Absorbable Drug-Eluting Lacrimal Sac Stent for Recurrent Chronic Dacryocystitis

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Dacryocystitis
• Intervention / Treatment: Device: Absorbable Lacrimal Sac Drug-Eluting Stent; Drug: Conventional Ostium Packing with Budesonide Nasal Spray

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 Type: Interventional
• Enrollment (Estimated): 40
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Chengshuo wang; Phone Number: 86-13911623569; Email: wangcs830@126.com

Study Locations

• China
  • Beijing, China
    • Beijing Tongren Hospital, Capital Medical University, Beijing, Beijing 100000
    • Contact: chengshuo wang; Phone Number: +86-13911623569; Email: wangcs830@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Uncontrolled hypertension, diabetes, or severe systemic diseases

Keloid tendency

Coagulation disorders

Pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Absorbable Lacrimal Sac Drug-Eluting Stent; 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.	Device: Absorbable Lacrimal Sac Drug-Eluting Stent; 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).; Other Names: Absorbable Lacrimal Sac Steroid-Eluting Stent; LN1509; LN1209; LN0907
Placebo Comparator: Standard E-DCR with Conventional Packing; 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.	Drug: Conventional Ostium Packing with 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.; Other Names: Budesonide Nasal Spray

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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%.	3 months postoperatively
Lacrimal Ostium Formation Rate at 3 Months	Assessment: endoscopic confirmation of epithelialized, patent ostium.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Operation Time	Duration of surgery measured from incision to closure, reported in minutes.	During surgery
Intraoperative Blood Loss	Volume of blood loss during surgery, reported in milliliters (mL).	During surgery
Length of Hospital Stay	Number of days from surgery to hospital discharge.	Postoperative hospitalization (within 1 week)
Recurrence Rate	Definition: recurrence of tearing with obstruction confirmed by irrigation.	3 months, 6 months, and 12 months
Patient Satisfaction Score	Scale: 0-100 (very satisfied 80-100, satisfied 60-79, dissatisfied <60).	12 months

Collaborators and Investigators

• Sponsor: Beijing Tongren Hospital
• Investigators: Study Chair: Chengshuo Wang, Beijing Tongren Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: December 27, 2025
• First Submitted That Met QC Criteria: March 25, 2026
• First Posted (Actual): March 30, 2026

Study Record Updates

• Last Update Posted (Actual): March 30, 2026
• Last Update Submitted That Met QC Criteria: March 25, 2026
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Chronic Dacryocystitis
• Other Study ID Numbers: LN-DCR-2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No