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
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 3 months.
Adherence to the intervention will be monitored by questioning of participants by study staff with responses recorded
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 3 months. Adherence to the intervention will be monitored by questioning of participants by study staff with responses recorded on case report forms. Arm 2: Sham (non-functional) device
Sponsors
Oculeve, Inc.
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Willing to sign the informed consent and deemed capable of following the study protocol; Corneal staining of greater than 2 and sum of corneal and interpalpebral conjunctival staining greater than 7 using Oxford criteria; Basal Schirmer tear test of less than or equal to 7 mm/5 minutes and Schirmer test after nasal stimulation with cotton swab at least 7 mm higher than the basal score; Baseline Ocular Surface Disease Index score of at least 30; Normal lid anatomy, blinking function and closure
Exclusion criteria
Chronic or recurrent epistaxis; Coagulation disorders that may lead to increased bleeding such as haemophilia and thrombocytopenia; Lacrimal gland, nasal or sinus neoplasia or significant trauma and prior lacrimal gland, nasal or sinus surgery leading to denervation of the gland or nasal passages; Cardiac demand pacemaker, implanted defibrillator, or other active implanted metallic or electronic device; Diagnosed epilepsy; A systemic condition or disease not stabilized or judged by the investigator to be incompatible with participation in the study or with the frequent assessments required by the study; The history or presence of any ocular disorder or condition in either eye that would likely interfere with the interpretation of the study results or patient safety; Known hypersensitivity to any of the procedural agents or materials in the study device that contact the nasal mucosa; 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
None listed