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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
History of Changes
  Purpose

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 Intervention
Myopia
 Device: Silicone hydrogel contact lens

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

Resource links provided by NLM:

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

Further study details as provided by University of Melbourne:

Study Start Date: May 2004
Estimated Study Completion Date: December 2006
  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00346593     History of Changes
Other Study ID Numbers: H03 010
Study First Received: June 29, 2006
Last Updated: February 8, 2007
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Additional relevant MeSH terms:
Myopia
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on May 16, 2013