NCT06780293: LADESJS

Laser Acupuncture on Dry Eye and Sjögren's Syndrome-related Dry Eye Symptoms (LADESJS)

Recruiting now Phase 2 Last updated 9 April 2025

What this trial tests

Phase 2 trial testing Laser acupuncture (LA) in Dry Eye Syndrome (DES) in 140 participants. Currently enrolling.

Timeline

3 February 2025

Primary endpoint
30 April 2025

31 December 2026

Quick facts

Lead sponsor	Taipei Veterans General Hospital, Taiwan
Phase	Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	140
Start date	3 February 2025
Primary completion	30 April 2025
Estimated completion	31 December 2026
Sites	1 location across Taiwan

Drugs / interventions tested

• Laser acupuncture (LA)
• Numerical Rating Scale (NRS)
• Schirmer's test
• Ocular Surface Disease Index (OSDI)
• EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI)
• Traditional Chinese Medicine (TCM) tongue diagnosis
• Traditional Chinese Medicine (TCM) pulse diagnosis
• Traditional Chinese Medicine (TCM) constitution questionnaire
• Traditional Chinese Medicine (TCM) heart rate variability analysis
• nailfold microcirculation assessment
• iris examination
• Sham Laser Acupuncture

Conditions studied

• Dry Eye Syndrome (DES) — all drugs for Dry Eye Syndrome (DES) →
• Laser Acupuncture — all drugs for Laser Acupuncture →
• Sjögren's Syndrome (SS) — all drugs for Sjögren's Syndrome (SS) →

Sponsor

Taipei Veterans General Hospital, Taiwan

Who can join

Adults 20 to 75, any sex, with Dry Eye Syndrome (DES) or Laser Acupuncture. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This randomized, double-blind, placebo-controlled clinical trial aims to evaluate the efficacy of adding laser acupuncture at Fengchi (GB20), Zanzhu (BL2), Hegu (LI4), and Quchi (LI11) acupoints to standard care for the treatment of dry eye symptoms in both Sjögren's Syndrome-related dry eye (SJS-DES) and non-Sjögren's Syndrome-related dry eye (Non-SJS-DES) populations. A total of 140 dry eye patients will be recruited and divided into two groups: 70 participants with SJS-DES and 70 with Non-SJS-DES. Participants will be randomly assigned into three groups: Sham+LA group (60 participants receiving 4 weeks of placebo laser acupuncture followed by 4 weeks of active laser acupuncture), LA+LA group (60 participants receiving 4 weeks of active laser acupuncture followed by another 4 weeks of active laser acupuncture), and a Waiting List group (20 participants receiving no laser acupuncture treatment). Each session will target the Fengchi (GB20), Zanzhu (BL2), Hegu (LI4), and Quchi (LI11) acupoints bilaterally, performed twice a week. The total study period is 8 weeks, and the treatment efficacy will be assessed at the end of the 8-week treatment. The Waiting List group (20 participants) will not receive any laser acupuncture treatment during this period. Efficacy will be evaluated using the Numerical Rating Scale (NRS), Schirmer's test, Ocular Surface Disease Index (OSDI), EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI), Traditional Chinese Medicine (TCM) tongue diagnosis, TCM pulse diagnosis, TCM constitution questionnaire, TCM heart rate variability analysis, nailfold microcirculation assessment, and iris examination. This study aims to investigate the impact of laser acupuncture on dry eye symptom improvement and the potential markers that differentiate between SJS-DES and Non-SJS-DES patients. The goal is to develop a comprehensive integrated care model for early screening, diagnosis, and personalized treatment plans for Dry Eye Syndrome and Sjögren's Syndrome, achieving the ultimate objective of "Holistic Health Care."

Publications & conference data

No peer-reviewed publications indexed yet for this trial.