Efficacy of an Intranasal Tear Neurostimulator in Sjogren’s Syndrome Patients

Abstract

Purpose : To assess the effectiveness of an intranasal tear neurostimulator (ITN) device in stimulating tear production in patients with Sjogren's syndrome (SS).

Methods : A prospective, 2 visit, randomized, subject-masked, controlled crossover study was performed in participants with SS. Eligibility was determined at the Baseline Visit. Participants had to have Schirmer scores with anesthesia ≤10 mm/5 min (in at least 1 eye) and cotton swab stimulated scores ≥4 mm higher in the same eye. Enrolled participants returned within 45 days for the Application Visit. They received 2 test applications (intranasal and extranasal) in random sequence, separated by at least 60 minutes. During each randomized application, Schirmer test with anesthesia was performed for 5 minutes to measure stimulated tear production in both eyes. Generalized linear models were used to evaluate the change from baseline in Schirmer scores during intranasal device application and extranasal control application in both eyes and to evaluate any effect of the order of application.

Results : 55 participants were screened and 35 were enrolled (all female), with an age range of 31-72 years (mean 57). Improvement in Schirmer scores were significantly greater for intranasal device application (13.5 mm, SD=1.6) compared to extranasal control application (0.8mm, SD=0.8) (p<0.0001). The application order did not significantly impact the results. Intranasal device application Schirmer scores were also significantly greater compared to Baseline intranasal cotton swab stimulation (10.2mm, SD=1.3) (p<0.003).
The same comparisons were calculated for two sub-groups of participants (systemic SS medications vs. no systemic SS medications and baseline Schirmer <5 mm vs. baseline Schirmer ≥5 mm). Internal device application was the most effective among all sub-groups (p≤0.03), except for the systemic SS medication subgroup (p=0.33). Neither the participant’s baseline Schirmer value grouping (p=0.51) nor systemic SS medication usage (p=0.3) is significantly associated with tear production using internal application.

Conclusions : We found that internal application of the ITN device significantly increased tear production in SS patients compared to baseline. It was more effective than intranasal cotton swab stimulation or external application of the device. Our results indicate that the ITN device can be an effective treatment to stimulate tear production in SS patients.

This is a 2020 ARVO Annual Meeting abstract.