Comparison of Ectoin® Containing Eye Drops and Ectoin® Containing Eye Spray With the Eye Spray Tears Again®

Study Overview
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Brief Summary
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This study aims to gain knowledge on the duration of symptom relief of environmental disorders of the eye as might be present in allergy sufferers after allergen exposure following application of the study products. Additionally, the extent of symptom relief as well as tolerability of this topic treatment will be evaluated.

Detailed Description
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The term disorder describes the general development of physical symptoms without vegetative or morphologically detectable impairment. These disorders cause physical symptoms with different severities and different impairments, e.g. exhaustion, fatigue, headache, stomach and back pain. The eye might also be prone to disorders. These manifest in symptoms like dry eyes, tightness of the eye lids, foreign body sensation and reddened, burning, itching or watery eyes. Disorders of the eye can be caused by extensive screen and computer work, air condition, dry heating air or draught, as well as some drugs like birth control pills, or beta blocker. Other causes are intense solar radiation or allergen exposure. To reduce the symptoms, medical products like artificial tears (with fat additives, if necessary, and applied as drops, gel or spray) are used to moisten the eyes and the eye lids. Besides, eye drops and eye sprays (with different supplements) are also used to stabilise the tear film. The positive effect of Ectoin® was already proven in many studies: Ectoin® containing products exhibited a good barrier function and effective protection against dehydration of the skin. Another formulation of Ectoin® for the use on the eye is Ectoin® Eye Spray Colloidal. This spray is - in analogy to Tears Again® eye spay - applied to the closed eye lids and moistens the surface of the eye with an Ectoin® containing liquid film after opening the eye. This form of application of Ectoin® is also registered as a medical product for dry, irritated and inflamed eyes as well as the adjacent skin. Ectoin® Allergy Eye Drops 2% protect against harmful influences of allergens and support the regeneration of irritated and sensitive conjunctiva. The package leaflet recommends the application of 1-2 drops in each eye several times a day. In the scope of this study, a one-time application of 1-2 drops in the more affected eye will be investigated. Ectoin® Eye Spray - Colloidal moistens the eye and thus protects the eye against hyperosmolarity of the tear fluid. The package leaflet recommends the application of 1-2 sprays on the closed eye 3-4 times a day. In the scope of this study, a one-time application of 1-2 sprays in the more affected eye will be investigated. Tears Again® is a liposomal eye spray, which stabilises the lipid layer of the tear film and thus improves the moistness of the surface of the eye: the underlying tear fluid is protected against quick evaporation or against flow off the lid edge. The summary of product characteristics recommends the application of 1-2 sprays on the closed eye up to 3-4 times a day. A more frequent application, especially in cases of severe disorders is possible without any problems. Within the current study, a on-time application of 1-2 sprays to the more affected eye will be investigated.

Official Title
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A Multicenter, Randomized, Controlled Study According to §23b Medical Devices Act (MPG) Comparison of Ectoin® Eyedrops & Ectoin® Eye Spray With Tears Again® for the Application of Environmental Disorders of the Eye of Allergic Patients.

Conditions
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Eye Manifestations

Intervention / Treatment
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* Device: Ectoin® Allergy Eye Drops 2%
* Device: Ectoin® Eye Spray Colloidal
* Device: Tears Again® eye spray


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients have to meet the following inclusion criteria in order to participate in the study: Signed and dated informed consent form Male and female patients aged 18 to 75 years Patients have to suffer from allergen exposure induced environmental disorder of the eye Exclusion Criteria: - Non-inclusion criteria Contraindications according to the package leaflet/summary of product characteristics currently wearing contact lenses

