Clinical Performance of Extended Wear Silicone Hydrogel Lenses

This study has been completed.

Sponsor:

Collaborators:

Menicon Co., Ltd.

Clinical Vision Research Australia

Information provided by:

University of Melbourne

ClinicalTrials.gov Identifier:

NCT00441233

First received: February 27, 2007

Last updated: December 27, 2007

Last verified: December 2007

History of Changes

Tracking Information

First Received Date ^ICMJE

February 27, 2007

Last Updated Date

December 27, 2007

Start Date ^ICMJE

March 2007

Primary Completion Date

November 2007 (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 NCT00441233 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

Clinical Performance of Extended Wear Silicone Hydrogel Lenses

Official Title ^ICMJE

Not Provided

Brief Summary

The primary purpose of this study is to investigate the clinical performance of a new silicone hydrogel contact lens over a period of 6 months of extended wear.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind
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

Not Provided

Completion Date

December 2007

Primary Completion Date

November 2007 (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 daily wear 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.

Gender

Both

Ages

18 Years to 45 Years

Accepts Healthy Volunteers

Not Provided

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Australia

Administrative Information

NCT Number ^ICMJE

NCT00441233

Other Study ID Numbers ^ICMJE

H07 001

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

University of Melbourne

Collaborators ^ICMJE

Menicon Co., Ltd.
Clinical Vision Research Australia

Investigators ^ICMJE

Principal Investigator:

Carol Lakkis, BScOptom, PhD, PGCertOcTher

Clinical Vision Research Australia, University of Melbourne

Information Provided By

University of Melbourne

Verification Date

December 2007

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

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