The Physiological Consequence of Silicone-hydrogel Care-solution Bio-incompatibility
Information source: Southern California College of Optometry
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Contact Lens Solution Toxicity
Intervention: PureVision lenses soaked in ReNu Multiplus (Device); PureVision lenses soaked in OptiFree RePlenish (Device)
Phase: N/A
Status: Completed
Sponsored by: Southern California College of Optometry Official(s) and/or principal investigator(s): Jerry R Paugh, OD, PhD, Principal Investigator, Affiliation: Southern California College of Optometry
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.
Clinical Details
Official title: The Physiological Consequence of Silicone-hydrogel Care-solution Bio-incompatibility
Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science
Primary outcome: The level/amount of sodium fluorescein dye in the anterior chamber at post wear timepoints
Secondary outcome: Corneal staining level post lens wear
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Southern California College of Optometry, Fullerton, California 92831, United States
Additional Information
Starting date: November 2008
Last updated: May 31, 2013
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