Time Course Comparison of Contact Lens Maintenance Systems for Hydrogel Lenses

NCT ID: NCT00732004

Last Updated: 2009-07-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

132 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2009-04-30

Brief Summary

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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

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Conditions

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Myopia Hyperopia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Investigators

Study Groups

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1

Group 1

Group Type EXPERIMENTAL

Silicone Hydrogel Contact Lenses

Intervention Type DEVICE

2

Group 2

Group Type EXPERIMENTAL

1x PMBH preserved MPS

Intervention Type DEVICE

3

Group 3

Group Type EXPERIMENTAL

1x Polyquad/Aldox MPS

Intervention Type DEVICE

Interventions

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Silicone Hydrogel Contact Lenses

Intervention Type DEVICE

1x PMBH preserved MPS

Intervention Type DEVICE

1x Polyquad/Aldox MPS

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Clinical Vision Research Australia

OTHER

Sponsor Role collaborator

Alcon Research

INDUSTRY

Sponsor Role collaborator

University of Melbourne

OTHER

Sponsor Role lead

Responsible Party

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Clinical Vision Research Australia

Locations

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Clinical Vision Research Australia

Melbourne, Victoria, Australia

Site Status

Countries

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Australia

Other Identifiers

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H08 002

Identifier Type: -

Identifier Source: org_study_id

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