Dry Eye Syndrome (DES)Phase 2LADESJSNCT06780293
Laser Acupuncture on Dry Eye and Sjögren's Syndrome-related Dry Eye Symptoms (LADESJS)
A Phase 2 study testing Laser acupuncture (LA), Numerical Rating Scale (NRS) and Schirmer's test in people with Dry Eye Syndrome (DES) and Laser Acupuncture, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Dry Eye Syndrome (DES), Laser Acupuncture, Sjögren's Syndrome (SS)
- What is being tested?
- Laser acupuncture (LA), Numerical Rating Scale (NRS) and Schirmer's test
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 1 siteTaiwan
- Study dates
- 3 Feb 2025to 31 Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged between 20 and 75 years
- Schirmer's test less than 10 mm/5 min
- primary or secondary SS
- aged between 20 and 75 years
- fulfilled the 2002 American-European Consensus Criteria for SS (AECG)
- had no abnormal findings of immune, liver, kidney, or blood function evaluations.
Who cannot join
- Pregnancy
- With eye inflammation or infectious eye disease
- Accepted operation of eye
- Sjögren's syndrome
- a history of alcohol abuse, diabetes mellitus, or major life-threatening condition
- pregnancy or breastfeeding
- steroid pulse therapy within three months prior to the commencement of our study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Ching-Mao Chang
Taipei, Taiwan, 886
Ching-Mao Chang, M.D., Ph.D., 88628757453 ext. 333, magicbjp@gmail.com
Ching-Mao Chang, M.D., Ph.D.
About this study
Official title: Exploring the Long-term Therapeutic Effects of Laser Acupuncture on Dry Eye and Sjögren's Syndrome-related Dry Eye Symptoms
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."
Read the detailed description
Method: 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."
Expected Results:
- Assess the therapeutic differences between Sham+LA and LA+LA groups in the SJS-DES population.
- Assess the therapeutic differences between Sham+LA and LA+LA groups in the Non-SJS-DES population.
- Evaluate the therapeutic differences between the SJS-DES and Non-SJS-DES populations.
Keywords: Dry eye syndrome, Sjögren's syndrome, Laser Acupuncture, GB20, BL2, LI4, LI11
- Being tested
- Laser acupuncture (LA), Numerical Rating Scale (NRS), Schirmer's test, Ocular Surface Disease Index (OSDI), EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI)
- Keywords
- Dry eye syndrome, Sjögren's syndrome, Laser Acupuncture, Fengchi (GB20), Zanzhu (BL2), Hegu (LI4), Quchi (LI11)
- Medical subject headings
- Dry Eye Syndromes, Sjogren's Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser acupuncture (LA)Other
The RJ-Laser acupuncture device (Reimers \& Janssen GmbH, Waldkirch, Germany) is used with a laser wavelength of 810 nm (infrared). The Bahr frequency B3 is set at 2398 Hz, with an energy output of 400 mW, operating in intermittent pulse mode. Each acupoint is irradiated for 15 seconds. A total of 8 bilateral acupoints are treated per session, with a total treatment time of approximately 120 seconds.
Numerical Rating Scale (NRS)Diagnostic test
LA+LA group of SJS-DES, Sham+LA group of SJS-DES, LA+LA group of Non-SJS-DES, Sham+LA group of Non-SJS-DES and Waiting list will take the Numerical Rating Scale (NRS).
Schirmer's testDiagnostic test
LA+LA group of SJS-DES, Sham+LA group of SJS-DES, LA+LA group of Non-SJS-DES, Sham+LA group of Non-SJS-DES and Waiting list will take the Schirmer's test.
Ocular Surface Disease Index (OSDI)Diagnostic test
LA+LA group of SJS-DES, Sham+LA group of SJS-DES, LA+LA group of Non-SJS-DES, Sham+LA group of Non-SJS-DES and Waiting list will take the OSDI test.
EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI)Diagnostic test
LA+LA group of SJS-DES, Sham+LA group of SJS-DES, LA+LA group of Non-SJS-DES, Sham+LA group of Non-SJS-DES and Waiting list will take the ESSPRI.
