Clinical Performance of Extended Wear Silicone Hydrogel Lenses

This study has been completed.
Menicon Co., Ltd.
Clinical Vision Research Australia
Information provided by:
University of Melbourne Identifier:
First received: February 27, 2007
Last updated: December 27, 2007
Last verified: December 2007
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 Intervention
Device: Silicone hydrogel contact lens

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by University of Melbourne:

Study Start Date: March 2007
Study Completion Date: December 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both

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
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Please refer to this study by its identifier: 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
  More Information

No publications provided Identifier: NCT00441233     History of Changes
Other Study ID Numbers: H07 001
Study First Received: February 27, 2007
Last Updated: December 27, 2007
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration processed this record on November 27, 2015