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Time Course Comparison of Contact Lens Maintenance Systems for Hydrogel Lenses

Sponsor
University of Melbourne (Other)
Overall Status
Completed
CT.gov ID
NCT00732004
Collaborator
Clinical Vision Research Australia (Other), Alcon Research (Industry)
132
Enrollment
1
Location
3
Arms
8
Duration (Months)
16.5
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Silicone Hydrogel Contact Lenses
  • Device: 1x PMBH preserved MPS
  • Device: 1x Polyquad/Aldox MPS
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
132 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Primary Purpose:
Basic Science
Study Start Date :
Aug 1, 2008
Actual Primary Completion Date :
Feb 1, 2009
Actual Study Completion Date :
Apr 1, 2009

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Clinical Vision Research Australia Melbourne Victoria Australia 3053

    Sponsors and Collaborators

    • University of Melbourne
    • Clinical Vision Research Australia
    • Alcon Research

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00732004
    Other Study ID Numbers:
    • H08 002
    First Posted:
    Aug 11, 2008
    Last Update Posted:
    Jul 2, 2009
    Last Verified:
    Jun 1, 2009
    Additional relevant MeSH terms:
    Hyperopia

    Study Results

    No Results Posted as of Jul 2, 2009