Clincosm LogoSign in Get a demo

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

Sponsor
University of Texas Southwestern Medical Center (Other)
Overall Status
Withdrawn
CT.gov ID
NCT01104961
Collaborator
(none)
0
Enrollment
1
Location
3
Arms
4
Duration (Months)
0
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Contact lens packaging solution
  • Device: Balanced salt solution (BSS)
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Single (Participant)
Primary Purpose:
Supportive Care
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 Start Date :
Apr 1, 2010
Actual Primary Completion Date :
Aug 1, 2010
Actual Study Completion Date :
Aug 1, 2010

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Bacterial binding of Pseudomonas Aeruginosa [5 weeks]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 38 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 UT Southwestern Medical Center Dallas Texas United States 75390

    Sponsors and Collaborators

    • University of Texas Southwestern Medical Center

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Danielle Robertson, Assistant Professor, University of Texas Southwestern Medical Center
    ClinicalTrials.gov Identifier:
    NCT01104961
    Other Study ID Numbers:
    • 032010-081
    First Posted:
    Apr 16, 2010
    Last Update Posted:
    Aug 17, 2018
    Last Verified:
    Aug 1, 2018
    Keywords provided by Danielle Robertson, Assistant Professor, University of Texas Southwestern Medical Center
    Bacterial infection
    Loss of epithelial cells
    Additional relevant MeSH terms:
    Corneal Ulcer
    Pharmaceutical Solutions

    Study Results

    No Results Posted as of Aug 17, 2018