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The Effect of Silicone Hydrogel Contact Lenses on Conjunctival Flora

NCT ID: NCT00531375

Last Updated: 2008-11-19

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

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2008-09-30

Brief Summary

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The primary purpose of this study is to investigate the effect of silicone hydrogel contact lenses on conjunctival flora over a period of 6 months of daily wear. A secondary aim is to compare the levels of microbial contamination of silicone hydrogel lenses after daily wear.

Detailed Description

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Conditions

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Myopia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Interventions

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Silicone hydrogel contact lens

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Is correctable to at least 6/9 distance visual acuity in each eye with spherical contact lenses.
* Is a current full time soft contact lens wearer.
* Has no clinically significant anterior eye findings.
* Has no other active ocular disease

Exclusion Criteria

* Has any systemic disease that might interfere with contact lens wear
* Is using any systemic or topical medications that will affect ocular health.
* Has any pre-existing ocular irritation that would preclude contact lens fitting.
* Has any ocular pathology or severe insufficiency of lacrimal secretion (dry eyes) that would affect the wearing of contact lenses.
* Has undergone corneal refractive surgery.
* Is pregnant, lactating or planning a pregnancy.
* Is participating in a concurrent clinical trial.
* Has a latex sensitivity.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Clinical Vision Research Australia

OTHER

Sponsor Role collaborator

Johnson & Johnson Vision Care, Inc.

INDUSTRY

Sponsor Role collaborator

University of Melbourne

OTHER

Sponsor Role lead

Responsible Party

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Clinical Vision Research Australia

Principal Investigators

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Carol Lakkis, BScOptom, PhD, PGCertOcTher

Role: PRINCIPAL_INVESTIGATOR

Clinical Vision Research Australia, Victorian College of Optometry

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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H07 003

Identifier Type: -

Identifier Source: org_study_id