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

The University of Texas System (UT)

Status: Withdrawn

Conditions: Corneal Ulcer

Treatments: Device: Balanced salt solution (BSS); Device: Contact lens packaging solution

Study type: Interventional

Funder types: Other

Identifiers

NCT01104961

032010-081

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18 to 38 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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0 participants in 3 patient groups, including a placebo group

Contact Lens Packaging Solution #1

Experimental group

Description:

Test solution - contact lens packaging solution

Treatment:

Device: Contact lens packaging solution

Contact lens packaging solution #2

Experimental group

Description:

Test solution - contact lens packaging solution

Treatment:

Device: Contact lens packaging solution

Balanced salt solution

Placebo Comparator group

Description:

Control solution

Treatment:

Device: Balanced salt solution (BSS)