Dry Eye DiseaseNCT06271005
Neurological Dry Eye Study Stimulating Both Lacrimal and Vagus Nerves
A study testing NeuroTears in people with Dry Eye Disease and Dry Eye, run by Genetic Disease Investigators.
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. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Dry Eye Disease, Dry Eye
- What is being tested?
- NeuroTears
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2024to 1 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
No sites are listed yet.
About this study
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.
Read the 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
- Dry Eye Disease, Dry Eye
- Being tested
- NeuroTears, Placebo
- 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
- Medical subject headings
- Dry Eye Syndromes, Ehlers-Danlos Syndrome, Lacerations, Autonomic Nervous System Diseases, Postural Orthostatic Tachycardia Syndrome, Constipation, Gastroparesis, Tachycardia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeuroTearsDietary supplement
Over-the-counter supplement
PlaceboDietary supplement
Oral placebo pill
| Study group | Role | What they receive |
|---|---|---|
| Treatment with NeuroTears | Active comparator | Not described Receives: Dietary Supplement: NeuroTears |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
OSDI
Ocular Surface Disease Index
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2024
- Study start1 Apr 2024 (estimated)
- Primary completion1 Oct 2024 (estimated)
- Study completion1 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Genetic Disease Investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06271005
- Sponsor's protocol ID
- 000824
- Status last verified
- Feb 2024
- First submitted
- 13 Feb 2024
- Last updated
- 21 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurological Dry Eye Study Stimulating Both Lacrimal and Vagus Nerves
- ClinicalTrials.gov ID
- NCT06271005
- Acronym / sponsor ID
- 000824
- Conditions
- Dry Eye Disease, Dry Eye
- Keywords
- vagus nerve, Ehlers-Danlos Syndrome, EDS, lacrimal nerves, dry eye, tear production, dysautonomia, POTS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Genetic Disease InvestigatorsUniversity, hospital or other
- Study start
- 1 Apr 2024 (estimated)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 21 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment with NeuroTears | Active comparator | Dietary Supplement: NeuroTears |
| Placebo | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NeuroTearsOver-the-counter supplement | Dietary supplement | Treatment with NeuroTears |
| PlaceboOral placebo pill | Dietary supplement | Placebo |
Primary outcome
OSDI
Time frame: 4 weeks
Ocular Surface Disease Index
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing NeuroTears in people with Dry Eye Disease and Dry Eye, run by Genetic Disease Investigators.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Diana Driscoll, OD (866-349-9905, orders@neurotears.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
OSDI (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2024.