Title

LYR-210 Depot (LYR-210) for Adult Subjects With Chronic Sinusitis (LANTERN Study)
A Phase II, Randomized, Blinded, Sham Procedure-Controlled, Parallel-Group Trial to Evaluate the Efficacy, Safety and Tolerability of LYR-210 in Adult Subjects With Chronic Sinusitis (LANTERN Study)
  • Phase

    Phase 2
  • Study Type

    Interventional
  • Status

    Completed No Results Posted
  • Intervention/Treatment

    LYR-210 ...
  • Study Participants

    71
This is a Phase II, Randomized, Blinded, Sham Procedure-Controlled, Parallel-Group Trial to Evaluate the Efficacy, Safety and Tolerability of LYR-210 in Adult Subjects with Chronic Sinusitis.
LYR-210 is a drug depot, which contains the anti-inflammatory medication mometasone furoate (MF) pre-loaded in a single use applicator. LYR-210 is intended to be placed bilaterally into the sino-nasal passages by an otolaryngologist. Once in place, each LYR-210 drug depot is designed to gradually deliver sustained topical doses of MF to the inflamed mucosal sinus tissue over 24 weeks.
Study Started
May 09
2019
Primary Completion
Mar 25
2020
Study Completion
Feb 04
2021
Last Update
Mar 23
2022

Drug LYR-210

A single administration of LYR-210 depot

Other Sham comparator

Sham comparator

LYR-210 (Low Dose) Experimental

In-office bilateral placement of the LYR-210 drug depot (mometasone furoate low dose) in the middle meatus

LYR-210 (High Dose) Experimental

In-office bilateral placement of the LYR-210 drug depot (mometasone furoate high dose) in the middle meatus

Sham Procedure Sham Comparator

In-office bilateral sham procedure

Criteria

Inclusion Criteria:

Diagnosis of CS.
Two trials of medical treatments for CS in the past.
Minimum CS symptom score.
Ability to tolerate topical anesthesia.
Has been informed of the nature of the study and has provided written informed consent as approved by the Institutional Review Board (IRB)/Ethics Committee (EC) of the respective clinical site.
Agrees to comply with all study requirements.

Exclusion Criteria:

Have undergone previous sinus surgery.
Pregnant or breast feeding.
Known history of hypersensitivity or intolerance to corticosteroids.
History or clinical evidence or suspicion of invasive fungal sinusitis, allergic fungal rhinosinusitis, or atrophic rhinitis.
Known history of hypothalamic pituitary adrenal axial dysfunction or having a morning serum cortisol level at screening outside of the normal range.
Had dental procedure/implant on maxillary dentition within 4 weeks of the Screening visit.
Past or present functional vision in only one eye.
Has cataracts
Past, present, or planned organ transplant or chemotherapy with immunosuppression.
Currently participating in an investigational drug or device study
No Results Posted