Back to resultsComparison of Contact Lens Maintenance Systems for Silicone Hydrogel Lenses
Primary Purpose
Myopia, Hyperopia
Status
Completed
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Silicone hydrogel contact lens
Sponsored by
About this trial
This is an interventional treatment trial for Myopia
Eligibility Criteria
Inclusion Criteria: Is correctable to at least 20/40 distance visual acuity in each eye with spherical contact lenses. Is an experienced soft contact lens wearer for at least 1 month. Has no clinically significant anterior eye findings. Has no other active ocular disease. Exclusion Criteria: Requires concurrent ocular medication. Eye surgery or injury within 12 weeks prior to enrolment. Has any systemic disease or ocular abnormality that might interfere with contact lens wear Has any pre-existing ocular irritation that would preclude contact lens fitting. PMMA lens wear previous 6 months. EW or CW in previous 1 month. Hydrogen peroxide users Latex sensitivity
Sites / Locations
- Clinical Vision Research Australia
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00363623
First Posted
August 10, 2006
Last Updated
March 20, 2008
Sponsor
University of Melbourne
Collaborators
CIBA VISION
1. Study Identification
Unique Protocol Identification Number
NCT00363623
Brief Title
Comparison of Contact Lens Maintenance Systems for Silicone Hydrogel Lenses
Study Type
Interventional
2. Study Status
Record Verification Date
February 2007
Overall Recruitment Status
Completed
Study Start Date
August 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University of Melbourne
Collaborators
CIBA VISION
4. Oversight
5. Study Description
Brief Summary
The primary purpose of this study is to investigate the performance of contact lens maintenance systems when used with silicone hydrogel contact lenses during daily wear over a period of 1 month.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia, Hyperopia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Single
Allocation
Randomized
Enrollment
44 (false)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Silicone hydrogel contact lens
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Is correctable to at least 20/40 distance visual acuity in each eye with spherical contact lenses.
Is an experienced soft contact lens wearer for at least 1 month.
Has no clinically significant anterior eye findings.
Has no other active ocular disease.
Exclusion Criteria:
Requires concurrent ocular medication.
Eye surgery or injury within 12 weeks prior to enrolment.
Has any systemic disease or ocular abnormality that might interfere with contact lens wear
Has any pre-existing ocular irritation that would preclude contact lens fitting.
PMMA lens wear previous 6 months.
EW or CW in previous 1 month.
Hydrogen peroxide users
Latex sensitivity
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carol Lakkis, BScOptom, PhD
Organizational Affiliation
Clinical Vision Research Australia, University of Melbourne
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical Vision Research Australia
City
Carlton
State/Province
Victoria
ZIP/Postal Code
3053
Country
Australia
12. IPD Sharing Statement
Links:
URL
http://www.vco.org.au/CVRA/index.html
Description
Related Info
Learn more about this trial
Comparison of Contact Lens Maintenance Systems for Silicone Hydrogel Lenses
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