Absorbable Drug-Eluting Lacrimal Sac Stent for Recurrent Chronic Dacryocystitis

NCT07499791 | Not Yet Recruiting Phase 2

• 1 other identifier: LN-DCR-2025
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Chronic Dacryocystitis

Keywords

Chronic Dacryocystitis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Operation Time

  During surgery

• Intraoperative Blood Loss

  During surgery

• Length of Hospital Stay

  Postoperative hospitalization (within 1 week)

• Recurrence Rate

  3 months, 6 months, and 12 months

• Patient Satisfaction Score

  12 months

Study Arms (2)

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.

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.

Drug: Conventional Ostium Packing with Budesonide Nasal Spray

Interventions

Absorbable Lacrimal Sac Drug-Eluting Stent DEVICE

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).

Also known as: Absorbable Lacrimal Sac Steroid-Eluting Stent, LN1509, LN1209, LN0907

Absorbable Lacrimal Sac Drug-Eluting Stent

Conventional Ostium Packing with Budesonide Nasal Spray DRUG

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.

Also known as: Budesonide Nasal Spray

Standard E-DCR with Conventional Packing

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Beijing Tongren Hospital: lead

Study Sites (1)

Beijing Tongren Hospital, Capital Medical University, Beijing, Beijing 100000

Beijing, China

Location

Study Officials

• Chengshuo Wang

  Beijing Tongren Hospital

  STUDY CHAIR

Central Study Contacts

Chengshuo wang

CONTACT

86-13911623569; wangcs830@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 27, 2025
• First Posted: March 30, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 30, 2026

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)