NCT06780293 Laser Acupuncture on Dry Eye and Sjögren's Syndrome-related Dry Eye Symptoms (LADESJS)
| NCT ID | NCT06780293 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Taipei Veterans General Hospital, Taiwan |
| Condition | Dry Eye Syndrome (DES) |
| Study Type | INTERVENTIONAL |
| Enrollment | 140 participants |
| Start Date | 2025-02-03 |
| Primary Completion | 2025-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 140 participants in total. It began in 2025-02-03 with a primary completion date of 2025-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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."
Eligibility Criteria
• Dry eye syndrome Inclusion Criteria: 1. aged between 20 and 75 years 2. Schirmer's test less than 10 mm/5 min Exclusion Criteria: 1. Pregnancy 2. With eye inflammation or infectious eye disease 3. Accepted operation of eye * Sjögren's syndrome Inclusion Criteria: 1. primary or secondary SS 2. aged between 20 and 75 years 3. fulfilled the 2002 American-European Consensus Criteria for SS (AECG) 4. had no abnormal findings of immune, liver, kidney, or blood function evaluations. Exclusion Criteria: 1. a history of alcohol abuse, diabetes mellitus, or major life-threatening condition 2. pregnancy or breastfeeding 3. steroid pulse therapy within three months prior to the commencement of our study.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06780293 clinical trial?
This trial is open to participants of all sexes, aged 20 Years or older, up to 75 Years, studying Dry Eye Syndrome (DES). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06780293 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06780293 currently recruiting?
Yes, NCT06780293 is actively recruiting participants. Contact the research team at magicbjp@gmail.com for enrollment information.
Where is the NCT06780293 trial being conducted?
This trial is being conducted at Taipei, Taiwan.
Who is sponsoring the NCT06780293 clinical trial?
NCT06780293 is sponsored by Taipei Veterans General Hospital, Taiwan. The trial plans to enroll 140 participants.