Efficacy and Safety of Piclosept in the Complex Treatment of Neonatal Dacryocystitis

This single-center, prospective, randomized, controlled, assessor-blinded study will evaluate the efficacy and safety of Piclosept® ophthalmic solution as an adjunct to standardized lacrimal sac massage in children aged 1 to 12 months with neonatal dacryocystitis. Participants will be randomized in a 1:1:1 ratio to standardized lacrimal sac massage alone, massage plus preservative-free levofloxacin, or massage plus Piclosept®. The primary outcome is clinical success on Day 14, defined as complete absence of purulent-mucoid discharge and reflux of purulent-mucoid material.

Inclusion Criteria Age 1 to 12 months inclusive. Clinical diagnosis of neonatal dacryocystitis. Purulent-mucoid discharge for at least 3 days before screening and/or reproducible reflux of purulent-mucoid material from the lacrimal puncta upon compression of the lacrimal sac. Absence of signs of acute complicated dacryocystitis. Ability of the legal representative to perform lacrimal sac massage and instillation procedures and attend scheduled follow-up visits. Written informed consent from the legal representative before any study procedures. Exclusion Criteria Fever, lethargy, or other systemic signs of infection. Painful swelling, marked skin hyperemia or fluctuation over the lacrimal sac, dacryocele/mucocele, fistula, abscess, preseptal or orbital cellulitis. Keratitis, corneal ulcer, severe blepharitis, or another condition requiring immediate treatment outside the protocol. Eyelid, lacrimal punctum, canalicular, facial, or nasal abnormalities considered by the investigator to be the primary cause of impaired tear drainage. Previous probing, intubation, balloon dacryoplasty, or other surgery involving the lacrimal drainage system. Topical antiseptic or antibiotic treatment within 72 hours before randomization or systemic antibiotics within 7 days before randomization. Need for continued use of any topical antimicrobial treatment not specified in the protocol. Known hypersensitivity to picloxidine or any component of Piclosept®. Immunodeficiency, severe concomitant disease, or prematurity with unstable clinical condition. Any circumstance that, in the investigator's opinion, makes participation unsafe or prevents reliable protocol compliance.