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

This study has been completed.
Sponsor:
Collaborator:
Alcon Laboratories
Information provided by:
Southern California College of Optometry
ClinicalTrials.gov Identifier:
NCT00829751
First received: January 23, 2009
Last updated: July 19, 2011
Last verified: July 2011
History of Changes

January 23, 2009
July 19, 2011
November 2008
June 2011   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00829751 on ClinicalTrials.gov Archive Site
Corneal staining level post lens wear [ Time Frame: On day of study ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
The Physiological Consequence of Silicone-hydrogel Care-solution Bio-incompatibility
The Physiological Consequence of Silicone-hydrogel Care-solution Bio-incompatibility

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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Contact Lens Solution Toxicity
  • Device: PureVision lenses soaked in ReNu Multiplus
    Purevision silicone hydrogel lenses
  • Device: PureVision lenses soaked in OptiFree RePlenish
    Purevision silicone hydrogel lenses soaked in OptiFree RePlenish
  • Active Comparator: ReNu Multiplus
    Purevision lenses will be soaked in ReNu Multiplus
    Intervention: Device: PureVision lenses soaked in ReNu Multiplus
  • Active Comparator: OptiFree RePlenish
    PureVision lenses will be soaked in OptiFree RePlenish
    Intervention: Device: PureVision lenses soaked in OptiFree RePlenish
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
26
June 2011
June 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00829751
08-8
No
Jerry R. Paugh, OD, PhD, PI, Southern California College of Optometry
Southern California College of Optometry
Alcon Laboratories
Principal Investigator: Jerry R Paugh, OD, PhD Southern California College of Optometry
Southern California College of Optometry
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP