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ACTIVE NOT RECRUITING
NCT07875517
PHASE4

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

Sponsor: Kazakh Eye Research Institute

View on ClinicalTrials.gov

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

DRUG

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.

DRUG

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.

PROCEDURE

Standardized lacrimal sac massage

Standardized lacrimal sac massage performed four times daily for 14 days.

Locations (1)

Kazakh Eye Research Institute

Almaty, Kazakhstan