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Time Course Comparison of Contact Lens Maintenance Systems for Hydrogel Lenses

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ClinicalTrials.gov Identifier: NCT00732004
Recruitment Status : Completed
First Posted : August 11, 2008
Last Update Posted : July 2, 2009
Sponsor:
Collaborators:
Clinical Vision Research Australia
Alcon Research
Information provided by:
University of Melbourne

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
Myopia Hyperopia Device: Silicone Hydrogel Contact Lenses Device: 1x PMBH preserved MPS Device: 1x Polyquad/Aldox MPS Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 132 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Basic Science
Study Start Date : August 2008
Actual Primary Completion Date : February 2009
Actual Study Completion Date : April 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear
U.S. FDA Resources

Arms and Interventions
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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
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Eligibility Criteria
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00732004


Locations
Australia, Victoria
Clinical Vision Research Australia
Melbourne, Victoria, Australia, 3053
Sponsors and Collaborators
University of Melbourne
Clinical Vision Research Australia
Alcon Research
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Carol Lakkis, Clinical Vision Research Australia
ClinicalTrials.gov Identifier: NCT00732004     History of Changes
Other Study ID Numbers: H08 002
First Posted: August 11, 2008    Key Record Dates
Last Update Posted: July 2, 2009
Last Verified: June 2009

Additional relevant MeSH terms:
Hyperopia
Refractive Errors
Eye Diseases