Ocular Responses to Short and Long-Term Lens Wear

This study is currently recruiting participants.

Verified by Bausch & Lomb, Inc., January 2009

First Received: July 24, 2008 Last Updated: January 16, 2009 History of Changes

Sponsored by:	Bausch & Lomb, Inc.
Information provided by:	Bausch & Lomb, Inc.
ClinicalTrials.gov Identifier:	NCT00722891

Purpose

This study will investigate the ocular response to lens wear in 30 subjects.

Condition	Intervention	Phase
Ametropia	Device: Balafilcon A Lenses with ReNu Multiplus Device: Balafilcon A Lenses with Optifree RepleniSH	Phase IV

Drug Information available for: Balafilcon A

Study Type:	Interventional
Study Design:	Basic Science, Randomized, Double Blind (Subject, Investigator), Active Control, Crossover Assignment, Efficacy Study
Official Title:	Ocular Responses to Acute and Chronic Lens Wear

Further study details as provided by Bausch & Lomb, Inc.:

Primary Outcome Measures:

Quantify the ocular response to acute and chronic lens wear using slit lamp examination, tear assay and corneal sensitivity. [ Time Frame: 5 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	July 2008
Estimated Study Completion Date:	September 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Balafilcon A lenses	Device: Balafilcon A Lenses with ReNu Multiplus Balafilcon A lenses using ReNu Multiplus lens solution for 28 days
2: Active Comparator Balafilcon A Lenses	Device: Balafilcon A Lenses with Optifree RepleniSH Balafilcon A lenses using Optifree RepleniSH lens solution for 28 days

Eligibility

Criteria

Inclusion Criteria:

Is at least 17 years old and has full legal capacity to volunteer;
Is correctable to a visual acuity of 6/7.5 (20/25) or better (both eyes) with their habitual vision correction;
Is a current soft lens wearer and wears contact lenses six or more days/week;
Has clear corneas and no active ocular disease.

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00722891

Contacts

Contact: William T. Reindel

585-338-8129

Locations

Canada, Ontario
University of Waterloo	Recruiting
Waterloo, Ontario, Canada, N2L 3G1
Contact: Craig A Woods, PhD 519-888-4567 ext 36547 cawoods@sciborg.uwaterloo.ca
Principal Investigator: Trefford Simpson, PhD

Sponsors and Collaborators

Bausch & Lomb, Inc.

Investigators

Principal Investigator:

Trefford Simpson, Dip Optom, MSc, PhD

University of Waterloo

More Information

No publications provided

Responsible Party:	Bausch & Lomb Incorporated ( William Reindel )
Study ID Numbers:	P/289/07/B
Study First Received:	July 24, 2008
Last Updated:	January 16, 2009
ClinicalTrials.gov Identifier:	NCT00722891 History of Changes
Health Authority:	Canada: Health Canada

Keywords provided by Bausch & Lomb, Inc.:

Eye Diseases

Study placed in the following topic categories:

Eye Diseases
Refractive Errors

Additional relevant MeSH terms:

Eye Diseases
Refractive Errors

ClinicalTrials.gov processed this record on May 07, 2009