The Physiological Consequence of Silicone-hydrogel Care-solution Bio-incompatibility

NCT00829751 | Completed

• 1 other identifier: 08-8
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Contact Lens Solution Toxicity

Keywords

staining; toxicity; fluorometry; dye diffusion; anterior chamber

Outcome Measures

Primary Outcomes (1)

• The level/amount of sodium fluorescein dye in the anterior chamber at post wear timepoints

  On day of experiment

Secondary Outcomes (1)

• Corneal staining level post lens wear

  On day of study

Study Arms (2)

ReNu Multiplus

ACTIVE COMPARATOR

Purevision lenses will be soaked in ReNu Multiplus

Device: PureVision lenses soaked in ReNu Multiplus

OptiFree RePlenish

ACTIVE COMPARATOR

PureVision lenses will be soaked in OptiFree RePlenish

Device: PureVision lenses soaked in OptiFree RePlenish

Interventions

PureVision lenses soaked in ReNu Multiplus DEVICE

Purevision silicone hydrogel lenses

ReNu Multiplus

PureVision lenses soaked in OptiFree RePlenish DEVICE

Purevision silicone hydrogel lenses soaked in OptiFree RePlenish

OptiFree RePlenish

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Southern California College of Optometry at Marshall B. Ketchum University: lead
• Alcon Research: collaborator

Study Sites (1)

Southern California College of Optometry

Fullerton, California, 92831, United States

Location

Study Officials

• Jerry R Paugh, OD, PhD

  Southern California College of Optometry at Marshall B. Ketchum University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Associate Dean for Research

Study Record Dates

• First Submitted: January 23, 2009
• First Posted: January 27, 2009
• Study Start: November 1, 2008
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: June 4, 2013

Record last verified: 2013-05

Locations

US (1)