Ignite Creation Date:
2024-05-06 @ 1:27 PM
Last Modification Date:
2024-10-26 @ 1:14 PM
Study NCT ID:
NCT04021225
Status:
COMPLETED
Last Update Posted:
2020-08-11
First Post:
2019-05-07
Brief Title:
Comparison of Ectoin Containing Eye Drops and Ectoin Containing Eye Spray With the Eye Spray Tears Again
Sponsor:
Bitop AG
Organization:
Bitop AG
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2020-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 eg 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
These disorders cause physical symptoms with different severities and different impairments eg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None