A Phase Ⅱa Study of the Safety, Tolerability and Efficacy of BD111 in Herpes Simplex Virus Type I Stromal Keratitis

Exclusion Criteria

• •1. Active ocular infection caused by other pathogens in the target eye or the fellow eye within 30 days before enrollment, including but not limited to blepharitis, infectious conjunctivitis, keratitis, scleritis, and endophthalmitis;
• •2. Patients with bilateral viral keratitis
• •3. Previous corneal transplant surgery in the study eye;
• •4. A history of adverse reactions or allergies to corticosteroids and sodium fluorescein, allergies to therapeutic or diagnostic protein products, allergies to ≥ two drugs or non-drug factors, or having an ongoing allergic disease;
• •5. Absence of tear film and blinking function;
• •6. Severe dry eye disease;
• •7. Malignant ocular surface tumor;
• •8. Glaucoma;
• •9. Patients with systemic autoimmune diseases;
• •10. Signs of systemic infection before enrollment, including fever and receiving antibiotic treatment (abnormal elevating values in white blood cells, lymphocytes, and neutrophils in routine blood tests);
• •11. Abnormal major organ function or other uncontrolled clinical problems, mainly including but not limited to the following:
• •* Severe kidney disease history, serum creatinine ≥ 133μmol/L;
• •* Liver dysfunction, transaminase level ≥ 80 IU/L;
• •* Uncontrolled hypertension, systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg;
• •* Uncontrolled diabetes, fasting blood glucose greater than or equal to 8.0 μmol/L;
• •* Cardiovascular disease history, with arrhythmia, myocardial ischemia, and myocardial infarction (diagnosed by electrocardiogram examination);
• •* Platelet level ≤ 100×10\^9/μL or ≥ 450×10\^9/μL due to any cause, hemoglobin level lower than 10.0g/dL (male) or 9.0g/dL (female).
• •12. HIV infection;
• •13. Pregnant and lactating women (pregnancy in this trial is defined as a positive urine pregnancy test);
• •14. Participation in other drug or medical device clinical trials;
• •15. Alcohol or drug abuse;
• •16. Lack of compliance with the trial or the ability to sign an informed consent form;
• •17. Other situations deemed unsuitable for participation in the trial by the investigator.