Chronic DacryocystitisPhase 2NCT07499791
Absorbable Drug-Eluting Lacrimal Sac Stent for Recurrent Chronic Dacryocystitis
A Phase 2 study testing Absorbable Lacrimal Sac Drug-Eluting Stent and Conventional Ostium Packing with Budesonide Nasal Spray in people with Chronic Dacryocystitis, run by Beijing Tongren Hospital at 2 sites in China.
Trial summary
This study aims to evaluate the safety and effectiveness of an absorbable lacrimal sac drug-eluting stent placed at the osteotomy site during endoscopic endonasal dacryocystorhinostomy (E-DCR) in patients with recurrent chronic dacryocystitis. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Dacryocystitis
- What is being tested?
- Absorbable Lacrimal Sac Drug-Eluting Stent and Conventional Ostium Packing with Budesonide Nasal Spray
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 2 sitesChina
- Study dates
- 1 May 2026to 1 Dec 2027
- Phase
- Phase 2
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed chronic dacryocystitis
- History of failed E-DCR or lacrimal intubation
- Preoperative dacryocystography showing lacrimal sac diameter ≥4 mm
- Age ≥18 years
- Able to consent and comply with procedures
Who cannot join
- Nasal cavity structural disease: severe septal deviation, tumor, severe sinusitis
- Lacrimal sac non-visualization on imaging
- Lacrimal sac rupture, traumatic duct/bone injuries
- Allergy to mometasone furoate or PLA/PGA polymers
- Poor general health, unable to tolerate surgery
- Psychiatric disorders or antipsychotic drug use
Show all 10Show fewer
- Uncontrolled hypertension, diabetes, or severe systemic diseases
- Keloid tendency
- Coagulation disorders
- Pregnancy
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Beijing Tongren Hospital
Beijing, Beijing Municipality, 100005
- Not yet recruiting
Beijing Tongren Hospital, Capital Medical University, Beijing, Beijing 100000
Beijing
chengshuo wang, +86-13911623569, wangcs830@126.com
About this study
Official title: A Prospective, Multicenter, Randomized Controlled Trial of an Absorbable Drug-Eluting Lacrimal Sac Stent in Recurrent Chronic Dacryocystitis Undergoing Endoscopic Endonasal Dacryocystorhinostomy
This study aims to evaluate the safety and effectiveness of an absorbable lacrimal sac drug-eluting stent placed at the osteotomy site during endoscopic endonasal dacryocystorhinostomy (E-DCR) in patients with recurrent chronic dacryocystitis. The stent is composed of absorbable polymer mesh coated with mometasone furoate to reduce postoperative inflammation and adhesion, maintain ostium patency, and improve surgical outcomes. A total of 40 patients will be randomized 1:1 to receive either the absorbable stent or conventional packing with routine postoperative intranasal budesonide therapy.
Read the detailed description
This is a prospective, multicenter, randomized, parallel-controlled clinical trial conducted to assess the safety and effectiveness of an absorbable lacrimal sac drug-eluting stent in patients with recurrent chronic dacryocystitis undergoing endoscopic endonasal dacryocystorhinostomy (E-DCR).
Eligible patients diagnosed with recurrent chronic dacryocystitis and meeting the inclusion criteria will be enrolled and randomly assigned in a 1:1 ratio to either the intervention group or the control group. Patients in the intervention group will receive implantation of an absorbable polymer mesh stent coated with mometasone furoate at the osteotomy site during E-DCR. Patients in the control group will undergo E-DCR with conventional packing, followed by routine postoperative intranasal budesonide therapy.
The absorbable drug-eluting stent is designed to locally release mometasone furoate to reduce postoperative inflammation and adhesion formation, thereby maintaining ostium patency and promoting mucosal healing. Patients will be followed postoperatively according to the study protocol, with scheduled assessments of clinical effectiveness, ostium formation, surgical indicators, recurrence, and patient satisfaction at predefined time points. Safety outcomes will include the incidence of procedure- or device-related adverse events throughout the follow-up period.
- Conditions
- Chronic Dacryocystitis
- Being tested
- Absorbable Lacrimal Sac Drug-Eluting Stent, Conventional Ostium Packing with Budesonide Nasal Spray
- Keywords
- Chronic Dacryocystitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Absorbable Lacrimal Sac Drug-Eluting StentDevice
Also called Absorbable Lacrimal Sac Steroid-Eluting Stent, LN1509, LN1209, LN0907
During E-DCR, the stent is implanted at the osteotomy site to provide mechanical separation and local release of mometasone furoate. The polymer scaffold is fully absorbable. Available models: LN1509 (15×9 mm), LN1209 (12×9 mm), LN0907 (9×7 mm).
