Investigation of the Clinical Performance of Silicone Hydrogel Contact Lenses During Continuous Wear

This study has been completed.
Sponsor:
Collaborators:
Clinical Vision Research Australia
Cooper Companies
Information provided by:
University of Melbourne
ClinicalTrials.gov Identifier:
NCT00346593
First received: June 29, 2006
Last updated: February 8, 2007
Last verified: February 2007

June 29, 2006
February 8, 2007
May 2004
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Complete list of historical versions of study NCT00346593 on ClinicalTrials.gov Archive Site
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Investigation of the Clinical Performance of Silicone Hydrogel Contact Lenses During Continuous Wear
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The primary purpose of this study is to investigate the clinical performance of a new silicone hydrogel contact lens during continuous wear (up to 30 nights) over a period of 24 months.

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Interventional
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Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double-Blind
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 2006
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Inclusion Criteria:

  • Has had an oculo-visual examination in the last 2 years.
  • Is correctable to at least 6/7.5 distance visual acuity in each eye with spherical contact lenses.
  • Is a current 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.
Both
18 Years to 45 Years
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Contact information is only displayed when the study is recruiting subjects
Australia
 
NCT00346593
H03 010
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University of Melbourne
  • Clinical Vision Research Australia
  • Cooper Companies
Principal Investigator: Carol Lakkis, BScOptom PhD Clinical Vision Research Australia
University of Melbourne
February 2007

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