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Completed

NCT Number: NCT07185854

Medical vs Acupuncture for Dry Eye

This randomized clinical trial was designed to evaluate the effectiveness of acupuncture combined with artificial tears compared to artificial tears alone in patients with moderate dry eye disease. A total of 90 participants were enrolled at the University of Health Sciences, Ankara Training and Research Hospital. Patients were randomly assigned to receive either artificial tears only or artificial tears with acupuncture. Acupuncture was performed twice weekly for ten sessions by a certified specialist.

Assessments were conducted at baseline, after treatment, and at one-month follow-up using the Ocular Surface Disease Index (OSDI), Schirmer test, and tear break-up time (tBUT). The primary outcome measure was the change in OSDI score, while secondary outcomes included Schirmer test values and tBUT.

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Key information

Conditions

Dry Eye Acupuncture Conjunctival Diseases Conjunctivitis Corneal Diseases Dry Eye Syndromes Eye Diseases Keratitis Keratoconjunctivitis Keratoconjunctivitis Sicca Lacrimal Apparatus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ankara Training and Research Hospital Ankara, Altindag, Turkey, 06230

Ankara, Altindag, 06230, Turkey (Türkiye)

About this study

Dry eye disease (DED) is a chronic ocular surface disorder characterized by instability of the tear film, ocular discomfort, and visual disturbance. It significantly impairs quality of life, limiting daily activities such as reading, driving, and computer use. Standard treatments, including artificial tears and anti-inflammatory agents, often provide only partial or temporary relief and may not adequately address the underlying inflammatory mechanisms. As a complementary approach, acupuncture has been suggested to improve lacrimal gland function, enhance tear secretion, and reduce ocular inflammation, yet comparative evidence in moderate DED remains limited.

The aim of this study was to evaluate the short-term efficacy of acupuncture combined with artificial tears compared to artificial tears alone in patients with moderate DED. This prospective, randomized, controlled, parallel-group trial was conducted at the University of Health Sciences, Ankara Training and Research Hospital. Ninety adults aged 18-65 years, diagnosed with moderate DED according to TFOS DEWS II criteria (Schirmer 5-10 mm and tear break-up time 6-10 seconds), were enrolled between January 2024 and May 2025. Participants were randomly allocated to two groups: Group 1 received artificial tears only, while Group 2 received artificial tears plus acupuncture.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age between 18 and 65 years
  • Diagnosis of moderate dry eye disease according to TFOS DEWS II criteria
  • Anesthetized Schirmer test result between 5-10 mm
  • Tear break-up time (tBUT) between 6-10 seconds
  • Ocular Surface Disease Index (OSDI) score ≥ 13
  • Symptom duration of at least 3 months
  • Signed informed consent form

Exclusion criteria

  • Sjögren's syndrome, active blepharitis, or meibomian gland dysfunction
  • Systemic rheumatologic, autoimmune, or metabolic disease (e.g., diabetes)
  • Use of systemic or topical treatment for dry eye within the last 6 months
  • Previous ocular surgery
  • Contact lens use
  • Pregnancy or lactation
  • History of neurological or psychiatric disorders

Treatment and study plan

Artificial Tears

Drug

Topical artificial tears were administered as standard therapy for moderate dry eye disease.

Other names: Lubricating Eye Drops, Artificial Tear Drops, Sodium Hyaluronate Eye Drops

Traditional Chinese Medicine Acupuncture

Other

Acupuncture therapy performed by a certified specialist using sterile disposable needles at predefined local and systemic acupoints (BL2, ST1, GB1, SJ23, Ex-HN5, LI4, ST36, SP6, LIV3, GB37, GB40, Ex-HN3, Du23, BL64). Sessions were delivered twice weekly for a total of 10 sessions, each lasting 20 minutes. Deqi sensation was obtained by manual stimulation. No additional systemic or topical treatments were provided to participants in this arm.

Other names: Needle Acupuncture, Manual Acupuncture

Primary outcomes

  1. Change in Ocular Surface Disease Index (OSDI) Score

    Time frame: Baseline (Day 1); End of Treatment (Week 5, after 10 sessions); 1-Month Follow-up (Week 9)

    The Ocular Surface Disease Index (OSDI) is a 12-item questionnaire used to assess the severity of dry eye symptoms and their impact on visual function. Scores range from 0 to 100, with higher scores indicating more severe disease. The primary outcome is the change in OSDI score from baseline to post-treatment and 1-month follow-up.

Secondary outcomes

  1. Change in Schirmer Test Values

    Time frame: Baseline (Day 1); End of Treatment (Week 5, after 10 sessions); 1-Month Follow-up (Week 9)

    The Schirmer test measures tear production using a standardized filter paper strip placed in the lower eyelid for 5 minutes. Values are recorded in millimeters of wetting. Lower scores indicate reduced tear secretion. The outcome is the change in tear production over time.

  2. Change in Tear Break-Up Time (tBUT)

    Time frame: Baseline (Day 1); End of Treatment (Week 5, after 10 sessions); 1-Month Follow-up (Week 9)

    Tear break-up time (tBUT) is assessed after instillation of fluorescein dye. The interval between the last blink and the first appearance of a dry spot on the corneal surface is measured in seconds. Shorter times indicate instability of the tear film. The outcome is the change in tBUT values across time points.

Sponsors and collaborators

Lead sponsor

Nadide Koca

Other

Registry information

Official study title

Acupuncture Combined With Artificial Tears Compared With Artificial Tears Alone in Moderate Dry Eye: A Randomized Controlled Trial

Acronym: ADET

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 22, 2025
Registry last updated
Sep 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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