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Transcutaneous Auricular Vagus Nerve Stimulation in Dry Eye Disease

StatusUnknown
PhasePhase 2
Started
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Record status
This record was last updated September 19, 2024 (before its estimated October 1, 2024 completion). Its status may not reflect the trial's current state.

Record History

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  1. Changed Registry marked status Unknown (sponsor has not verified the record since Sep 2024); last known: Recruiting
  2. Phase: Not applicable to Phase 2v4 Show 12 more changesShow less
    • Enrollment target: 29 to 128
    • Primary completion date: Oct 1, 2020 to Oct 1, 2024
    • Start date: Jul 1, 2018 to Jul 1, 2021
    • Primary endpoint revised
    • Trial status: Completed to Recruiting
    • Study sites: 1 to 2
    • Study completion date: Nov 1, 2020 to Oct 20, 2024
    • Interventions: Transcutaneous Auricular Vagus Nerve Stimulation (Device) to Hyaluronic acid eye drops (Drug), Transcutaneous Auricular Vagus Nerve Stimulation (Device)
    • Eligibility criteria shortened, about 6 words
    • Secondary endpoints: 2 to 5
    • Study title revised
    • Study arms: 1 to 2
  3. Re-verified, no change to tracked fieldsv3
  4. Phase: Not specified to Not applicablev2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 256 patients at Beijing Tongren Hospital. Patients completed questionnaires at baseline, 1 month, 3 months, and 6 months.OSDI score, TBUT, Schirmer I, tCFS, MGD score, and psychological status to evaluate the therapeutic effects. A difference of P \< 0.05 was considered statistically significant.
Trial Details
NCT Number NCT04673643
Lead Sponsor Beijing Tongren Hospital
Conditions
(from sponsor)		 Dry Eye Disease
Related terms Dry Eye Syndromes
Enrollment 128 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov