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

Conditions

• Allergic Rhinitis
• Seasonal Allergic Rhinitis (SAR)

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• PL-14 Allergy Blocker — DEVICE
  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.
• Ayr® Saline Nasal Mist — DEVICE
  Ayr® Saline Nasal Mist is a non-medicated isotonic saline nasal spray used as the control comparator in this study.

Study Details

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 Dates

First listed

May 15, 2026

Start date

Sep 1, 2026

Status verified

May 2026

Primary completion

Jul 15, 2027

Completion

Sep 30, 2027

Study Design

Enrollment

120 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: PL-14 Allergy Blocker
  Participants assigned to this arm will self-administer PL-14 Allergy Blocker intranasally for up to 30 days according to the study Instructions for Use.
• Active Comparator: Ayr® Saline Nasal Mist
  Participants assigned to this arm will self-administer Ayr® Saline Nasal Mist intranasally for up to 30 days according to the manufacturer Instructions for Use.

Primary Outcome Measure

Difference in mean daily reflective Total Nasal Symptom Score (rTNSS) between treatment groups [ Time Frame: 14 treatment days ]

Central Contacts

• Hilla Ben-Ezra
  +972-52-6511131
  [email protected]
• Tidhar Turgeman, PhD
  +972-52 6999113
  [email protected]

Locations (5)

Find similar trials in Normal, IL

Related Studies

• Viral Mucosal Reprogramming
  PHASE2 · Recruiting · The University of Texas Medical Branch, Galveston · Galveston, Texas
• Harnessing Digital Medicine to Improve Allergic Rhinitis Management in Primary Care (DMAR)
  Enrolling By Invitation · QHSLab, Inc. · West Palm Beach, Florida