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

NCT ID: NCT07273318

Last Updated: 2025-12-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-09
• Study Completion Date: 2022-12-19

Brief Summary

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:

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.

Conditions

Dry Nose

Keywords

dry nose; medical device; randomized study; single-blind

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

OSMONAR Nasal Gel

Medical Device Class IIa

Group Type: EXPERIMENTAL

Osmonar

Intervention Type: DEVICE

one application per nostril twice daily (in the morning and in the evening) administered for 14 consecutive days

Isotonic saline solution

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

one application per nostril twice daily (in the morning and in the evening) administered for 14 consecutive days

Interventions

Osmonar

one application per nostril twice daily (in the morning and in the evening) administered for 14 consecutive days

Intervention Type: DEVICE

Placebo

one application per nostril twice daily (in the morning and in the evening) administered for 14 consecutive days

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Opera CRO, a TIGERMED Group Company

OTHER

Sponsor Role: collaborator

Michele Grasso

OTHER

Sponsor Role: lead

Responsible Party

Michele Grasso

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Michele Grasso, Dr.

Role: PRINCIPAL_INVESTIGATOR

Presidio Ospedaliero di Lamezia Terme Giovanni Paolo II

Locations

Department of Otolaryngology - Presidio Ospedaliero di Lamezia Terme Giovanni Paolo II

Lamezia Terme, CZ, Italy

Countries

Italy

Other Identifiers

DMS/21/OSMONAR/01

Identifier Type: -

Identifier Source: org_study_id