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NCT06271005 Clinical Trial

Neurological Dry Eye Study Stimulating Both Lacrimal and Vagus Nerves

Dry Eye Clinical Trial

Official title:
Neurological Dry Eye Study Stimulating Both Lacrimal and Vagus Nerves

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06271005
Other study ID # 000824
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date April 1, 2024
Est. completion date October 1, 2024

Study information
Verified date February 2024
Source Genetic Disease Investigators
Contact Diana Driscoll, OD
Phone 866-349-9905
Email orders@neurotears.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 75
Est. completion date October 1, 2024
Est. primary completion date October 1, 2024
Accepts healthy volunteers No
Gender All
Age group 20 Years to 65 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• NeuroTears
Over-the-counter supplement
• Placebo
Oral placebo pill

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Genetic Disease Investigators

Outcome
Type Measure Description Time frame Safety issue
Primary OSDI Ocular Surface Disease Index 4 weeks
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