Conjunctivitis, Bacterial Clinical Trial
Official title:
Microbiologic Alterations of the Conjunctiva of Hot Tub-soaking Ophthalmologists
The purpose of this study is to determine if there are microbiologic alterations of the ocular surface after hot tub exposure. The study will evaluate the number of microbes before and after hot tub use in order to find out whether hot tub exposure has any change on the organisms present on the ocular surface. Participants will be randomized to dunk or not to dunk their head during their time in the hot tub.
Keratitis is a rare destructive cause of blindness. It typically affects young and healthy
individuals, is excruciatingly painful, and difficult to treat. With 60% of cases
mis-diagnosed at presentation, acanthamoeba keratitis carries a far worse visual prognosis
compared to other cornea infections. Exposure to hot tubs is a widely accepted risk factor.
However, the mechanism of infection and prediction of who is at risk is unknown as the vast
majority of hot tub users do not become infected.In vivo changes to ocular microbiology after
hot tub exposure has never been described.
Changes to ocular microbiology after exposure to hot tubs have not been described. The
purpose of this study is to investigate whether there are significant alterations in the
microbiology of the conjunctiva after hot tub exposure that may contribute to these changes.
This study will recruit at least 34 subjects, who will be randomized to head submersion
versus no head submersion, using at least three different hot tubs. A conjunctival swab, a
minimal-risk test performed routinely in the eye clinic, will be performed before and after
15 minutes of hot tub exposure on one eye (randomized) per subject. The swabs will be plated
on blood agar (bacterial cultures) and non-nutrient agar (acanthamoeba cultures).
In this prospective study, healthy subjects will be recruited. The study will be Health
Insurance Portability and Accountability Act compliant and approved by the Institutional
Review Board. All subjects will review and sign an informed consent form.
Each patient will have the conjunctiva of one eye (randomized) cultured. This practically
no-risk technique entails touching a polyester-tip swab to the lining of the lower eyelid.
Each subject will be randomized to head submersion or no head submersion; this exposure will
be masked by the study coordinator. After 15 minutes of hot tub exposure, the subject will
have the same eye swabbed for cultures.
Each sample (pre- and post-hot tub) will be randomly assigned a study number. One study
coordinator will record and mask data. Water from each tub will be cultured.
The culture plates will be sent to our microbiology facility at UCSF and identification of
organisms on the blood agar plates will be performed on our MALDI (mass spectrometry to
identify bacteria and fungi). Non-nutrient agar plates will be plated with E. coli overlay
and incubated for up to 7 days. The plates will be randomized and the microbiologists will be
masked to exposures.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00407589 -
Systemic Pharmacokinetics of BOL-303224-A
|
Phase 1 | |
| Terminated |
NCT03696342 -
Efficacy of the Ophthalmic Pazufloxacin 0.6% for Bacterial Conjunctivitis, Compared to Gatifloxacin 0.3%.
|
Phase 3 | |
| Withdrawn |
NCT03698045 -
Safety and Tolerability of PRO-143 Ophthalmic Solution in Healthy Volunteers.
|
Phase 1 | |
| Completed |
NCT00357773 -
Efficacy and Safety of T1225 1.5% Versus Tobramycin 0.3 % in the Treatment of Purulent Bacterial Conjunctivitis
|
Phase 3 | |
| Completed |
NCT03519516 -
Safety and Tolerability of the PRO-174 Versus Sophixín Ofteno®, on the Ocular Surface of Healthy Subjects
|
Phase 1 | |
| Withdrawn |
NCT01721694 -
Antibiotic Steroid Combination Compared With Individual Administration in the in the Treatment of Ocular Inflammation and Infection
|
Phase 3 |