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

• Status: Recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: China Medical University Hospital
• Treatments: Carbopol 940; Ophthalmic Solutions

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.