NCT04021225

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

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.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Bitop AG · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Eye Manifestations

Interventions

Type	Name	Description
DEVICE	Ectoin® Allergy Eye Drops 2%	A one-time application of 1-2 drops in the more affected eye will be investigated.
DEVICE	Ectoin® Eye Spray Colloidal	A one-time application of 1-2 drops in the more affected eye will be investigated.
DEVICE	Tears Again® eye spray	A one-time application of 1-2 drops in the more affected eye will be investigated.

Timeline

• Start date: 2019-01-01
• Primary completion: 2019-06-28
• Completion: 2019-06-28
• First posted: 2019-07-16
• Last updated: 2020-08-11

Locations

1 site across 1 country: Germany