A Phase ā ”a Study of the Safety, Tolerability and Efficacy of BD111 in Herpes Simplex Virus Type Iā¦ (NCT06474442) | Clinical Trial Compass
RecruitingPhase 2
A Phase ā ”a Study of the Safety, Tolerability and Efficacy of BD111 in Herpes Simplex Virus Type I Stromal Keratitis
China40 participantsStarted 2025-04-28
Plain-language summary
This study aims to compare the clinical efficacy and safety of BD111 injection in combination with standard therapy vs. standard therapy in herpes simplex virus type I stromal keratitis (HSK), providing preliminary confirmation of the clinical effectiveness of BD111 in combination with standard therapy.
Who can participate
Age range18 Years ā 70 Years
SexALL
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Inclusion criteria
ā. Aged 18 to 70 years old;
ā. Clinically diagnosed with herpes simplex virus stromal keratitis;
ā. Tear swab HSV-1 nucleic acid test (qPCR method) positive;
ā. No use of systemic antiviral drugs or corticosteroids within 48 hours before enrollment;
ā. No systemic immune eye diseases;
ā. Good eyelid structure and blinking function;
ā. Eye structure and function assessment showing potential for visual recovery;
ā. No retinal detachment, with generally normal visual function;
Exclusion criteria
ā. 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;
ā. Patients with bilateral viral keratitis
ā. Previous corneal transplant surgery in the study eye;
ā. A history of adverse reactions or allergies to corticosteroids and sodium fluorescein, allergies to therapeutic or diagnostic protein products, allergies to ā„ two drugs or non-drug factors, or having an ongoing allergic disease;
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What they're measuring
1
Clinical cure rate of HSK at Day 70 and Day112 post-administration