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
Sponsor study identifier
interventional
90
1 country
1
Study Start
August 25, 2026
Actual (reported)Primary Completion
November 20, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
November 20, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 20, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 25, 2026
Actual (reported)August 25, 2026
Actual (reported)October 15, 2026
Actual (reported)November 20, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
November 20, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Resolution of congenital nasolacrimal duct obstruction
The primary outcome is the proportion of patients demonstrating clinical resolution of nasolacrimal duct obstruction by Day 14 of treatment. Resolution is defined as the absence of persistent tearing or tear pooling, absence of mucous or mucopurulent discharge, and restoration of lacrimal drainage as confirmed by a functional lacrimal drainage test.
Baseline to Day 14
Clinical success at Day 14
Proportion of participants with complete absence of purulent-mucoid discharge during the preceding 24 hours according to the legal representative and absence of spontaneous discharge or reflux of purulent-mucoid material during clinical examination.
Day 14 ± 2
Clinical success at Day 7
Day 7 ± 1
Change in severity of purulent-mucoid discharge
Baseline, 12, 24, 48 hours, Day 3, Day 7, Day 10 and Day 14
Change in lacrimation
Baseline, Day 7 ± 1 and Day 14 ± 2
Change in conjunctival hyperemia
Baseline, Day 7 ± 1, and Day 14 ± 2
Time to first complete disappearance of discharge
From initiation of treatment through Day 14
Participants receive standardized lacrimal sac massage four times daily for 14 days.
Participants receive standardized lacrimal sac massage four times daily for 14 days plus preservative-free levofloxacin ophthalmic solution 5 mg/mL, one drop four times daily for 10 days.
Participants receive standardized lacrimal sac massage four times daily for 14 days plus Piclosept® ophthalmic solution containing picloxidine 0.5 mg/mL, one drop in the affected eye four times daily for 10 days.
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.
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.
Kazakh Eye Research Institute
Almaty, 050000, Kazakhstan
Kairat Ruslanuly
Kazakh Research Institute of Eye Diseases
First Submitted
August 25, 2026
First Posted
October 15, 2026
Study Start
August 25, 2026
Actual (reported)Levofloxacin Pharmacokinetics (PK) in the Severely Obese
Standardized lacrimal sac massage performed four times daily for 14 days.
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Primary Completion
November 20, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
November 20, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 15, 2026
Record last verified: 2026-10
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Source: ClinicalTrials.gov.
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