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

Contact Lens Solution Toxicity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00829751
• Other study ID #: 08-8
• Status: Completed
• Phase: N/A
• First received: January 23, 2009
• Last updated: May 31, 2013
• Start date: November 2008
• Est. completion date: June 2011

Study information

• Verified date: May 2013
• Source: Southern California College of Optometry
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Contact Lens Solution Toxicity

Intervention

Device:
• PureVision lenses soaked in ReNu Multiplus
Purevision silicone hydrogel lenses
• PureVision lenses soaked in OptiFree RePlenish
Purevision silicone hydrogel lenses soaked in OptiFree RePlenish

Locations

Country	Name	City	State
United States	Southern California College of Optometry	Fullerton	California

Sponsors (2)

Lead Sponsor	Collaborator
Southern California College of Optometry	Alcon Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The level/amount of sodium fluorescein dye in the anterior chamber at post wear timepoints		On day of experiment
Secondary	Corneal staining level post lens wear		On day of study