Dry eye
Conditions
Interventions
Treatment Group:Cyclosporin A eye gel, Hypromellose eye drops
Control group:Placebo
Sponsors
The Second Affiliated Hospital of Anhui Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1) Ages from 18 to 80, regardless of gender; 2) According to the symptoms, signs and ophthalmic examination, subjects should meet the following 4 points at the same time and be diagnosed as moderate to severe dry eyes: A) EDS score, i.e. dryness score (VAS score of 0-100 points) >= 40 points; B) Tear film break-up time (BUT) = 2; 3) Agree to participate in this study and voluntarily sign the informed consent.
Exclusion criteria
Exclusion criteria: 1) Patients with severe dry eyes requiring surgical treatment; 2) Had inner eye surgery within 12 months prior to screening or required inner eye surgery during the study period; Eyelid surgery was performed within 6 months before screening; 3) Patients receiving permanent lacrimal insertion or patients receiving temporary lacrimal insertion within 6 months prior to screening; 4) Operation-induced dry eye; 5) Glaucoma patients; 6) Patients who cannot avoid wearing contact lenses during the study; 7) Active infection of the whole body or eyes; 8) Patients with multiple episodes of viral keratitis; 9) Patients with pemphigus with ocular scar, obvious conjunctiva scar, chemical burns of the eyes, and neurotrophic keratoconjunctivitis; 10) Patients with malignant tumors in the past 5 years, except the thoroughly cured basal cell carcinoma of skin, squamous cell carcinoma in situ of skin, and primordial cervical cancer; 11) Perimenopausal women who are taking hormone replacement therapy; 12) Patients who cannot stop using other eye drops and other ophthalmic preparations during the study period; 13) Patients with severe cardiopulmonary diseases, uncontrolled hypertension and diabetes, etc. that affect the collection or compliance of study parameters; 14) Laboratory examination of ALT and AST >= 2 times of the normal upper limit and serum creatinine (Cr) >= 1.5 times of the normal upper limit; 15) Has a history of central nervous system disease or epilepsy, and/or is unable to cooperate with a mental state; 16) Women who are pregnant or breastfeeding, or women or men of childbearing age are unable to use effective contraceptive methods during the study period; 17) Screening those who have participated in other clinical trials or are participating in other clinical trials within the previous month; 18) Screening for systemic or ocular local use of cyclosporin drugs within 1 month before; 19) Known allergy to cyclosporin, fluorescein, or any component of the study drug; 20) Patients considered unsuitable for the study by the researchers, including those who were unable or unwilling to comply with protocol requirements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ocular surface microorganism; | — |
Secondary
| Measure | Time frame |
|---|---|
| OSDI assessment;BUT;Schirmer test;Corn conjunctiva staining and photography;Slit-lamp examinatio; | — |
Countries
China
Contacts
Public ContactQing Zhang
The Second Affiliated Hospital of Anhui Medical University
Outcome results
None listed