Traditional Chinese Medicine (TCM) tongue diagnosisDiagnostic test
LA+LA group of SJS-DES, Sham+LA group of SJS-DES, LA+LA group of Non-SJS-DES, Sham+LA group of Non-SJS-DES and Waiting list will take the Traditional Chinese Medicine (TCM) tongue diagnosis.
Traditional Chinese Medicine (TCM) pulse diagnosisDiagnostic test
LA+LA group of SJS-DES, Sham+LA group of SJS-DES, LA+LA group of Non-SJS-DES, Sham+LA group of Non-SJS-DES and Waiting list will take the Traditional Chinese Medicine (TCM) pulse diagnosis.
Traditional Chinese Medicine (TCM) constitution questionnaireDiagnostic test
LA+LA group of SJS-DES, Sham+LA group of SJS-DES, LA+LA group of Non-SJS-DES, Sham+LA group of Non-SJS-DES and Waiting list will take the Traditional Chinese Medicine (TCM) constitution questionnaire.
Traditional Chinese Medicine (TCM) heart rate variability analysisDiagnostic test
LA+LA group of SJS-DES, Sham+LA group of SJS-DES, LA+LA group of Non-SJS-DES, Sham+LA group of Non-SJS-DES and Waiting list will take the Traditional Chinese Medicine (TCM) heart rate variability analysis.
nailfold microcirculation assessmentDiagnostic test
LA+LA group of SJS-DES, Sham+LA group of SJS-DES, LA+LA group of Non-SJS-DES, Sham+LA group of Non-SJS-DES and Waiting list will take the nailfold microcirculation assessment.
iris examinationDiagnostic test
LA+LA group of SJS-DES, Sham+LA group of SJS-DES, LA+LA group of Non-SJS-DES, Sham+LA group of Non-SJS-DES and Waiting list will take the iris examination.
Sham Laser AcupunctureOther
The RJ-Laser acupuncture device (Reimers \& Janssen GmbH, Waldkirch, Germany) is used with a laser wavelength of 810 nm (infrared). The Bahr frequency B3 is set at 2398 Hz, with an energy output of 400 mW, operating in intermittent pulse mode. Each acupoint is irradiated for 15 seconds. A total of 8 bilateral acupoints are treated per session, with a total treatment time of approximately 120 seconds.
The sham laser acupuncture procedure follows the same process as the true laser acupuncture protocol, including the positioning, cleaning of acupoints, and wearing of protective goggles. However, no laser emission is delivered during the treatment. This ensures a consistent experience for the patient while maintaining the blinding integrity of the study.
| Study group | Role | What they receive |
|---|---|---|
| LA+LA group of SJS-DES | Experimental | LA+LA group of SJS-DES will receive laser acupuncture at acupoint GB20, BL2, LI4 and LI11 twice a week 8 weeks for efficacy evaluation. And we could use 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 for this purpose. Receives: Other: Laser acupuncture (LA); Diagnostic Test: Numerical Rating Scale (NRS); Diagnostic Test: Schirmer's test; Diagnostic Test: Ocular Surface Disease Index (OSDI); Diagnostic Test: EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI); Diagnostic Test: Traditional Chinese Medicine (TCM) tongue diagnosis; Diagnostic Test: Traditional Chinese Medicine (TCM) pulse diagnosis; Diagnostic Test: Traditional Chinese Medicine (TCM) constitution questionnaire; Diagnostic Test: Traditional Chinese Medicine (TCM) heart rate variability analysis; Diagnostic Test: nailfold microcirculation assessment; Diagnostic Test: iris examination |
| Sham+LA group of SJS-DES | Sham comparator | Sham+LA group of SJS-DES will receive sham acupuncture twice a week 4 weeks and then laser acupuncture at acupoint GB20, BL2, LI4 and LI11 twice a week 4 weeks for efficacy evaluation. And we could use 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 for this purpose. Receives: Other: Laser acupuncture (LA); Diagnostic Test: Numerical Rating Scale (NRS); Diagnostic Test: Schirmer's test; Diagnostic Test: Ocular Surface Disease Index (OSDI); Diagnostic Test: EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI); Diagnostic Test: Traditional Chinese Medicine (TCM) tongue diagnosis; Diagnostic Test: Traditional Chinese Medicine (TCM) pulse diagnosis; Diagnostic Test: Traditional Chinese Medicine (TCM) constitution questionnaire; Diagnostic Test: Traditional Chinese Medicine (TCM) heart rate variability analysis; Diagnostic Test: nailfold microcirculation assessment; Diagnostic Test: iris examination; Other: Sham Laser Acupuncture |
