Status:

COMPLETED

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

Lead Sponsor:

University of Melbourne

Collaborating Sponsors:

Clinical Vision Research Australia

Cooper Companies

Conditions:

Myopia

Eligibility:

All Genders

18-45 years

Phase:

NA

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.

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

May 1 2004

Trial Type :

INTERVENTIONAL

End Date :

December 1 2006

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT00346593

Start Date

May 1 2004

End Date

December 1 2006

Last Update

February 12 2007

Active Locations (1)

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Clinical Vision Research Australia

Carlton, Victoria, Australia, 3053