Conventional Ostium Packing with Budesonide Nasal SprayDrug
Also called Budesonide Nasal Spray
After standard E-DCR, the ostium is packed with conventional materials. Postoperatively, participants use budesonide nasal spray (2 sprays/day) for 3 months. All other postoperative care is the same as in the experimental group.
| Study group | Role | What they receive |
|---|---|---|
| Absorbable Lacrimal Sac Drug-Eluting Stent | Experimental | Participants undergo endoscopic dacryocystorhinostomy (E-DCR) with implantation of an absorbable lacrimal sac drug-eluting stent (LN1509, LN1209, or LN0907; PuYi Biotech, Shanghai). The stent provides mechanical separation and sustained local release of mometasone furoate. Postoperatively, all participants receive systemic antibiotics for 1-3 days and topical low-dose corticosteroid and antibiotic eye drops for approximately 2 weeks. Nasal endoscopy and lacrimal irrigation are performed at 1 week, 2 weeks, 1 month, 2 months, and 3 months post-surgery. Granulation tissue is removed as necessary to maintain ostium patency. Receives: Device: Absorbable Lacrimal Sac Drug-Eluting Stent |
| Standard E-DCR with Conventional Packing | Placebo comparator | Participants undergo standard endoscopic dacryocystorhinostomy (E-DCR) without a stent. The ostium is packed with conventional materials. Postoperatively, participants receive the same systemic antibiotics and topical eye drops as the experimental group. Additionally, they use budesonide nasal spray (2 sprays/day) for 3 months. Nasal endoscopy and lacrimal irrigation follow the same schedule as the experimental group, with granulation tissue removed as needed. Receives: Drug: Conventional Ostium Packing with Budesonide Nasal Spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Clinical Effectiveness Rate at 3 Months
Based on symptom resolution and lacrimal irrigation:
Cured: complete symptom resolution and patent irrigation
Effective: mild tearing, patent or pressurized irrigation
Ineffective: persistent tearing or obstruction Total effectiveness = (cured + effective cases) / total × 100%.
Measured: 3 months postoperatively
Lacrimal Ostium Formation Rate at 3 Months
Assessment: endoscopic confirmation of epithelialized, patent ostium.
Measured: 3 months
Secondary outcomes (5)
Operation Time
Duration of surgery measured from incision to closure, reported in minutes.
Measured: During surgery
Intraoperative Blood Loss
Volume of blood loss during surgery, reported in milliliters (mL).
Measured: During surgery
Length of Hospital Stay
Number of days from surgery to hospital discharge.
Measured: Postoperative hospitalization (within 1 week)
Recurrence Rate
Definition: recurrence of tearing with obstruction confirmed by irrigation.
Measured: 3 months, 6 months, and 12 months
Patient Satisfaction Score
Scale: 0-100 (very satisfied 80-100, satisfied 60-79, dissatisfied <60).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2026
- Study start1 May 2026
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic DacryocystitisStudies of the same condition, open and under way.
- More trials run by Beijing Tongren HospitalThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tongren Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chengshuo Wang, Study chair, Beijing Tongren Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07499791
- Sponsor's protocol ID
- LN-DCR-2025
- Status last verified
- Aug 2026
- First submitted
- 27 Dec 2025
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Randomized Controlled Trial of an Absorbable Drug-Eluting Lacrimal Sac Stent in Recurrent Chronic Dacryocystitis Undergoing Endoscopic Endonasal Dacryocystorhinostomy
- ClinicalTrials.gov ID
- NCT07499791
- Acronym / sponsor ID
- LN-DCR-2025
- Conditions
- Chronic Dacryocystitis
- Keywords
- Chronic Dacryocystitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Beijing Tongren HospitalUniversity, hospital or other
- Study start
- 1 May 2026 (actual)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 30 Mar 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 study aims to evaluate the safety and effectiveness of an absorbable lacrimal sac drug-eluting stent placed at the osteotomy site during endoscopic endonasal dacryocystorhinostomy (E-DCR) in patients with recurrent chronic dacryocystitis. The stent is composed of absorbable polymer mesh coated with mometasone furoate to reduce postoperative inflammation and adhesion, maintain ostium patency, and improve surgical outcomes. A total of 40 patients will be randomized 1:1 to receive either the absorbable stent or conventional packing with routine postoperative intranasal budesonide therapy.
Detailed description
This is a prospective, multicenter, randomized, parallel-controlled clinical trial conducted to assess the safety and effectiveness of an absorbable lacrimal sac drug-eluting stent in patients with recurrent chronic dacryocystitis undergoing endoscopic endonasal dacryocystorhinostomy (E-DCR).
Eligible patients diagnosed with recurrent chronic dacryocystitis and meeting the inclusion criteria will be enrolled and randomly assigned in a 1:1 ratio to either the intervention group or the control group. Patients in the intervention group will receive implantation of an absorbable polymer mesh stent coated with mometasone furoate at the osteotomy site during E-DCR. Patients in the control group will undergo E-DCR with conventional packing, followed by routine postoperative intranasal budesonide therapy.
