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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 19, 2014