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A nonrandomized, open-label study to evaluate the effect of nasal stimulation on tear production in subjects with dry eye disease.

Friedman NJ, Butron K, Robledo N, Loudin J, Baba SN, Chayet A - Clin Ophthalmol (2016)

Bottom Line: Mean stimulated Schirmer scores were significantly higher than the unstimulated scores at all visits, and corneal and conjunctival staining and symptom scores from baseline to day 180 were significantly reduced.No significant findings from other clinical examinations were noted.Neurostimulation of the nasolacrimal pathway is a safe and effective means of increasing tear production and reducing symptoms of dry eye in patients with DED.

View Article: PubMed Central - PubMed

Affiliation: Department of Ophthalmology, Stanford University, Mid-Peninsula Ophthalmology Medical Group, Palo Alto, CA, USA.

ABSTRACT

Background: Dry eye disease (DED), a chronic disorder affecting the tear film and lacrimal functional unit, is a widely prevalent condition associated with significant burden and unmet treatment needs. Since specific neural circuits play an important role in maintaining ocular surface health, microelectrical stimulation of these pathways could present a promising new approach to treating DED. This study evaluated the efficacy and safety of nasal electrical stimulation in patients with DED.

Methods: This prospective, open-label, single-arm, nonrandomized pilot study included 40 patients with mild to severe DED. After undergoing two screening visits, enrolled subjects were provided with a nasal stimulation device and instructed to use it at home four times daily (or more often as needed). Follow-up assessments were conducted up to day 180. The primary efficacy endpoint was the difference between unstimulated and stimulated tear production quantified by Schirmer scores. Additional efficacy endpoints included change from baseline in corneal and conjunctival staining, symptoms evaluated on a Visual Analog Scale, and Ocular Surface Disease Index scores. Safety parameters included adverse event (AE) rates, visual acuity, intraocular pressure, slit-lamp biomicroscopy, indirect ophthalmoscopy, and endoscopic nasal examinations.

Results: Mean stimulated Schirmer scores were significantly higher than the unstimulated scores at all visits, and corneal and conjunctival staining and symptom scores from baseline to day 180 were significantly reduced. No serious device-related AEs and nine nonserious AEs (three device-related) were reported. Intraocular pressure remained stable and most subjects showed little or no change in visual acuity at days 30 and 180. No significant findings from other clinical examinations were noted.

Conclusion: Neurostimulation of the nasolacrimal pathway is a safe and effective means of increasing tear production and reducing symptoms of dry eye in patients with DED.

No MeSH data available.


Related in: MedlinePlus

Schirmer scores with and without stimulation.Notes: The difference between the stimulated and unstimulated Schirmer score for each eye was statistically significant at all time points (P<0.001). Data represents mean ± SEM. The thin dashed horizontal reference line represents the mean unstimulated value for both eyes at day 0.Abbreviations: OD, right eye; OS, left eye; SEM, standard error of the mean.
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f1-opth-10-795: Schirmer scores with and without stimulation.Notes: The difference between the stimulated and unstimulated Schirmer score for each eye was statistically significant at all time points (P<0.001). Data represents mean ± SEM. The thin dashed horizontal reference line represents the mean unstimulated value for both eyes at day 0.Abbreviations: OD, right eye; OS, left eye; SEM, standard error of the mean.

Mentions: Acute tear production was measured using the Schirmer test, and the stimulated value minus the unstimulated (preadministration) value at each visit served as the study’s primary endpoint (Figure 1). The mean stimulated Schirmer score at each visit was higher than the mean unstimulated score taken at the same visit. On study day 0, the unstimulated and stimulated Schirmer scores, respectively, were 9.4±1.3 and 22.4±1.9 (a 138.3% increase) in the right eye and 10.5±1.1 and 22.5±1.8 (114.3% increase) in the left eye. After an initial period of ~2 weeks, the average increase in the stimulated Schirmer score stabilized; at day 180, the respective values were 12.7±1.7 and 19.9±2.0 (56.7% increase) in the right eye and 13.2±1.6 and 20.5±2.0 (55.3% increase) in the left eye. The difference between the stimulated and unstimulated Schirmer scores was statistically significant (P<0.001) for both eyes at all follow-up visits. Additionally, the similarity in stimulated Schirmer scores at day 0 and day 180 indicated that the enhancement of tear production persisted with chronic stimulation.


