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

Not Applicable

Completed

• Conditions: Contact Lens Solution Toxicity
• Interventions: Device: PureVision lenses soaked in ReNu Multiplus; Device: PureVision lenses soaked in OptiFree RePlenish

• Registration Number: NCT00829751
• Lead Sponsor: Southern California College of Optometry at Marshall B. Ketchum University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11
• Study First Submitted: 2009-01-23
• Study First Submitted QC: 2009-01-26
• Study First Posted: 2009-01-27
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-31
• Last Update Posted: 2013-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
ReNu Multiplus	PureVision lenses soaked in ReNu Multiplus	Purevision lenses will be soaked in ReNu Multiplus
OptiFree RePlenish	PureVision lenses soaked in OptiFree RePlenish	PureVision lenses will be soaked in OptiFree RePlenish

Primary Outcome Measures

Name	Time	Method
The level/amount of sodium fluorescein dye in the anterior chamber at post wear timepoints	On day of experiment

Secondary Outcome Measures

Name	Time	Method
Corneal staining level post lens wear	On day of study

Trial Locations

Locations (1)

Southern California College of Optometry; 🇺🇸 Fullerton, California, United States