Time Course Comparison of Contact Lens Maintenance Systems for Hydrogel Lenses

This study has been completed.

Sponsor:

Collaborators:

Clinical Vision Research Australia

Alcon Research

Information provided by:

University of Melbourne

ClinicalTrials.gov Identifier:

NCT00732004

First received: August 8, 2008

Last updated: June 30, 2009

Last verified: June 2009

History of Changes

Tracking Information
First Received Date ^ICMJE	August 8, 2008
Last Updated Date	June 30, 2009
Start Date ^ICMJE	August 2008
Primary Completion Date	February 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00732004 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Time Course Comparison of Contact Lens Maintenance Systems for Hydrogel Lenses
Official Title ^ICMJE	Not Provided
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Basic Science
Condition ^ICMJE	Myopia Hyperopia
Intervention ^ICMJE	Device: Silicone Hydrogel Contact Lenses Device: 1x PMBH preserved MPS Device: 1x Polyquad/Aldox MPS
Study Arm (s)	Experimental: 1 Group 1 Intervention: Device: Silicone Hydrogel Contact Lenses Experimental: 2 Group 2 Intervention: Device: 1x PMBH preserved MPS Experimental: 3 Group 3 Intervention: Device: 1x Polyquad/Aldox MPS
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Estimated Enrollment ^ICMJE	132
Completion Date	April 2009
Primary Completion Date	February 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Australia

Administrative Information
NCT Number ^ICMJE	NCT00732004
Other Study ID Numbers ^ICMJE	H08 002
Has Data Monitoring Committee	Not Provided
Responsible Party	Carol Lakkis, Clinical Vision Research Australia
Study Sponsor ^ICMJE	University of Melbourne
Collaborators ^ICMJE	Clinical Vision Research Australia Alcon Research
Investigators ^ICMJE	Not Provided
Information Provided By	University of Melbourne
Verification Date	June 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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