Safety and Efficacy of Ectoin Allergy Nasal Spray and Ectoin Allergy Eye Drops in the Treatment of Seasonal Allergic Rhinitis (SAR) in Children and Adolescents

Inclusion Criteria:

• Children aged 5-17 years

• diagnosed seasonal allergic rhinitis

• general good health condition other than SAR, and free of any concomitant conditionsor treatment that could interfere with clinical investigation conduct, influence theinterpretation of clinical investigation observations/results, or put the patient atincreased risk during the clinical investigation

• Sum of Total Nasal Score (TNSS) ≥ 6

• Sum of Total Ocular Score (TOSS) ≥ 4

Exclusion Criteria:

• • Confirmed diagnosis of acute or chronic rhinosinusitis, as determined by theinvestigator

• History of physical findings of nasal pathology, including nasal polyps or otherclinically significant respiratory tract malformations, recent nasal biopsy, nasaltrauma or surgery, atrophic rhinitis, or rhinitis medicamentosa (all within the last 60 days prior to the screening visit)

• Chronic or intermittent use of intranasal, oral, intramuscular, intravenous orophthalmic corticosteroids

• Ocular disorder other than allergic conjunctivitis, except hyperopia and myopia andstrabismus

• Upper and lower airway respiratory infection or disorder [including, but not limitedto bronchitis, pneumonia, chronic sinusitis, influenza, severe acute respiratorysyndrome (SARS)] within 4 weeks prior to clinical investigation start or developmentof a respiratory infection during the run-in period

• Start of specific immunotherapy within 1 month preceding enrolment in the clinicalinvestigation or change in dose of immunotherapy throughout the trial

• Chronic moderate to severe asthma according to GINA criteria which is treated withinhaled corticosteroids (ICS) and additional anti-asthmatic treatment. Patients withmild co-seasonal asthma must not change their dose regimen of ICS within 4 weeks priorto the enrolment into the clinical investigation nor during the clinical investigation

• Other respiratory diseases (e.g. Chronic obstructive pulmonary disease (COPD), cysticfibrosis, alpha-1-Antitrypsin deficiency, sarcoidosis, bronchiectasis, allergicalveolitis, tuberculosis, emphysema, etc.)

• on investigators discretion