NCT06271005

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2024

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 13, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 21, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
Last Updated

February 21, 2024

Status Verified

February 1, 2024

Enrollment Period

6 months

First QC Date

February 13, 2024

Last Update Submit

February 14, 2024

Conditions

Dry Eye DiseaseDry Eye

Keywords

vagus nerveEhlers-Danlos SyndromeEDSlacrimal nervesdry eyetear productiondysautonomiaPOTSPostural Orthostatic Tachycardia SyndromeconstipationgastroparesistachycardiaNeuroTearsMast Cell Activation Syndromevagus nerve stimulationMCASPost-COVIDCOVIDLonghaulers

Outcome Measures

Primary Outcomes (1)

  • OSDI

    Ocular Surface Disease Index

    4 weeks

Study Arms (2)

Treatment with NeuroTears

ACTIVE COMPARATOR
Dietary Supplement: NeuroTears

Placebo

PLACEBO COMPARATOR
Dietary Supplement: Placebo

Interventions

NeuroTearsDIETARY_SUPPLEMENT

Over-the-counter supplement

Treatment with NeuroTears
PlaceboDIETARY_SUPPLEMENT

Oral placebo pill

Placebo

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Dry Eye SyndromesEhlers-Danlos SyndromeLacerationsAutonomic Nervous System DiseasesPostural Orthostatic Tachycardia SyndromeConstipationGastroparesisTachycardiaMast Cell Activation Syndrome

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye DiseasesHemostatic DisordersVascular DiseasesCardiovascular DiseasesHemorrhagic DisordersHematologic DiseasesHemic and Lymphatic DiseasesSkin AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSkin Diseases, GeneticGenetic Diseases, InbornCollagen DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesSkin DiseasesWounds and InjuriesNervous System DiseasesOrthostatic IntolerancePrimary DysautonomiasSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsStomach DiseasesGastrointestinal DiseasesDigestive System DiseasesParalysisNeurologic ManifestationsArrhythmias, CardiacHeart DiseasesCardiac Conduction System DiseasePathologic ProcessesMast Cell Activation DisordersImmune System Diseases

Central Study Contacts

Diana Driscoll, OD

CONTACT

866-349-9905orders@neurotears.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 13, 2024

First Posted

February 21, 2024

Study Start

April 1, 2024

Primary Completion

October 1, 2024

Study Completion

October 1, 2024

Last Updated

February 21, 2024

Record last verified: 2024-02