Dry Eye Clinical Trial
Official title:
A Study To Investigate The Effects Of A Low Humidity Environment And Visual Tasking On Tear Film Protein Composition
The purpose of the study is to collect valuable data on the role of controlled humidity, temperature, airflow, and visual tasking in altering the tear film protein composition. The results from this preliminary study will help to explore the role of tear film markers in inflammatory and disease conditions. This can also be extended to understand the role of the tear film in protecting the ocular surface when individuals are exposed to low humidity environments which may incite discomfort symptoms.
An investigational study, to evaluate the effects of a low humidity environment and visual
tasking on tear film protein composition Screening Visit 1A: Subjects will be screened based
on their medical history, symptom questionnaires (e.g. OSDI) and a full ophthalmic
examination.
Screening Visit 1A: Subjects will be screened based on their medical history, symptom
questionnaires (e.g. OSDI) and a full ophthalmic examination which will include baseline
measures including visual acuity and biomicroscopic evaluations of the anterior segment
(i.e. Tear Break Up Time (TBUT), corneal and conjunctival staining, lid wiper
epitheliopathy, conjunctival redness and tear film evaluation).
Post-screening, approximately sixteen (16) subjects, meeting the inclusion and exclusion
criteria, will be asked to participate in the study. Of those enrolled in the study,
approximately eight (8) subjects will have mild to moderate symptoms and signs of dry eye
syndrome and approximately eight (8) subject will not have signs or symptoms of dry eye
syndrome.
On Visit IB, subjects will have VA and biomicroscopy performed. A basal tear sample of
approximately 5 µL will be collected via capillary tubes from the outer canthus of each eye
and stored on dry ice then placed in a -80c ± 10°C freezer for storage. Photographic
assessments of the ocular surface may be taken. After waiting 5 minutes for the tear film to
stabilize, tear osmolarity may be measured in each eye.
Prior to entered the low humidity Environmental Exposure Chamber (EEC), subjects will be
asked to fill out their baseline symptoms. Subjects will then enter and remain in the EEC
for approximately 180 minutes and symptom diary cards will be completed after entry at
pre-specified timepoints. Throughout the EEC visit, subjects will be asked to complete
visual tasks on a digital screen to ensure the ocular surface is exposed to the airflow and
humidity levels in the room.
After approximately 180 minutes of exposure to dry eye conditions, prior to exiting chamber,
basal tears will be collected via capillary tubes for each eye and stored on dry ice then
placed in a -80°C ± 10°C freezer for storage. Photographic assessments of the ocular surface
may be taken. After waiting 5 minutes for the tear film to stabilize, tear osmolarity may be
measured for each eye.
After exiting the EEC, subjects will remain in the medical clinic for an additional 60
minutes and will continue to conduct visual tasks during this period. Symptom diary cards
will then be completed at pre-specified time points after leaving the EEC.
Following 60 minutes in the clinic and prior to study exit, a final collection of basal
tears via capillary tubes will be taken and stored on dry ice and then placed in a -80°C ±
10°C freezer for storage. Once again photographic assessments may be taken. Biomicroscopy
will be performed.
The tear samples collected before and after exposure to the chamber will be taken from
(-80°C) freezer storage and packaged on dry ice for shipment to the University of Waterloo
Centre for Contact Lens Research (CCLR) for analysis. A variety of proteins and cytokines
will be analyzed.
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Observational Model: Case Control, Time Perspective: Prospective
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