| LA+LA group of Non-SJS-DES | Experimental | LA+LA group of Non-SJS-DES will receive laser acupuncture at acupoint GB20, BL2, LI4 and LI11 twice a week 8 weeks for efficacy evaluation. And we could use 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 for this purpose. Receives: Other: Laser acupuncture (LA); Diagnostic Test: Numerical Rating Scale (NRS); Diagnostic Test: Schirmer's test; Diagnostic Test: Ocular Surface Disease Index (OSDI); Diagnostic Test: EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI); Diagnostic Test: Traditional Chinese Medicine (TCM) tongue diagnosis; Diagnostic Test: Traditional Chinese Medicine (TCM) pulse diagnosis; Diagnostic Test: Traditional Chinese Medicine (TCM) constitution questionnaire; Diagnostic Test: Traditional Chinese Medicine (TCM) heart rate variability analysis; Diagnostic Test: nailfold microcirculation assessment; Diagnostic Test: iris examination |
| Sham+LA group of Non-SJS-DES | Sham comparator | Sham+LA group of Non-SJS-DES will receive sham acupuncture twice a week 4 weeks and then laser acupuncture at acupoint GB20, BL2, LI4 and LI11 twice a week 4 weeks for efficacy evaluation. And we could use 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 for this purpose. Receives: Other: Laser acupuncture (LA); Diagnostic Test: Numerical Rating Scale (NRS); Diagnostic Test: Schirmer's test; Diagnostic Test: Ocular Surface Disease Index (OSDI); Diagnostic Test: EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI); Diagnostic Test: Traditional Chinese Medicine (TCM) tongue diagnosis; Diagnostic Test: Traditional Chinese Medicine (TCM) pulse diagnosis; Diagnostic Test: Traditional Chinese Medicine (TCM) constitution questionnaire; Diagnostic Test: Traditional Chinese Medicine (TCM) heart rate variability analysis; Diagnostic Test: nailfold microcirculation assessment; Diagnostic Test: iris examination; Other: Sham Laser Acupuncture |
| Waiting list | Other | Group Waiting list will not receive any treatment at acupoint GB20, BL2, LI4 and LI11 twice a week 8 weeks for efficacy evaluation. And we could use 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 for this purpose. Receives: Diagnostic Test: Numerical Rating Scale (NRS); Diagnostic Test: Schirmer's test; Diagnostic Test: Ocular Surface Disease Index (OSDI); Diagnostic Test: EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI); Diagnostic Test: Traditional Chinese Medicine (TCM) tongue diagnosis; Diagnostic Test: Traditional Chinese Medicine (TCM) pulse diagnosis; Diagnostic Test: Traditional Chinese Medicine (TCM) constitution questionnaire; Diagnostic Test: Traditional Chinese Medicine (TCM) heart rate variability analysis; Diagnostic Test: nailfold microcirculation assessment; Diagnostic Test: iris examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical Rating Scale (NRS)
Numerical Rating Scale (NRS) is a tool for evaluating pain among the Dry eye syndrome (DES).
Measured: one year
Schirmer's test
Schirmer's test is a tool for evaluating aqueous tear production among the Dry eye syndrome (DES).
Measured: one year
Ocular Surface Disease Index (OSDI)
Ocular Surface Disease Index (OSDI) is a tool to rate the severity of dry eye disease among the Dry eye syndrome (DES).
Measured: one year
Secondary outcomes (7)
EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI)
EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) is a tool for evaluating the symptoms of SJS among the Dry eye syndrome (DES).
