Stimulation Therapy to Produce Tears for the Treatment of Dry Eye

Neurostimulation to Increase Tear Production Measured Objectively via Schirmer Test in Adult Patients with Mild to Severe Dry Eye Disease - Pilot Study

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12613001075774

Enrollment

Registered

2013-09-25

Start date

2013-05-21

Completion date

2014-02-07

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The purpose of this study is to demonstrate that neurostimulation increases tear production and improves symptoms of dry eye disease over baseline measurements.

Interventions

Arm 1 - Neurostimulation device (EMS 2000) - Lacrimal gland neurostimulation. The current provided is approximately 1 milliamp with the patient controlling the amplitude with a knob. The recommended duration of treatment is approximately 30 seconds and the recommended treatment frequency is four times per day or as needed. The duration of the intervention period is 6 months. Patient diaries are used to monitor adherence to the intervention.

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Willing to sign the informed consent and deemed capable of following the study protocol Basal Schirmer tear test of less than or equal to 15 mm; Schirmer test at least twice or at least 10 mm higher after nasal stimulation with cotton swab Baseline Ocular Surface Disease Index score of at least 13 Normal lid anatomy, blinking function and closure Corrected visual acuity of 20/200 (Snellen equivalent) or better in each eye

Exclusion criteria

Individuals with a history or presence of any systemic disorder or condition that is not stabilized or would likely interfere with the interpretation of study results or subject safety Presence of severe systemic allergy or acute or chronic rhinitis or sinusitis Individuals with the presence or history of any ocular disorder or condition that would likely interfere with the interpretation of study results or subject safety Nasal, orbital or lacrimal trauma, surgery, tumour or cancer Significant corneal or conjunctival scarring of any aetiology Known hypersensitivity to one of the components of the study device or procedural medications Patients with a history of chronic or recurrent epistaxis Participation in any clinical trial with a new active substance or a new device during the past 3 months Women who are pregnant, planning a pregnancy or nursing at study entry

Outcome results