The absorbable drug-eluting stent is designed to locally release mometasone furoate to reduce postoperative inflammation and adhesion formation, thereby maintaining ostium patency and promoting mucosal healing. Patients will be followed postoperatively according to the study protocol, with scheduled assessments of clinical effectiveness, ostium formation, surgical indicators, recurrence, and patient satisfaction at predefined time points. Safety outcomes will include the incidence of procedure- or device-related adverse events throughout the follow-up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Absorbable Lacrimal Sac Drug-Eluting Stent | Experimental | Device: Absorbable Lacrimal Sac Drug-Eluting StentParticipants undergo endoscopic dacryocystorhinostomy (E-DCR) with implantation of an absorbable lacrimal sac drug-eluting stent (LN1509, LN1209, or LN0907; PuYi Biotech, Shanghai). The stent provides mechanical separation and sustained local release of mometasone furoate. Postoperatively, all participants receive systemic antibiotics for 1-3 days and topical low-dose corticosteroid and antibiotic eye drops for approximately 2 weeks. Nasal endoscopy and lacrimal irrigation are performed at 1 week, 2 weeks, 1 month, 2 months, and 3 months post-surgery. Granulation tissue is removed as necessary to maintain ostium patency. |
| Standard E-DCR with Conventional Packing | Placebo comparator | Drug: Conventional Ostium Packing with Budesonide Nasal SprayParticipants undergo standard endoscopic dacryocystorhinostomy (E-DCR) without a stent. The ostium is packed with conventional materials. Postoperatively, participants receive the same systemic antibiotics and topical eye drops as the experimental group. Additionally, they use budesonide nasal spray (2 sprays/day) for 3 months. Nasal endoscopy and lacrimal irrigation follow the same schedule as the experimental group, with granulation tissue removed as needed. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosed chronic dacryocystitis
- History of failed E-DCR or lacrimal intubation
- Preoperative dacryocystography showing lacrimal sac diameter ≥4 mm
- Age ≥18 years
- Able to consent and comply with procedures
Key exclusion criteria (10 listed)
- Nasal cavity structural disease: severe septal deviation, tumor, severe sinusitis
- Lacrimal sac non-visualization on imaging
- Lacrimal sac rupture, traumatic duct/bone injuries
- Allergy to mometasone furoate or PLA/PGA polymers
- Poor general health, unable to tolerate surgery
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 |
|---|---|---|
| Absorbable Lacrimal Sac Drug-Eluting StentAlso: Absorbable Lacrimal Sac Steroid-Eluting Stent, LN1509, LN1209, LN0907During E-DCR, the stent is implanted at the osteotomy site to provide mechanical separation and local release of mometasone furoate. The polymer scaffold is fully absorbable. Available models: LN1509 (15×9 mm), LN1209 (12×9 mm), LN0907 (9×7 mm). | Device | Absorbable Lacrimal Sac Drug-Eluting Stent |
| Conventional Ostium Packing with Budesonide Nasal SprayAlso: Budesonide Nasal SprayAfter standard E-DCR, the ostium is packed with conventional materials. Postoperatively, participants use budesonide nasal spray (2 sprays/day) for 3 months. All other postoperative care is the same as in the experimental group. | Drug | Standard E-DCR with Conventional Packing |
Primary outcome
Total Clinical Effectiveness Rate at 3 Months
Time frame: 3 months postoperatively
Based on symptom resolution and lacrimal irrigation: Cured: complete symptom resolution and patent irrigation Effective: mild tearing, patent or pressurized irrigation Ineffective: persistent tearing or obstruction Total effectiveness = (cured + effective cases) / total × 100%.
Lacrimal Ostium Formation Rate at 3 Months
Time frame: 3 months
Assessment: endoscopic confirmation of epithelialized, patent ostium.
5 secondary outcomes
Operation Time
Time frame: During surgery
Intraoperative Blood Loss
Time frame: During surgery
Length of Hospital Stay
Time frame: Postoperative hospitalization (within 1 week)
Recurrence Rate
Time frame: 3 months, 6 months, and 12 months
Patient Satisfaction Score
Time frame: 12 months
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 27 Aug 2026.
- Individual participant dataSharing planned: No
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.
Chengshuo Wang study chair
Beijing Tongren Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Absorbable Lacrimal Sac Drug-Eluting Stent and Conventional Ostium Packing with Budesonide Nasal Spray in people with Chronic Dacryocystitis, run by Beijing Tongren Hospital at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. 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: looking for participants now, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Contact Chengshuo wang (86-13911623569, wangcs830@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Clinical Effectiveness Rate at 3 Months (time frame: 3 months postoperatively). 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 27 Aug 2026.