has read and signed an information consent letter, after having the opportunity to ask questions and receive acceptable answers

    3. Is willing and able to follow instructions and maintain the study appointment schedule

    4. Is correctable to a visual acuity of 6/7.5 (20/25) or better (both eyes) with their habitual vision correction

    5. Has normal binocular vision (no strabismus, no amblyopia, and anisometropia less than or equal to 1.00 D)

    6. Has clear corneas and no active ocular disease

    7. Has had an ocular examination in the last two years.

    8. Has a functional pair of spectacles

    9. Is a current soft lens wearer replacing their lenses at least monthly

    10. Has a distance contact lens prescription between +6.00D to -10.00 DS and can be successfully fitted with the study lens

    11. Has astigmatism less than or equal to -1.00DC

    12. Agrees to wear the study lenses on a daily wear basis

    Exclusion Criteria:
    A person will be excluded from the study if he/she:

    1. Has any signs or symptoms of dry eye

    2. Has any clinically significant blepharitis

    3. Has undergone corneal refractive surgery

    4. Is aphakic

    5. Has any systemic disease affecting ocular health

    6. Is using any systemic or topical medications that may affect ocular health

    7. Is pregnant or lactating

    8. Is participating in any other type of clinical or research study

    9. Currently wears daily disposable lenses

    10. Currently wears lenses on a continuous or extended wear basis

    11. Is unable to successfully wear contact lenses without routinely using rewetting drops

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Centre for Contact Lens Research, University of Waterloo Waterloo Ontario Canada N2L 3G1

    Sponsors and Collaborators

    • University of Waterloo
    • Menicon Co., Ltd.

    Investigators

    • Principal Investigator: Desmond Fonn, M Optom, University of Waterloo
    • Principal Investigator: Craig Woods, PhD, University of Waterloo

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00520689
    Other Study ID Numbers:
    • P/264/07/M
    First Posted:
    Aug 24, 2007
    Last Update Posted:
    Feb 16, 2009
    Last Verified:
    Feb 1, 2009
    Additional relevant MeSH terms:
    Hyperopia

    Study Results

    No Results Posted as of Feb 16, 2009