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Efficacy and Safety of Piclosept in the Complex Treatment of Neonatal Dacryocystitis
Sponsor: Kazakh Eye Research Institute
Summary
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.
Official title: A Single-Center, Prospective, Randomized, Controlled, Assessor-Blinded Study Evaluating the Efficacy and Safety of the Antiseptic Ophthalmic Solution Piclosept in the Complex Treatment of Neonatal Dacryocystitis
Key Details
Gender
All
Age Range
1 Month - 12 Months
Study Type
INTERVENTIONAL
Enrollment
90
Start Date
2026-08-25
Completion Date
2026-11-20
Last Updated
2026-10-15
Healthy Volunteers
No
Interventions
Picloxidine
Picloxidine 0.5 mg/mL ophthalmic solution; one drop in the affected eye four times daily for 10 days, in addition to standardized lacrimal sac massage.
Levofloxacin
Preservative-free levofloxacin ophthalmic solution 5 mg/mL; one drop in the affected eye four times daily for 10 days, in addition to standardized lacrimal sac massage.
Standardized lacrimal sac massage
Standardized lacrimal sac massage performed four times daily for 14 days.
Locations (1)
Kazakh Eye Research Institute
Almaty, Kazakhstan