A nonrandomized, open-label study to evaluate the effect of nasal stimulation on tear production in subjects with dry eye disease.

Friedman NJ, Butron K, Robledo N, Loudin J, Baba SN, Chayet A - Clin Ophthalmol (2016)

Schirmer scores with and without stimulation.Notes: The difference between the stimulated and unstimulated Schirmer score for each eye was statistically significant at all time points (P<0.001). Data represents mean ± SEM. The thin dashed horizontal reference line represents the mean unstimulated value for both eyes at day 0.Abbreviations: OD, right eye; OS, left eye; SEM, standard error of the mean.
© Copyright Policy
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC4862385&req=5

f1-opth-10-795: Schirmer scores with and without stimulation.Notes: The difference between the stimulated and unstimulated Schirmer score for each eye was statistically significant at all time points (P<0.001). Data represents mean ± SEM. The thin dashed horizontal reference line represents the mean unstimulated value for both eyes at day 0.Abbreviations: OD, right eye; OS, left eye; SEM, standard error of the mean.
Mentions: Acute tear production was measured using the Schirmer test, and the stimulated value minus the unstimulated (preadministration) value at each visit served as the study’s primary endpoint (Figure 1). The mean stimulated Schirmer score at each visit was higher than the mean unstimulated score taken at the same visit. On study day 0, the unstimulated and stimulated Schirmer scores, respectively, were 9.4±1.3 and 22.4±1.9 (a 138.3% increase) in the right eye and 10.5±1.1 and 22.5±1.8 (114.3% increase) in the left eye. After an initial period of ~2 weeks, the average increase in the stimulated Schirmer score stabilized; at day 180, the respective values were 12.7±1.7 and 19.9±2.0 (56.7% increase) in the right eye and 13.2±1.6 and 20.5±2.0 (55.3% increase) in the left eye. The difference between the stimulated and unstimulated Schirmer scores was statistically significant (P<0.001) for both eyes at all follow-up visits. Additionally, the similarity in stimulated Schirmer scores at day 0 and day 180 indicated that the enhancement of tear production persisted with chronic stimulation.

Bottom Line: Mean stimulated Schirmer scores were significantly higher than the unstimulated scores at all visits, and corneal and conjunctival staining and symptom scores from baseline to day 180 were significantly reduced.No significant findings from other clinical examinations were noted.Neurostimulation of the nasolacrimal pathway is a safe and effective means of increasing tear production and reducing symptoms of dry eye in patients with DED.

View Article: PubMed Central - PubMed

Affiliation: Department of Ophthalmology, Stanford University, Mid-Peninsula Ophthalmology Medical Group, Palo Alto, CA, USA.

ABSTRACT

Background: Dry eye disease (DED), a chronic disorder affecting the tear film and lacrimal functional unit, is a widely prevalent condition associated with significant burden and unmet treatment needs. Since specific neural circuits play an important role in maintaining ocular surface health, microelectrical stimulation of these pathways could present a promising new approach to treating DED. This study evaluated the efficacy and safety of nasal electrical stimulation in patients with DED.

Methods: This prospective, open-label, single-arm, nonrandomized pilot study included 40 patients with mild to severe DED. After undergoing two screening visits, enrolled subjects were provided with a nasal stimulation device and instructed to use it at home four times daily (or more often as needed). Follow-up assessments were conducted up to day 180. The primary efficacy endpoint was the difference between unstimulated and stimulated tear production quantified by Schirmer scores. Additional efficacy endpoints included change from baseline in corneal and conjunctival staining, symptoms evaluated on a Visual Analog Scale, and Ocular Surface Disease Index scores. Safety parameters included adverse event (AE) rates, visual acuity, intraocular pressure, slit-lamp biomicroscopy, indirect ophthalmoscopy, and endoscopic nasal examinations.

Results: Mean stimulated Schirmer scores were significantly higher than the unstimulated scores at all visits, and corneal and conjunctival staining and symptom scores from baseline to day 180 were significantly reduced. No serious device-related AEs and nine nonserious AEs (three device-related) were reported. Intraocular pressure remained stable and most subjects showed little or no change in visual acuity at days 30 and 180. No significant findings from other clinical examinations were noted.

Conclusion: Neurostimulation of the nasolacrimal pathway is a safe and effective means of increasing tear production and reducing symptoms of dry eye in patients with DED.

No MeSH data available.


Related in: MedlinePlus