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

Inclusion Criteria: Participants must meet all of the following inclusion criteria to be enrolled in this study.

1. Aged 18 to 70 years old;

2. Clinically diagnosed with herpes simplex virus stromal keratitis;

3. Tear swab HSV-1 nucleic acid test (qPCR method) positive;

4. No use of systemic antiviral drugs or corticosteroids within 48 hours beforeenrollment;

5. No systemic immune eye diseases;

6. Good eyelid structure and blinking function;

7. Eye structure and function assessment showing potential for visual recovery;

8. No retinal detachment, with generally normal visual function;

9. No history of corneal trauma;

10. Visual acuity in the fellow eye is better than 20/200;

11. Fertile males or females must use highly effective contraceptive methods (such asoral contraceptives, intrauterine devices, abstinence, or barrier contraceptioncombined with spermicides) during the trial and continue contraception for 12 monthsafter administration;

12. Participants voluntarily join the study, sign an informed consent form, have goodcompliance, and cooperate with follow-up visits.

Exclusion Criteria: Patients with any of the following conditions cannot be enrolled in this study

1. Active ocular infection caused by other pathogens in the target eye or the felloweye 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 sodiumfluorescein, 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 receivingantibiotic 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, mainlyincluding 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 diastolicblood pressure ≥100 mmHg;

• Uncontrolled diabetes, fasting blood glucose greater than or equal to 8.0 μmol/L;

• Cardiovascular disease history, with arrhythmia, myocardial ischemia, andmyocardial infarction (diagnosed by electrocardiogram examination);

• Platelet level ≤ 100×10^9/μL or ≥ 450×10^9/μL due to any cause, hemoglobinlevel 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 urinepregnancy 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 theinvestigator.