The Effect of Silicone Hydrogel Contact Lenses on Conjunctival Flora

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00531375
Recruitment Status : Completed
First Posted : September 18, 2007
Last Update Posted : November 19, 2008
Clinical Vision Research Australia
Johnson & Johnson Vision Care, Inc.
Information provided by:
University of Melbourne

Brief Summary:
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 or disease Intervention/treatment Phase
Myopia Device: Silicone hydrogel contact lens Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : September 2007
Actual Primary Completion Date : June 2008
Actual Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00531375

Australia, Victoria
Clinical Vision Research Australia
Melbourne, Victoria, Australia, 3053
Sponsors and Collaborators
University of Melbourne
Clinical Vision Research Australia
Johnson & Johnson Vision Care, Inc.
Principal Investigator: Carol Lakkis, BScOptom, PhD, PGCertOcTher Clinical Vision Research Australia, Victorian College of Optometry

Responsible Party: Dr Carol Lakkis, Clinical Vision Research Australia Identifier: NCT00531375     History of Changes
Other Study ID Numbers: H07 003
First Posted: September 18, 2007    Key Record Dates
Last Update Posted: November 19, 2008
Last Verified: November 2008