Neurological Dry Eye Study Stimulating Both Lacrimal and Vagus Nerves

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-01

Study Completion Date

2024-10-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Dry Eye Disease Dry Eye

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Treatment with NeuroTears

Group Type ACTIVE_COMPARATOR

NeuroTears

Intervention Type DIETARY_SUPPLEMENT

Over-the-counter supplement

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Oral placebo pill

Interventions

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NeuroTears

Over-the-counter supplement

Intervention Type DIETARY_SUPPLEMENT

Placebo

Oral placebo pill

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No