A Study of the Safety, Tolerability and Prelinminary 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 patients with recurrent herpes simplex virus type I stromalkeratitis (HSK). Definition of recurrence: the patient had been diagnosed with HSKand received "local antiviral eye drugs and oral antiviral drugs + localglucocorticoid eye drops" for 3 weeks with successful clinical efficacy. Beforeenrollment, the clinical recurrence of HSK occurred again with symptoms includingtearing, photophobia, pain, blurred vision and foreign body sensation, and signs asrecurrence of active inflammatory lesions examined by slit lamp;

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

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

5. No systemic immune diseases;

6. Good eyelid structure and blinking function;

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

8. No retinal detachment;

9. No history of corneal trauma;

10. The best visual acuity in the fellow eye (BCVA) ≥ 38 (ETDRS);

11. Fertile males or females must use highly effective contraceptive methods, such as,oral 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 infectiousconjunctivitis, keratitis, scleritis, and endophthalmitis;

2. Patients with bilateral viral keratitis

3. Previous corneal transplant surgery in the study eye;

4. Any medicine or food allergic history;

5. Absence of tear film and blinking function;

6. Severe dry eye disease;

7. Ocular surface tumor;

8. Glaucoma;

9. Patients with systemic autoimmune diseases;

10. Signs of systemic infection before enrollment, including fever and receivingantibiotic treatment (systemic infection in this trial is defined as abnormal valuesin white blood cells, lymphocytes, and neutrophils in routine blood tests);

11. Severe diseases in the major organs including but not limited to cardiovascular,lung, liver, kidney, or other uncontrolled diseases;

12. HIV infection;

13. Pregnant and lactating women (pregnancy in this trial is defined as a positive urineor blood pregnancy test);

14. Participation in other drug or medical device clinical trials at present;

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.