The Effect of Silicone Hydrogel Contact Lenses on Conjunctival Flora

This study has been completed.

Sponsor:

Collaborators:

Clinical Vision Research Australia

Vistakon

Information provided by:

University of Melbourne

ClinicalTrials.gov Identifier:

NCT00531375

First received: September 17, 2007

Last updated: November 17, 2008

Last verified: November 2008

History of Changes

Tracking Information

First Received Date ^ICMJE

September 17, 2007

Last Updated Date

November 17, 2008

Start Date ^ICMJE

September 2007

Primary Completion Date

June 2008 (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 NCT00531375 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

The Effect of Silicone Hydrogel Contact Lenses on Conjunctival Flora

Official Title ^ICMJE

Not Provided

Brief Summary

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

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Myopia

Intervention ^ICMJE

Device: Silicone hydrogel contact lens

Study Arm (s)

Not Provided

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

Enrollment ^ICMJE

Completion Date

September 2008

Primary Completion Date

June 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years to 45 Years

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

NCT00531375

Other Study ID Numbers ^ICMJE

H07 003

Has Data Monitoring Committee

Not Provided

Responsible Party

Dr Carol Lakkis, Clinical Vision Research Australia

Study Sponsor ^ICMJE

University of Melbourne

Collaborators ^ICMJE

Clinical Vision Research Australia
Vistakon

Investigators ^ICMJE

Principal Investigator:

Carol Lakkis, BScOptom, PhD, PGCertOcTher

Clinical Vision Research Australia, Victorian College of Optometry

Information Provided By

University of Melbourne

Verification Date

November 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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