Text Size

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

This study has been completed.
Sponsor:
Information provided by:
University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT01104961
First received: April 9, 2010
Last updated: October 13, 2010
Last verified: April 2010
History of Changes
  Purpose

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 Intervention
Corneal Ulcer
 Device: Contact lens packaging solution
Device: Balanced salt solution (BSS)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Texas Southwestern Medical Center:

Primary Outcome Measures:
  • Bacterial binding of Pseudomonas Aeruginosa [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]
    Counting the number of bacteria that bind to surface epithelial cells.


Estimated Enrollment: 20
Study Start Date: April 2010
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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 Name: Saline solution

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.

  Eligibility

Ages Eligible for Study:   18 Years to 38 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01104961

Locations
United States, Texas
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
  More Information

No publications provided

Responsible Party: Dr. Danielle Robertson, UT Southwestern
ClinicalTrials.gov Identifier: NCT01104961     History of Changes
Other Study ID Numbers: 032010-081
Study First Received: April 9, 2010
Last Updated: October 13, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of Texas Southwestern Medical Center:
Bacterial infection
Loss of epithelial cells

Additional relevant MeSH terms:
Corneal Ulcer
Ulcer
Eye Infections
Infection
 Keratitis
Corneal Diseases
Eye Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 21, 2013