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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2011-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Contact Lens Solution Toxicity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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ReNu Multiplus

Purevision lenses will be soaked in ReNu Multiplus

Group Type ACTIVE_COMPARATOR

PureVision lenses soaked in ReNu Multiplus

Intervention Type DEVICE

Purevision silicone hydrogel lenses

OptiFree RePlenish

PureVision lenses will be soaked in OptiFree RePlenish

Group Type ACTIVE_COMPARATOR

PureVision lenses soaked in OptiFree RePlenish

Intervention Type DEVICE

Purevision silicone hydrogel lenses soaked in OptiFree RePlenish

Interventions

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PureVision lenses soaked in ReNu Multiplus

Purevision silicone hydrogel lenses

Intervention Type DEVICE

PureVision lenses soaked in OptiFree RePlenish

Purevision silicone hydrogel lenses soaked in OptiFree RePlenish

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes