Studying the Relationship Between Contact Lens Packaging Solutions and Bacterial Binding to Surface Eye Cells

Study Overview
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Brief Summary
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The goal of this study is to investigate the overall theory that the use of chemically preserved solutions associated with contact lenses promotes an increase in bacterial infection.

Detailed Description
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The purpose of this study is to investigate the theory of bacterial binding to surface eye cells through the use of chemically preserved solutions.

Official Title
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A Masked, Randomized, Prospective, Single Center Crossover Clinical Trial on the Relationship Between Chemically Preserved Contact Lens Packaging Solutions and Bacterial Binding to Corneal Epithelial Cells

Conditions
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Corneal Ulcer

Intervention / Treatment
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* Device: Contact lens packaging solution
* Device: Balanced salt solution (BSS)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age range: 18-38 years Any sex, race or national origin accepted as with our past studies. Minority representation will be proactively encouraged. No prior history of any contact lens wear within one month of entry into the study. No history of allergic eye disease either seasonal or associated with previous contact lens wear. Exclusion Criteria: Any patient that is a current contact lens wearer. Patients with active ocular infection or inflammatory disease, history of herpetic keratitis, glaucoma, etc. Uncontrolled systemic disease or the presence of any significant illness or condition that could, in the judgment of the investigator, interfere with interpretation of the study results. Any patient using ocular tears, anti-histamine based ocular therapies, glaucoma therapy, vasoconstricting drops, etc.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 38 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Contact Lens Packaging Solution #1<br>Test solution - contact lens packaging solution | Device: Contact lens packaging solution<br>* These test solutions are the intervention being tested.<br>* Other names: Blister pack solution;|
| Experimental: Contact lens packaging solution #2<br>Test solution - contact lens packaging solution | Device: Contact lens packaging solution<br>* These test solutions are the intervention being tested.<br>* Other names: Blister pack solution;|
| Placebo Comparator: Balanced salt solution<br>Control solution | Device: Balanced salt solution (BSS)<br>* BSS is isotonic to the tissues of the eyes.<br>* Other names: Saline solution;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bacterial binding of Pseudomonas Aeruginosa | Counting the number of bacteria that bind to surface epithelial cells. | 5 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bacterial infection, Loss of epithelial cells