DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Page last updated: August 20, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017