The Effects of Ectoin® Allergy Nasal Spray and Ectoin® Allergy Eye Drops Compared to Placebo (PPL-003)

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.

Study Overview

• Status: Completed
• Conditions: Allergic Rhinitis; Allergic Conjunctivitis
• Intervention / Treatment: Device: Ectoin® Allergy Nasal Spray and Ectoin® Allergy Eye Drops; Device: Placebo

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Phase 1

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Mississauga, Ontario, Canada, L4W 1N2
      • Cetero Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patients must have a clinical history of SAR with seasonal onset and offset of nasal and ocular allergy symptoms at least during each of the last two ragweed allergy seasons.
2. Adults (males and females) aged 18 to 65, inclusive.
3. Patients must have documentation of a positive skin test within 12 months of screening to ragweed or a positive skin prick and/or intradermal test for ragweed allergen at Visit 1. A positive response is defined as a wheal diameter of at least 3 mm larger than the negative control for the skin prick test or at least 7 mm larger than the negative control for the intradermal test.

4. Non-pregnant, non-lactating women not of childbearing potential who are post-menopausal [defined as at least 6 months natural spontaneous amenorrhea], or are surgically sterile (hysterectomy; bilateral oophorectomy; bilateral tubal ligation with surgery at least 6 weeks prior to study initiation). Surgical sterility should be supported with clinical documentation.

   Females must have a confirmed absence of pregnancy according to a negative serum pregnancy test or urine pregnancy test at the times described in Section 11.

   Female subjects of child bearing potential must agree to use a reliable and highly effective method of birth control with a low failure rate (i.e. less than 1% per year) when used consistently and correctly (e.g. implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partners) during the trial, as judged by the investigator. For subjects using a hormonal contraceptive method, information regarding the product under evaluation and its potential effect on the contraceptive should be addressed.

5. In generally good health on the basis of medical history and physical examination.
6. Willingness to attend all study visits.
7. Capable of following and understanding instructions.
8. Willing and able to provide written informed consent prior to initiation of any study procedures, including initiation of washout of any concomitant medications.

Exclusion Criteria:

1. Asthma based on medical history or investigator judgment (stable mild asthmatics may be included).
2. Current smoker and ex-smokers with more than 10 pack years smoking history. One pack year is defined as 20 cigarettes/day for 1 year. Smoking must have been stopped more than 6 months ago
3. History of lower or upper airway infection in the last four weeks prior to screening.
4. Clinically significant physical findings of nasal anatomical deformities causing greater than 50% obstruction based on the clinical estimate of the investigator, including nasal polyps, septal defects or other clinically significant respiratory tract malformations, nasal piercing, recent nasal biopsy, nasal trauma, or surgery and atrophic rhinitis or rhinitis medicamentosa within 60 days prior to the Screening Visit.
5. Pregnancy or breastfeeding, or plans to become pregnant or donate gametes (ova or sperm) for in vitro fertilization during the study period, or for 30 days following the study period.
6. Currently participating in a clinical trial or has been exposed to an investigational treatment within the 30 days prior to the Screening Visit.
7. A known or suspected hypersensitivity, and/or contraindication to any of the ingredients of the investigational products.
8. History of alcohol or drug abuse, as judged by the investigator, within the two years prior to the Screening Visit.
9. Use of any of the prohibited medications within the identified exclusion periods (see Section 3.2.4)
10. Any acute or chronic disease that, in the opinion of the investigator, would affect the study objectives or subject safety (e.g., Diabetes mellitus type I, malignant neoplasia, chronic renal failure, inflammatory diseases of liver or kidneys, emphysema, bronchiectasis).
11. Any clinically significant (as determined by the investigator) psychiatric and/or psychological disorders, including impairment of cooperation (e.g. alcohol or drug abuse).
12. Patients not able to follow study procedures (e.g. language problems, psychological disorders).
13. Suspected non-compliance to study protocol. Non-compliance is e.g. application of less than 60% (according to post treatment container's weight) or missing more than one application on either of the last two days before EEC.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ectoin® Eye Drops/Nasal Spray; Eye Drops/Nasal Spray	Device: Ectoin® Allergy Nasal Spray and Ectoin® Allergy Eye Drops
Placebo Comparator: Placebo Eye Drops/Nasal Spray	Device: Placebo; Placebo Eye Drops/Nasal Spray

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description
Ectoin Allergy Eye Drops and Ectoine Allergy Nasal Spray assess the relative efficacy	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).

Secondary Outcome Measures

Outcome Measure	Measure Description
Relative efficacy of Ectoin Allergy Eye Drops and Ectoin Allergy Nasal Spray compared to placebo	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).

Collaborators and Investigators

• Sponsor: Bitop AG

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (Actual): March 1, 2010

Study Registration Dates

• First Submitted: November 10, 2011
• First Submitted That Met QC Criteria: November 14, 2011
• First Posted (Estimate): November 15, 2011

Study Record Updates

• Last Update Posted (Estimate): November 21, 2011
• Last Update Submitted That Met QC Criteria: November 18, 2011
• Last Verified: November 1, 2011

More Information

Terms related to this study

• Keywords: Allergic Rhinitis; Eye; Eye Drops; Nasal Spray; Conjunctivitis; AUC; Total Nasal Symptom Score; Bitop; Total Ocular Symptom Score
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Eye Diseases; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Nose Diseases; Conjunctival Diseases; Hypersensitivity; Rhinitis; Rhinitis, Allergic; Conjunctivitis; Conjunctivitis, Allergic; Pharmaceutical Solutions; Ophthalmic Solutions
• Other Study ID Numbers: P2JH09001