Eye Manifestations Clinical Trial
Official title:
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.
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.
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.
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