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
  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:


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
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: 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 August 18, 2014