Medical vs Acupuncture for Dry Eye

NCT07185854 | Completed

• 2 other identifiers: AnkaraTRH-FTR-NK-092023/11-090224
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dry Eye; Acupuncture

Keywords

Dry eye; Keratoconjunctivitis sicca; Acupuncture; Artificial tears; Ocular Surface Disease Index (OSDI); Schirmer test; Tear break-up time (tBUT); Complementary therapy

Outcome Measures

Primary Outcomes (1)

• Change in Ocular Surface Disease Index (OSDI) Score

  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.

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

Secondary Outcomes (2)

• Change in Schirmer Test Values

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

• Change in Tear Break-Up Time (tBUT)

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

Study Arms (2)

Artificial Tears Only

ACTIVE COMPARATOR

Participants received topical artificial tears (sodium hyaluronate/CMC-based eye drops) according to standard treatment protocol. No additional intervention was given.

Drug: Artificial tears

Experimental: Artificial Tears + Acupuncture

EXPERIMENTAL

Participants received artificial tears plus acupuncture therapy, administered by a certified specialist, twice weekly for 10 sessions. Each session lasted 20 minutes.

Drug: Artificial tears; Other: Traditional Chinese Medicine Acupuncture

Interventions

Artificial tears DRUG

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

Also known as: Lubricating Eye Drops, Artificial Tear Drops, Sodium Hyaluronate Eye Drops

Artificial Tears Only; Experimental: Artificial Tears + Acupuncture

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.

Also known as: Needle Acupuncture, Manual Acupuncture

Experimental: Artificial Tears + Acupuncture

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nadide Koca: lead

Study Sites (1)

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

Ankara, Altindag, 06230, Turkey (Türkiye)

Location

Related Publications (20)

• Duan H, Zhou Y, Ma B, Liu R, Yang T, Chu H, Huo Z, Qi H. Effect of Acupuncture Treatment on the Ocular Pain, Mental State and Ocular Surface Characteristics of Patients with Dry Eye Disease: A Non-Randomized Pilot Study. Clin Ophthalmol. 2024 Oct 3;18:2751-2764. doi: 10.2147/OPTH.S476573. eCollection 2024.

  PMID: 39376907 BACKGROUND

• Zhang X, Zhang B, Peng S, Zhang G, Ma J, Zhu W. Effectiveness of acupuncture at acupoint BL1 (Jingming) in comparison with artificial tears for moderate to severe dry eye disease: a randomized controlled trial. Trials. 2022 Jul 27;23(1):605. doi: 10.1186/s13063-022-06486-4.

  PMID: 35897025 BACKGROUND

• Wang Y, Peng J, Xiao L, Deng Y, Lu J, Zhou YS, Yang YJ, Peng QH. Effectiveness of acupuncture combined with artificial tears in managing dry eye syndrome: A systematic review and meta-analysis. Medicine (Baltimore). 2024 Jan 5;103(1):e36374. doi: 10.1097/MD.0000000000036374.

  PMID: 38181299 BACKGROUND

• Moon SY, Chung HS, Lee JH, Lee H, Tchah H, Kim JY. Effectiveness of cyclosporine nanoemulsion eye drops in patients with mild-to-moderate dry eyes: objective and subjective evaluation. BMC Ophthalmol. 2024 Sep 9;24(1):401. doi: 10.1186/s12886-024-03620-5.

  PMID: 39251947 BACKGROUND

• Bawazeer AM, Hodge WG. One-minute schirmer test with anesthesia. Cornea. 2003 May;22(4):285-7. doi: 10.1097/00003226-200305000-00001.

  PMID: 12792467 BACKGROUND

• Kuang H, Zhu X, Chen H, Tang H, Zhao H. The immunomodulatory mechanism of acupuncture treatment for ischemic stroke: research progress, prospects, and future direction. Front Immunol. 2024 May 2;15:1319863. doi: 10.3389/fimmu.2024.1319863. eCollection 2024.

  PMID: 38756772 BACKGROUND

• Oh JE, Kim SN. Anti-Inflammatory Effects of Acupuncture at ST36 Point: A Literature Review in Animal Studies. Front Immunol. 2022 Jan 12;12:813748. doi: 10.3389/fimmu.2021.813748. eCollection 2021.

  PMID: 35095910 BACKGROUND

• McCann P, Kruoch Z, Lopez S, Malli S, Qureshi R, Li T. Interventions for Dry Eye: An Overview of Systematic Reviews. JAMA Ophthalmol. 2024 Jan 1;142(1):58-74. doi: 10.1001/jamaophthalmol.2023.5751.

  PMID: 38127364 BACKGROUND

• McMonnies CW. Why the symptoms and objective signs of dry eye disease may not correlate. J Optom. 2021 Jan-Mar;14(1):3-10. doi: 10.1016/j.optom.2020.10.002. Epub 2020 Nov 23.

