Dry Eye DiseasePhase 2NCT04785261
Effect of Traditional Chinese Medicine on Basic Tear Secretion and Tear Cytokines in Patients With Dry Eye Disease
A Phase 2 study testing Methylhydroxypropylcellulose, Carbomer and TCM Formula in people with Dry Eye Disease and Dry Eye Syndromes, run by China Medical University Hospital at 1 site in Taiwan.
Trial summary
This is a single center, randomized, single-blind, controlled pilot study of CJDHW plus JWXYS as a complementary therapy to treat dry eye disease during a 12-week period. The investigators intend to enroll 60 subjects aged between 20 and 75 years old (treatment group(N=30); controlled group(N=30)). Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Dry Eye Disease, Dry Eye Syndromes, Dry Eye
- What is being tested?
- Methylhydroxypropylcellulose, Carbomer and TCM Formula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 16 Mar 2021to 31 May 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Age between 20 and 75 years.
- A confirmed diagnosis of DED by ophthalmologists.
- Willing to sign informed consent form.
Who cannot join
- With autoimmune diseases.
- Pregnant or lactating.
- Underwent transplant surgery and got graft-versus-host disease in the past.
- With eye infection, inflammation, trauma, or underwent eye surgery in the past three months.
- Underwent dry eye intense pulse light treatment in the past three months.
- Underwent other treatments including TCM drugs or acupuncture in the past month or during the trial.
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- Persistent in taking diuretics, antidepressant, antihistamines and anticholinergics.
- Combined treatment with autologous serum, cyclosporine or steroid eye drops during the trial.
- Took fish oil or vitamin D during the trial.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
China Medical University Hospital
Taichung, 404332
Teng-I Huang, MD, +886-4-22052121, d31204@mail.cmuh.org.tw
Hui-Ju Lin, PhD
About this study
Official title: Pilot Study on The Effect of Traditional Chinese Medicine on Basic Tear Secretion and Tear Cytokines in Patients With Dry Eye Disease
This is a single center, randomized, single-blind, controlled pilot study of CJDHW plus JWXYS as a complementary therapy to treat dry eye disease during a 12-week period. The investigators intend to enroll 60 subjects aged between 20 and 75 years old (treatment group(N=30); controlled group(N=30)). Treatment group will be treated with artificial tears combined with TCM, while control group will use artificial tears only. The aim of this study is to explore the efficacy of TCM for dry eye disease.
Read the detailed description
Dry eye disease (DED) is a chronic inflammatory disease. In severe cases, it may cause corneal ulcers, blurred vision, and even blindness. The prevalence of DED is about 30% in Taiwan. With the popularity of technological products and prolonged average life expectancy, the incidence of dry eye disease is increasing at a rate of 10% per year in Taiwan. However, treatment of DED mainly focuses on symptom relief in modern medicine. It is a difficult problem to improve the pathological state of patients with DED. Hence, there is an urgent need for a more effective and safe method of treating this disease.
Chi-Ju-Di-Huang-Wan (CJDHW) is commonly used in traditional Chinese medicine (TCM) for eye diseases. However, current research shows that use CJDHW alone to treat dry eye is less effective for tear secretion, which may be related to the unimproved inflammation state. Ligustilide and ferulic acid, which own significant anti-inflammatory effects, are the effective ingredients of Jia-Wei-Xiao-Yao-San (JWXYS). Many studies have demonstrated that JWXYS can reduce serum TNF-α and IFN-γ levels in patients with DED. Therefore, the investigators choose to use CJDHW plus JWXYS for treatment in this study.
This is a single center, randomized, single-blind, controlled pilot study of CJDHW plus JWXYS as a complementary therapy to treat dry eye disease during a 12-week period. The investigators intend to enroll 60 subjects aged between 20 and 75 years old (treatment group(N=30); controlled group(N=30)). Treatment group will be treated with artificial tears combined with TCM, while control group will use artificial tears only. The evaluation will be conducted on 1st, 4th, 8th,12th week. Primary endpoints include Schirmer's test and non-invasive tear film breakup time(NiBUT); secondary endpoints include tear meniscus height, meibomian gland loss rate, tear cytokines and matrix metalloproteinases (MMPs) levels and Ocular Surface Disease Index (OSDI).
The aim of this study is to explore the efficacy and possible mechanism of TCM for DED.
