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

Primary Purpose

Myopia

Status
Completed
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Silicone hydrogel contact lens
Sponsored by
University of Melbourne
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myopia

Eligibility Criteria

18 Years - 45 Years (Adult)All Sexes

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.

Sites / Locations

  • Clinical Vision Research Australia

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
June 29, 2006
Last Updated
February 8, 2007
Sponsor
University of Melbourne
Collaborators
Clinical Vision Research Australia, Cooper Companies
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1. Study Identification

Unique Protocol Identification Number
NCT00346593
Brief Title
Investigation of the Clinical Performance of Silicone Hydrogel Contact Lenses During Continuous Wear
Study Type
Interventional

2. Study Status

Record Verification Date
February 2007
Overall Recruitment Status
Completed
Study Start Date
May 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University of Melbourne
Collaborators
Clinical Vision Research Australia, Cooper Companies

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 during continuous wear (up to 30 nights) over a period of 24 months.

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
Single Group Assignment
Masking
Double
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: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carol Lakkis, BScOptom PhD
Organizational Affiliation
Clinical Vision Research Australia
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

Learn more about this trial

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

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