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ectoin® Allergy Eye Drops 2%<br>20 Patients: - Ectoin® Allergy Eye Drops 2% (bitop AG) | Device: Ectoin® Allergy Eye Drops 2%<br>* A one-time application of 1-2 drops in the more affected eye will be investigated.<br>|
| Active Comparator: Ectoin® Eye Spray Colloidal<br>20 Patients: -Ectoin® Eye Spray Colloidal (bitop AG) | Device: Ectoin® Eye Spray Colloidal<br>* A one-time application of 1-2 drops in the more affected eye will be investigated.<br>|
| Active Comparator: Tears Again® Eye Spray<br>20 Patients: - Tears Again® Eye Spray (Optima Pharmazeutische GmbH) | Device: Tears Again® eye spray<br>* A one-time application of 1-2 drops in the more affected eye will be investigated.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient questionnaire | Relief of environmental disorders of the eye will be assessed by determining the time to onset of action using a patient questionnaire. The extent of relief as the degree of effectiveness will be determined using the following variables: • Patient questionnaire The questions from the patient questionnaire are: How do you rate your eyesight at this time? Unimpaired, impaired Do you have difficulties reading normal printed material in the newspaper? (no, a little, strong, stopped trying) | Change is being assessed between before the application of the medical product and 30 minutes after the application of the medical product. | 
| Assessment of the redness of the eye | Relief of environmental disorders of the eye will be assessed by determining the time to onset of action using a patient questionnaire. The extent of relief as the degree of effectiveness will be determined using the following variables: • Digital analysis of the redness of the eye. The redness of the eye is evaluated by means of digital image analysis. The patient's more affected eye is photographed parallel to the entries on the VAS. To capture the images, the same construction for attaching the camera as well as fixed camera settings are used to create comparable conditions. Captured data analyzed by MATLAB V.9.5. | Change is being assessed between before the application of the medical product and 30 minutes after the application of the medical product. | 
| Assessment of the redness of the eye by an external observer | Relief of environmental disorders of the eye will be assessed by determining the time to onset of action using a patient questionnaire. The extent of relief as the degree of effectiveness will be determined using the following variables: • Assessment of the redness of the eye by an external observer Redness of eye evaluated by a physician. | Change is being assessed between before the application of the medical product and 30 minutes after the application of the medical product. | 
| Visual Analogue Scale | Relief of environmental disorders of the eye will be assessed by determining the time to onset of action using a patient questionnaire. The extent of relief as the degree of effectiveness will be determined using the following variables: • Visual Analogue Scale The evaluation of effectiveness data is collected by the patient using a visual analogue scale. To this end, the patient marks on a visual analog scale by a vertical line the extent of his discomfort between the endpoints most severe complaints = 100 and no complaints = 0. | Change is being assessed between before the application of the medical product and 30 minutes after the application of the medical product. | 
| Tolerability: The degree of irritation of the tested eye is being measured using a visual analogue scale. | It will be assessed using the following variables: • The patient questionnaires are: Please evaluate the degree of irritation of the tested eye (itching, foreign body sensation, lacrimation and/or swelling of the eyelid) after administration of the investigational medicinal product. The evaluation of effectiveness data is collected by the patient using a visual analogue scale. To this end, the patient marks on a visual analog scale by a vertical line the extent of his discomfort between the endpoints most severe complaints = 100 and no complaints = 0. | Change is being assessed between 0 minutes and 30 minutes after the application of the medical product. | 
| Safety: All adverse reactions and adverse events that occur after signing the informed consent form must be reported, even if no investigational medicinal product was taken. | It will be assessed using the following variables: • The occurrence of adverse events. Safety: Adverse events and serious adverse events evaluated by physicians. Any side effects that were not present before the visit, and any side effects that reoccur or worsen after the visit. Abnormal clinically relevant results from diagnostic procedures, including out-of-range laboratory testing, should be considered as an AE. If adverse reactions occur after the visit, the patient is encouraged to contact the doctor by telephone. | Up to 12 hours after the application of medical product. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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According to section 23b Medical Devices Act, environmental disorder eye, allergen exposure, Ectoin® Allergy Eye Drops 2%, Ectoin® Eye Spray Colloidal, Ectoin