Clinical Performance of Extended Wear Silicone Hydrogel Lenses
December 27, 2007 updated by: University of Melbourne
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.
Study Overview
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Victoria
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Melbourne, Victoria, Australia, 3053
- Clinical Vision Research Australia
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Carol Lakkis, BScOptom, PhD, PGCertOcTher, Clinical Vision Research Australia, University of Melbourne
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2007
Primary Completion (Actual)
November 1, 2007
Study Completion (Actual)
December 1, 2007
Study Registration Dates
First Submitted
February 27, 2007
First Submitted That Met QC Criteria
February 27, 2007
First Posted (Estimate)
February 28, 2007
Study Record Updates
Last Update Posted (Estimate)
January 9, 2008
Last Update Submitted That Met QC Criteria
December 27, 2007
Last Verified
December 1, 2007
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H07 001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.