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

Inclusion Criteria:

1. Patients must have a clinical history of SAR with seasonal onset and offset of nasaland ocular allergy symptoms at least during each of the last two ragweed allergyseasons.

2. Adults (males and females) aged 18 to 65, inclusive.

3. Patients must have documentation of a positive skin test within 12 months ofscreening to ragweed or a positive skin prick and/or intradermal test for ragweedallergen 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 mmlarger than the negative control for the intradermal test.

4. Non-pregnant, non-lactating women not of childbearing potential who arepost-menopausal [defined as at least 6 months natural spontaneous amenorrhea], orare surgically sterile (hysterectomy; bilateral oophorectomy; bilateral tuballigation with surgery at least 6 weeks prior to study initiation). Surgicalsterility should be supported with clinical documentation. Females must have a confirmed absence of pregnancy according to a negative serumpregnancy 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 highlyeffective method of birth control with a low failure rate (i.e. less than 1% peryear) when used consistently and correctly (e.g. implants, injectables, combinedoral contraceptives, some IUDs, sexual abstinence or vasectomised partners) duringthe trial, as judged by the investigator. For subjects using a hormonalcontraceptive method, information regarding the product under evaluation and itspotential 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 anystudy procedures, including initiation of washout of any concomitant medications.

Exclusion Criteria:

1. Asthma based on medical history or investigator judgment (stable mild asthmatics maybe included).

2. Current smoker and ex-smokers with more than 10 pack years smoking history. One packyear is defined as 20 cigarettes/day for 1 year. Smoking must have been stopped morethan 6 months ago

3. History of lower or upper airway infection in the last four weeks prior toscreening.

4. Clinically significant physical findings of nasal anatomical deformities causinggreater than 50% obstruction based on the clinical estimate of the investigator,including nasal polyps, septal defects or other clinically significant respiratorytract malformations, nasal piercing, recent nasal biopsy, nasal trauma, or surgeryand atrophic rhinitis or rhinitis medicamentosa within 60 days prior to theScreening Visit.

5. Pregnancy or breastfeeding, or plans to become pregnant or donate gametes (ova orsperm) for in vitro fertilization during the study period, or for 30 days followingthe study period.

6. Currently participating in a clinical trial or has been exposed to aninvestigational treatment within the 30 days prior to the Screening Visit.

7. A known or suspected hypersensitivity, and/or contraindication to any of theingredients of the investigational products.

8. History of alcohol or drug abuse, as judged by the investigator, within the twoyears 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 affectthe study objectives or subject safety (e.g., Diabetes mellitus type I, malignantneoplasia, chronic renal failure, inflammatory diseases of liver or kidneys,emphysema, bronchiectasis).

11. Any clinically significant (as determined by the investigator) psychiatric and/orpsychological disorders, including impairment of cooperation (e.g. alcohol or drugabuse).

12. Patients not able to follow study procedures (e.g. language problems, psychologicaldisorders).

13. Suspected non-compliance to study protocol. Non-compliance is e.g. application ofless than 60% (according to post treatment container's weight) or missing more thanone application on either of the last two days before EEC.