Study Stopped
Other projects took precedence, no mechanism of funding establed
Studying the Relationship Between Contact Lens Packaging Solutions and Bacterial Binding to Surface Eye Cells
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
1 other identifier
interventional
N/A
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Apr 2010
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2010
CompletedFirst Submitted
Initial submission to the registry
April 9, 2010
CompletedFirst Posted
Study publicly available on registry
April 16, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2010
CompletedAugust 17, 2018
August 1, 2018
4 months
April 9, 2010
August 15, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Bacterial binding of Pseudomonas Aeruginosa
Counting the number of bacteria that bind to surface epithelial cells.
5 weeks
Study Arms (3)
Contact Lens Packaging Solution #1
EXPERIMENTALTest solution - contact lens packaging solution
Contact lens packaging solution #2
EXPERIMENTALTest solution - contact lens packaging solution
Balanced salt solution
PLACEBO COMPARATORControl solution
Interventions
These test solutions are the intervention being tested.
BSS is isotonic to the tissues of the eyes.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UT Southwestern Medical Center
Dallas, Texas, 75390, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Danielle Robertson, OD, PhD
University of Texas Southwestern Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
April 9, 2010
First Posted
April 16, 2010
Study Start
April 1, 2010
Primary Completion
August 1, 2010
Study Completion
August 1, 2010
Last Updated
August 17, 2018
Record last verified: 2018-08