  PMID: 33243674 BACKGROUND

• Villani E, Campagna G, Gentili V, Postorino EI, Genovese P, Palino P, Maini G, Carbucicchio A, Ferioli E, Nucci P, Rizzo R, Aragona P. Hydroxypropyl-Methylcellulose and GlicoPro(R) Eyedrops in the Treatment of Dry Eye Disease: In Vitro and Clinical Study. Ophthalmol Ther. 2025 Apr;14(4):787-803. doi: 10.1007/s40123-025-01101-6. Epub 2025 Mar 1.

  PMID: 40024993 BACKGROUND

• Cartes C, Aravena C, Monsalve A, Segovia C, Romero C, Quidel D, Cid F, Monsalve R, Navarro L, Araya D, Araneda D, Sepulveda M. Prevalence of Dry Eye Disease in Laser-Assisted In Situ Keratomileusis Candidates. Eye Contact Lens. 2024 Jul 1;50(7):305-310. doi: 10.1097/ICL.0000000000001095. Epub 2024 May 2.

  PMID: 38918902 BACKGROUND

• Chen A, Augello P, Asbell P, Ying GS; DREAM Research Group. The repeatability of tests for dry eye signs and symptoms in the dry eye assessment and management (DREAM) study. Cont Lens Anterior Eye. 2025 Apr;48(2):102322. doi: 10.1016/j.clae.2024.102322. Epub 2024 Oct 30.

  PMID: 39477774 BACKGROUND

• Qian L, Wei W. Identified risk factors for dry eye syndrome: A systematic review and meta-analysis. PLoS One. 2022 Aug 19;17(8):e0271267. doi: 10.1371/journal.pone.0271267. eCollection 2022.

  PMID: 35984830 BACKGROUND

• Kwon J, Moghtader A, Kang C, Bibak Bejandi Z, Shahjahan S, Alzein A, Djalilian AR. Overview of Dry Eye Disease for Primary Care Physicians. Medicina (Kaunas). 2025 Mar 6;61(3):460. doi: 10.3390/medicina61030460.

  PMID: 40142272 BACKGROUND

• Mathebula SD, Khosa PR, Maleswene MM. Comparison of patient reported dry eye symptoms as evaluated by the ocular surface disease index and symptom assessment. Afr J Prim Health Care Fam Med. 2025 May 21;17(1):e1-e7. doi: 10.4102/phcfm.v17i1.4861.

  PMID: 40459105 BACKGROUND

• Bhatt K, Singh S, Singh K, Kumar S, Dwivedi K. Prevalence of dry eye, its categorization (Dry Eye Workshop II), and pathological correlation: A tertiary care study. Indian J Ophthalmol. 2023 Apr;71(4):1454-1458. doi: 10.4103/IJO.IJO_2591_22.

  PMID: 37026281 BACKGROUND

• Britten-Jones AC, Wang MTM, Samuels I, Jennings C, Stapleton F, Craig JP. Epidemiology and Risk Factors of Dry Eye Disease: Considerations for Clinical Management. Medicina (Kaunas). 2024 Sep 5;60(9):1458. doi: 10.3390/medicina60091458.

  PMID: 39336499 BACKGROUND

• Bhujbal S, Rupenthal ID, Steven P, Agarwal P. Inflammation in Dry Eye Disease-Pathogenesis, Preclinical Animal Models, and Treatments. J Ocul Pharmacol Ther. 2024 Dec;40(10):638-658. doi: 10.1089/jop.2024.0103. Epub 2024 Oct 2.

  PMID: 39358844 BACKGROUND

• Sheppard J, Shen Lee B, Periman LM. Dry eye disease: identification and therapeutic strategies for primary care clinicians and clinical specialists. Ann Med. 2023 Dec;55(1):241-252. doi: 10.1080/07853890.2022.2157477.

  PMID: 36576348 BACKGROUND

• Craig JP, Nichols KK, Akpek EK, Caffery B, Dua HS, Joo CK, Liu Z, Nelson JD, Nichols JJ, Tsubota K, Stapleton F. TFOS DEWS II Definition and Classification Report. Ocul Surf. 2017 Jul;15(3):276-283. doi: 10.1016/j.jtos.2017.05.008. Epub 2017 Jul 20.

  PMID: 28736335 BACKGROUND

MeSH Terms

Conditions

Dry Eye Syndromes; Keratoconjunctivitis Sicca

Interventions

Lubricant Eye Drops

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases

Intervention Hierarchy (Ancestors)

Ophthalmic Solutions; Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Lubricants; Specialty Uses of Chemicals

Study Officials

• Nadide Koca

  Department of Physical Therapy and Rehabilitation, University of Health Sciences, Ankara Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator, M.D., Department of Physical Therapy and Rehabilitation, University of Health Sciences, Ankara Training and Research Hospital

Model Details: Two-arm parallel group randomized controlled trial comparing artificial tears alone with artificial tears plus acupuncture in patients with moderate dry eye disease.

Study Record Dates

• First Submitted: September 8, 2025
• First Posted: September 22, 2025
• Study Start: January 15, 2024
• Primary Completion: June 30, 2025
• Study Completion: August 1, 2025
• Last Updated: September 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)