Measured: one year
Traditional Chinese Medicine (TCM) tongue diagnosis
Traditional Chinese Medicine (TCM) tongue diagnosis is a tool for detecting tongue expression among the Dry eye syndrome (DES).
Measured: one year
Traditional Chinese Medicine (TCM) pulse diagnosis
Traditional Chinese Medicine (TCM) pulse diagnosis is a tool for detecting tongue expression pulse pattern among the Dry eye syndrome (DES).
Measured: one year
Traditional Chinese Medicine (TCM) constitution questionnaire
Traditional Chinese Medicine (TCM) constitution questionnaire is a tool for detecting the constitution among the Dry eye syndrome (DES).
Measured: one year
Traditional Chinese Medicine (TCM) heart rate variability analysis
Traditional Chinese Medicine (TCM) heart rate variability analysis is a tool for detecting ratio between High-frequency (HF) activity and low-frequency (LF) activity among the Dry eye syndrome (DES).
Measured: one year
Nailfold microcirculation assessment
Nailfold microcirculation assessment is a tool for detecting the status of nailfold microcirculation among the Dry eye syndrome (DES).
Measured: one year
Iris examination
Iris examination is a tool for detecting the status of iris among the Dry eye syndrome (DES).
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2025
- Study start3 Feb 2025
- Primary completion30 Apr 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye Syndrome (DES)Studies of the same condition, open and under way.
- More trials run by Taipei Veterans General Hospital, TaiwanThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ching-Mao Chang, Taipei Veterans General Hospital, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06780293
- Sponsor's protocol ID
- 2024-11-008C
- Acronym
- LADESJS
- Status last verified
- Apr 2025
- First submitted
- 13 Jan 2025
- Last updated
- 9 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The decision to share individual participant data (IPD) is currently undecided due to ongoing discussions regarding data management, privacy concerns, and compliance with institutional and regulatory requirements. Additional considerations include the establishment of appropriate data-sharing agreements, ensuring participant confidentiality, and defining the scope and method of data access. Once these factors are thoroughly evaluated and addressed, a final decision regarding IPD sharing will be made in accordance with ethical guidelines and applicable regulations.
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Long-term Therapeutic Effects of Laser Acupuncture on Dry Eye and Sjögren's Syndrome-related Dry Eye Symptoms
- ClinicalTrials.gov ID
- NCT06780293
- Acronym / sponsor ID
- LADESJS / 2024-11-008C
- Keywords
- Dry eye syndrome, Sjögren's syndrome, Laser Acupuncture, Fengchi (GB20), Zanzhu (BL2), Hegu (LI4), Quchi (LI11)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Study start
- 3 Feb 2025 (actual)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 17 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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."
Detailed description
Method: 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."
Expected Results:
- Assess the therapeutic differences between Sham+LA and LA+LA groups in the SJS-DES population.
- Assess the therapeutic differences between Sham+LA and LA+LA groups in the Non-SJS-DES population.
- Evaluate the therapeutic differences between the SJS-DES and Non-SJS-DES populations.
