Fungal keratitis
Conditions
Interventions
Experimental group (Patients with fungal keratitis):CH001 eye drops were applied to the affected eye, 1 drop/eye/time.
1) Initial regimen: the first 3 hours, every 30 minutes of eye drops, 3 hours lat
2) After 3 days of medication, the investigator reduced the frequency of administration according to the eye condition of the subjects: once every 1.5 hours, 1 drop once, 8 times a day
3) After 7 days of treatment, the frequency of administration was reduced to 1 drop every 3 hours, 4 times a day until the end of 14 days of treatment.
Sponsors
Shandong Eye Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. The subjects were fully aware of the purpose, nature, methods and possible adverse reactions of the trial, were willing to communicate well with the investigators, understood and respected the requirements of the study, and signed the written informed consent; 2. Age 18-80 years old, regardless of gender; 3. Clinical diagnosis of fungal keratitis with: 1) The corneal lesion area was confirmed to be fungal infection (fungal hyphae were found by corneal scraping microscopy); 2) or identification of fungal hyphae by laser confocal microscopy; 3) the subject's largest measurable fungal keratitis lesion (based on fluorescein staining), with a maximum diameter of >=2mm and <=5mm, and invading no more than the anterior half of the corneal stroma (based on OCT measurement).
Exclusion criteria
Exclusion criteria: 1. Any eye combined with other eye diseases including but not limited to: night blindness, color blindness, eyelid dysclosure, other ocular infectious diseases and ocular trauma (except trauma causing fungal keratitis); And patients with fungal keratitis in both eyes; 2. Any eye had a history of intraocular surgery and laser surgery; Patients with vision in one eye; Patients with one eye; 3. Patients with symptoms or related history of any major diseases, including but not limited to the cardiovascular and cerebrovascular system, digestive system, respiratory system, skin, blood, endocrine, rheumatic immune, nervous system, mental system, and tumor history, or any other diseases or physiological conditions that may interfere with the results of the trial in the judgment of the investigators; 4. Abnormalities in clinical laboratory tests (routine blood test, urine test, blood biochemistry, glycosylated hemoglobin, fasting blood glucose) and 12-lead electrocardiogram that are judged to be clinically significant (repeat tests can be used to confirm if necessary) during screening, or at least one of the following: (1) fasting blood glucose level >=7.0mmol/L, and/or glycosylated hemoglobin >= 6.5%; Alanine aminotransferase (ALT) or aspartate aminotransferase (AST)>=1.5 times the upper limit of normal (ULN); (3) Total bilirubin (TBIL)>=1.5 times upper limit of normal value (ULN) 5. Subjects who used and/or could not stop using the following drugs or foods within 1 month before enrollment: (1) Immunosuppressive agents (including but not limited to tacrolimus, sirolimus, etc.); (2) Glucocorticoid drugs 6. Patients with active infection (except eye) or other acute diseases during the screening period; 7. Received a live attenuated vaccine within 3 months before enrollment or plan to receive a live attenuated vaccine during the study period; 8. Patients who had undergone major organ surgery (excluding diagnostic surgery) within 3 months before enrollment or had not recovered after surgery or needed surgery during the study period; 9. Use of any investigational drug within the 5 half-lives (if known) prior to the screening period or within 3 months (whichever is longer); 10. If the female subjects are pregnant or lactating, or if the male and female subjects plan to give birth within 6 months after the end of the study; 11. Other circumstances considered by the investigator to be inappropriate for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in corneal lesion area from baseline after 14 days of treatment (visit 3); | — |
Secondary
| Measure | Time frame |
|---|---|
| The changes of corneal lesion area at each visit (except visit 3) after treatment were compared with baseline;The depth of corneal lesions at each visit after treatment was changed from baseline;Changes in ocular pain from baseline at each visit after medication;Changes in the degree of conjunctival hyperemia from baseline at each visit after medication; | — |
Countries
China
Contacts
Public ContactWang Ting
Shandong Eye Hospital
Outcome results
None listed