Abstract
Purpose:
The purpose of this study was to evaluate the ocular signs and symptoms of DE and NDE participants when exposed to a LH-EEC whilst collecting tear samples for analysis of biomarkers.
Methods:
8 DE and 8 NDE participants entered the LH-EEC for approximately 3hrs, then exited and remained in the clinic for an additional hour. Total Ocular Symptom Scores (TOSS) including dryness, grittiness, burning, tearing, blurring, and soreness were rated 0-4 at entry using electronic Patient Data Acquisition Tablets (ePDAT) at set intervals during the visit. Tear Break Up Time (TBUT), fluorescein corneal staining (FLCS) and lissamine green conjunctival staining (LGCS) were collected pre and post EEC using a 0-4 scale on the NEI grid. Tears were collected pre and post chamber, immediately and up to 1hr afterward.
Results:
TOSS were collected throughout 3hr exposure with change of +2.63±0.89 units in the DE group (p=0.02) and +0.38±0.50 in the NDE group (p=0.48) from pre and post chamber. Both groups returned to baseline after 60min post exit. Mean Change from Baseline (MCFB) of FLCS was +1.13±0.74 and +1.94±0.37 and MCFB LGCS was +0.03±0.38 +0.94±0.45 for DE and NDE respectively. The average TBUT pre-EEC for DE was 4.06±0.46s compared to 10.40±0.52s for NDE (p<0.01). However, following EEC exposure, TBUT for DE decreased only modestly at -0.58±0.35s while NDE decreased -5.38±0.67s. Tear collection times took -0.6±0.35s in DE and -0.5±0.29s in NDE following EEC exposure.
Conclusions:
The LH-EEC model provides a valuable clinical research option for the study of dry eye. It shows high sensitivity in signs upon desiccation of the ocular surface effectively in both NDE and DE as well as high specificity to exacerbate the symptoms of participants with dry eye significantly more than those without dry eye.
Keywords: 486 cornea: tears/tear film/dry eye •
466 clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials •
468 clinical research methodology