Keywords: Dry eye syndrome, Sjögren's syndrome, Laser Acupuncture, GB20, BL2, LI4, LI11
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| LA+LA group of SJS-DES | Experimental | Other: Laser acupuncture (LA), Diagnostic Test: Numerical Rating Scale (NRS), Diagnostic Test: Schirmer's test, Diagnostic Test: Ocular Surface Disease Index (OSDI), Diagnostic Test: EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI), Diagnostic Test: Traditional Chinese Medicine (TCM) tongue diagnosis, Diagnostic Test: Traditional Chinese Medicine (TCM) pulse diagnosis, Diagnostic Test: Traditional Chinese Medicine (TCM) constitution questionnaire, Diagnostic Test: Traditional Chinese Medicine (TCM) heart rate variability analysis, Diagnostic Test: nailfold microcirculation assessment, Diagnostic Test: iris examinationLA+LA group of SJS-DES will receive laser acupuncture at acupoint GB20, BL2, LI4 and LI11 twice a week 8 weeks for efficacy evaluation. And we could use 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 for this purpose. |
| Sham+LA group of SJS-DES | Sham comparator | Other: Laser acupuncture (LA), Diagnostic Test: Numerical Rating Scale (NRS), Diagnostic Test: Schirmer's test, Diagnostic Test: Ocular Surface Disease Index (OSDI), Diagnostic Test: EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI), Diagnostic Test: Traditional Chinese Medicine (TCM) tongue diagnosis, Diagnostic Test: Traditional Chinese Medicine (TCM) pulse diagnosis, Diagnostic Test: Traditional Chinese Medicine (TCM) constitution questionnaire, Diagnostic Test: Traditional Chinese Medicine (TCM) heart rate variability analysis, Diagnostic Test: nailfold microcirculation assessment, Diagnostic Test: iris examination, Other: Sham Laser AcupunctureSham+LA group of SJS-DES will receive sham acupuncture twice a week 4 weeks and then laser acupuncture at acupoint GB20, BL2, LI4 and LI11 twice a week 4 weeks for efficacy evaluation. And we could use 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 for this purpose. |
| LA+LA group of Non-SJS-DES | Experimental | Other: Laser acupuncture (LA), Diagnostic Test: Numerical Rating Scale (NRS), Diagnostic Test: Schirmer's test, Diagnostic Test: Ocular Surface Disease Index (OSDI), Diagnostic Test: EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI), Diagnostic Test: Traditional Chinese Medicine (TCM) tongue diagnosis, Diagnostic Test: Traditional Chinese Medicine (TCM) pulse diagnosis, Diagnostic Test: Traditional Chinese Medicine (TCM) constitution questionnaire, Diagnostic Test: Traditional Chinese Medicine (TCM) heart rate variability analysis, Diagnostic Test: nailfold microcirculation assessment, Diagnostic Test: iris examinationLA+LA group of Non-SJS-DES will receive laser acupuncture at acupoint GB20, BL2, LI4 and LI11 twice a week 8 weeks for efficacy evaluation. And we could use 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 for this purpose. |
| Sham+LA group of Non-SJS-DES | Sham comparator | Other: Laser acupuncture (LA), Diagnostic Test: Numerical Rating Scale (NRS), Diagnostic Test: Schirmer's test, Diagnostic Test: Ocular Surface Disease Index (OSDI), Diagnostic Test: EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI), Diagnostic Test: Traditional Chinese Medicine (TCM) tongue diagnosis, Diagnostic Test: Traditional Chinese Medicine (TCM) pulse diagnosis, Diagnostic Test: Traditional Chinese Medicine (TCM) constitution questionnaire, Diagnostic Test: Traditional Chinese Medicine (TCM) heart rate variability analysis, Diagnostic Test: nailfold microcirculation assessment, Diagnostic Test: iris examination, Other: Sham Laser AcupunctureSham+LA group of Non-SJS-DES will receive sham acupuncture twice a week 4 weeks and then laser acupuncture at acupoint GB20, BL2, LI4 and LI11 twice a week 4 weeks for efficacy evaluation. And we could use 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 for this purpose. |
