| Abstract: | PurposeTo evaluate the safety and effectiveness of the intranasal tear neurostimulator (ITN) in improving dry eye symptoms assessed in a controlled adverse environment (CAE®).MethodsStudy 1: Multicenter, subject-masked, randomized-sequence, crossover design. Single intranasal (active) and extranasal (control) ITN administration during CAE exposure. Study 2: Single-arm, open-label design. Intranasal ITN administration ≥2 times/day for 45 days, CAE assessment at days 0 and 45. In both studies, upon CAE entry, and every 5 min thereafter, subjects assessed eye dryness score (visual analog scale, 0–100 mm; EDS-VAS), and ocular discomfort score (ODS; Ora Calibra?, 0–4), for ≈2 h. Study 1: when ODS was ≥3 at 2 consecutive timepoints, subjects applied ITN intranasally or extranasally for ≈3 min, and again when achieving the same ODS criteria in randomized sequence. Study 2: days 0 and 45, ITN was applied for ≈3 min employing the same ODS criteria as Study 1.ResultsStudy 1: Significantly greater pre- to post-application reductions in mean SEM] EDS (?16.5 1.7] vs ?3.1 1.7], P < 0.0001) and ODS (?0.93 0.08] vs ?0.34 0.08], P < 0.0001; n = 143) with intranasal vs extranasal stimulation. Study 2: On day 0 (n = 52) and day 45 (n = 48), significant pre- to post-application reductions in mean SEM] EDS (?15.9 2.7] and ?15.2 2.4]; P < 0.0001), and ODS (?1.3 0.2] and ?1.3 0.1]; P < 0.0001). Few device-related adverse events were reported, none serious.ConclusionsAcute symptom relief is significant with the ITN and remains undiminished after daily use. |
