Osmonar® Nasal Gel Versus Saline Solution in Patients With Dry Nose

Randomized, Open-Label, Comparative, Non-Profit Study to Evaluate the Performance and Safety of Osmonar® Medical Device Nasal Gel Versus Saline Solution in Patients With Dry Nose

This study is being done to understand how well a medical device called OSMONAR Nasal Gel works and how safe it is for people who suffer from a dry nose.

A dry nose can cause discomfort, crusting, irritation, and breathing difficulties. There are not many effective treatments available. This study may help doctors find a new and safe option for people with this condition.

About 60 adults with symptoms of dry nose will take part.

• 30 people will use OSMONAR Nasal Gel
• 30 people will use a saline solution (a simple salt-water solution) Both groups will have similar symptoms. This helps doctors compare the two products fairly.

Each participant will use the assigned product for 14 days applying it twice a day as follows:

• once in each nostril in the morning
• once in each nostril in the evening

Each participant will have three visits:

• Visit 1 - Start of the study
• Visit 2 - Day 7
• Day 14 (End of treatment)

At each visit, the study doctor will:

• Perform a general medical check-up;
• Confirm the diagnosis of dry nose;
• Ask the participant to rate how dry their nose feels using a 10-cm Visual Analog Scale (VAS);
• Examine the inside of the nose using a fiber-optic rhinoscope to check for crusts, blockage, or breathing problems;
• Ask about satisfaction with the product and how easy it was to use;
• Check the participant's safety and whether the product is well tolerated.

The study will look at:

• How well symptoms improve.
• Changes in nasal dryness and discomfort.
• How the inside of the nose looks during examination.
• How safe and well tolerated the treatment is.
• How satisfied participants are with the treatment.

This study was planned, organized, and performed autonomously as a non-profit study without any external support by the principal investigator of the Otorhinolaryngology Department at Giovanni Paolo II Hospital in Lamezia Terme.

The results of the study will help doctors learn whether OSMONAR Nasal Gel can be a safe and effective treatment for people with dry nose and whether it works better than saline solution:

Study Overview

• Status: Completed
• Conditions: Dry Nose
• Intervention / Treatment: Device: Osmonar; Other: Placebo

Detailed Description

Nasal dryness is a frequent condition caused by mucosal atrophy, chronic irritation, infections, environmental factors, or systemic diseases such as Sjögren's syndrome. Symptoms may include crusting, nasal obstruction, irritation, and breathing discomfort. Management typically involves eliminating triggering factors, maintaining hydration, humidifying the environment, and using topical agents such as saline solutions, oils, or hyaluronic-acid-based products.

This study evaluates the performance and safety of OSMONAR Nasal Gel, a medical device containing pyrohyaluronate (PCA) and hyaluronic acid (HA). The product is designed to hydrate the nasal mucosa, form a protective film against external irritants, and support mucosal repair. The aim is to determine whether OSMONAR can improve symptoms associated with dry nose more effectively than saline solution.

A total of 60 adults with dry nose syndrome will be randomized into two groups:

• OSMONAR Nasal Gel: one application per nostril twice daily for 14 days;
• Placebo (Isotonic saline solution): 1 application per nostril twice daily for 14 days.

The study is randomized and single-blind and includes three visits: baseline (Day 0), interim (Day 7), and final evaluation (Day 14). At each visit, participants will rate nasal dryness using a 10-cm Visual Analog Scale (VAS). In addition, nasal crusting, obstruction, and respiratory discomfort will be assessed by Investigator using fiber-optic rhinoscopy. Safety will be evaluated by monitoring adverse events.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • CZ
    • Lamezia Terme, CZ, Italy, 88046
      • Department of Otolaryngology - Presidio Ospedaliero di Lamezia Terme Giovanni Paolo II

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. Age ≥ 18 years old;
2. Patients affected by dry nose;
3. Willing to comply with study requirements, using the tested products for 14 consecutive days;
4. Readiness not to participate in another clinical study during this study;
5. Commitment to using contraceptive methods (for women of childbearing age only);
6. Negative pregnancy testing (beta human chorionic gonadotropin test in urine) at baseline (only for women in childbearing age);
7. Written informed consent by the participant.

Exclusion Criteria:

1. Known allergy or hypersensitivity to the components of the OSMONAR or of saline solution; 4. Lesions/infections in the nasal area;

5. Use of preparations that may influence the study outcome within the last 2 weeks prior to baseline and during the study (e.g. antibiotics, corticosteroids etc.);

6. History or presence of any other clinically significant known (self-reported) condition /disorder, which per investigator's judgement could interfere with the results of the study or the safety of the subject;

7. Pregnancy, nursing or within first 3 months post-partum;

8. History of or current abuse of drugs, alcohol or medication;

9. Participation in another study during the last 30 days prior to baseline.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: OSMONAR Nasal Gel; Medical Device Class IIa	Device: Osmonar; one application per nostril twice daily (in the morning and in the evening) administered for 14 consecutive days
Placebo Comparator: Isotonic saline solution; Placebo	Other: Placebo; one application per nostril twice daily (in the morning and in the evening) administered for 14 consecutive days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of adverse events	The incidence of adverse events (AEs), serious adverse events (SAEs), adverse device effects (ADEs), and serious adverse device effects (SADEs) will be collected by Investigators, compared between the two groups, and analyzed with the incidence in standard population	14 days
Subjective nasal dryness	The change in subjective nasal dryness, as evaluated by the patient using a Visual Analogue Scale (VAS) score ranging from 0 (no nasal dryness) to 10 (maximum level of nasal dryness), will be assessed from baseline to final visit (day 14). The mean values will be compared between the two treatment groups	14 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence of nasal crusts	Percentage of subjects with nasal crusts evaluated by fiber-optic rhinoscopy at baseline and at Final Visit (day 14). The decrease in % will be compared between the two treatment groups	14 days
Presence of nasal obstruction	Percentage of subjects with nasal obstruction evaluated by fiber-optic rhinoscopy at baseline and at Final Visit (day 14). The decrease in % will be compared between the two treatment groups	14 days
Presence of respiratory discomfort	Percentage of subjects with respiratory discomfort evaluated by fiber-optic rhinoscopy at baseline and at Final Visit (day 14). The decrease in % will be compared between the two treatment groups	14 days

Collaborators and Investigators

• Sponsor: Michele Grasso
• Collaborators: Opera CRO, a TIGERMED Group Company
• Investigators: Principal Investigator: Michele Grasso, Dr., Presidio Ospedaliero di Lamezia Terme Giovanni Paolo II

Study record dates

Study Major Dates

• Study Start (Actual): September 9, 2021
• Primary Completion (Actual): October 20, 2021
• Study Completion (Actual): December 19, 2022

Study Registration Dates

• First Submitted: November 26, 2025
• First Submitted That Met QC Criteria: November 26, 2025
• First Posted (Estimated): December 9, 2025

Study Record Updates

• Last Update Posted (Actual): December 18, 2025
• Last Update Submitted That Met QC Criteria: December 10, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: medical device; randomized study; single-blind; dry nose
• Other Study ID Numbers: DMS/21/OSMONAR/01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The individual participant data (IPD) that underlie results in a publication
• IPD Sharing Time Frame: IPD will be available from the corresponding author, upon reasonable request after the result publication.
• IPD Sharing Access Criteria: Other researchers will receive the IPD upon reasonable request from the corresponding author.
• IPD Sharing Supporting Information Type: CSR

Drug and device information, study documents

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