Application of Ectoine Containing Nasal Spray and Eye Drops in Patients With Allergic Rhinitis

Bitop AG48 enrolled

Overview

This is a comparative, open label, parallel group, non interventional study to further demonstrate the effectiveness and tolerability of Ectoin Allergy Nasal Spray and Eye drops. In addition the effectiveness and safety shall be compared to Azelastine containing nasal Sprays and Eye drops. The patient applied Ectoin® Rhinitis Nasal Spray / Eye drops or takes Azelastine nasals spray and eye drops according to the instructions for use. The observation takes place over a period of 7 days. Response to treatment is recorded at day 7 by the physician and in daily by the patient in a dairy.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Allergic Rhinoconjunctivitis

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * male or female patients * aged 18-70 years * Patients with proven allergy and acute symptoms in nose and eye which are treated with Ectoin Allergy Nasal Spray and Ectoin Allergy Eye Drops or Azelastine Nasal Spray and Azelastine Eye Drops during the observational period Exclusion Criteria: * pregnancy and nursing women, * drug addicts and persons unable to give consent to study participation, * patients with intolerance against ingredients of any of the study treatments, * previous eye or nose surgery, * concomitant treatment with anti-allergic drugs, and * diseases which might influence the output of the study according to the physicians' judgment. * contra indications according to the label

Locations (1)

HNO Praxis Elmshorn

Elmshorn, Germany

Outcomes

Primary Outcomes

Change in primary allergic symptoms symptoms

Change in the primary allergic nasal and ophthalmic symptoms: Degree of nasal breathing impairment, Rhinorrhea, Frequency of sneezing, Nasal itching,Eye itching, Watery eyes, Conjunctivitis score (eye redness)

Time frame: Day1, Day 7

Secondary Outcomes

Palatal itching score

Time frame: day 1 and day 7

Efficacy and tolerability assessment by the patients

Patients assess the efficacy and tolerability separately based on a general an Scale from 0 to 8

Time frame: day1 and day 7

Data from ClinicalTrials.gov

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