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Time Course Comparison of Contact Lens Maintenance Systems for Hydrogel Lenses

Primary Purpose

Myopia, Hyperopia

Status
Completed
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Silicone Hydrogel Contact Lenses
1x PMBH preserved MPS
1x Polyquad/Aldox MPS
Sponsored by
University of Melbourne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Myopia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Distance contact lens prescription between +8.00 and -10.00D.
  • Cylindrical component of refractive error no greater than 1.25D in either eye.
  • Vision correctable to 6/12 (0.30 logMAR) or better in each eye.
  • Healthy normal eyes without anterior segment infection, inflammation or abnormality, or significant slitlamp findings.

Exclusion Criteria:

  • Concurrent ocular medication
  • Eye injury or surgery within twelve weeks immediately prior to enrolment.
  • Current ocular irritation that would preclude contact lens fitting.
  • Evidence of systemic or ocular abnormality, infection or disease likely to affect successful wear of contact lenses or use of their accessory solutions.
  • Pregnant, lactating or planning a pregnancy.

Sites / Locations

  • Clinical Vision Research Australia

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

1

2

3

Arm Description

Group 1

Group 2

Group 3

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
August 8, 2008
Last Updated
June 30, 2009
Sponsor
University of Melbourne
Collaborators
Clinical Vision Research Australia, Alcon Research
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1. Study Identification

Unique Protocol Identification Number
NCT00732004
Brief Title
Time Course Comparison of Contact Lens Maintenance Systems for Hydrogel Lenses
Study Type
Interventional

2. Study Status

Record Verification Date
June 2009
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
April 2009 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

5. Study Description

Brief Summary
The principal aim of this project is to determine the time course of development of contact lens and contact lens case contamination during daily wear of silicone hydrogel lenses. The secondary aim of the study is to determine whether the time course of development of contact lens and contact lens case contamination varies between two different contact lens care systems.

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
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
132 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Group 1
Arm Title
2
Arm Type
Experimental
Arm Description
Group 2
Arm Title
3
Arm Type
Experimental
Arm Description
Group 3
Intervention Type
Device
Intervention Name(s)
Silicone Hydrogel Contact Lenses
Intervention Type
Device
Intervention Name(s)
1x PMBH preserved MPS
Intervention Type
Device
Intervention Name(s)
1x Polyquad/Aldox MPS

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Distance contact lens prescription between +8.00 and -10.00D. Cylindrical component of refractive error no greater than 1.25D in either eye. Vision correctable to 6/12 (0.30 logMAR) or better in each eye. Healthy normal eyes without anterior segment infection, inflammation or abnormality, or significant slitlamp findings. Exclusion Criteria: Concurrent ocular medication Eye injury or surgery within twelve weeks immediately prior to enrolment. Current ocular irritation that would preclude contact lens fitting. Evidence of systemic or ocular abnormality, infection or disease likely to affect successful wear of contact lenses or use of their accessory solutions. Pregnant, lactating or planning a pregnancy.
Facility Information:
Facility Name
Clinical Vision Research Australia
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3053
Country
Australia

12. IPD Sharing Statement

Links:
URL
http://www.vco.org.au/CVRA/
Description
Clinical Vision Research Australia

Learn more about this trial

Time Course Comparison of Contact Lens Maintenance Systems for Hydrogel Lenses

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