Comparison of Two Multi-Purpose Solution and Lens Material Combinations on Corneal Barrier Function - Full Text View

Purpose

The purpose of this study is to measure the relative "barrier" function of the top layer of the cornea (called the epithelium), or the degree to which the cornea can prevent the penetration of the colored dye sodium fluorescein into the eye. This is a clinical investigation of the effect on corneal barrier function following wear of two contact lens materials and two contact lens care systems, approved for marketing in the US by the Food and Drug Administration. These contact lenses will be worn for two hours, following soak in one of two marketed contact lens disinfecting solutions. Approximately 25 young, adapted contact lens wearers will participate.

Condition	Intervention	Phase
Contact Lens Disinfecting Solutions	Drug: ProClear Lens Material soaked in ReNu Multiplus Multipurpose Solution Drug: Acuvue Advance Lens Material soaked in ReNu Multiplus Multipurpose Solution Drug: Acuvue Advance Lens Material soaked in Optifree RepleniSH Multipurpose Solution Drug: ProClear Lens Material soaked in Optifree RepleniSH Multipurpose Solution	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	Comparison of Two Multi-Purpose Solution and Contact Lens Material Combinations on Human Corneal Barrier Function

Resource links provided by NLM:

MedlinePlus related topics: Eye Wear

U.S. FDA Resources

Further study details as provided by Southern California College of Optometry:

Primary Outcome Measures:

Epithelial penetration rate of sodium fluoeescein, in nm/sec [ Time Frame: Immediately post measurement ]

Secondary Outcome Measures:

Corneal staining [ Time Frame: Immediately following barrier determination ]

Estimated Enrollment:	25
Study Start Date:	September 2007
Study Completion Date:	March 2008
Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 2 contact lenses disinfected in multipurpose solution	Drug: ProClear Lens Material soaked in ReNu Multiplus Multipurpose Solution Contact lens soaked in multipuprpose solution for 8 hours, then worn for two hours
Experimental: 3 contact lenses disinfected in multipurpose solution	Drug: Acuvue Advance Lens Material soaked in ReNu Multiplus Multipurpose Solution Contact lens soaked in multipuprpose solution for 8 hours, then worn for two hours
Experimental: 4 contact lenses disinfected in multipurpose solution	Drug: Acuvue Advance Lens Material soaked in Optifree RepleniSH Multipurpose Solution Contact lens soaked in multipuprpose solution for 8 hours, then worn for two hours
Experimental: 1 contact lenses disinfected in multipurpose solution	Drug: ProClear Lens Material soaked in Optifree RepleniSH Multipurpose Solution Contact lens soaked in multipuprpose solution for 8 hours, then worn for two hours

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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 periods of three days prior to barrier function determination.
- Possess a functional spectacle prescription to allow adequate vision during the de-adaptation and barrier function determination periods.
- 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 lens wear (i.e. antihistamines, beta-blockers, steroids).

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.
- Less than one month successful, full time (defined as more than 8 hours per day, and more than 5 days per week) soft lens wear.
- Systemic disease or uses of medication, which may interfere with contact 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00560898

Locations

United States, California
Southern California College of Optometry
Fullerton, California, United States, 92831

Sponsors and Collaborators

Southern California College of Optometry

Alcon Research

Investigators

Principal Investigator:

Jerry R Paugh, OD, PhD

Southern California College of Optometry

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00560898 History of Changes
Other Study ID Numbers:	00001418, 00001418
Study First Received:	November 15, 2007
Last Updated:	May 19, 2008
Health Authority:	United States: Institutional Review Board

Keywords provided by Southern California College of Optometry:

staining
epithelial barrier function

ClinicalTrials.gov processed this record on May 21, 2013