A Phase 1/2 interventional study of taVNS and Hyaluronic acid eye drops in Dry Eye, sponsored by Beijing Tongren Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-08-09.
Sponsored by Beijing Tongren Hospital · Phase 1/2, Interventional, and Treatment
Objective: To evaluate the effect of transcutaneous auricular vagus nerve stimulation (taVNS) for the patients with dry eye disease with meibomian gland dysfunction.
Methods: We enrolled 270 patients at Beijing Tongren Hospital. All treatments were self-administered by the patients at home after training at the hospital. Patients completed questionnaires at baseline, 1 month, 3 months, and 6 months.
OSDI score, TBUT, OPAS, NPSI-eye, and Schirmer I expressibility and secretion score to evaluate the therapeutic effects. A difference of P \< 0.05 was considered statistically significant.
1,325 studies on the registry are indexed under Dry Eye Syndromes; 193 are open to participants now.
This study's planned enrollment of 135 is above the median of 60 across 1,103 interventional studies indexed under Dry Eye Syndromes.
Browse Dry Eye Syndromes studies →Beijing Tongren Hospital is the lead sponsor of 163 studies on the registry; 53 are open to participants now.
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Device: taVNS · Drug: Hyaluronic acid eye drops
Device: taVNS · Drug: Hyaluronic acid eye drops
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.
Participants in both groups received hyaluronic acid eye drops (HYLO COMOD® eye drops, Ursapharm, Ltd., Germany) with the treatment of 3 times a day.
OSDI
Ocular Surface Disease Index (OSDI) questionnaire: The OSDI questionnaire is designed to assess the severity of symptoms and the impact of ocular surface diseases, such as dry eye disease, on a patient's quality of life.
Time frame: Baseline, month 1, 3, and 6
OPAS
Ocular Surface Disease Index-Personalized Assessment Score (OPAS): The OPAS is a tailored version of the traditional Ocular Surface Disease Index (OSDI). It is designed to offer a more personalized assessment of ocular surface diseases by adapting the standard questionnaire to reflect individual patient experiences and symptoms more accurately. The personalized nature of OPAS aims to offer a more precise measure of how the disease impacts the patient's quality of life and daily functioning.
Time frame: Baseline, month 1, 3, and 6
NPSI-eye
Neuropathic Pain Symptom Inventory - Eye (NPSI-eye): The NPSI-eye is a specialized tool designed to assess neuropathic pain symptoms specifically in the context of eye conditions. It helps in identifying and quantifying symptoms associated with neuropathic pain in the ocular region. Higher scores indicate more severe or frequent neuropathic pain symptoms.
Time frame: Baseline, month 1, 3, and 6
TBUT
Tear Breakup Time (TBUT): TBUT is a diagnostic test used to evaluate the stability of the tear film and diagnose dry eye disease. It measures the time it takes for dry spots to appear on the corneal surface after blinking while using a fluorescent dye. A shorter TBUT indicates less stable tear film, which is often associated with dry eye disease.
Time frame: Baseline, month 1, 3, and 6
SchirmerI
The Schirmer I test assesses tear production to diagnose dry eye syndrome. The length of the wetting is measured in millimeters. A lower measurement indicates reduced tear production, suggesting dry eye disease.
Time frame: Baseline, month 1, 3, and 6
Started Jun 2021 (actual). Primary completion is estimated for Oct 2024, 40 months after the start.
Of 20 phase 1/2 interventional studies under Dry Eye Syndromes, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 24. This study's planned 40 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Hyaluronic Acid