Clinical trial NCT04021225: Comparison of Ectoin® Containing Eye Drops and Ectoin® Containing Eye Spray With the Eye Spray Tears Again®
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Eye Manifestations
Keywords: According to section 23b Medical Devices Act
environmental disorder eye
allergen exposure
Ectoin® Allergy Eye Drops 2%
Ectoin® Eye Spray Colloidal
Ectoin
Lead sponsor: Bitop AG
Sponsor class: INDUSTRY
First posted: 2019-07-16
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: OTHER

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Patient questionnaire
timeFrame: Change is being assessed between before the application of the medical product and 30 minutes after the application of the medical product.
measure: Assessment of the redness of the eye
timeFrame: Change is being assessed between before the application of the medical product and 30 minutes after the application of the medical product.
measure: Assessment of the redness of the eye by an external observer
timeFrame: Change is being assessed between before the application of the medical product and 30 minutes after the application of the medical product.
measure: Visual Analogue Scale
timeFrame: Change is being assessed between before the application of the medical product and 30 minutes after the application of the medical product.
measure: Tolerability: The degree of irritation of the tested eye is being measured using a visual analogue scale.
timeFrame: Change is being assessed between 0 minutes and 30 minutes after the application of the medical product.
measure: 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.
timeFrame: Up to 12 hours after the application of medical product.
Secondary outcomes:
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: Facharzt für HNO-Heilkunde, Allergologie
state: NRW
Study officials:
affiliation: ClinCompetence
name: Ralph Mösges, Dr.
role: STUDY_DIRECTOR
References: