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

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

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01104961

Enrollment

Registered

2010-04-16

Start date

2010-04-30

Completion date

2010-08-31

Last updated

2018-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Corneal Ulcer

Keywords

Bacterial infection, Loss of epithelial cells

Brief summary

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

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

Interventions

DEVICEBalanced salt solution (BSS)

BSS is isotonic to the tissues of the eyes.

DEVICEContact lens packaging solution

These test solutions are the intervention being tested.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

SUPPORTIVE_CARE

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 38 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026