Evaluation of the Effectiveness of Auricular Acupuncture in Improving Dry Eye Symptoms in University Students

September 18, 2025 updated by: Bui Pham Minh Man, University of Medicine and Pharmacy at Ho Chi Minh City

Evaluation of the Effectiveness of Auricular Acupuncture in Improving Dry Eye Symptoms in University Students: A Randomized Controlled Trial

Dry eye symptoms can cause various discomforts in the eyes and/or visual disturbances. This condition not only limits daily personal activities and reduces quality of life and mental health but also has negative economic impacts on families and society. Currently, complementary and alternative methods have been employed, with acupuncture being a promising treatment for patients with dry eye disease. Among these, auricular acupuncture has been proven effective in managing eye diseases and improving dry eye symptoms.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Participants and Methods: A randomized controlled trial was conducted to evaluate the effectiveness of auricular acupuncture in improving dry eye symptoms by stimulating five acupoints: Auricular Shenmen (TF4), Eye 1 (TG2b), Eye 2 (AT1b), Liver (CO12), and Kidney (CO10), combined with the application of artificial tears 5-6 times per day for 4 weeks and the potential adverse effects of auricular acupuncture. A total of 50 participants were randomly assigned to 2 group (A and B) and the allocation ratio was 1:1. In group A: Participants received sham auricular acupuncture by sticking patches at specific points on one ear, combined with artificial tear drops. In group B: Participants underwent auricular acupuncture at the same points on one ear, combined with artificial tear drops. Stimulation was performed three times daily by pressing each needle or adhesive patch for approximately 10 seconds or until the ear turned red or became slightly painful. The total duration of the study was 4 weeks. Participants alternated auricular acupuncture or sham acupuncture between ears for five sessions, with each session lasting 5 days. Our study evaluate: (1) The improvement in dry eye symptoms acccording to the Ocular Surface Disease Index (OSDI) and the 5-item Dry Eye Questionnaire (DEQ-5); (2) The impact on quality of life was evaluated using the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) and (3) Adverse effects during auricular acupuncture: Pain, allergy at the site of auricular acupuncture, acupuncture vertigo.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Vietnam
    • Ho Chi Minh
      • Ho Chi Minh City, Ho Chi Minh, Vietnam, 700000
        • University of Medical Center HCMC - Branch no.3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

Participants must meet the following criteria:

  • Be at least 18 years of age.
  • Exhibit symptoms of dry eye, such as dryness, eye fatigue, eye itching, a foreign body sensation in the eye, burning or stinging sensations, blurry vision, light sensitivity, excessive tearing, or drooping eyelids.
  • Have no refractive errors or related eye conditions.
  • Visual acuity of both eyes ≥ 8/10 on the Snellen chart (normal vision).
  • Show signs of dry eye with an OSDI score of ≥ 13 points
  • Have never undergone auricular acupuncture before.
  • Voluntarily agree to participate in the study.

Exclusion Criteria:

Participants must meet at least one of the following criteria:

