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OpenTrials
Completed

NCT Number: NCT00829751

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.

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Key information

Conditions

Contact Lens Solution Toxicity

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Southern California College of Optometry

Fullerton, California, 92831, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PureVision lenses soaked in ReNu Multiplus

Device

Purevision silicone hydrogel lenses

PureVision lenses soaked in OptiFree RePlenish

Device

Purevision silicone hydrogel lenses soaked in OptiFree RePlenish

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

Sponsors and collaborators

Lead sponsor

Southern California College of Optometry at Marshall B. Ketchum University

Other

Collaborators

  • Alcon Research

Registry information

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Jan 27, 2009
Registry last updated
Jun 4, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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