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

Corneal Ulcer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01104961
• Other study ID #: 032010-081
• Status: Withdrawn
• Phase: N/A
• Start date: April 2010
• Est. completion date: August 2010

Study information

• Verified date: August 2018
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 38 Years

Eligibility

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.

Related Conditions & MeSH terms

• Corneal Ulcer

Intervention

Device:
• Contact lens packaging solution
These test solutions are the intervention being tested.
• Balanced salt solution (BSS)
BSS is isotonic to the tissues of the eyes.

Locations

Country	Name	City	State
United States	UT Southwestern Medical Center	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome

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