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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01104961
First Posted: April 16, 2010
Last Update Posted: October 15, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Texas Southwestern Medical Center
  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 (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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Bacterial binding of Pseudomonas Aeruginosa [ Time Frame: 5 weeks ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 38 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Dr. Danielle Robertson, UT Southwestern
ClinicalTrials.gov Identifier: NCT01104961     History of Changes
Other Study ID Numbers: 032010-081
First Submitted: April 9, 2010
First Posted: April 16, 2010
Last Update Posted: October 15, 2010
Last Verified: April 2010

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

Additional relevant MeSH terms:
Corneal Ulcer
Eye Infections
Infection
Keratitis
Corneal Diseases
Eye Diseases
Pharmaceutical Solutions