Efficacy of an Intranasal Tear Neurostimulator in Sjögren Syndrome Patients

Figures & data

Figure 1 Intranasal neurostimulator and various application methods. (A) Intranasal neurostimulator device; (B) intranasal application; (C) extranasal application (Photos courtesy of Allergan©).

Table 1 Demographic and Clinical Characteristics of Patients at Baseline (n=35)

Baseline Characteristics
Age (years): Mean (SD)	57 (11.4)
Race, n (%)
White	26 (74)
Black	5 (14)
Asian	2 (6)
Unknown	2 (6)
Ethnicity, n (%)
Hispanic or Latino	1 (3)
Non-Hispanic or Latino	34 (97)
Ocular Surface Disease Index Score: Mean (SD)	50.5 (21.0)
Schirmer score (mm/5min): Mean (SD)	6.4 (3.5)
Schirmer <5, eyes (%)	17 (24.3)
Schirmer ≥5, eyes (%)	53 (75.7)
On systemic medications for Sjögren syndrome, n (%)
Yes	26 (74.3)
No	9 (25.7)

Table 2 Comparison Between the Effect of Extranasal and Intranasal Stimulation on Change from Baseline in Schirmer Test Scores in All Participants and by Subgroups

		Sjögren Syndrome Medication Use		Baseline Schirmer Score (mm/5 min)
Change from baseline in Schirmer test score	All participants (n=70 eyes)	Yes (n=52 eyes)	No (n=18 eyes)	<5 (n=17 eyes)	≥5 (n=53 eyes)
Extranasal stimulation: Mean (SE) (mm/5 min)	0.8 (0.8)	1.5 (1.1)	−1.1 (0.8)	2.9 (1.3)	−0.5 (1.0)
Intranasal stimulation: Mean (SE) (mm/5 min)	13.5 (1.6)	14.3 (1.9)	11.1 (2.5)	14.8 (2.8)	12.6 (1.8)
Difference (95% CI) (mm/5 min)	−12.7 (−15.1, −10.2)	−12.8 (−15.8, −9.8)	−12.2 (−16.2, −8.2)	−11.9 (−16.7, −7.2)	−13.1 (−15.8, −10.4)
P-value	<0.0001	<0.0001	0.007	0.004	<0.0001

Table 3 Comparison of the Effect of Extranasal Stimulation and Intranasal Stimulation on Change from Baseline in Schirmer Scores Between Subgroups Defined by Sjögren Syndrome Medication Use and Baseline Schirmer Score

Change from Baseline in Schirmer Test Score	Extranasal Stimulation	Intranasal Stimulation
On Sjögren Syndrome Medication (n=52 eyes): Mean (SE) mm/5 min	1.5 (1.1)	14.3 (1.9)
Not on Sjögren Syndrome Medication (n=18 eyes): Mean (SE) mm/5 min	−1.1 (0.8)	11.1 (2.5)
Difference (95% CI) mm/5 min	2.6 (−0.05, 5.2)	3.2 (−2.9, 9.4)
P-value	0.054	0.30
Baseline Schirmer <5 mm/5 min (n=17 eyes): Mean (SE) mm/5 min	2.9 (1.3)	14.8 (2.8)
Baseline Schirmer ≥5 mm/5 min (n=53 eyes): Mean (SE) mm/5 min	−0.5 (1.0)	12.6 (1.8)
Difference (95% CI) mm/5 min	3.4 (0.1, 6.6)	2.2 (−4.4, 8.8)
P-value	0.04	0.51