- Conditions
- Dry Eye Disease, Dry Eye Syndromes, Dry Eye
- Being tested
- Methylhydroxypropylcellulose, Carbomer, TCM Formula
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethylhydroxypropylcelluloseDrug
Also called Artelac® Eye Drops
1-2 drips each time, every 4 hours, for 12 weeks.
CarbomerDrug
Also called Vidisic® Gel
1 drip each time, at bedtime, for 12 weeks.
TCM FormulaDrug
6.0g Chi-Ju-Di-Huang-Wan plus 6.0g Jia-Wei-Xiao-Yao-San, 6.0g twice daily for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| conventional treatment | Active comparator | Patients in this group will be given conventional treatment including Artelac® Eye Drops (1-2 drips each time, every 4 hours) and Vidisic® Gel (1 drip each time, at bedtime) for 12 weeks. Receives: Drug: Methylhydroxypropylcellulose; Drug: Carbomer |
| conventional treatment + TCM | Experimental | Patients in this group will be given conventional treatment and traditional Chinese medicine (6.0g twice daily) for 12 weeks. Receives: Drug: Methylhydroxypropylcellulose; Drug: Carbomer; Drug: TCM Formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Schirmer's Test
Uses paper strips inserted into the eye for 5 minutes to measure the production of tears. Both eyes are tested at the same time.
Measured: Change from baseline Schirmer's Test at week 4, week 8 and week 12
Non-invasive Tear Film Break-up Time (NiBUT)
Measured by Antares Corneal Topography.
Measured: Change from baseline NiBUT at week 4, week 8 and week 12
Secondary outcomes (4)
Tear Meniscus Height
Measured by Antares Corneal Topography.
Measured: Change from baseline Tear meniscus height at week 4, week 8 and week 12
Meibomian Gland Loss Rate
Measured by Antares Corneal Topography.
Measured: Change from baseline Meibomian gland loss rate at week 4, week 8 and week 12
Tear Cytokines
Measured: Change from baseline Tear cytokines at week 4, week 8 and week 12
Ocular Surface Disease Index (OSDI)
Measured: Change from baseline OSDI at week 4, week 8 and week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2021
- Study start16 Mar 2021
- Primary completion31 May 2022 (estimated)
- Study completion31 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye DiseaseStudies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hui-Ju Lin, PhD, Principal investigator, China Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04785261
- Sponsor's protocol ID
- CMUH109-REC2-169
- Status last verified
- Dec 2021
- First submitted
- 3 Mar 2021
- Last updated
- 6 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study on The Effect of Traditional Chinese Medicine on Basic Tear Secretion and Tear Cytokines in Patients With Dry Eye Disease
- ClinicalTrials.gov ID
- NCT04785261
- Acronym / sponsor ID
- CMUH109-REC2-169
- Conditions
- Dry Eye Disease, Dry Eye Syndromes, Dry Eye
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- 16 Mar 2021 (actual)
- Primary completion
- 31 May 2022 (estimated)
- Study completion
- 31 May 2022 (estimated)
- First posted
- 5 Mar 2021 (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 is a single center, randomized, single-blind, controlled pilot study of CJDHW plus JWXYS as a complementary therapy to treat dry eye disease during a 12-week period. The investigators intend to enroll 60 subjects aged between 20 and 75 years old (treatment group(N=30); controlled group(N=30)). Treatment group will be treated with artificial tears combined with TCM, while control group will use artificial tears only. The aim of this study is to explore the efficacy of TCM for dry eye disease.
Detailed description
Dry eye disease (DED) is a chronic inflammatory disease. In severe cases, it may cause corneal ulcers, blurred vision, and even blindness. The prevalence of DED is about 30% in Taiwan. With the popularity of technological products and prolonged average life expectancy, the incidence of dry eye disease is increasing at a rate of 10% per year in Taiwan. However, treatment of DED mainly focuses on symptom relief in modern medicine. It is a difficult problem to improve the pathological state of patients with DED. Hence, there is an urgent need for a more effective and safe method of treating this disease.