| Waiting list | Other | Diagnostic Test: Numerical Rating Scale (NRS), Diagnostic Test: Schirmer's test, Diagnostic Test: Ocular Surface Disease Index (OSDI), Diagnostic Test: EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI), Diagnostic Test: Traditional Chinese Medicine (TCM) tongue diagnosis, Diagnostic Test: Traditional Chinese Medicine (TCM) pulse diagnosis, Diagnostic Test: Traditional Chinese Medicine (TCM) constitution questionnaire, Diagnostic Test: Traditional Chinese Medicine (TCM) heart rate variability analysis, Diagnostic Test: nailfold microcirculation assessment, Diagnostic Test: iris examinationGroup Waiting list will not receive any treatment at acupoint GB20, BL2, LI4 and LI11 twice a week 8 weeks for efficacy evaluation. And we could use 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 for this purpose. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- aged between 20 and 75 years
- Schirmer's test less than 10 mm/5 min
- primary or secondary SS
- aged between 20 and 75 years
- fulfilled the 2002 American-European Consensus Criteria for SS (AECG)
Key exclusion criteria (7 listed)
- Pregnancy
- With eye inflammation or infectious eye disease
- Accepted operation of eye
- a history of alcohol abuse, diabetes mellitus, or major life-threatening condition
- pregnancy or breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laser acupuncture (LA)The RJ-Laser acupuncture device (Reimers \& Janssen GmbH, Waldkirch, Germany) is used with a laser wavelength of 810 nm (infrared). The Bahr frequency B3 is set at 2398 Hz, with an energy output of 400 mW, operating in intermittent pulse mode. Each acupoint is irradiated for 15 seconds. A total of 8 bilateral acupoints are treated per session, with a total treatment time of approximately 120 seconds. | Other | LA+LA group of Non-SJS-DES, LA+LA group of SJS-DES, Sham+LA group of Non-SJS-DES, Sham+LA group of SJS-DES |
| Numerical Rating Scale (NRS)LA+LA group of SJS-DES, Sham+LA group of SJS-DES, LA+LA group of Non-SJS-DES, Sham+LA group of Non-SJS-DES and Waiting list will take the Numerical Rating Scale (NRS). | Diagnostic test | LA+LA group of Non-SJS-DES, LA+LA group of SJS-DES, Sham+LA group of Non-SJS-DES, Sham+LA group of SJS-DES, Waiting list |
| Schirmer's testLA+LA group of SJS-DES, Sham+LA group of SJS-DES, LA+LA group of Non-SJS-DES, Sham+LA group of Non-SJS-DES and Waiting list will take the Schirmer's test. | Diagnostic test | LA+LA group of Non-SJS-DES, LA+LA group of SJS-DES, Sham+LA group of Non-SJS-DES, Sham+LA group of SJS-DES, Waiting list |
| Ocular Surface Disease Index (OSDI)LA+LA group of SJS-DES, Sham+LA group of SJS-DES, LA+LA group of Non-SJS-DES, Sham+LA group of Non-SJS-DES and Waiting list will take the OSDI test. | Diagnostic test | LA+LA group of Non-SJS-DES, LA+LA group of SJS-DES, Sham+LA group of Non-SJS-DES, Sham+LA group of SJS-DES, Waiting list |
| EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI)LA+LA group of SJS-DES, Sham+LA group of SJS-DES, LA+LA group of Non-SJS-DES, Sham+LA group of Non-SJS-DES and Waiting list will take the ESSPRI. | Diagnostic test | LA+LA group of Non-SJS-DES, LA+LA group of SJS-DES, Sham+LA group of Non-SJS-DES, Sham+LA group of SJS-DES, Waiting list |
| Traditional Chinese Medicine (TCM) tongue diagnosisLA+LA group of SJS-DES, Sham+LA group of SJS-DES, LA+LA group of Non-SJS-DES, Sham+LA group of Non-SJS-DES and Waiting list will take the Traditional Chinese Medicine (TCM) tongue diagnosis. | Diagnostic test | LA+LA group of Non-SJS-DES, LA+LA group of SJS-DES, Sham+LA group of Non-SJS-DES, Sham+LA group of SJS-DES, Waiting list |
| Traditional Chinese Medicine (TCM) pulse diagnosisLA+LA group of SJS-DES, Sham+LA group of SJS-DES, LA+LA group of Non-SJS-DES, Sham+LA group of Non-SJS-DES and Waiting list will take the Traditional Chinese Medicine (TCM) pulse diagnosis. | Diagnostic test | LA+LA group of Non-SJS-DES, LA+LA group of SJS-DES, Sham+LA group of Non-SJS-DES, Sham+LA group of SJS-DES, Waiting list |
| Traditional Chinese Medicine (TCM) constitution questionnaireLA+LA group of SJS-DES, Sham+LA group of SJS-DES, LA+LA group of Non-SJS-DES, Sham+LA group of Non-SJS-DES and Waiting list will take the Traditional Chinese Medicine (TCM) constitution questionnaire. | Diagnostic test | LA+LA group of Non-SJS-DES, LA+LA group of SJS-DES, Sham+LA group of Non-SJS-DES, Sham+LA group of SJS-DES, Waiting list |
