None listed
Conditions
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
Neurostimulation device (EMS 2000) – Lacrimal gland neurostimulation is administered nasally. 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 3 months.
Adherence to the intervention will be monitored by questioning of participants by study staff with res
Neurostimulation device (EMS 2000) – Lacrimal gland neurostimulation is administered nasally. 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 3 months. Adherence to the intervention will be monitored by questioning of participants by study staff with responses recorded on case report forms.
Sponsors
Oculeve, Inc.
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
No
Inclusion criteria
Patients who completed the three month randomized controlled trial, ACTRN12613001110774 Willing to sign the informed consent and deemed capable of following the study protocol
Exclusion criteria
A change in an ocular or systemic disorder or condition during the previous study judged by the investigator to be incompatible with participation in the study, with patient safety, with the frequent assessments required by the study or confounding to the interpretation of study results Be currently taking any medication known to cause ocular drying (e.g., cyclosporine, antihistamines, tricyclic antidepressants, anxiolytics, antimuscarinics, beta-blocking agents, diuretics, phenothiazines, steroids, etc.) that has not been used on a stable dosing regimen for 30 days prior to Day 0 Punctal plugs (participants with permanent occlusion of punctal ducts are eligible) Contact lens use for the duration of the study Participation in any clinical trial with a new active substance or a new device during the course of the study Women who are pregnant, planning a pregnancy or nursing at study entry
Outcome results
None listed