Chi-Ju-Di-Huang-Wan (CJDHW) is commonly used in traditional Chinese medicine (TCM) for eye diseases. However, current research shows that use CJDHW alone to treat dry eye is less effective for tear secretion, which may be related to the unimproved inflammation state. Ligustilide and ferulic acid, which own significant anti-inflammatory effects, are the effective ingredients of Jia-Wei-Xiao-Yao-San (JWXYS). Many studies have demonstrated that JWXYS can reduce serum TNF-α and IFN-γ levels in patients with DED. Therefore, the investigators choose to use CJDHW plus JWXYS for treatment in this study.
This is a single center, randomized, single-blind, controlled pilot study of CJDHW plus JWXYS as a complementary therapy to treat dry eye disease during a 12-week period. The investigators intend to enroll 60 subjects aged between 20 and 75 years old (treatment group(N=30); controlled group(N=30)). Treatment group will be treated with artificial tears combined with TCM, while control group will use artificial tears only. The evaluation will be conducted on 1st, 4th, 8th,12th week. Primary endpoints include Schirmer's test and non-invasive tear film breakup time(NiBUT); secondary endpoints include tear meniscus height, meibomian gland loss rate, tear cytokines and matrix metalloproteinases (MMPs) levels and Ocular Surface Disease Index (OSDI).
The aim of this study is to explore the efficacy and possible mechanism of TCM for DED.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional treatment | Active comparator | Drug: Methylhydroxypropylcellulose, Drug: CarbomerPatients in this group will be given conventional treatment including Artelac® Eye Drops (1-2 drips each time, every 4 hours) and Vidisic® Gel (1 drip each time, at bedtime) for 12 weeks. |
| conventional treatment + TCM | Experimental | Drug: Methylhydroxypropylcellulose, Drug: Carbomer, Drug: TCM FormulaPatients in this group will be given conventional treatment and traditional Chinese medicine (6.0g twice daily) for 12 weeks. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age between 20 and 75 years.
- A confirmed diagnosis of DED by ophthalmologists.
- Willing to sign informed consent form.
Key exclusion criteria (9 listed)
- With autoimmune diseases.
- Pregnant or lactating.
- Underwent transplant surgery and got graft-versus-host disease in the past.
- With eye infection, inflammation, trauma, or underwent eye surgery in the past three months.
- Underwent dry eye intense pulse light treatment in the past three months.
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 |
|---|---|---|
| MethylhydroxypropylcelluloseAlso: Artelac® Eye Drops1-2 drips each time, every 4 hours, for 12 weeks. | Drug | conventional treatment, conventional treatment + TCM |
| CarbomerAlso: Vidisic® Gel1 drip each time, at bedtime, for 12 weeks. | Drug | conventional treatment, conventional treatment + TCM |
| TCM Formula6.0g Chi-Ju-Di-Huang-Wan plus 6.0g Jia-Wei-Xiao-Yao-San, 6.0g twice daily for 12 weeks. | Drug | conventional treatment + TCM |
Primary outcome
Schirmer's Test
Time frame: Change from baseline Schirmer's Test at week 4, week 8 and week 12
Uses paper strips inserted into the eye for 5 minutes to measure the production of tears. Both eyes are tested at the same time.
Non-invasive Tear Film Break-up Time (NiBUT)
Time frame: Change from baseline NiBUT at week 4, week 8 and week 12
Measured by Antares Corneal Topography.
4 secondary outcomes
Tear Meniscus Height
Time frame: Change from baseline Tear meniscus height at week 4, week 8 and week 12
Meibomian Gland Loss Rate
Time frame: Change from baseline Meibomian gland loss rate at week 4, week 8 and week 12
Tear Cytokines
Time frame: Change from baseline Tear cytokines at week 4, week 8 and week 12
Ocular Surface Disease Index (OSDI)
Time frame: Change from baseline OSDI at week 4, week 8 and week 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2021.
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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. This study is not recruiting at the moment.
Hui-Ju Lin, PhD principal investigator
China Medical University Hospital
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 Methylhydroxypropylcellulose, Carbomer and TCM Formula in people with Dry Eye Disease and Dry Eye Syndromes, run by China Medical University Hospital 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 3 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 6 Dec 2021. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Teng-I Huang, MD (+886-4-22052121, d31204@mail.cmuh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Schirmer's Test (time frame: Change from baseline Schirmer's Test at week 4, week 8 and week 12). The study lists 2 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 6 Dec 2021; AzTrials last refreshed its copy on 6 Nov 2026.