The Effects of Ectoin® Allergy Nasal Spray and Ectoin® Allergy Eye Drops Compared to Placebo (NCT01471184) | Clinical Trial Compass
CompletedNot Applicable
The Effects of Ectoin® Allergy Nasal Spray and Ectoin® Allergy Eye Drops Compared to Placebo
Canada46 participantsStarted 2009-09
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
. Adults (males and females) aged 18 to 65, inclusive.
. 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.
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Ectoin Allergy Eye Drops and Ectoine Allergy Nasal Spray assess the relative efficacy
Timeframe: From baseline to end of treatment at 13 days
. In generally good health on the basis of medical history and physical examination.
. Willingness to attend all study visits.
. Capable of following and understanding instructions.
. 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
. Asthma based on medical history or investigator judgment (stable mild asthmatics may be included).
. 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
. History of lower or upper airway infection in the last four weeks prior to screening.
. 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.
. 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.
. Currently participating in a clinical trial or has been exposed to an investigational treatment within the 30 days prior to the Screening Visit.
. A known or suspected hypersensitivity, and/or contraindication to any of the ingredients of the investigational products.
. History of alcohol or drug abuse, as judged by the investigator, within the two years prior to the Screening Visit.