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The Effect of Silicone Hydrogel Contact Lenses on Conjunctival Flora

Sponsor
University of Melbourne (Other)
Overall Status
Completed
CT.gov ID
NCT00531375
Collaborator
Clinical Vision Research Australia (Other), Johnson & Johnson Vision Care, Inc. (Industry)
60
Enrollment
1
Location
12
Duration (Months)
5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary purpose of this study is to investigate the effect of silicone hydrogel contact lenses on conjunctival flora over a period of 6 months of daily wear. A secondary aim is to compare the levels of microbial contamination of silicone hydrogel lenses after daily wear.

Condition or Disease Intervention/Treatment Phase
  • Device: Silicone hydrogel contact lens
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Study Start Date :
Sep 1, 2007
Actual Primary Completion Date :
Jun 1, 2008
Actual Study Completion Date :
Sep 1, 2008

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Is correctable to at least 6/9 distance visual acuity in each eye with spherical contact lenses.

    • Is a current full time soft contact lens wearer.

    • Has no clinically significant anterior eye findings.

    • Has no other active ocular disease

    Exclusion Criteria:

    • Has any systemic disease that might interfere with contact lens wear

    • Is using any systemic or topical medications that will affect ocular health.

    • Has any pre-existing ocular irritation that would preclude contact lens fitting.

    • Has any ocular pathology or severe insufficiency of lacrimal secretion (dry eyes) that would affect the wearing of contact lenses.

    • Has undergone corneal refractive surgery.

    • Is pregnant, lactating or planning a pregnancy.

    • Is participating in a concurrent clinical trial.

    • Has a latex sensitivity.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Clinical Vision Research Australia Melbourne Victoria Australia 3053

    Sponsors and Collaborators

    • University of Melbourne
    • Clinical Vision Research Australia
    • Johnson & Johnson Vision Care, Inc.

    Investigators

    • Principal Investigator: Carol Lakkis, BScOptom, PhD, PGCertOcTher, Clinical Vision Research Australia, Victorian College of Optometry

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00531375
    Other Study ID Numbers:
    • H07 003
    First Posted:
    Sep 18, 2007
    Last Update Posted:
    Nov 19, 2008
    Last Verified:
    Nov 1, 2008
    Additional relevant MeSH terms:
    Myopia

    Study Results

    No Results Posted as of Nov 19, 2008