Dry Eye DiseaseNCT06696625
Transcutaneous Auricular Vagus Nerve Stimulation in Dry Eye
A study testing Transcutaneous Auricular Vagus Nerve Stimulation and 0.1% sodium hyaluronate eye drop in people with Dry Eye Disease, run by Beijing Tongren Hospital at 1 site in China.
Trial summary
Objective: To evaluate the effect of transcutaneous auricular vagus nerve stimulation (taVNS) for the patients with dry eye disease. Methods: The investigators enrolled 256 patients at Beijing Tongren Hospital. Patients completed questionnaires at baseline, 1 month, 3 months, and 6 months. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Dry Eye Disease
- What is being tested?
- Transcutaneous Auricular Vagus Nerve Stimulation and 0.1% sodium hyaluronate eye drop
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 256 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2021to 1 Dec 2025
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >=18 and Age <=65.
- complaint of DED symptoms for 6 months or longer at screening.
- ocular surface disease index (OSDI) score of 25 or higher.
- tear film breakup time (TFBUT) of 5 seconds or less.
- Schirmer I test without anesthesia of 5 mm or more at 5 minutes.
- tCFS score of 4 or higher.
Who cannot join
- History systemic autoimmune diseases and ocular/periocular malignancy.
- Clinically relevant slitlamp findings or abnormal lid anatomy.
- Active ocular allergies and active infection.
- Pregnant or lactating women.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
China Beijing TongRen Hospital, Capital Medical University Beijing, China
Beijing, Beijing Municipality, 100730
Dong Wu, Doctor, 8613810988682, wudong0120@outlook.com
About this study
Official title: Transcutaneous Auricular Vagus Nerve Stimulation in Dry Eye: a Randomized Clinical Trial
Objective: To evaluate the effect of transcutaneous auricular vagus nerve stimulation (taVNS) for the patients with dry eye disease.
Methods: The investigators enrolled 256 patients at Beijing Tongren Hospital. Patients completed questionnaires at baseline, 1 month, 3 months, and 6 months. OSDI score, TBUT, Schirmer I, CFS, SF36, DEQ5, and psychological status to evaluate the therapeutic effects. A difference of P < 0.05 was considered statistically significant.
- Conditions
- Dry Eye Disease
- Being tested
- Transcutaneous Auricular Vagus Nerve Stimulation, 0.1% sodium hyaluronate eye drop
- Keywords
- taVNS, Dry eye, RCT
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous Auricular Vagus Nerve StimulationDevice
taVNS device (Elmmedicare, EC100, Shenzhen, China) was used to apply stimulation for patients.
Stimulation parameters comprised an electrical current of 1 mA at a frequency of 20 Hz, with a waveform width of 1 ms. Repurposed off-the-shelf devices were utilized for this purpose, with the stimulator generating single square-wave pulses lasting 1 ms each. Enhancing conductivity was achieved by wiping the ear with tap water. The electrodes were placed on the cymba conchae and concha around the affected ear, which is the region of rich vagus nerve branch distribution.
0.1% sodium hyaluronate eye dropDrug
Participants received 0.1% sodium hyaluronate eye drop (HYLO COMOD® eye drops, Ursapharm, Ltd., Germany).
| Study group | Role | What they receive |
|---|---|---|
| taVNS group | Experimental | taVNS device (Elmmedicare, EC100, Shenzhen, China) was used to apply stimulation for patients.
Stimulation parameters comprised an electrical current of 1 mA at a frequency of 20 Hz, with a waveform width of 1 ms. Repurposed off-the-shelf devices were utilized for this purpose, with the stimulator generating single square-wave pulses lasting 1 ms each. Enhancing conductivity was achieved by wiping the ear with tap water. The electrodes were placed on the cymba conchae and concha around the affected ear, which is the region of rich vagus nerve branch distribution. Receives: Device: Transcutaneous Auricular Vagus Nerve Stimulation; Drug: 0.1% sodium hyaluronate eye drop |
| Control Group | Sham comparator | taVNS device (Elmmedicare, EC100, Shenzhen, China) was used to apply stimulation for patients.
Stimulation parameters comprised an electrical current of 1 mA at a frequency of 20 Hz, with a waveform width of 1 ms. Repurposed off-the-shelf devices were utilized for this purpose, with the stimulator generating single square-wave pulses lasting 1 ms each. Enhancing conductivity was achieved by wiping the ear with tap water. The electrodes were placed on the cymba conchae and concha around the affected ear, which is the region of rich vagus nerve branch distribution. Patients in control group were applied using the same stimulator, stimulation parameters and same sessions. However, the electrodes were placed on the antihelix around the affected ear, which is the region of few vagus nerve branch distribution. Receives: Device: Transcutaneous Auricular Vagus Nerve Stimulation; Drug: 0.1% sodium hyaluronate eye drop |
What is being measured
The primary outcome is the main question the study is designed to answer.
