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

NCT01015768 | Completed Results

• 1 other identifier: 08-10
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Contact Lens-induced Corneal Fluorescein Staining

Keywords

corneal staining; barrier function; contact lenses; contact lens care solutions; contact lens material and care solution bioincompatibility

Outcome Measures

Primary Outcomes (2)

• The Primary Outcome Measure Will be Corneal Epithelial Dye Diffusion Rate in Nanometers Per Second, for the Test and Control Eyes.

  The fluorescein dye diffusion rate in nanometers per second, is a diffusion rate into the corneal tissue. The fluorescein dye diffuses from the tears, where it is in high concentration, into the cornea, where it is in low concentration. It's diffusion is limited (or not) by the barrier properties and health of the epithelium.

  After eight hours of wear

• Permeability Rate, nm/Sec

  A penetration rate, in nm/sec

  After eight hours of wear

Secondary Outcomes (1)

• The Secondary Outcome Measure Will be the Corneal Staining Grade, Compared Between the Test and Control Eye, as Well as Between the Baseline and Final Staining for Each Eye.

  After eight hours of wear

Study Arms (2)

Test eye

EXPERIMENTAL

Uses ReNu Multiplus as multipurpose soaking solution

Device: ReNu Multiplus multipurpose disinfecting solution

Control

ACTIVE COMPARATOR

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

Device: Control

Interventions

ReNu Multiplus multipurpose disinfecting solution DEVICE

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

Test eye

Control DEVICE

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

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Southern California College of Optometry at Marshall B. Ketchum University: lead

Study Sites (1)

Southern California Colege of Optometry

Fullerton, California, 92831, United States

Location

Limitations and Caveats

No limitations

Results Point of Contact

• Title: Jerry R. Paugh, OD, PhD
• Organization: Southern California College of Optometry

jpaugh@scco.edu

714-449-7487

Study Officials

• Jerry R Paugh, OD, PhD

  Southern California College of Optometry at Marshall B. Ketchum University

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Associate Dean or Research

Study Record Dates

• First Submitted: November 16, 2009
• First Posted: November 18, 2009
• Study Start: October 1, 2009
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: September 18, 2020
• Results First Posted: September 18, 2020

Record last verified: 2020-08

Locations

US (1)