Neurological Dry Eye Study Stimulating Both Lacrimal and Vagus Nerves

Genetic Disease Investigators

Status: Not yet enrolling

Conditions: Dry Eye; Dry Eye Disease

Treatments: Dietary Supplement: NeuroTears; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06271005

000824

Details and patient eligibility

About

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.

Full 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.

Enrollment: 75 estimated patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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75 participants in 2 patient groups, including a placebo group

Treatment with NeuroTears

Active Comparator group

Treatment:

Dietary Supplement: NeuroTears

Placebo

Placebo Comparator group

Treatment:

Dietary Supplement: Placebo