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.

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.

Study Overview

• Status: Completed
• Conditions: Eye Manifestations
• Intervention / Treatment: Device: Ectoin® Allergy Eye Drops 2%; Device: Ectoin® Eye Spray Colloidal; Device: Tears Again® eye spray

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • NRW
    • Aachen, NRW, Germany, 52074
      • Facharzt für HNO-Heilkunde, Allergologie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Ectoin® Allergy Eye Drops 2%; 20 Patients: - Ectoin® Allergy Eye Drops 2% (bitop AG)	Device: Ectoin® Allergy Eye Drops 2%; A one-time application of 1-2 drops in the more affected eye will be investigated.
Active Comparator: Ectoin® Eye Spray Colloidal; 20 Patients: -Ectoin® Eye Spray Colloidal (bitop AG)	Device: Ectoin® Eye Spray Colloidal; A one-time application of 1-2 drops in the more affected eye will be investigated.
Active Comparator: Tears Again® Eye Spray; 20 Patients: - Tears Again® Eye Spray (Optima Pharmazeutische GmbH)	Device: Tears Again® eye spray; A one-time application of 1-2 drops in the more affected eye will be investigated.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient questionnaire	Relief of environmental disorders of the eye will be assessed by determining the time to onset of action using a patient questionnaire. The extent of relief as the degree of effectiveness will be determined using the following variables: • Patient questionnaire The questions from the patient questionnaire are: How do you rate your eyesight at this time? Unimpaired, impaired; Do you have difficulties reading normal printed material in the newspaper? (no, a little, strong, stopped trying)	Change is being assessed between before the application of the medical product and 30 minutes after the application of the medical product.
Assessment of the redness of the eye	Relief of environmental disorders of the eye will be assessed by determining the time to onset of action using a patient questionnaire. The extent of relief as the degree of effectiveness will be determined using the following variables: • Digital analysis of the redness of the eye. The redness of the eye is evaluated by means of digital image analysis. The patient's more affected eye is photographed parallel to the entries on the VAS. To capture the images, the same construction for attaching the camera as well as fixed camera settings are used to create comparable conditions. Captured data analyzed by MATLAB V.9.5.	Change is being assessed between before the application of the medical product and 30 minutes after the application of the medical product.
Assessment of the redness of the eye by an external observer	Relief of environmental disorders of the eye will be assessed by determining the time to onset of action using a patient questionnaire. The extent of relief as the degree of effectiveness will be determined using the following variables: • Assessment of the redness of the eye by an external observer Redness of eye evaluated by a physician.	Change is being assessed between before the application of the medical product and 30 minutes after the application of the medical product.
Visual Analogue Scale	Relief of environmental disorders of the eye will be assessed by determining the time to onset of action using a patient questionnaire. The extent of relief as the degree of effectiveness will be determined using the following variables: • Visual Analogue Scale The evaluation of effectiveness data is collected by the patient using a visual analogue scale. To this end, the patient marks on a visual analog scale by a vertical line the extent of his discomfort between the endpoints most severe complaints = 100 and no complaints = 0.	Change is being assessed between before the application of the medical product and 30 minutes after the application of the medical product.
Tolerability: The degree of irritation of the tested eye is being measured using a visual analogue scale.	It will be assessed using the following variables: • The patient questionnaires are: Please evaluate the degree of irritation of the tested eye (itching, foreign body sensation, lacrimation and/or swelling of the eyelid) after administration of the investigational medicinal product. The evaluation of effectiveness data is collected by the patient using a visual analogue scale. To this end, the patient marks on a visual analog scale by a vertical line the extent of his discomfort between the endpoints most severe complaints = 100 and no complaints = 0.	Change is being assessed between 0 minutes and 30 minutes after the application of the medical product.
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.	It will be assessed using the following variables: • The occurrence of adverse events. Safety: Adverse events and serious adverse events evaluated by physicians. Any side effects that were not present before the visit, and any side effects that reoccur or worsen after the visit. Abnormal clinically relevant results from diagnostic procedures, including out-of-range laboratory testing, should be considered as an AE. If adverse reactions occur after the visit, the patient is encouraged to contact the doctor by telephone.	Up to 12 hours after the application of medical product.

Collaborators and Investigators

• Sponsor: Bitop AG
• Investigators: Study Director: Ralph Mösges, Dr., ClinCompetence

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Actual): June 28, 2019
• Study Completion (Actual): June 28, 2019

Study Registration Dates

• First Submitted: May 7, 2019
• First Submitted That Met QC Criteria: July 15, 2019
• First Posted (Actual): July 16, 2019

Study Record Updates

• Last Update Posted (Actual): August 11, 2020
• Last Update Submitted That Met QC Criteria: August 10, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: Ectoin; According to section 23b Medical Devices Act; environmental disorder eye; allergen exposure; Ectoin® Allergy Eye Drops 2%; Ectoin® Eye Spray Colloidal
• Additional Relevant MeSH Terms: Eye Diseases; Eye Manifestations; Pharmaceutical Solutions; Ophthalmic Solutions
• Other Study ID Numbers: btph-015-2018-AAT04-EES09

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No