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

Primary Purpose

Corneal Ulcer

Status

Withdrawn

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Contact lens packaging solution

Balanced salt solution (BSS)

About this trial

This is an interventional supportive care trial for Corneal Ulcer focused on measuring Bacterial infection, Loss of epithelial cells

Eligibility Criteria

18 Years - 38 Years (Adult)All SexesAccepts 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.

Sites / Locations

UT Southwestern Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

Contact Lens Packaging Solution #1

Contact lens packaging solution #2

Balanced salt solution

Arm Description

Test solution - contact lens packaging solution

Control solution

Outcomes

Primary Outcome Measures

Bacterial binding of Pseudomonas Aeruginosa

Counting the number of bacteria that bind to surface epithelial cells.

Secondary Outcome Measures

Full Information

NCT ID

NCT01104961

First Posted

April 9, 2010

Last Updated

August 15, 2018

Sponsor

University of Texas Southwestern Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT01104961

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2018

Overall Recruitment Status

Withdrawn

Why Stopped

Other projects took precedence, no mechanism of funding establed

Study Start Date

April 2010 (undefined)

Primary Completion Date

August 2010 (Actual)

Study Completion Date

August 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Texas Southwestern Medical Center

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Corneal Ulcer

Keywords

Bacterial infection, Loss of epithelial cells

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

Participant

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Contact Lens Packaging Solution #1

Arm Type

Experimental

Arm Description

Test solution - contact lens packaging solution

Arm Title

Contact lens packaging solution #2

Arm Type

Experimental

Arm Description

Test solution - contact lens packaging solution

Arm Title

Balanced salt solution

Arm Type

Placebo Comparator

Arm Description

Control solution

Intervention Type

Device

Intervention Name(s)

Contact lens packaging solution

Other Intervention Name(s)

Blister pack solution

Intervention Description

These test solutions are the intervention being tested.

Intervention Type

Device

Intervention Name(s)

Balanced salt solution (BSS)

Other Intervention Name(s)

Saline solution

Intervention Description

BSS is isotonic to the tissues of the eyes.

Primary Outcome Measure Information:

Title

Bacterial binding of Pseudomonas Aeruginosa

Description

Counting the number of bacteria that bind to surface epithelial cells.

Time Frame

5 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

38 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Danielle Robertson, OD, PhD

Organizational Affiliation

UT Southwestern Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

UT Southwestern Medical Center

City

Dallas

State/Province

Texas

ZIP/Postal Code

75390

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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