Dry Eye SymptomsNCT06876077

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

A study testing Auricular acupuncture and Artificial Tears (AT) in people with Dry Eye Symptoms, run by University of Medicine and Pharmacy at Ho Chi Minh City at 1 site in Vietnam.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Dry Eye Symptoms
What is being tested?: Auricular acupuncture and Artificial Tears (AT)
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 50 participants
Where: 1 siteVietnam
Study dates: 15 Mar 2025to 31 Aug 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 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Show all 11Show fewer

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.

Trial locations and contacts

1 site in 1 country.

Vietnam1 site

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

Other trials in Vietnam

About this study

Official title: 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.

Read the 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.

Conditions: Dry Eye Symptoms
Being tested: Auricular acupuncture, Sham auricular acupuncture, Artificial Tears (AT)
Keywords: Auricular Acupuncture, Dry eye symptoms, University students

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Auricular acupunctureOther
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.
Sham auricular acupunctureOther
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.
Artificial Tears (AT)Other
Artificial tear drops were applied 5-6 times per day over the 4-week period

Study groups in NCT06876077
Study group	Role	What they receive
Auricular acupuncture + Artificial Tears	Experimental	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. Receives: Other: Auricular acupuncture; Other: Artificial Tears (AT)
Sham auricular acupuncture + Artificial Tears	Sham comparator	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. Receives: Other: Sham auricular acupuncture; Other: Artificial Tears (AT)

What is being measured

The primary outcome is the main question the study is designed to answer.

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
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.
Measured: Baseline, Day 1, Day 6, Day 11, Day 16, Day 21 and Day 26

Secondary outcomes (2)

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
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
Measured: 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
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).
Measured: Baseline, Day 1, Day 6, Day 11, Day 16, Day 21 and Day 26

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Mar 202531 Aug 2025

First posted14 Mar 2025
Study start15 Mar 2025
Primary completion31 Jul 2025
Study completion31 Aug 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (6)Papers the sponsor has linked to this study.
Other trials for Dry Eye SymptomsStudies of the same condition, open and under way.
More trials run by University of Medicine and Pharmacy at Ho Chi Minh CityThe 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
Model description: Randomized controlled trial
Masking: Single blind
Who is masked: Participant
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06876077
Sponsor's protocol ID: 2468/DHYD-HDDD
Status last verified: Sep 2025
First submitted: 28 Feb 2025
Last updated: 24 Sep 2025
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Wrobel-Dudzinska D, Osial N, Stepien PW, Gorecka A, Zarnowski T. Prevalence of Dry Eye Symptoms and Associated Risk Factors among University Students in Poland. Int J Environ Res Public Health. 2023 Jan 11;20(2):1313. doi: 10.3390/ijerph20021313.
PubMed 36674068
Hou PW, Hsu HC, Lin YW, Tang NY, Cheng CY, Hsieh CL. The History, Mechanism, and Clinical Application of Auricular Therapy in Traditional Chinese Medicine. Evid Based Complement Alternat Med. 2015;2015:495684. doi: 10.1155/2015/495684. Epub 2015 Dec 28.
PubMed 26823672
Tan JY, Molassiotis A, Wang T, Suen LK. Adverse events of auricular therapy: a systematic review. Evid Based Complement Alternat Med. 2014;2014:506758. doi: 10.1155/2014/506758. Epub 2014 Nov 10.
PubMed 25435890
Zhang CS, Yang AW, Zhang AL, May BH, Xue CC. Sham control methods used in ear-acupuncture/ear-acupressure randomized controlled trials: a systematic review. J Altern Complement Med. 2014 Mar;20(3):147-61. doi: 10.1089/acm.2013.0238. Epub 2013 Oct 19.
PubMed 24138333
Huang Q, Zhan M, Hu Z. Auricular Acupressure for Dry Eye Disease: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Medicina (Kaunas). 2023 Jan 16;59(1):177. doi: 10.3390/medicina59010177.
PubMed 36676806
Asiedu K, Kyei S, Boampong F, Ocansey S. Symptomatic Dry Eye and Its Associated Factors: A Study of University Undergraduate Students in Ghana. Eye Contact Lens. 2017 Jul;43(4):262-266. doi: 10.1097/ICL.0000000000000256.
PubMed 26963438

