CClinicalTrials.gg
Sign In
CompletedNCT00829751Updated Jun 4, 2013

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

An interventional study of PureVision lenses soaked in ReNu Multiplus and PureVision lenses soaked in OptiFree RePlenish in Contact Lens Solution Toxicity, sponsored by Southern California College of Optometry at Marshall B. Ketchum University. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-06-04.

Sponsored by Southern California College of Optometry at Marshall B. Ketchum University · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
26
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Contact Lens Solution Toxicity

Keywords

  • staining
  • toxicity
  • fluorometry
  • dye diffusion
  • anterior chamber
03

In context

Lead sponsor

Southern California College of Optometry at Marshall B. Ketchum University is the lead sponsor of 19 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
26 participants (actual)

Study arms

  • Active comparator
    ReNu Multiplus

    Purevision lenses will be soaked in ReNu Multiplus

    Device: PureVision lenses soaked in ReNu Multiplus

  • Active comparator
    OptiFree RePlenish

    PureVision lenses will be soaked in OptiFree RePlenish

    Device: PureVision lenses soaked in OptiFree RePlenish

Interventions

  • DevicePureVision lenses soaked in ReNu Multiplus

    Purevision silicone hydrogel lenses

  • DevicePureVision lenses soaked in OptiFree RePlenish

    Purevision silicone hydrogel lenses soaked in OptiFree RePlenish

06

What researchers measure

Primary outcomes

  1. The level/amount of sodium fluorescein dye in the anterior chamber at post wear timepoints

    Time frame: On day of experiment

Secondary outcomes

  1. Corneal staining level post lens wear

    Time frame: On day of study

07

Study locations

1 site
  • Southern California College of Optometry
    Fullerton, California 92831, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 4, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00829751
Lead sponsor
Southern California College of Optometry at Marshall B. Ketchum University
Collaborators
Alcon Research
Responsible party
Jerry R. Paugh, OD, PhD (Professor, Associate Dean for Research, Southern California College of Optometry at Marshall B. Ketchum University) — Principal investigator
First posted
Jan 27, 2009
Start date
Nov 2008
Primary completion
Jun 2011
Completion
Jun 2011
Last update
Jun 4, 2013

Study contacts

Jerry R Paugh, OD, PhD
principal investigator · Southern California College of Optometry at Marshall B. Ketchum University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2013. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

Southern California College of Optometry at Marshall B. Ketchum University

Start the discussion