RESUMEN
PURPOSE: The intranasal tear neurostimulator (ITN) activates the nasolacrimal pathway, which is involved with basal and bolus tear secretion. These studies characterized the acute and long-term effectiveness of the ITN in stimulating tear production in subjects with dry eye disease (DED). METHODS: Study 1: Randomized, double-masked, dual-controlled, 1-day crossover. Study 2: Single-arm, open-label, 180-day prospective cohort. Eligible subjects had basal unstimulated Schirmer test (with anesthesia) ≤10â¯mm and intranasal cotton swab-stimulated Schirmer test at least 7â¯mm greater in the same eye, and Ocular Surface Disease Index® ≥13 andâ¯≥â¯23, in Studies 1 and 2, respectively. Study 1: Subjects (nâ¯=â¯48) received three randomized test applications: active intranasal, extranasal (active control), and sham intranasal (inactive control) stimulation, 3â¯min/application with 1-hour minimum between applications. Primary outcome measure was the difference in Schirmer test scores during active intranasal and control applications. Study 2: Subjects (nâ¯=â¯97) performed intranasal neurostimulation for ≤3â¯min/application, 2-10 times/day. Primary outcome measure was the difference in Schirmer scores (stimulated minus unstimulated) at day 180. Both studies recorded device-related adverse events (AEs). RESULTS: Study 1: Schirmer scores (mean⯱â¯SEM) were significantly greater (pâ¯<â¯0.0001) with active intranasal (25.3⯱â¯1.5â¯mm) vs extranasal (9.5⯱â¯1.2â¯mm) and sham (9.2⯱â¯1.1â¯mm) applications. Study 2: Schirmer scores were significantly greater (pâ¯<â¯0.0001) with ITN stimulation vs unstimulated at day 180 (17.3⯱â¯1.3â¯mm vs 7.9⯱â¯0.7â¯mm). No serious device-related AEs were reported in either study. CONCLUSION: The ITN was well-tolerated and effective in stimulating tear production with acute and long-term use in DED. CLINICALTRIALS. GOV IDENTIFIER: NCT02680158 and NCT02526290.