NCT04785261

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: China Medical University Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Dry Eye Disease
• Dry Eye Syndromes
• Dry Eye

Interventions

Type	Name	Description
DRUG	Methylhydroxypropylcellulose	1-2 drips each time, every 4 hours, for 12 weeks.
DRUG	Carbomer	1 drip each time, at bedtime, for 12 weeks.
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.

Timeline

• Start date: 2021-03-16
• Primary completion: 2022-05-31
• Completion: 2022-05-31
• First posted: 2021-03-05
• Last updated: 2021-12-06

Locations

1 site across 1 country: Taiwan