Contact Lens Solution Toxicity
Conditions
Keywords
staining, toxicity, fluorometry, dye diffusion, anterior chamber
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.
Interventions
DEVICEPureVision lenses soaked in ReNu Multiplus
Purevision silicone hydrogel lenses
DEVICEPureVision lenses soaked in OptiFree RePlenish
Purevision silicone hydrogel lenses soaked in OptiFree RePlenish
Sponsors
Alcon Research
Southern California College of Optometry at Marshall B. Ketchum University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The level/amount of sodium fluorescein dye in the anterior chamber at post wear timepoints | On day of experiment |
Secondary
| Measure | Time frame |
|---|---|
| Corneal staining level post lens wear | On day of study |
Countries
United States
Outcome results
None listed