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NOT YET RECRUITING
NCT07588672
NA

Evaluation of the Efficacy, Safety, and Tolerability of PL-14 Allergy Blocker Compared to Saline Spray in Patients With Seasonal Allergic Rhinitis

Sponsor: Polyrizon Ltd.

View on ClinicalTrials.gov

Summary

This study is designed to evaluate the efficacy, safety, and tolerability of PL-14 Allergy Blocker compared to saline spray in adults with Seasonal Allergic Rhinitis (SAR). PL-14 Allergy Blocker is a non-pharmacological, drug-free intranasal mucoadhesive hydrogel designed to form a mechanical barrier on the nasal mucosa and reduce contact between airborne allergens and the nasal lining. This is a prospective, randomized, single-blind, multi-center clinical investigation in up to 120 participants at up to 8 sites in the United States. Eligible participants with a history of seasonal allergic rhinitis will be randomized in a 1:1 ratio to receive either PL-14 Allergy Blocker or Ayr® Saline Nasal Mist for up to 30 days. The study will evaluate the effect of PL-14 Allergy Blocker on nasal allergy symptoms, quality of life, rescue medication use, and symptom-free days. Safety and local tolerability assessments will also be performed throughout this study period.

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2026-07-15

Completion Date

2027-09-30

Last Updated

2026-05-15

Healthy Volunteers

No

Interventions

DEVICE

PL-14 Allergy Blocker

PL-14 Allergy Blocker is a non-pharmacological, drug-free intranasal mucoadhesive hydrogel designed to act as a mechanical barrier in the nasal cavity to reduce contact between inhaled allergens and the nasal mucosa.

DEVICE

Ayr® Saline Nasal Mist

Ayr® Saline Nasal Mist is a non-medicated isotonic saline nasal spray used as the control comparator in this study.