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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04021225
Recruitment Status : Completed
First Posted : July 16, 2019
Last Update Posted : July 18, 2019
Sponsor:
Information provided by (Responsible Party):
Bitop AG

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.


Condition or disease Intervention/treatment Phase
Eye Manifestations Device: Ectoin® Allergy Eye Drops 2% Device: Ectoin® Eye Spray Colloidal Device: Tears Again® eye spray Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Single (Participant)
Primary Purpose: Other
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.
Actual Study Start Date : January 1, 2019
Actual Primary Completion Date : June 28, 2019
Actual Study Completion Date : June 28, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears

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.




Primary Outcome Measures :
  1. Patient questionnaire [ Time Frame: Change is being assessed between before the application of the medical product and 30 minutes after the application of the medical product. ]

    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)

  2. Assessment of the redness of the eye [ Time Frame: Change is being assessed between before the application of the medical product and 30 minutes after the application of the medical product. ]

    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.


  3. Assessment of the redness of the eye by an external observer [ Time Frame: Change is being assessed between before the application of the medical product and 30 minutes after the application of the medical product. ]

    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.


  4. Visual Analogue Scale [ Time Frame: Change is being assessed between before the application of the medical product and 30 minutes after the application of the medical product. ]

    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.


  5. Tolerability: The degree of irritation of the tested eye is being measured using a visual analogue scale. [ Time Frame: Change is being assessed between 0 minutes and 30 minutes after the application of the medical product. ]

    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.


  6. 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. [ Time Frame: Up to 12 hours after the application of medical product. ]

    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.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04021225


Locations
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Germany
Facharzt für HNO-Heilkunde, Allergologie
Aachen, NRW, Germany, 52074
Sponsors and Collaborators
Bitop AG
Investigators
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Study Chair: Andreas Bilstein, Dr. Bitop AG

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Responsible Party: Bitop AG
ClinicalTrials.gov Identifier: NCT04021225     History of Changes
Other Study ID Numbers: btph-015-2018-AAT04-EES09
First Posted: July 16, 2019    Key Record Dates
Last Update Posted: July 18, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bitop AG:
According to section 23b Medical Devices Act
environmental disorder eye
allergen exposure
Ectoin® Allergy Eye Drops 2%
Ectoin® Eye Spray Colloidal
Ectoin
Additional relevant MeSH terms:
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Eye Manifestations
Eye Diseases
Signs and Symptoms
Ophthalmic Solutions
Pharmaceutical Solutions