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

August 15, 2018 updated by: Danielle Robertson, University of Texas Southwestern Medical Center

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75390
        • UT Southwestern Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 38 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Contact Lens Packaging Solution #1
Test solution - contact lens packaging solution
Device: Contact lens packaging solution
These test solutions are the intervention being tested.
Other Names:
  • Blister pack solution
EXPERIMENTAL: Contact lens packaging solution #2
Test solution - contact lens packaging solution
Device: Contact lens packaging solution
These test solutions are the intervention being tested.
Other Names:
  • Blister pack solution
PLACEBO_COMPARATOR: Balanced salt solution
Control solution
Device: Balanced salt solution (BSS)
BSS is isotonic to the tissues of the eyes.
Other Names:
  • Saline solution

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Texas Southwestern Medical Center

Investigators

  • Principal Investigator: Danielle Robertson, OD, PhD, UT Southwestern Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (ACTUAL)

August 1, 2010

Study Completion (ACTUAL)

August 1, 2010

Study Registration Dates

First Submitted

April 9, 2010

First Submitted That Met QC Criteria

April 14, 2010

First Posted (ESTIMATE)

April 16, 2010

Study Record Updates

Last Update Posted (ACTUAL)

August 17, 2018

Last Update Submitted That Met QC Criteria

August 15, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 032010-081

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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