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

S

Southern California College of Optometry at Marshall B. Ketchum University

Status

Completed

Conditions

Contact Lens Solution Toxicity

Treatments

Device: PureVision lenses soaked in OptiFree RePlenish
Device: PureVision lenses soaked in ReNu Multiplus

Study type

Interventional

Funder types

Other
Industry

Identifiers

Details and patient eligibility

About

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.

Enrollment

26 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

26 participants in 2 patient groups

ReNu Multiplus
Active Comparator group
Description:
Purevision lenses will be soaked in ReNu Multiplus
Treatment:
Device: PureVision lenses soaked in ReNu Multiplus
OptiFree RePlenish
Active Comparator group
Description:
PureVision lenses will be soaked in OptiFree RePlenish
Treatment:
Device: PureVision lenses soaked in OptiFree RePlenish

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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