| Traditional Chinese Medicine (TCM) heart rate variability analysisLA+LA group of SJS-DES, Sham+LA group of SJS-DES, LA+LA group of Non-SJS-DES, Sham+LA group of Non-SJS-DES and Waiting list will take the Traditional Chinese Medicine (TCM) heart rate variability analysis. | Diagnostic test | LA+LA group of Non-SJS-DES, LA+LA group of SJS-DES, Sham+LA group of Non-SJS-DES, Sham+LA group of SJS-DES, Waiting list |
| nailfold microcirculation assessmentLA+LA group of SJS-DES, Sham+LA group of SJS-DES, LA+LA group of Non-SJS-DES, Sham+LA group of Non-SJS-DES and Waiting list will take the nailfold microcirculation assessment. | Diagnostic test | LA+LA group of Non-SJS-DES, LA+LA group of SJS-DES, Sham+LA group of Non-SJS-DES, Sham+LA group of SJS-DES, Waiting list |
| iris examinationLA+LA group of SJS-DES, Sham+LA group of SJS-DES, LA+LA group of Non-SJS-DES, Sham+LA group of Non-SJS-DES and Waiting list will take the iris examination. | Diagnostic test | LA+LA group of Non-SJS-DES, LA+LA group of SJS-DES, Sham+LA group of Non-SJS-DES, Sham+LA group of SJS-DES, Waiting list |
| Sham Laser AcupunctureThe RJ-Laser acupuncture device (Reimers \& Janssen GmbH, Waldkirch, Germany) is used with a laser wavelength of 810 nm (infrared). The Bahr frequency B3 is set at 2398 Hz, with an energy output of 400 mW, operating in intermittent pulse mode. Each acupoint is irradiated for 15 seconds. A total of 8 bilateral acupoints are treated per session, with a total treatment time of approximately 120 seconds. The sham laser acupuncture procedure follows the same process as the true laser acupuncture protocol, including the positioning, cleaning of acupoints, and wearing of protective goggles. However, no laser emission is delivered during the treatment. This ensures a consistent experience for the patient while maintaining the blinding integrity of the study. | Other | Sham+LA group of Non-SJS-DES, Sham+LA group of SJS-DES |
Primary outcome
Numerical Rating Scale (NRS)
Time frame: one year
Numerical Rating Scale (NRS) is a tool for evaluating pain among the Dry eye syndrome (DES).
Schirmer's test
Time frame: one year
Schirmer's test is a tool for evaluating aqueous tear production among the Dry eye syndrome (DES).
Ocular Surface Disease Index (OSDI)
Time frame: one year
Ocular Surface Disease Index (OSDI) is a tool to rate the severity of dry eye disease among the Dry eye syndrome (DES).
7 secondary outcomes
EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI)
Time frame: one year
Traditional Chinese Medicine (TCM) tongue diagnosis
Time frame: one year
Traditional Chinese Medicine (TCM) pulse diagnosis
Time frame: one year
Traditional Chinese Medicine (TCM) constitution questionnaire
Time frame: one year
Traditional Chinese Medicine (TCM) heart rate variability analysis
Time frame: one year
Nailfold microcirculation assessment
Time frame: one year
Iris examination
Time frame: one year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2025.
- Individual participant dataSharing planned: Undecided. The decision to share individual participant data (IPD) is currently undecided due to ongoing discussions regarding data management, privacy concerns, and compliance with institutional and regulatory requirements. Additional considerations include the establishment of appropriate data-sharing agreements, ensuring participant confidentiality, and defining the scope and method of data access. Once these factors are thoroughly evaluated and addressed, a final decision regarding IPD sharing will be made in accordance with ethical guidelines and applicable regulations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Laser acupuncture (LA), Numerical Rating Scale (NRS) and Schirmer's test in people with Dry Eye Syndrome (DES) and Laser Acupuncture, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ching-Mao Chang, M.D., Ph.D. (886-28757453, 333, magicbjp@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numerical Rating Scale (NRS) (time frame: one year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2025.