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

Not Applicable

Withdrawn

• Conditions: Corneal Ulcer
• Interventions: Device: Contact lens packaging solution; Device: Balanced salt solution (BSS)

• Registration Number: NCT01104961
• Lead Sponsor: University of Texas Southwestern Medical Center

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.

Study Timeline

• Study Start: 2010-04
• Study First Submitted: 2010-04-09
• Study First Submitted QC: 2010-04-14
• Study First Posted: 2010-04-16
• Primary Completion: 2010-08
• Study Completion: 2010-08
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-15
• Last Update Posted: 2018-08-17

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Contact Lens Packaging Solution #1	Contact lens packaging solution	Test solution - contact lens packaging solution
Contact lens packaging solution #2	Contact lens packaging solution	Test solution - contact lens packaging solution
Balanced salt solution	Balanced salt solution (BSS)	Control solution

Primary Outcome Measures

Name	Time	Method
Bacterial binding of Pseudomonas Aeruginosa	5 weeks	Counting the number of bacteria that bind to surface epithelial cells.

Trial Locations

Locations (1)

UT Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States