Allergic Rhinitis Clinical Trial
Official title:
A Double-Blind, Randomized, Cross-Over Study of The Effects of Ectoin® Allergy Nasal Spray and Ectoin® Allergy Eye Drops Compared to Placebo, in Patients With Allergic Rhinitis and Allergic Conjunctivitis in an Environmental Exposure Chamber (EEC) Model
The primary objective of this study is to assess the relative efficacy of Ectoin® Allergy
Eye Drops and Ectoine® Allergy Nasal Spray compared to placebo, by evaluating Total Nasal
Symptom Score (TNSS) and Total Ocular Symptom Score (TOSS).
The secondary objectives are :
- To evaluate the relative efficacy of Ectoin® Allergy Eye Drops and Ectoin® Allergy
Nasal Spray compared to placebo by evaluating Total Non Nasal Symptom Score (TNNSS),
congestion symptom scores, red eye symptom scores, watery eye symptom scores, itchy eye
symptom scores, and by evaluating the mean cross-sectional area (MCA) using acoustic
rhinometry (AcR).
- To assess the change from baseline (post-EEC from pre-EEC) in inflammatory parameters
of nasal secretions, comparing Ectoin® Allergy Eye Drops and Ectoin® Allergy Nasal
Spray to placebo at each post-treatment visit.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
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