Time Course Comparison of Contact Lens Maintenance Systems for Hydrogel Lenses

June 30, 2009 updated by: University of Melbourne
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

132

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Victoria
      • Melbourne, Victoria, Australia, 3053
        • Clinical Vision Research Australia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Group 1
Device: Silicone Hydrogel Contact Lenses
Experimental: 2
Group 2
Device: 1x PMBH preserved MPS
Experimental: 3
Group 3
Device: 1x Polyquad/Aldox MPS

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Melbourne

Collaborators

Alcon Research
Clinical Vision Research Australia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (Actual)

February 1, 2009

Study Completion (Actual)

April 1, 2009

Study Registration Dates

First Submitted

August 8, 2008

First Submitted That Met QC Criteria

August 8, 2008

First Posted (Estimate)

August 11, 2008

Study Record Updates

Last Update Posted (Estimate)

July 2, 2009

Last Update Submitted That Met QC Criteria

June 30, 2009

Last Verified

June 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H08 002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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