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Dry Eye Symptoms trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of the Effectiveness of Auricular Acupuncture in Improving Dry Eye Symptoms in University Students: A Randomized Controlled Trial
ClinicalTrials.gov ID: NCT06876077
Acronym / sponsor ID: 2468/DHYD-HDDD
Conditions: Dry Eye Symptoms
Keywords: Auricular Acupuncture, Dry eye symptoms, University students
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: University of Medicine and Pharmacy at Ho Chi Minh CityUniversity, hospital or other
Study start: 15 Mar 2025 (actual)
Primary completion: 31 Jul 2025 (actual)
Study completion: 31 Aug 2025 (actual)
First posted: 14 Mar 2025 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2
Model description: Randomized controlled trial

Arm	Type	Receives
Auricular acupuncture + Artificial Tears	Experimental	Other: Auricular acupuncture, Other: Artificial Tears (AT)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.
Sham auricular acupuncture + Artificial Tears	Sham comparator	Other: Sham auricular acupuncture, Other: Artificial Tears (AT)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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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

Key exclusion criteria (11 listed)

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.

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
Auricular acupunctureAuricular 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	Auricular acupuncture + Artificial Tears
Sham auricular acupunctureSham 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.	Other	Sham auricular acupuncture + Artificial Tears
Artificial Tears (AT)Artificial tear drops were applied 5-6 times per day over the 4-week period	Other	Auricular acupuncture + Artificial Tears, Sham auricular acupuncture + Artificial Tears

Primary outcome

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.

2 secondary outcomes

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
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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2025.
Background: PubMed 36674068Wrobel-Dudzinska D, Osial N, Stepien PW, Gorecka A, Zarnowski T. Prevalence of Dry Eye Symptoms and Associated Risk Factors among University Students in Poland. Int J Environ Res Public Health. 2023 Jan 11;20(2):1313. doi: 10.3390/ijerph20021313.
Background: PubMed 26823672Hou PW, Hsu HC, Lin YW, Tang NY, Cheng CY, Hsieh CL. The History, Mechanism, and Clinical Application of Auricular Therapy in Traditional Chinese Medicine. Evid Based Complement Alternat Med. 2015;2015:495684. doi: 10.1155/2015/495684. Epub 2015 Dec 28.
Background: PubMed 25435890Tan JY, Molassiotis A, Wang T, Suen LK. Adverse events of auricular therapy: a systematic review. Evid Based Complement Alternat Med. 2014;2014:506758. doi: 10.1155/2014/506758. Epub 2014 Nov 10.
Background: PubMed 24138333Zhang CS, Yang AW, Zhang AL, May BH, Xue CC. Sham control methods used in ear-acupuncture/ear-acupressure randomized controlled trials: a systematic review. J Altern Complement Med. 2014 Mar;20(3):147-61. doi: 10.1089/acm.2013.0238. Epub 2013 Oct 19.
Background: PubMed 36676806Huang Q, Zhan M, Hu Z. Auricular Acupressure for Dry Eye Disease: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Medicina (Kaunas). 2023 Jan 16;59(1):177. doi: 10.3390/medicina59010177.
Background: PubMed 26963438Asiedu K, Kyei S, Boampong F, Ocansey S. Symptomatic Dry Eye and Its Associated Factors: A Study of University Undergraduate Students in Ghana. Eye Contact Lens. 2017 Jul;43(4):262-266. doi: 10.1097/ICL.0000000000000256.
The Effects of Auriculotherapy on Relieving Symptoms of Dry Eye SyndromeLink provided by the sponsor.

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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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Auricular acupuncture and Artificial Tears (AT) in people with Dry Eye Symptoms, run by University of Medicine and Pharmacy at Ho Chi Minh City at 1 site in Vietnam.

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 8 inclusion and 11 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: finished, as of the sponsor's last update on 24 Sep 2025. 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 Vietnam. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06876077, which also lists 6 linked publications.

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 24 Sep 2025.