  • Have symptoms suggesting an acute infection or conditions affecting the conjunctiva, sclera, eyelids, cornea, or systemic diseases.
  • Are using other methods to treat eye diseases.
  • Have undergone eye-related surgery within the past 3 months.
  • Have changed or worn contact lenses during the study period.
  • Have inflamed or ulcerated skin in both ears.
  • Are debilitated, exhausted, or have severe concomitant diseases.
  • Are using medications affecting vision (diuretics, antihistamines, antihypertensives) or eye drops.
  • Have a history of acupuncture vertigo.
  • Are contraindicated with Sodium Hyaluronate.
  • Are participating in other interventional studies.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Auricular acupuncture + Artificial Tears
Auricular acupuncture is administered in each side of the ear for four weeks, with five sessions lasting five days each. Artificial tears were continuously administered over the four-week intervention period.
Other: Auricular acupuncture
Auricular acupuncture is administered in each side of the ear for 4 weeks using patches, each possessing a square shape with a side length of 10 mm, coupled with a sterilized needle measuring 0.25 x 1.3 mm. Five acupoints are selected on one ear, including the will be performed at Shenmen (TF4), Mu 1 (TG2b), Mu 2 (AT1b), Kidney (CO10), and Liver (CO12). These acupoints are believed to be effective in relieving dry eye symptoms. The patch will be kept on the auricle for 5 days and be replaced 5 times during the experimental period.
Other: Artificial Tears (AT)
Artificial tear drops were applied 5-6 times per day over the 4-week period
Sham Comparator: Sham auricular acupuncture + Artificial Tears
Sham auricular acupuncture is administered in each side of the ear for four weeks, with five sessions lasting five days each. The artificial tear is continuously administered over the four-week intervention period.
Other: Artificial Tears (AT)
Artificial tear drops were applied 5-6 times per day over the 4-week period
Other: Sham auricular acupuncture
Sham auricular acupuncture is administered in each side of the ear for 4 weeks using patches, each possessing a square shape with a side length of 10 mm, without a needle. Five acupoints are selected on one ear, including the will be performed at Shenmen (TF4), Mu 1 (TG2b), Mu 2 (AT1b), Kidney (CO10), and Liver (CO12). These acupoints are believed to be effective in relieving dry eye symptoms. The patch will be kept on the auricle for 5 days and be replaced 5 times during the experimental period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of OSDI between auricular acupuncture at TF4, TG2b, AT1b, CO12 and CO10 points combined with artificial tear drops and Sham acupuncture at TF4, TG2b, AT1b, CO12 and CO10 points combined with artificial tear drops group
Time Frame: Baseline, Day 1, Day 6, Day 11, Day 16, Day 21 and Day 26
The Ocular Surface Disease Index (OSDI) OSDI is a 12-item questionnaire that assesses dry eye symptoms occurring during the last week. The questions are divided into three sections which examine, respectively: subjective ocular symptoms, limitations in performing daily activities due to eye problems, and the influence of environmental conditions on eye comfort. Responses to every question ranged from 0, which represents "none of the time", to 4, which represents "all of the time". The final score ranges from 0 to 100 (sum of the 12 questions multiplied by 25 and divided by 12, and then rounded to the next integer) with higher scores representing greater disability: normal (0-12), mild (13-22), moderate (23-32), severe (33-100). A subject is classified as symptomatic when the total OSDI score is equal to or over thirteen points.
Baseline, Day 1, Day 6, Day 11, Day 16, Day 21 and Day 26

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of DEQ-5 between auricular acupuncture at TF4, TG2b, AT1b, CO12 and CO10 points combined with artificial tear drops and Sham acupuncture at TF4, TG2b, AT1b, CO12 and CO10 points combined with artificial tear drops group
Time Frame: Baseline, Day 1, Day 6, Day 11, Day 16, Day 21 and Day 26
The 5-Item Dry Eye Questionnaire (DEQ-5) is a short subset of the full Dry Eye Questionnaire (DEQ) items which contains five questions regarding the frequency and intensity of eye discomfort, eye dryness and watery eyes in the past month. Responses are collected with two types of scales of the answers ranging from 0 to 4 or 5, with 0 corresponding to "never", and 4 with "constantly" in questions regarding the frequency of symptoms, or 0 with "never have it" and 5 with "very intense" in questions regarding the intensity of symptoms. The final score ranges from 0 to 22, a score > 6 suggests dry eye
Baseline, Day 1, Day 6, Day 11, Day 16, Day 21 and Day 26
Comparison of NEI VFQ-25 between auricular acupuncture at TF4, TG2b, AT1b, CO12 and CO10 points combined with artificial tear drops and Sham acupuncture at TF4, TG2b, AT1b, CO12 and CO10 points combined with artificial tear drops group
Time Frame: Baseline, Day 1, Day 6, Day 11, Day 16, Day 21 and Day 26
The National Eye Institute Visual Functioning Questionnaire-25 (NEI VFQ-25) is composed of 25 items designed to assess visual disability and health-related quality of life. It contains 12 subcategories: general health, general vision, ocular pain, near vision activities, distance activities, social functioning, mental health, role difficulties, dependency, driving, color vision and peripheral vision. The questionnaire has a total score ranging from 0 to 100 (a higher score indicates better vision-specific quality of life).
Baseline, Day 1, Day 6, Day 11, Day 16, Day 21 and Day 26

Other Outcome Measures

Outcome Measure
Time Frame
Adverse effects during auricular acupuncture
Time Frame: During procedure
During procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Medicine and Pharmacy at Ho Chi Minh City

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 15, 2025

Primary Completion (Actual)

July 31, 2025

Study Completion (Actual)

August 31, 2025

Study Registration Dates

First Submitted

February 28, 2025

First Submitted That Met QC Criteria

March 9, 2025

First Posted (Actual)

March 14, 2025

Study Record Updates

Last Update Posted (Estimated)

September 24, 2025

Last Update Submitted That Met QC Criteria

September 18, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2468/DHYD-HDDD

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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