Neonatal DacryocystitisPhase 4NCT07875517
Efficacy and Safety of Piclosept in the Complex Treatment of Neonatal Dacryocystitis
A Phase 4 study testing Picloxidine, Levofloxacin and Standardized lacrimal sac massage in people with Neonatal Dacryocystitis and Congenital Nasolacrimal Duct Obstruction, run by Kazakh Eye Research Institute at 1 site in Kazakhstan.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 month to 12 months
- Conditions the study is for
- Neonatal Dacryocystitis, Congenital Nasolacrimal Duct Obstruction
- What is being tested?
- Picloxidine, Levofloxacin and Standardized lacrimal sac massage
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteKazakhstan
- Study dates
- 25 Aug 2026to 20 Nov 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 12 months
- All sexes
- No healthy volunteers
- Child
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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the detailed description
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.
- Being tested
- Picloxidine, Levofloxacin, Standardized lacrimal sac massage
- Keywords
- Congenital Nasolacrimal Duct Obstruction, Piclosept, Picloxidine, Lacrimal sac massage, Purulent-mucoid discharge, Pediatric ophthalmology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PicloxidineDrug
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.
LevofloxacinDrug
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 massageProcedure or surgery
Standardized lacrimal sac massage performed four times daily for 14 days.
| Study group | Role | What they receive |
|---|---|---|
| Standardized Lacrimal Sac Massage | Other | Participants receive standardized lacrimal sac massage four times daily for 14 days. Receives: Procedure: Standardized lacrimal sac massage |
| Lacrimal Sac Massage Plus Levofloxacin | Active comparator | 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. Receives: Drug: Levofloxacin |
| Lacrimal Sac Massage Plus Piclosept | Experimental | 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. Receives: Drug: Picloxidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Day 14 ± 2
Secondary outcomes (9)
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.
Measured: Day 7 ± 1
Change in severity of purulent-mucoid discharge
Change in severity of purulent-mucoid discharge
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Days 11-14
Treatment adherence
Proportion of prescribed doses administered during the treatment period, assessed using the participant diary and returned study product.
Measured: From Day 0 through Day 14
Adverse events
Incidence and severity of adverse events occurring from randomization through the end of the study.
Measured: From randomization through Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2026
- Study start25 Aug 2026
- Primary completion20 Nov 2026 (estimated)
- Study completion20 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal DacryocystitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomly assigned to parallel study groups and receive the assigned intervention according to the study protocol.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kazakh Eye Research Institute
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Kairat Ruslanuly, Principal investigator, Kazakh Research Institute of Eye Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07875517
- Sponsor's protocol ID
- 16-2026
- Status last verified
- Oct 2026
- First submitted
- 25 Aug 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07875517
- Acronym / sponsor ID
- 16-2026
- Keywords
- Congenital Nasolacrimal Duct Obstruction, Piclosept, Picloxidine, Lacrimal sac massage, Purulent-mucoid discharge, Pediatric ophthalmology
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Kazakh Eye Research InstituteResearch network
- Study start
- 25 Aug 2026 (actual)
- Primary completion
- 20 Nov 2026 (estimated)
- Study completion
- 20 Nov 2026 (estimated)
- First posted
- 15 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Participants are randomly assigned to parallel study groups and receive the assigned intervention according to the study protocol.
| Arm | Type | Receives |
|---|---|---|
| Standardized Lacrimal Sac Massage | Other | Procedure: Standardized lacrimal sac massageParticipants receive standardized lacrimal sac massage four times daily for 14 days. |
| Lacrimal Sac Massage Plus Levofloxacin | Active comparator | Drug: LevofloxacinParticipants 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. |
| Lacrimal Sac Massage Plus Piclosept | Experimental | Drug: PicloxidineParticipants 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. |
Who may qualify
- Ages
- 1 month to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PicloxidinePicloxidine 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 | Lacrimal Sac Massage Plus Piclosept |
| LevofloxacinPreservative-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. | Drug | Lacrimal Sac Massage Plus Levofloxacin |
| Standardized lacrimal sac massageStandardized lacrimal sac massage performed four times daily for 14 days. | Procedure or surgery | Standardized Lacrimal Sac Massage |
Primary outcome
Resolution of congenital nasolacrimal duct obstruction
Time frame: Baseline to Day 14
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.
Clinical success at Day 14
Time frame: Day 14 ± 2
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.
9 secondary outcomes
Clinical success at Day 7
Time frame: Day 7 ± 1
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
Time frame: Baseline, Day 7 ± 1 and Day 14 ± 2
Change in conjunctival hyperemia
Time frame: Baseline, Day 7 ± 1, and Day 14 ± 2
Time to first complete disappearance of discharge
Time frame: From initiation of treatment through Day 14
Need for rescue therapy
Time frame: From randomization through Day 14
Recurrence of discharge after completion of treatment
Time frame: Days 11-14
Treatment adherence
Time frame: From Day 0 through Day 14
Adverse events
Time frame: From randomization through Day 14
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kairat Ruslanuly principal investigator
Kazakh Research Institute of Eye Diseases
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Picloxidine, Levofloxacin and Standardized lacrimal sac massage in people with Neonatal Dacryocystitis and Congenital Nasolacrimal Duct Obstruction, run by Kazakh Eye Research Institute at 1 site in Kazakhstan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kazakhstan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resolution of congenital nasolacrimal duct obstruction (time frame: Baseline to Day 14). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026; AzTrials last refreshed its copy on 8 Nov 2026.