Effect of Traditional Chinese Medicine on Basic Tear Secretion and Tear Cytokines in Patients With Dry Eye Disease

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.

Study Overview

• Status: Recruiting
• Conditions: Dry Eye; Dry Eye Syndromes; Dry Eye Disease
• Intervention / Treatment: Drug: Methylhydroxypropylcellulose; Drug: Carbomer; Drug: TCM Formula

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Teng-I Huang, MD; Phone Number: +886-4-22052121; Email: d31204@mail.cmuh.org.tw

Study Locations

• Taiwan
  • Taichung, Taiwan, 404332
    • Recruiting
    • China Medical University Hospital
    • Contact: Teng-I Huang, MD; Phone Number: +886-4-22052121; Email: d31204@mail.cmuh.org.tw
    • Principal Investigator: Hui-Ju Lin, PhD
    • Sub-Investigator: Hung-Jen Lin, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: conventional treatment; 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.	Drug: Methylhydroxypropylcellulose; 1-2 drips each time, every 4 hours, for 12 weeks.; Other Names: Artelac® Eye Drops; Drug: Carbomer; 1 drip each time, at bedtime, for 12 weeks.; Other Names: Vidisic® Gel
Experimental: conventional treatment + TCM; Patients in this group will be given conventional treatment and traditional Chinese medicine (6.0g twice daily) for 12 weeks.	Drug: Methylhydroxypropylcellulose; 1-2 drips each time, every 4 hours, for 12 weeks.; Other Names: Artelac® Eye Drops; Drug: Carbomer; 1 drip each time, at bedtime, for 12 weeks.; Other Names: Vidisic® Gel; Drug: TCM Formula; 6.0g Chi-Ju-Di-Huang-Wan plus 6.0g Jia-Wei-Xiao-Yao-San, 6.0g twice daily for 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Change from baseline NiBUT at week 4, week 8 and week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tear Meniscus Height	Measured by Antares Corneal Topography.	Change from baseline Tear meniscus height at week 4, week 8 and week 12
Meibomian Gland Loss Rate	Measured by Antares Corneal Topography.	Change from baseline Meibomian gland loss rate at week 4, week 8 and week 12
Tear Cytokines		Change from baseline Tear cytokines at week 4, week 8 and week 12
Ocular Surface Disease Index (OSDI)		Change from baseline OSDI at week 4, week 8 and week 12

Collaborators and Investigators

• Sponsor: China Medical University Hospital
• Investigators: Principal Investigator: Hui-Ju Lin, PhD, China Medical University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 16, 2021
• Primary Completion (Anticipated): May 31, 2022
• Study Completion (Anticipated): May 31, 2022

Study Registration Dates

• First Submitted: March 3, 2021
• First Submitted That Met QC Criteria: March 3, 2021
• First Posted (Actual): March 5, 2021

Study Record Updates

• Last Update Posted (Actual): December 6, 2021
• Last Update Submitted That Met QC Criteria: December 3, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Eye Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Pharmaceutical Solutions; Ophthalmic Solutions
• Other Study ID Numbers: CMUH109-REC2-169

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No