NCT07185854

Medical vs Acupuncture for Dry Eye

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Nadide Koca · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Dry Eye
• Acupuncture

Interventions

Type	Name	Description
DRUG	Artificial tears	Topical artificial tears were administered as standard therapy for moderate dry eye disease.
OTHER	Traditional Chinese Medicine Acupuncture	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.

Timeline

• Start date: 2024-01-15
• Primary completion: 2025-06-30
• Completion: 2025-08-01
• First posted: 2025-09-22
• Last updated: 2025-09-22

Locations

1 site across 1 country: Turkey (Türkiye)