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The Effect of Silicone Hydrogel Contact Lenses on Conjunctival Flora

This study has been completed.
Sponsor:
Collaborators:
Clinical Vision Research Australia
Vistakon
Information provided by:
University of Melbourne
ClinicalTrials.gov Identifier:
NCT00531375
First received: September 17, 2007
Last updated: November 17, 2008
Last verified: November 2008
History of Changes
  Purpose

The primary purpose of this study is to investigate the effect of silicone hydrogel contact lenses on conjunctival flora over a period of 6 months of daily wear. A secondary aim is to compare the levels of microbial contamination of silicone hydrogel lenses after daily wear.


Condition Intervention
Myopia
 Device: Silicone hydrogel contact lens

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
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:

Enrollment: 60
Study Start Date: September 2007
Study Completion Date: September 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Is correctable to at least 6/9 distance visual acuity in each eye with spherical contact lenses.
  • Is a current full time 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.
  • Is participating in a concurrent clinical trial.
  • Has a latex sensitivity.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00531375

Locations
Australia, Victoria
Clinical Vision Research Australia
Melbourne, Victoria, Australia, 3053
Sponsors and Collaborators
University of Melbourne
Clinical Vision Research Australia
Vistakon
Investigators
Principal Investigator: Carol Lakkis, BScOptom, PhD, PGCertOcTher Clinical Vision Research Australia, Victorian College of Optometry
  More Information

No publications provided

Responsible Party: Dr Carol Lakkis, Clinical Vision Research Australia
ClinicalTrials.gov Identifier: NCT00531375     History of Changes
Other Study ID Numbers: H07 003
Study First Received: September 17, 2007
Last Updated: November 17, 2008
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 19, 2013