Dry eye disease
Conditions
Interventions
Group of Runmu Granules + Placebo Eye Drops:Runmu Granules shall be dissolved in boiling water for oral administration twice daily, combined with Polyvinyl Alcohol Eye Drops instilled 1-2 drops each t
Placebo + Polyvinyl Alcohol Eye Drops Group:The placebo shall be dissolved in boiling water for oral administration twice daily, combined with Polyvinyl Alcohol Eye Drops instilled 1-2 drops per time,
Sponsors
China Academy of Chinese Medical Sciences Ophthalmic Hospital
Eligibility
Sex/Gender
All
Age
35 Years to 70 Years
Inclusion criteria
Inclusion criteria: (1) Patients with aqueous-deficient dry eye meeting the Western medical diagnostic criteria;(2) TCM syndrome differentiation consistent with qi-yin deficiency type;(3) Aged 35-70 years old;(4) Patients who have signed the informed consent form and voluntarily participated in this clinical study.
Exclusion criteria
Exclusion criteria: (1) Patients with ocular surface diseases that affect observation and efficacy evaluation, such as keratitis, corneal ulcer, iridocyclitis, and pterygium;(2) Patients with diseases that significantly affect physical status, such as tumors and liver cirrhosis;(3) Patients with systemic autoimmune diseases, such as Sjögren's syndrome;(4) Patients scheduled for surgery during the trial period;(5) Patients participating in other research trials simultaneously during the treatment and observation period;(6) Patients using drugs that interfere with efficacy during the medication period, such as anticholinergic drugs and corticosteroids;(7) Pregnant or lactating women, and patients with allergies;(8) Patients with poor compliance who cannot cooperate with treatment and observation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| fluorescein breakup time,FBUT;Tear Secretion Test (Schirmer I Test);Reduce the frequency of artificial tear instillation.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Measurement of tear meniscus height (TMH);(corneal fluorescein staining,CFS);Meibomian Gland Function Assessment;Dry Eye Symptom Score;TCM syndrome score;Serum lipid metabolism; | — |
Countries
China
Contacts
Public ContactYan jing
China Academy of Chinese Medical Sciences Ophthalmic Hospital
Outcome results
None listed