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Jeff Penzner, David Hollander, Gail Torkildsen, Stephanie Baba, Mark Holdbrook, Michelle Senchyna; Evaluation of the Durability of Dry Eye Symptom Relief Following Daily Use of TrueTear™. Invest. Ophthalmol. Vis. Sci. 2018;59(9):914. doi: https://doi.org/.
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© ARVO (1962-2015); The Authors (2016-present)
The Intranasal Tear Neurostimulator (TrueTear, Allergan plc) was designed to deliver microcurrents to the nasal cavity, stimulating the nasolacrimal pathway. Studies have demonstrated that use of TrueTear results in a significant increase in acute tear production that is maintained following 180 days of daily use. As ~50% of the global population experiences symptoms of dry eye disease (DED), this study was designed to assess the durability of acute dry eye symptom relief during exposure to a Controlled Adverse Environment (CAE®) following use of TrueTear for 45 days.
This was a prospective, open-label, single-arm study in adults with DED. Subjects exposed to a CAE on study Days 0 and 45 were assessed for dry eye symptoms using a visual analog scale (Eye Dryness Score, EDS) and ocular discomfort with the Ora Calibra® Ocular Discomfort Scale (ODS) every 5 minutes. Upon reaching the ODS threshold, subjects applied TrueTear for ~3 minutes between symptom measures. Between Days 0 and 45, subjects were instructed to apply TrueTear 2–10 times daily as needed, for no more than 3 minutes/application. The primary effectiveness measure was the change in EDS from the measure immediately prior to TrueTear application to the measure immediately following application in the CAE at Day 45. The primary safety measure was device-related adverse events (AEs).
57 subjects were enrolled; 54 completed the study and 3 discontinued due to AEs (2 were device-related). Mean (SEM) change in EDS from pre- to post-application of TrueTear on Day 45 (primary endpoint) was −15.2 (2.4) (p<.0001). Mean (SEM) change in EDS from pre- to post-application of TrueTear on Day 0 was −15.9 (2.7) (p<.0001). Mean (SEM) change in ODS from pre- to post-application was −1.3 (0.2) and −1.3 (0.1) on Days 0 and 45, respectively (both p<.0001). Mean (SEM) acute tear production (post-application minus basal Schirmer score) on Day 7 was 16.0 (1.5) (right eye) and 17.4 (1.4) (left eye) (both p<.0001). Eight device-related AEs were reported, none serious.
TrueTear application significantly improves dry eye symptoms (ocular discomfort and eye dryness) following both initial application and after 45 days of daily use. TrueTear was safe and well tolerated. The sustained ability to increase tear production and reduce DED symptoms positions TrueTear as a promising new management strategy for DED.
This is an abstract that was submitted for the 2018 ARVO Annual Meeting, held in Honolulu, Hawaii, April 29 - May 3, 2018.
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