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

May 31, 2013 updated by: Jerry R. Paugh, OD, PhD, Southern California College of Optometry at Marshall B. Ketchum University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Fullerton, California, United States, 92831
        • Southern California College of Optometry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: ReNu Multiplus
Purevision lenses will be soaked in ReNu Multiplus
Device: PureVision lenses soaked in ReNu Multiplus
Purevision silicone hydrogel lenses
ACTIVE_COMPARATOR: OptiFree RePlenish
PureVision lenses will be soaked in OptiFree RePlenish
Device: PureVision lenses soaked in OptiFree RePlenish
Purevision silicone hydrogel lenses soaked in OptiFree RePlenish

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The level/amount of sodium fluorescein dye in the anterior chamber at post wear timepoints
Time Frame: On day of experiment
On day of experiment

Secondary Outcome Measures

Outcome Measure
Time Frame
Corneal staining level post lens wear
Time Frame: On day of study
On day of study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Southern California College of Optometry at Marshall B. Ketchum University

Collaborators

Alcon Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (ACTUAL)

June 1, 2011

Study Completion (ACTUAL)

June 1, 2011

Study Registration Dates

First Submitted

January 23, 2009

First Submitted That Met QC Criteria

January 26, 2009

First Posted (ESTIMATE)

January 27, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

June 4, 2013

Last Update Submitted That Met QC Criteria

May 31, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 08-8

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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