OSDI
The Ocular Surface Disease Index (OSDI) includes 12 questions grouped by poor symptoms and visual disturbance (light sensitivity, eyes feel gritty, painful or sore eyes, blurred vision or poor vision); visual function/tasks (problems when reading, driving at night, working on a computer or watching TV); and environmental questions (problems in windy conditions, places/areas with low humidity or areas that are air conditioned). The scores range from 0 to 100. On the basis of the score, the patient's symptoms can be categorized as normal (0-12), mild dry eye (13-22), moderate dry eye (23-32), or severe dry eye (33-100).
Measured: Baseline, month 1, 3, and 6
Secondary outcomes (6)
TBUT
Tear breakup time (TBUT) is a clinical test used to assess for evaporative dry eye disease. To measure TBUT,
fluorescein is instilled into the patient's tear film and the patient is asked not to blink while the tear film is observed
under a broad beam of cobalt blue illumination. The TBUT is recorded as the number of seconds that elapse between
the last blink and the appearance of the first dry spot in the tear film, as seen in this progression of these slit lamps' photos over time. A TBUT under 10 seconds is considered abnormal.
Measured: Baseline, month 1, 3, and 6
Schirmer
The Schirmer test is objectively used to measure tear secretion without anesthetized. A healthy eye should wet more than 10 mm of the standard filter strip in 5 minutes. The travel rate along the test strip is proportional to the tear production rate.
Measured: Baseline, month 1, 3, and 6
CFS
Corneal Fluorescein Staining (CFS) was measured using the National Eye Institute (NEI) scale, which ranges from 0 (no staining) to 3 (heavy staining) for each of the 5 areas of the cornea (inferior, superior, central, nasal, and temporal).
The total score ranging from 0 to 15 is the sum of the 5 regions, with higher scores indicating greater symptom severity.
Measured: Baseline, month 1, 3, and 6
DEQ-5
The 5-Item Dry Eye Questionnaire (DEQ-5) contains five questions regarding the frequency and intensity of eye discomfort, eye dryness and watery eyes in the past month. The score ranges from 0 to 22, a score > 6 suggests dry eye, with higher scores indicating greater symptom severity.
Measured: Baseline, month 1, 3, and 6
PHQ-9
Depression was assessed with the 9-item Patient Health Questionnaire (PHQ). Patients were classified as having no depression (PHQ score: 0-4), mild (PHQ, score: 5-9), and moderate to severe depression (PHQ score: 10-27). Scores range from 0 to 27, with higher scores indicating greater symptom severity.
Measured: Baseline, month 1, 3, and 6
SF-36
36-Item Short Form Health Survey (SF36) measures quality of life on the basis of eight dimensions or concepts
that are frequently used in health studies. These eight dimensions are estimated from eight subscales that examine
physical functioning (SF36-PF), role functioning-physical (SF36-RP), bodily pain (SF36-BP), general health (SF36-
GH), vitality (SF36-VT), social functioning (SF36-SF), role functioning-emotional (SF36-RE), mental health (SF36-MH)
and reported health transition (SF36-HT). Item responses were ranging from 0 (best) to 100 (worst), with higher scores are equivalent to greater severity of better quality of life.
Measured: Baseline, month 3, 6 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2024
- Study start1 Jul 2021
- Primary completion1 Nov 2025 (estimated)
- Study completion1 Dec 2025 (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.
- More trials run by Beijing Tongren HospitalThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 256 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tongren Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06696625
- Sponsor's protocol ID
- DED_taVNS_2024
- Status last verified
- Oct 2024
- First submitted
- 18 Nov 2024
- Last updated
- 20 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcutaneous Auricular Vagus Nerve Stimulation in Dry Eye: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06696625
- Acronym / sponsor ID
- DED_taVNS_2024
- Conditions
- Dry Eye Disease
- Keywords
- taVNS, Dry eye, RCT
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 256 participants (estimated)
- Lead sponsor
- Beijing Tongren HospitalUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 1 Nov 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 20 Nov 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.
Objective: To evaluate the effect of transcutaneous auricular vagus nerve stimulation (taVNS) for the patients with dry eye disease.
