Viewing Study NCT01471184



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Last Modification Date: 2024-10-26 @ 10:43 AM
Study NCT ID: NCT01471184
Status: COMPLETED
Last Update Posted: 2011-11-21
First Post: 2011-11-10

Brief Title: The Effects of Ectoin Allergy Nasal Spray and Ectoin Allergy Eye Drops Compared to Placebo
Sponsor: Bitop AG
Organization: Bitop AG

Study Overview

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
Status: COMPLETED
Status Verified Date: 2011-11
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: PPL-003
Brief Summary: 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
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None