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

Purpose

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	Intervention
Myopia Hyperopia	Device: Silicone Hydrogel Contact Lenses Device: 1x PMBH preserved MPS Device: 1x Polyquad/Aldox MPS


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Basic Science

Resource links provided by NLM:

MedlinePlus related topics: Eye Wear

U.S. FDA Resources

Further study details as provided by University of Melbourne:


Estimated Enrollment:	132
Study Start Date:	August 2008
Study Completion Date:	April 2009
Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility


Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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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Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided


Responsible Party:	Carol Lakkis, Clinical Vision Research Australia
ClinicalTrials.gov Identifier:	NCT00732004 History of Changes
Other Study ID Numbers:	H08 002
Study First Received:	August 8, 2008
Last Updated:	June 30, 2009
Health Authority:	Australia: Department of Health and Ageing Therapeutic Goods Administration

ClinicalTrials.gov processed this record on February 27, 2015

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