Clinical trial NCT04785261: Effect of Traditional Chinese Medicine on Basic Tear Secretion and Tear Cytokines in Patients With Dry Eye Disease
Official title: Pilot Study on The Effect of Traditional Chinese Medicine on Basic Tear Secretion and Tear Cytokines in Patients With Dry Eye Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Dry Eye Disease
Dry Eye Syndromes
Dry Eye
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2021-03-05
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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)). 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.

Eligibility criteria: Inclusion Criteria:

* Age between 20 and 75 years.
* A confirmed diagnosis of DED by ophthalmologists.
* Willing to sign informed consent form.

Exclusion Criteria:

* 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.
* 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.

Primary outcomes:
measure: Schirmer's Test
timeFrame: Change from baseline Schirmer's Test at week 4, week 8 and week 12
measure: Non-invasive Tear Film Break-up Time (NiBUT)
timeFrame: Change from baseline NiBUT at week 4, week 8 and week 12
Secondary outcomes:
measure: Tear Meniscus Height
timeFrame: Change from baseline Tear meniscus height at week 4, week 8 and week 12
measure: Meibomian Gland Loss Rate
timeFrame: Change from baseline Meibomian gland loss rate at week 4, week 8 and week 12
measure: Tear Cytokines
timeFrame: Change from baseline Tear cytokines at week 4, week 8 and week 12
measure: Ocular Surface Disease Index (OSDI)
timeFrame: Change from baseline OSDI at week 4, week 8 and week 12
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: China Medical University Hospital
Study officials:
affiliation: China Medical University Hospital
name: Hui-Ju Lin, PhD
role: PRINCIPAL_INVESTIGATOR
References: