Xerophthalmia
Conditions
Interventions
Experimental group:Sodium hyaluronate eye drops (0.1%), 1 drop, 5 times a day. Oral Zhangyanming tablets, 2 tablets each time, 3 times a day.
Control group:Sodium hyaluronate eye drops (0.1%), 1 drop, 5 times a day. Oral Zhangyanming placebo tablets, 2 tablets each time, 3 times a day.
Sponsors
Zhongshan Ophthalmic Center Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
40 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Agree to participate in the clinical trial and sign the informed consent form; 2. Meet the diagnostic criteria of xerophthalmia; 3. Meet the diagnostic criteria of TCM of GanShenyinxu syndrome; 4. Aged 40-75 years, no gender limit; 5. Simple dry eye disease; 6. Before entering the group, no other drug treatment was used, or other drug treatment was used, but the drug was stopped for more than 2 weeks; 7. Binocular corrected visual acuity >= 0.2.
Exclusion criteria
Exclusion criteria: 1. Known or suspected allergic history or severe adverse reaction to the test drug and its excipients, or allergic constitution. 2. Systemic diseases, diabetes, glaucoma. 3. Complicated with severe liver and kidney disease, or abnormal liver and kidney function (ALT and AST >= 1.5 times the upper limit of normal, SCr > the upper limit of normal). 4. Unable to cooperate or unwilling to cooperate because of neurological or mental illness. 5. Suspected or confirmed history of alcohol and drug abuse. 6. Pregnant or lactating patients or those who have recently planned to give birth. 7. Patients in other situations considered unsuitable by the researchers for this study. 8. Patients who had participated in other clinical trials within 1 month before inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| tear film break time (BUT);Schirmer ? test;Ocular Surface Disease Index; | — |
Secondary
| Measure | Time frame |
|---|---|
| fluorescein staining of cornea and conjunctiva;TCM syndrome score; | — |
Countries
China
Contacts
Public ContactGu Jianjun
Outcome results
None listed