Corneal Staining and Physiological Compromise After Eight Hours of Soft Contact Lens Wear

NCT ID: NCT01015768

Last Updated: 2020-09-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2010-01-31

Brief Summary

The purpose of this study is to assess corneal staining and to measure the relative corneal epithelial "barrier" function (the degree to which the cornea can prevent penetration of colored sodium fluorescein dye into the eye) after 8 hours of wear with a known soft contact lens and multipurpose lens care solution combination.

Detailed Description

This investigation will evaluate corneal staining and epithelial barrier function after eight hours of contact lens wear, which is past the peak staining time and more typical of daily lens wear time. A silicone hydrogel lens and multipurpose solution combination shown to induce significant corneal staining ( e.g. equivalent Grade 3 out of Grade 4 scale) will be used to evaluate potential corneal compromise. The study will be a prospective, single-center, double-masked, contralateral, daily wear investigation in adapted soft contact lens wearers. After a three day washout period (without lens wear, lenses will then be worn on one day for eight hours. Corneal staining and barrier function will be determined for a regimen and a saline control situation for each subject. Staining will be graded using the Efron Grading Scale, and permeability data will be estimated as the fluorescein penetration rate, Pdc in nm/sec for the test and control condition.

Conditions

Contact Lens-induced Corneal Fluorescein Staining

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: TRIPLE

Study Groups

Test eye

Uses ReNu Multiplus as multipurpose soaking solution

Group Type: EXPERIMENTAL

ReNu Multiplus multipurpose disinfecting solution

Intervention Type: DEVICE

A new lens (PureVision) soaked 6 hours to overnight in ReNu Multiplus

Control

A new lens (PureVision) is soaked for 2 hours in non-preserved saline

Group Type: ACTIVE_COMPARATOR

Control

Intervention Type: DEVICE

A new lens (PureVision) is soaked for two hours in non-preserved saline

Interventions

ReNu Multiplus multipurpose disinfecting solution

A new lens (PureVision) soaked 6 hours to overnight in ReNu Multiplus

Intervention Type: DEVICE

Control

A new lens (PureVision) is soaked for two hours in non-preserved saline

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• At least 18 years of age.
• Understand your rights as a research subject and give written informed consent by signing the Informed Consent Form, Subject Bill of Rights, and Patient Authorization for Use and Release of Health and Research Study Information (HIPAA form).
• Be likely to finish the entire study, understand the study instructions, and be willing to follow the instructions.
• Contact lens prescription between +4.00 D to -9.00 D (spherical equivalent).
• Best correctable visual acuity of at least 20/40 in each eye.
• Willing to de-adapt (do not wear) from habitual contact lenses for a period of at least two days prior to eligibility visit and at least two days prior to the testing day.
• Possess a functional spectacle (eyeglass) prescription to allow adequate vision during the de-adaptation and barrier function determination periods.
• No known allergies, which may interfere with contact lens wear.
• No known systemic (pertaining to general health) disease, or need for medication that may interfere with contact lens wear (i.e. antihistamines, beta-blockers, steroids).

Exclusion Criteria

• Less than one month successful, full time (defined as at least 8 hours per day, and more than 5 days per week) soft lens wear.
• Clinically significant corneal swelling (greater than grade 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.
• Any active ocular infection.
• Prior corneal refractive surgery (i.e., LASIK, PRK, etc).
• Have used medications within 24 hours of study entry or have an ongoing need to use ocular medication.
• Are taking part in any other study or have taken part in a study within the last 14 days
• Have a medical condition that your study eye doctor thinks may make it not appropriate for you to participate in this study.
• Are pregnant, or anticipate becoming pregnant during the course of this study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Southern California College of Optometry at Marshall B. Ketchum University

OTHER

Sponsor Role: lead

Responsible Party

Jerry R. Paugh, OD, PhD

Professor, Associate Dean or Research

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jerry R Paugh, OD, PhD

Role: STUDY_DIRECTOR

Southern California College of Optometry at Marshall B. Ketchum University

Locations

Southern California Colege of Optometry

Fullerton, California, United States

Countries

United States

Other Identifiers

08-10

Identifier Type: -

Identifier Source: org_study_id