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A Randomized Controlled Trial to Evaluate the Safety and Efficacy of Combined Acupuncture (Body Acupuncture and Intradermal Acupuncture) Compared to Artificial Tear Drops

A Randomized, single-blinded, artificial tear drop Controlled, Parallel, Prospective, Investigator's Clinical Trial to Evaluate the Safety and Efficacy of Acupuncture with Intradermal Acupuncture

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0008563
Enrollment
30
Registered
2023-06-27
Start date
2023-07-05
Completion date
Unknown
Last updated
2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug, Medical Device : Thirty patients with dry eye syndrome are equally randomized into the combined acupuncture (body acupuncture-intradermal acupuncture) therapy group or the artificial tear drops

Sponsors

Naju Dongshin University Korean Medicine Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Male or female patients aged 19-65 at the screening visit. (2) Patients who have typical dry eye symptoms including pruritus, foreign body sensation, pain, dryness, blurry eye, dazzle, eye congestion, and illacrimation, and whose ocular surface disease index (OSDI) score is =13. (3) The result of Schirmer ? test is =10 mm/5 min. (4) Patients with tear film break-up time (TFBUT) of = 10 seconds. (5) Patients who voluntarily submitted written consent.

Exclusion criteria

Exclusion criteria: (1) Dry eye syndrome caused by eyelids or eyelashes. (2) Irritated eye caused by acute inflammation arising from the eyelid, eyeball, or ocular appendage. (3) Patients who have secondary dry eye due to scarring caused by irradiation, alkali burn, Stevens-Johnson syndrome, pemphigoid, etc. (4) Patients who are diagnosed with vitamin A deficiency. (5) Patients who have damages caused by injury of the eyeball or ocular appendage. (6) Patients who had an operation to the anterior segment of the eye or operation via the anterior eye including cataract or LASIK within recent 3 months. (7) Patients who have difficulty in blink due to facial palsy. (8) Patients who received punctal plug or punctal occlusion. (9) Patients who used anti-inflammatory drops, including cyclosporine, corticosteroids, or autoserotherapy, directly to the eye within recent 2 weeks. (10) Patients who have active ocular infections including anterior uveitis or anterior blepharitis. (11) Patients who have ocular allergy or who are receiving treatments for allergic eye diseases. (12) Patients who have viral conjunctivitis symptoms or who are receiving treatments for viral conjunctivitis. (13) Patients whose intraocular pressure is more than 25 mmHg in a single eye or both eyes or who are diagnosed with glaucoma. (14) Patients who wore contact lenses within the recent two weeks or who have to wear contact lenses during the trial period. (15) Patients taking systemic corticosteroids or immunosuppressants. (16) Pregnant, lactating women, or women planning pregnancy. (17) Others whom investigators determined inadequate.

Design outcomes

Primary

MeasureTime frame
Ocular surface disease index;Tear film break-up time

Secondary

MeasureTime frame
Subjective symptoms visual analog scale;Quality of life;Schirmer I test;Lactoferrin level in tears;Treatment satisfaction;Safety

Countries

Korea, Republic of

Contacts

Public ContactJi-Hoon Song

Dongshin University

kmdsjh0122@nate.com+82-61-338-7858

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 7, 2026