A Phase 4 interventional study of Picloxidine and Levofloxacin in Neonatal Dacryocystitis and Congenital Nasolacrimal Duct Obstruction, sponsored by Kazakh Eye Research Institute. Active, not recruiting at 1 site in Kazakhstan. Open to participants aged 1 Month to 12 Months. Per ClinicalTrials.gov, last updated 2026-10-15.
Sponsored by Kazakh Eye Research Institute · Phase 4, Interventional, and Treatment
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.
Neonatal dacryocystitis is commonly associated with congenital nasolacrimal duct obstruction and may present with purulent-mucoid discharge and reflux from the lacrimal puncta. Standard conservative management includes lacrimal sac massage, while topical antimicrobial treatment may be used when clinically indicated.
This study will evaluate whether adding Piclosept® ophthalmic solution containing picloxidine 0.5 mg/mL to standardized lacrimal sac massage provides additional short-term clinical benefit compared with standardized massage alone and massage combined with preservative-free levofloxacin. The study will include children aged 1 to 12 months with clinical signs of neonatal dacryocystitis.
Participants will be randomly assigned in a 1:1:1 ratio to three parallel treatment groups. All participants will receive standardized lacrimal sac massage. The intervention group will additionally receive Piclosept®, while the active comparator group will receive preservative-free levofloxacin. Treatment with the study eye drops will continue for 10 days, while standardized massage will continue for 14 days.
Clinical assessments will be performed at baseline, Day 7, and Day 14. The primary assessment will determine clinical success at Day 14 based on the absence of purulent-mucoid discharge and reflux. Additional assessments will evaluate the early course of symptoms, treatment tolerability, adherence, rescue therapy, recurrence, and adverse events.
The study uses a masked outcome assessor to reduce potential assessment bias. The study is conducted at the Kazakh Research Institute of Eye Diseases in Almaty, Kazakhstan.
Kazakh Eye Research Institute is the lead sponsor of 7 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Participants receive standardized lacrimal sac massage four times daily for 14 days.
Procedure: Standardized lacrimal sac massage
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.
Drug: Levofloxacin
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.
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.
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 performed four times daily for 14 days.
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.
Time frame: 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.
Time frame: Day 14 ± 2
Clinical success at Day 7
Proportion of participants with clinical success at Day 7, defined as absence of discharge reported by the legal representative during the preceding 24 hours and absence of spontaneous discharge or purulent-mucous reflux on examination.
Time frame: Day 7 ± 1
Change in severity of purulent-mucoid discharge
Change in severity of purulent-mucoid discharge
Time frame: Baseline, 12, 24, 48 hours, Day 3, Day 7, Day 10 and Day 14
Change in lacrimation
Change from baseline in the severity of tearing, assessed using a 4-point ordinal scale from 0 (absent) to 3 (severe).
Time frame: Baseline, Day 7 ± 1 and Day 14 ± 2
Change in conjunctival hyperemia
Change from baseline in the severity of conjunctival hyperemia, assessed using a 4-point ordinal scale from 0 (absent) to 3 (severe).
Time frame: Baseline, Day 7 ± 1, and Day 14 ± 2
Time to first complete disappearance of discharge
Time from initiation of treatment to the first complete disappearance of purulent-mucous discharge, based on daily observations recorded by the legal representative.
Time frame: From initiation of treatment through Day 14
Need for rescue therapy
Proportion of participants requiring rescue therapy due to clinical deterioration, persistent or worsening symptoms, or other predefined criteria requiring treatment outside the assigned study intervention.
Time frame: From randomization through Day 14
Recurrence of discharge after completion of treatment
Proportion of participants with recurrence of purulent-mucous discharge after completion of the 10-day treatment course and before the Day 14 assessment.
Time frame: Days 11-14
Treatment adherence
Proportion of prescribed doses administered during the treatment period, assessed using the participant diary and returned study product.
Time frame: From Day 0 through Day 14
Adverse events
Incidence and severity of adverse events occurring from randomization through the end of the study.
Time frame: From randomization through Day 14
Started Aug 2026 (actual). Primary completion is estimated for Nov 2026, 2 months after the start.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Kazakh Eye Research Institute