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

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.

Inclusion criteria

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

Exclusion criteria

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

• 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.);

• 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;

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

• History of or current abuse of drugs, alcohol or medication;

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