Efficacy of an Intranasal Tear Neurostimulator in Sjögren Syndrome Patients

Abstract

Purpose: To assess the efficacy and safety of an intranasal tear neurostimulator (ITN) device in Sjögren syndrome (SS) patients. Methods: This was a two-visit prospective, randomized, controlled, same-day crossover study in participants with SS. Inclusion criteria were assessed at a baseline screening visit and included an Ocular Surface Disease Index (OSDI) score ≥13, and a Schirmer with anesthesia ≤10 mm/5 min (in at least one eye), with a cotton swab stimulation induced increase of ≥4 mm in the same eye. Participants returned for the application visit, where they received intranasal and extranasal applications of the ITN in random sequence, separated by at least 60 min. Schirmer scores were measured in both eyes after each application and compared to baseline values. Generalized linear models were performed to compare the change in Schirmer scores from baseline, and generalized estimating equations were used to account for correlations from repeated measurements in the same eye and measurements from two eyes of the same patient. Results: Fifty-five participants were screened and 35 were enrolled (all female), ranging in age from 31 to 72 years (mean, 57 years). The baseline OSDI score ranged from 14 to 91 (mean, 50.5), and the baseline Schirmer score had a mean (SD) of 6.4 (3.5) ranging from 0 to 20 (mm/5min). Improvement in Schirmer scores was significantly greater for intranasal device application (13.5 mm/5min, 95% CI: 10.4, 16.5) compared to extranasal device application (0.8mm/5min, 95% CI: −0.9, 2.4) (p<0.0001). The effects of the intranasal device application were significant regardless of the participant's baseline Schirmer score and systemic SS medication usage (p<0.05). Conclusion: Intranasal application of the ITN device significantly increased tear production in a subset of SS patients compared to baseline and was more effective than extranasal application. While production of the ITN device was recently discontinued, our findings suggest that other therapies that neurostimulate the lacrimal function unit may be effective in a subset of SS patients.

Efficacy and safety of trigeminal parasympathetic pathway stimulation for dry eye: A systematic review and meta-analysis

“…A total of 3592 records were retrieved through a comprehensive search, among which fourteen RCTs[ 12 21 22 23 24 25 26 27 28 29 30 31 32 33 34 ] were included in this meta-analysis [ Fig. 1 ].…”

Effectiveness of Intranasal Tear Neurostimulation for Treatment of Dry Eye Disease: A Meta-Analysis

“…There was heterogeneity among these studies ( I 2 = 95%), so a random-effect model was applied for analysis. In these 6 trials, the highest mean difference was 19.80 mm, and the 95% CI was from 16.51 to 23.09 mm in Patter’s [ 23 ]; the lowest mean difference was 7.10 mm, and the 95% CI was from 5.83 to 8.37 mm in Lilley’s study [ 21 ]. For the sensitivity analysis, omitting each study showed no changes in the significant output from the meta-analysis for the Schirmer II test.…”

“…The risk of bias assessment for eight included RCTs was performed using the Cochrane Collaboration Tool by two individual reviewers. Five studies were assessed as having a low risk of selection bias [17][18][19][20][21], while the others were assessed as having an unclear risk [22][23][24]. For detection bias, reporting bias and other bias, all trials had unclear risk.…”

Advances in Dry Eye Disease Examination Techniques

“…However, the relationship between the PRT and Schirmer's test in the measurement of tear secretion is not clear (27). Although Schirmer's test without anesthesia may not be acceptable given its shortcomings, it can be considered a valid option for diagnosing severe dry eye because of its reproducibility (32)(33)(34).…”