Neurological Dry Eye Study Stimulating Both Lacrimal and... | NCT06271005

Studies
Neurological Dry Eye Study Stimulating Both Lacrimal and Vagus Nerves

NCT06271005

Sponsor

Genetic Disease Investigators

Status

Unknown status

Last Update Posted

Feb 21, 2024Actual

Enrollment

75Estimated

Phase

Not Applicable

Conditions

Dry Eye Disease
Dry Eye

Interventions

NeuroTears
Placebo

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2024Estimated

Primary Completion Date

Oct 1, 2024Estimated

Completion Date

Oct 1, 2024Estimated

First Submitted Date

Feb 13, 2024

First Submission Date that Met QC Criteria

Feb 14, 2024

First Posted Date

Feb 21, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 14, 2024

Last Update Posted Date

Feb 21, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Conditions Module

Conditions

Dry Eye Disease
Dry Eye

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

75Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treatment with NeuroTears	Active Comparator		Dietary Supplement: NeuroTears
Placebo	Placebo Comparator		Dietary Supplement: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
NeuroTears	Dietary Supplement	Over-the-counter supplement	Treatment with NeuroTears

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
OSDI	Ocular Surface Disease Index	4 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Diana Driscoll, OD	Contact	866-349-9905		orders@neurotears.com

Overall Officials

Not provided

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D015352	Dry Eye Syndromes
D004535	Ehlers-Danlos Syndrome
D022125	Lacerations
D001342	Autonomic Nervous System Diseases
D054972	Postural Orthostatic Tachycardia Syndrome
D003248	Constipation
D018589	Gastroparesis
D013610	Tachycardia
D000090267	Mast Cell Activation Syndrome

Ancestor Terms

ID	Term
D007766	Lacrimal Apparatus Diseases
D005128	Eye Diseases
D020141	Hemostatic Disorders
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided