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Neurological Dry Eye Study Stimulating Both Lacrimal and Vagus Nerves

Neurological Dry Eye Study Stimulating Both Lacrimal and Vagus Nerves

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06271005
Enrollment
75
Registered
2024-02-21
Start date
2024-04-01
Completion date
2024-10-01
Last updated
2024-02-21

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

Conditions

Dry Eye, Dry Eye Disease

Keywords

vagus nerve, Ehlers-Danlos Syndrome, EDS, lacrimal nerves, dry eye, tear production, dysautonomia, POTS, Postural Orthostatic Tachycardia Syndrome, constipation, gastroparesis, tachycardia, NeuroTears, Mast Cell Activation Syndrome, vagus nerve stimulation, MCAS, Post-COVID, COVID, Longhaulers

Brief summary

This is a study on neurological dry eye disease, focusing on a patented over-the-counter supplement supporting tear production neurologically, including the lacrimal and vagus nerves.

Detailed description

Chronic inflammation is implicated in the majority of chronic dry eyes. The parasympathetic nervous system is responsible for both basal tear secretion (the aqueous layer) by the lacrimal functional unit, and is responsible for controlling many aspects of chronic inflammation via the vagus nerve. This study will document its effects on dry eyes, in addition to other symptoms/signs of low parasympathetic nervous system functioning using an over-the-counter supplement.

Interventions

DIETARY_SUPPLEMENTNeuroTears

Over-the-counter supplement

DIETARY_SUPPLEMENTPlacebo

Oral placebo pill

Sponsors

Genetic Disease Investigators
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* Must have dry eye (OSDI score 30 and above) * Tear break up time of less than or equal to 7 seconds * Must be able to come for baseline tests and again at 4 weeks

Exclusion criteria

* Demodex * Corneal scarring * must not take Physostigmine (glaucoma), Pyridostigmine (Mestinon), Neostigmine (for Myasthenia Gravis); Aricept (for Alzheimer's), or ingredients to NeuroTears * No known allergies to ingredients in NeuroTears

Design outcomes

Primary

MeasureTime frameDescription
OSDI4 weeksOcular Surface Disease Index

Contacts

Primary ContactDiana Driscoll, OD
orders@neurotears.com866-349-9905

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026