Back to resultsClinical Performance of Extended Wear Silicone Hydrogel Lenses
Primary Purpose
Myopia
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 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.
Sites / Locations
- Clinical Vision Research Australia
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00441233
First Posted
February 27, 2007
Last Updated
December 27, 2007
Sponsor
University of Melbourne
Collaborators
Menicon Co., Ltd., Clinical Vision Research Australia
1. Study Identification
Unique Protocol Identification Number
NCT00441233
Brief Title
Clinical Performance of Extended Wear Silicone Hydrogel Lenses
Study Type
Interventional
2. Study Status
Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
November 2007 (Actual)
Study Completion Date
December 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Melbourne
Collaborators
Menicon Co., Ltd., Clinical Vision Research Australia
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
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
Maximum Age & Unit of Time
45 Years
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carol Lakkis, BScOptom, PhD, PGCertOcTher
Organizational Affiliation
Clinical Vision Research Australia, University of Melbourne
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical Vision Research Australia
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3053
Country
Australia
12. IPD Sharing Statement
Learn more about this trial
Clinical Performance of Extended Wear Silicone Hydrogel Lenses
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