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The Effects of Ectoin® Allergy Nasal Spray and Ectoin® Allergy Eye Drops Compared to Placebo

NCT01471184 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2026-01-30

No results posted yet for this study

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.

Conditions

  • Allergic Rhinitis
  • Allergic Conjunctivitis

Interventions

DEVICE

Ectoin® Allergy Nasal Spray and Ectoin® Allergy Eye Drops

DEVICE

Placebo

Placebo Eye Drops/Nasal Spray

Sponsors & Collaborators

  • Bitop AG

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2010-03-31
Completion
2010-03-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01471184 on ClinicalTrials.gov