Clinical Performance of Extended Wear Silicone Hydrogel Lenses

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00441233
Recruitment Status : Completed
First Posted : February 28, 2007
Last Update Posted : January 9, 2008
Menicon Co., Ltd.
Clinical Vision Research Australia
Information provided by:
University of Melbourne

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
Myopia Device: Silicone hydrogel contact lens Not Applicable

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Study Start Date : March 2007
Actual Primary Completion Date : November 2007
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00441233

Australia, Victoria
Clinical Vision Research Australia
Melbourne, Victoria, Australia, 3053
Sponsors and Collaborators
University of Melbourne
Menicon Co., Ltd.
Clinical Vision Research Australia
Principal Investigator: Carol Lakkis, BScOptom, PhD, PGCertOcTher Clinical Vision Research Australia, University of Melbourne Identifier: NCT00441233     History of Changes
Other Study ID Numbers: H07 001
First Posted: February 28, 2007    Key Record Dates
Last Update Posted: January 9, 2008
Last Verified: December 2007