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Clinical Performance of Extended Wear Silicone Hydrogel Lenses

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00441233
First Posted: February 28, 2007
Last Update Posted: January 9, 2008
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.
Collaborators:
Menicon Co., Ltd.
Clinical Vision Research Australia
Information provided by:
University of Melbourne
February 27, 2007
February 28, 2007
January 9, 2008
March 2007
November 2007   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00441233 on ClinicalTrials.gov Archive Site
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Clinical Performance of Extended Wear Silicone Hydrogel Lenses
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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.
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Interventional
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Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Myopia
Device: Silicone hydrogel contact lens
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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December 2007
November 2007   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 45 Years   (Adult)
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Contact information is only displayed when the study is recruiting subjects
Australia
 
 
NCT00441233
H07 001
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University of Melbourne
  • Menicon Co., Ltd.
  • Clinical Vision Research Australia
Principal Investigator: Carol Lakkis, BScOptom, PhD, PGCertOcTher Clinical Vision Research Australia, University of Melbourne
University of Melbourne
December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP