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The Effect of Silicone Hydrogel Contact Lenses on Conjunctival Flora

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 SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Is correctable to at least 6/9 distance visual acuity in each eye with spherical contact lenses.
  • Is a current full time 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.
  • Is participating in a concurrent clinical trial.
  • Has a latex sensitivity.

Sites / Locations

  • Clinical Vision Research Australia

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 17, 2007
Last Updated
November 17, 2008
Sponsor
University of Melbourne
Collaborators
Clinical Vision Research Australia, Johnson & Johnson Vision Care, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00531375
Brief Title
The Effect of Silicone Hydrogel Contact Lenses on Conjunctival Flora
Study Type
Interventional

2. Study Status

Record Verification Date
November 2008
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
September 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Melbourne
Collaborators
Clinical Vision Research Australia, Johnson & Johnson Vision Care, Inc.

4. Oversight

5. Study Description

Brief Summary
The primary purpose of this study is to investigate the effect of silicone hydrogel contact lenses on conjunctival flora over a period of 6 months of daily wear. A secondary aim is to compare the levels of microbial contamination of silicone hydrogel lenses after daily 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
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Actual)

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
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Is correctable to at least 6/9 distance visual acuity in each eye with spherical contact lenses. Is a current full time 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. Is participating in a concurrent clinical trial. Has a latex sensitivity.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carol Lakkis, BScOptom, PhD, PGCertOcTher
Organizational Affiliation
Clinical Vision Research Australia, Victorian College of Optometry
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

The Effect of Silicone Hydrogel Contact Lenses on Conjunctival Flora

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