Comparison of Ectoin® Containing Eye Drops and Ectoin® Containing Eye Spray With the Eye Spray Tears Again®
Condition: Eye Manifestations
MeSH terms: Eye Manifestations
Study type: Interventional

Summary: 
      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: 
      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.
    

Intervention name(s): Ectoin® Allergy Eye Drops 2%; Ectoin® Eye Spray Colloidal; Tears Again® eye spray
Intervention type(s): Device; Device; Device
Intervention description(s): A one-time application of 1-2 drops in the more affected eye will be investigated.; A one-time application of 1-2 drops in the more affected eye will be investigated.; A one-time application of 1-2 drops in the more affected eye will be investigated.
Intervention MeSH terms: Ophthalmic Solutions
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Single (Participant)
Primary purpose: Other
Keywords: According to section 23b Medical Devices Act; environmental disorder eye; allergen exposure; Ectoin® Allergy Eye Drops 2%; Ectoin® Eye Spray Colloidal; Ectoin