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Michelle Senchyna, George W Ousler, Gary Jerkins, Guruprasad Pattar, David Evans, Mark Holdbrook, Stephanie Baba; Effect of TrueTear™ on Dry Eye Symptoms During Exposure to a Controlled Adverse Environment. Invest. Ophthalmol. Vis. Sci. 2018;59(9):918.
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© ARVO (1962-2015); The Authors (2016-present)
A novel Intranasal Tear Neurostimulator (TrueTear, Allergan plc) was designed to deliver microcurrents to the nasal cavity, stimulating the nasolacrimal pathway. TrueTear recently received FDA approval to provide a temporary increase in tear production in adult patients. This study evaluated the safety and effectiveness of TrueTear applied intranasally (active) or extranasally (control) in reducing dry eye symptoms during exposure to a Controlled Adverse Environment (CAE®).
This was a prospective, multicenter, randomized-sequence, subject-masked, cross-over study. Subjects with dry eye disease were exposed to the CAE and when the ocular discomfort score (ODS) threshold measured with the Ora Calibra® Ocular Discomfort Scale was reached, subjects performed either the intranasal or extranasal application, administered in a randomized sequence, for ~3 minutes. The eye dryness score (EDS, assessed with a visual analog scale) and ODS were measured every five minutes during CAE exposure including prior to and following TrueTear application. The primary effectiveness measure was the change in EDS from the measure immediately prior to TrueTear application to the measure immediately following application. The primary safety measure was device-related adverse events (AEs).
185 subjects (mean age 59 y, 74.6% female) were enrolled; 143 (77.3%) performed both applications and completed the study. Mean change in EDS (standard error [SE]) from pre- to post-application was significantly greater with intranasal (−16.5 [1.7]) than extranasal application (−3.1 [1.7]) (LS mean difference [SE], 13.4 [2.0]; p<.0001; ANOVA). Mean decrease in ODS score in the analysis eye from pre-to post-application was also significantly greater with intranasal application (−0.93 [0.08]) than extranasal application (−0.34 [0.08]) (LS mean difference [SE], 0.60 [0.10]; p<.0001; ANOVA). Only one AE was reported: transient mild epistaxis.
Intranasal application of TrueTear during CAE exposure resulted in statistically significant improvements in eye dryness and ocular discomfort compared with the control application of the device. TrueTear demonstrated a good safety profile; there were no serious adverse events and no subject discontinued the study because of an adverse event. By increasing tear production and reducing DED symptoms, TrueTear represents 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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