Investigation of the Clinical Performance of Silicone Hydrogel Contact Lenses During Continuous Wear

This study has been completed.

Sponsors and Collaborators:	University of Melbourne Clinical Vision Research Australia Cooper Companies
Information provided by:	University of Melbourne
ClinicalTrials.gov Identifier:	NCT00346593

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

MedlinePlus related topics: Eye Wear

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Single Group Assignment

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

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

Study ID Numbers:	H03 010
Study First Received:	June 29, 2006
Last Updated:	February 8, 2007
ClinicalTrials.gov Identifier:	NCT00346593
Health Authority:	Australia: Department of Health and Ageing Therapeutic Goods Administration

Study placed in the following topic categories:

Myopia

ClinicalTrials.gov processed this record on January 14, 2009