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

NCT00560898 | Completed Phase 4

• 1 other identifier: 00001418
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Contact Lens Disinfecting Solutions

Keywords

staining; epithelial barrier function

Outcome Measures

Primary Outcomes (1)

• Epithelial penetration rate of sodium fluoeescein, in nm/sec

  Immediately post measurement

Secondary Outcomes (1)

• Corneal staining

  Immediately following barrier determination

Study Arms (4)

2

EXPERIMENTAL

contact lenses disinfected in multipurpose solution

Drug: ProClear Lens Material soaked in ReNu Multiplus Multipurpose Solution

3

EXPERIMENTAL

contact lenses disinfected in multipurpose solution

Drug: Acuvue Advance Lens Material soaked in ReNu Multiplus Multipurpose Solution

4

EXPERIMENTAL

contact lenses disinfected in multipurpose solution

Drug: Acuvue Advance Lens Material soaked in Optifree RepleniSH Multipurpose Solution

1

EXPERIMENTAL

contact lenses disinfected in multipurpose solution

Drug: ProClear Lens Material soaked in Optifree RepleniSH Multipurpose Solution

Interventions

ProClear Lens Material soaked in ReNu Multiplus Multipurpose Solution DRUG

Contact lens soaked in multipuprpose solution for 8 hours, then worn for two hours

2

Acuvue Advance Lens Material soaked in ReNu Multiplus Multipurpose Solution DRUG

Contact lens soaked in multipuprpose solution for 8 hours, then worn for two hours

3

Acuvue Advance Lens Material soaked in Optifree RepleniSH Multipurpose Solution DRUG

Contact lens soaked in multipuprpose solution for 8 hours, then worn for two hours

4

ProClear Lens Material soaked in Optifree RepleniSH Multipurpose Solution DRUG

Contact lens soaked in multipuprpose solution for 8 hours, then worn for two hours

1

Eligibility Criteria

• Age: 18 Years - 80 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 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Southern California College of Optometry

Fullerton, California, 92831, United States

Location

Study Officials

• Jerry R Paugh, OD, PhD

  Southern California College of Optometry at Marshall B. Ketchum University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 15, 2007
• First Posted: November 20, 2007
• Study Start: September 1, 2007
• Primary Completion: December 1, 2007
• Study Completion: March 1, 2008
• Last Updated: May 20, 2008

Record last verified: 2008-05

Locations

US (1)