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Clinical Performance of Extended Wear Silicone Hydrogel Lenses

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00441233
First Posted: February 28, 2007
Last Update Posted: January 9, 2008
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.
Collaborators:
Menicon Co., Ltd.
Clinical Vision Research Australia
Information provided by:
University of Melbourne
  Purpose
The primary purpose of this study is to investigate the clinical performance of a new silicone hydrogel contact lens over a period of 6 months of extended wear.

Condition Intervention
Myopia Device: Silicone hydrogel contact lens

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by University of Melbourne:

Study Start Date: March 2007
Study Completion Date: December 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
  Eligibility

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
Criteria

Inclusion Criteria:

  • Is correctable to at least 6/9 distance visual acuity in each eye with spherical contact lenses.
  • Is a current daily wear 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
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 ClinicalTrials.gov identifier (NCT number): NCT00441233


Locations
Australia, Victoria
Clinical Vision Research Australia
Melbourne, Victoria, Australia, 3053
Sponsors and Collaborators
University of Melbourne
Menicon Co., Ltd.
Clinical Vision Research Australia
Investigators
Principal Investigator: Carol Lakkis, BScOptom, PhD, PGCertOcTher Clinical Vision Research Australia, University of Melbourne
  More Information

ClinicalTrials.gov Identifier: NCT00441233     History of Changes
Other Study ID Numbers: H07 001
First Submitted: February 27, 2007
First Posted: February 28, 2007
Last Update Posted: January 9, 2008
Last Verified: December 2007