Allergic RhinitisPPL-003NCT01471184
The Effects of Ectoin® Allergy Nasal Spray and Ectoin® Allergy Eye Drops Compared to Placebo
A study testing Ectoin® Allergy Nasal Spray and Ectoin® Allergy Eye Drops in people with Allergic Rhinitis and Allergic Conjunctivitis, run by Bitop AG at 1 site in Canada.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Allergic Rhinitis, Allergic Conjunctivitis
- What is being tested?
- Ectoin® Allergy Nasal Spray and Ectoin® Allergy Eye Drops
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2009to Mar 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
- Use of any of the prohibited medications within the identified exclusion periods (see Section 3.2.4)
- 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).
- Any clinically significant (as determined by the investigator) psychiatric and/or psychological disorders, including impairment of cooperation (e.g. alcohol or drug abuse).
- Patients not able to follow study procedures (e.g. language problems, psychological disorders).
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Allergic Rhinitis, Allergic Conjunctivitis
- Being tested
- Ectoin® Allergy Nasal Spray and Ectoin® Allergy Eye Drops, Placebo
- Keywords
- Allergic Rhinitis, Conjunctivitis, Bitop, Eye, Eye Drops, Nasal Spray, Total Nasal Symptom Score, Total Ocular Symptom Score, AUC
- Medical subject headings
- Rhinitis, Allergic, Conjunctivitis, Allergic, Conjunctivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ectoin® Allergy Nasal Spray and Ectoin® Allergy Eye DropsDevice
PlaceboDevice
Placebo Eye Drops/Nasal Spray
| Study group | Role | What they receive |
|---|---|---|
| Ectoin® Eye Drops/Nasal Spray | Experimental | Eye Drops/Nasal Spray Receives: Device: Ectoin® Allergy Nasal Spray and Ectoin® Allergy Eye Drops |
| Placebo Eye Drops/Nasal Spray | Placebo comparator | Not described Receives: Device: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: From baseline to end of treatment at 13 days
Secondary outcomes (1)
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).
Measured: From baseline to end of treatment at 13 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2011 (estimated)
- Study startSep 2009
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic RhinitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bitop AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01471184
- Sponsor's protocol ID
- P2JH09001
- Acronym
- PPL-003
- Status last verified
- Jan 2026
- First submitted
- 10 Nov 2011
- Last updated
- 30 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01471184
- Acronym / sponsor ID
- PPL-003 / P2JH09001
- Conditions
- Allergic Rhinitis, Allergic Conjunctivitis
- Keywords
- Allergic Rhinitis, Conjunctivitis, Bitop, Eye, Eye Drops, Nasal Spray, Total Nasal Symptom Score, Total Ocular Symptom Score
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Bitop AGIndustry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 15 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ectoin® Eye Drops/Nasal Spray | Experimental | Device: Ectoin® Allergy Nasal Spray and Ectoin® Allergy Eye DropsEye Drops/Nasal Spray |
| Placebo Eye Drops/Nasal Spray | Placebo comparator | Device: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ectoin® Allergy Nasal Spray and Ectoin® Allergy Eye Drops | Device | Ectoin® Eye Drops/Nasal Spray |
| PlaceboPlacebo Eye Drops/Nasal Spray | Device | Placebo Eye Drops/Nasal Spray |
Primary outcome
Ectoin Allergy Eye Drops and Ectoine Allergy Nasal Spray assess the relative efficacy
Time frame: From baseline to end of treatment at 13 days
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).
1 secondary outcome
Relative efficacy of Ectoin Allergy Eye Drops and Ectoin Allergy Nasal Spray compared to placebo
Time frame: From baseline to end of treatment at 13 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ectoin® Allergy Nasal Spray and Ectoin® Allergy Eye Drops in people with Allergic Rhinitis and Allergic Conjunctivitis, run by Bitop AG at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ectoin Allergy Eye Drops and Ectoine Allergy Nasal Spray assess the relative efficacy (time frame: From baseline to end of treatment at 13 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2026.