The Physiological Consequence of Silicone-Hydrogel Care-Solution Bio-Incompatibility

This study is enrolling participants by invitation only.

First Received: January 23, 2009 Last Updated: January 26, 2009 History of Changes

Sponsor:	Southern California College of Optometry
Collaborator:	Alcon Laboratories
Information provided by:	Southern California College of Optometry
ClinicalTrials.gov Identifier:	NCT00829751

Purpose

The purpose of this study is to more objectively evaluate potential lens-material/care solution bio-incompatibilities. We will do this by measuring corneal staining and the amount of fluorescein dye diffusion into the eye.

Condition	Intervention
Contact Lens Solution Toxicity	Device: PureVision lenses soaked in ReNu Multiplus Device: PureVision lenses soaked in OptiFree RePlenish

Study Type:	Interventional
Study Design:	Basic Science, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Pharmacokinetics/Dynamics Study
Official Title:	The Physiological Consequence of Silicone-Hydrogel Care-Solution Bio-Incompatibility

Resource links provided by NLM:

Drug Information available for: Silicone

U.S. FDA Resources

Further study details as provided by Southern California College of Optometry:

Primary Outcome Measures:

The level/amount of sodium fluorescein dye in the anterior chamber at post wear timepoints [ Time Frame: On day of experiment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Corneal staining level post lens wear [ Time Frame: On day of study ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	30
Study Start Date:	November 2008
Estimated Study Completion Date:	May 2009
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
ReNu Multiplus: Active Comparator Purevision lenses will be soaked in ReNu Multiplus	Device: PureVision lenses soaked in ReNu Multiplus Purevision silicone hydrogel lenses
OptiFree RePlenish: Active Comparator PureVision lenses will be soaked in OptiFree RePlenish	Device: PureVision lenses soaked in OptiFree RePlenish Purevision silicone hydrogel lenses soaked in OptiFree RePlenish

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

At least 18 years of age.
Best correctable vision to 20/40 in each eye.
Possess a functional spectacle prescription to allow adequate vision during the de-adaptation and fluorometry measurement period.
No known ocular or systemic allergies, which may interfere with contact lens wear.
No known systemic disease, or need for medication that may interfere with contact les wear (i.e. antihistamines, beta-blockers, steroids, ect.).

Exclusion Criteria:

Subjects demonstrating any medical condition that may affect the results of this study SHOULD NOT be enrolled. The following are specific conditions that exclude subjects from enrollment in this study.
Eye (ocular) or systemic allergies that may interfere with contact lens wear.
Clinically significant corneal swelling (greater than 3 or 4 on a 0-4 scale), corneal blood vessel growth (vascularization), corneal staining, bulbar redness, tarsal redness, or any other abnormality of the cornea that may cause unsafe contact lens wear.
Are taking part in any other study or have taken part in a study within the last 14 days.
Are pregnant, or anticipating to become pregnant during the course of the study.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00829751

Locations

United States, California
Southern California College of Optometry
Fullerton, California, United States, 92831

Sponsors and Collaborators

Southern California College of Optometry

Alcon Laboratories

Investigators

Principal Investigator:

Jerry R Paugh, OD, PhD

Southern California College of Optometry

More Information

No publications provided

Responsible Party:	Southern California College of Optometry ( Jerry R. Paugh, OD, PhD, PI )
Study ID Numbers:	08-8
Study First Received:	January 23, 2009
Last Updated:	January 26, 2009
ClinicalTrials.gov Identifier:	NCT00829751 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Southern California College of Optometry:

staining
toxicity
fluorometry
dye diffusion
anterior chamber

ClinicalTrials.gov processed this record on February 08, 2010