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

This study has been completed.
Sponsor:
Collaborator:
Alcon Laboratories
Information provided by (Responsible Party):
Jerry R. Paugh, OD, PhD, Southern California College of Optometry
ClinicalTrials.gov Identifier:
NCT00829751
First received: January 23, 2009
Last updated: May 31, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention
Contact Lens Solution Toxicity
Device: PureVision lenses soaked in ReNu Multiplus
Device: PureVision lenses soaked in OptiFree RePlenish

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: The Physiological Consequence of Silicone-hydrogel Care-solution Bio-incompatibility

Further study details as provided by Southern California College of Optometry:

Primary Outcome Measures:
  • The level/amount of sodium fluorescein dye in the anterior chamber at post wear timepoints [ Time Frame: On day of experiment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Corneal staining level post lens wear [ Time Frame: On day of study ] [ Designated as safety issue: Yes ]

Enrollment: 26
Study Start Date: November 2008
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00829751

Locations
United States, California
Southern California College of Optometry
Fullerton, California, United States, 92831
Sponsors and Collaborators
Southern California College of Optometry
Alcon Laboratories
Investigators
Principal Investigator: Jerry R Paugh, OD, PhD Southern California College of Optometry
  More Information

No publications provided

Responsible Party: Jerry R. Paugh, OD, PhD, Professor, Associate Dean for Research, Southern California College of Optometry
ClinicalTrials.gov Identifier: NCT00829751     History of Changes
Other Study ID Numbers: 08-8
Study First Received: January 23, 2009
Last Updated: May 31, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Southern California College of Optometry:
staining
toxicity
fluorometry
dye diffusion
anterior chamber

ClinicalTrials.gov processed this record on April 17, 2014