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
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.
Each participant will use the assigned product for 14 days applying it twice a day as follows:
Each participant will have three visits:
At each visit, the study doctor will:
The study will look at:
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:
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:
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:
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.