The effectiveness of contact lens care solutions on Pseudomonas biofilms formed in the presence of neutrophils

Study ID
STU 092010-057

Cancer Related
No

Healthy Volunteers
Yes

Study Sites

Contact
Mike Molai
214-645-2014
mike.molai@utsouthwestern.edu

Principal Investigator
Danielle Robertson

Summary

Blood will be collected from 20 healthy volunteers. neutrophils will be isolated in the laboratory using the plasma Percoll method previously described in detail. Stimulated neutrophils will be incubated along with an infectious corneal isolate of Pseudomonas that is fluorescently conjugated to eGFP and a silicone hydrogel contact lens. after 24 and 48 hour incubation periods, biofilm formation will be assessed by colony forming unit analysis and laser confocal microscopy of contact lens surfaces. To evaluate the efficacy of currently available contact lens care solutions, both chemically preserved MPS and peroxide care systems will be used as directed by manufacturer instructions to clean lenses after 24 and 48 hours of biofilm formation and biofilm will be assessed using the aforementioned assays.

in addition, there will also be 55 established contact lens wearers with no current history of red eyes or ocular infections (no infiltrates) that will be consented for this study. as part of routine standard of care, patients will be prompted with a courtesy call one-day before their clinical appointment with their optometrist and reminded to bring their used contact lenses and case with them. The courtesy call is performed by the optometry office staff. at the time of the appointment, each optometrist will speak with the prospective patient and ask if they would be interested in a research study and also in donating their used lenses and case for research purposes, rather than inspected and discarded, as standard policy. The standard of care management for these used lenses and case is to discard them, when receiving new lenses with a case.

if the patient agrees to submit his/her lenses and case to the research staff, the research coordinator, will then, consent the patient. These 55 patients will be consented to submit their worn contact lenses and lens case, to the research staff. in total there will only be 1 pair of lenses, at maximum, per patient. We will collect lenses from patients that wear acuvue oasys[RegisteredTM] and air optix[RegisteredTM]. in addition to contact lens collection, each subject will have the following de-identified information collected:

* Subjects will be queried with respect to the type of silicone hydrogel they are wearing. if unknown and/or not documented in the eMR, contact lens collection will not be made.
* Subjects will be queried about their current wearing regimen.
* Subjects will be queried whether the lens is a daily or extended wear (was lens wear for at least 6 hours/day/everyday?)
* Subjects will be queried to the type of contact lens solution supply they are currently using to clean and disinfect their lenses. a contact lens solution picture guide will be presented to the patient in the event they cannot remember most commonly prescribed solutions.
* Subjects will be queried to the length of time they have been a contact lens wearer?
* Subjects age and gender will also be collected.

These contact lenses will be incubated and assessed, as per the unworn contact lenses, described above. The principal investigator may elect to share the worn, de-identified contact lenses and cases with other research collaborators that are researching this or other medical conditions. Language pertaining to the Pi's desire for internal as well as external scientific collaboration will be made in the clinical study consent forms.

Participant Eligibility

All healthy, non-pregnant adults of any race and sex, ages 18 and up, who have unremarkable medical histories, and who weigh at least 110 pounds. The amounts of blood to be drawn will not exceed 550 ml in an 8 week period and will not occur more frequently than 2 times per week. Patients will also need to be established prescription contact lens wearers.