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

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ClinicalTrials.gov Identifier: NCT00346593
Recruitment Status : Completed
First Posted : June 30, 2006
Last Update Posted : February 12, 2007
Sponsor:
Collaborators:
Clinical Vision Research Australia
Cooper Companies
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 during continuous wear (up to 30 nights) over a period of 24 months.

Condition or disease Intervention/treatment Phase
Myopia Device: Silicone hydrogel contact lens Not Applicable

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Study Start Date : May 2004
Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear
U.S. FDA Resources





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
Criteria

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.

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 ClinicalTrials.gov identifier (NCT number): NCT00346593


Locations
Australia, Victoria
Clinical Vision Research Australia
Carlton, Victoria, Australia, 3053
Sponsors and Collaborators
University of Melbourne
Clinical Vision Research Australia
Cooper Companies
Investigators
Principal Investigator: Carol Lakkis, BScOptom PhD Clinical Vision Research Australia

ClinicalTrials.gov Identifier: NCT00346593     History of Changes
Other Study ID Numbers: H03 010
First Posted: June 30, 2006    Key Record Dates
Last Update Posted: February 12, 2007
Last Verified: February 2007