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Clinical Performance of Extended Wear Silicone Hydrogel Lenses

Sponsor
University of Melbourne (Other)
Overall Status
Completed
CT.gov ID
NCT00441233
Collaborator
Menicon Co., Ltd. (Industry), Clinical Vision Research Australia (Other)
1
Location
9
Duration (Months)

Study Details

Study Description

Brief Summary

The primary purpose of this study is to investigate the clinical performance of a new silicone hydrogel contact lens over a period of 6 months of extended wear.

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

Study Design

Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single
Primary Purpose:
Treatment
Study Start Date :
Mar 1, 2007
Actual Primary Completion Date :
Nov 1, 2007
Actual Study Completion Date :
Dec 1, 2007

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    All
    Inclusion Criteria:

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

    • Is a current daily wear 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.

    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
    • Menicon Co., Ltd.
    • Clinical Vision Research Australia

    Investigators

    • Principal Investigator: Carol Lakkis, BScOptom, PhD, PGCertOcTher, Clinical Vision Research Australia, University of Melbourne

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00441233
    Other Study ID Numbers:
    • H07 001
    First Posted:
    Feb 28, 2007
    Last Update Posted:
    Jan 9, 2008
    Last Verified:
    Dec 1, 2007
    Additional relevant MeSH terms:
    Myopia

    Study Results

    No Results Posted as of Jan 9, 2008