Methods: The investigators enrolled 256 patients at Beijing Tongren Hospital. Patients completed questionnaires at baseline, 1 month, 3 months, and 6 months. OSDI score, TBUT, Schirmer I, CFS, SF36, DEQ5, and psychological status to evaluate the therapeutic effects. A difference of P < 0.05 was considered statistically significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| taVNS group | Experimental | Device: Transcutaneous Auricular Vagus Nerve Stimulation, Drug: 0.1% sodium hyaluronate eye droptaVNS device (Elmmedicare, EC100, Shenzhen, China) was used to apply stimulation for patients. Stimulation parameters comprised an electrical current of 1 mA at a frequency of 20 Hz, with a waveform width of 1 ms. Repurposed off-the-shelf devices were utilized for this purpose, with the stimulator generating single square-wave pulses lasting 1 ms each. Enhancing conductivity was achieved by wiping the ear with tap water. The electrodes were placed on the cymba conchae and concha around the affected ear, which is the region of rich vagus nerve branch distribution. |
| Control Group | Sham comparator | Device: Transcutaneous Auricular Vagus Nerve Stimulation, Drug: 0.1% sodium hyaluronate eye droptaVNS device (Elmmedicare, EC100, Shenzhen, China) was used to apply stimulation for patients. Stimulation parameters comprised an electrical current of 1 mA at a frequency of 20 Hz, with a waveform width of 1 ms. Repurposed off-the-shelf devices were utilized for this purpose, with the stimulator generating single square-wave pulses lasting 1 ms each. Enhancing conductivity was achieved by wiping the ear with tap water. The electrodes were placed on the cymba conchae and concha around the affected ear, which is the region of rich vagus nerve branch distribution. Patients in control group were applied using the same stimulator, stimulation parameters and same sessions. However, the electrodes were placed on the antihelix around the affected ear, which is the region of few vagus nerve branch distribution. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age >=18 and Age <=65.
- complaint of DED symptoms for 6 months or longer at screening.
- ocular surface disease index (OSDI) score of 25 or higher.
- tear film breakup time (TFBUT) of 5 seconds or less.
- Schirmer I test without anesthesia of 5 mm or more at 5 minutes.
Key exclusion criteria (4 listed)
- History systemic autoimmune diseases and ocular/periocular malignancy.
- Clinically relevant slitlamp findings or abnormal lid anatomy.
- Active ocular allergies and active infection.
- Pregnant or lactating women.
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 |
|---|---|---|
| Transcutaneous Auricular Vagus Nerve StimulationtaVNS device (Elmmedicare, EC100, Shenzhen, China) was used to apply stimulation for patients. Stimulation parameters comprised an electrical current of 1 mA at a frequency of 20 Hz, with a waveform width of 1 ms. Repurposed off-the-shelf devices were utilized for this purpose, with the stimulator generating single square-wave pulses lasting 1 ms each. Enhancing conductivity was achieved by wiping the ear with tap water. The electrodes were placed on the cymba conchae and concha around the affected ear, which is the region of rich vagus nerve branch distribution. | Device | Control Group, taVNS group |
| 0.1% sodium hyaluronate eye dropParticipants received 0.1% sodium hyaluronate eye drop (HYLO COMOD® eye drops, Ursapharm, Ltd., Germany). | Drug | Control Group, taVNS group |
Primary outcome
OSDI
Time frame: Baseline, month 1, 3, and 6
The Ocular Surface Disease Index (OSDI) includes 12 questions grouped by poor symptoms and visual disturbance (light sensitivity, eyes feel gritty, painful or sore eyes, blurred vision or poor vision); visual function/tasks (problems when reading, driving at night, working on a computer or watching TV); and environmental questions (problems in windy conditions, places/areas with low humidity or areas that are air conditioned). The scores range from 0 to 100. On the basis of the score, the patient's symptoms can be categorized as normal (0-12), mild dry eye (13-22), moderate dry eye (23-32), or severe dry eye (33-100).
6 secondary outcomes
TBUT
Time frame: Baseline, month 1, 3, and 6
Schirmer
Time frame: Baseline, month 1, 3, and 6
CFS
Time frame: Baseline, month 1, 3, and 6
DEQ-5
Time frame: Baseline, month 1, 3, and 6
PHQ-9
Time frame: Baseline, month 1, 3, and 6
SF-36
Time frame: Baseline, month 3, 6 and 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2024.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous Auricular Vagus Nerve Stimulation and 0.1% sodium hyaluronate eye drop in people with Dry Eye Disease, run by Beijing Tongren Hospital at 1 site in China.
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 6 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 20 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Dong Wu, Doctor (8613810988682, wudong0120@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
OSDI (time frame: Baseline, month 1, 3, and 6). 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 20 Nov 2024.