Eye ManifestationsNCT04021225
Comparison of Ectoin® Containing Eye Drops and Ectoin® Containing Eye Spray With the Eye Spray Tears Again®
A study testing Ectoin® Allergy Eye Drops 2%, Ectoin® Eye Spray Colloidal and Tears Again® eye spray in people with Eye Manifestations, run by Bitop AG at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Eye Manifestations
- What is being tested?
- Ectoin® Allergy Eye Drops 2%, Ectoin® Eye Spray Colloidal and Tears Again® eye spray
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jan 2019to 28 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- -
- Non-inclusion criteria
- Contraindications according to the package leaflet/summary of product characteristics
- currently wearing contact lenses
Trial locations and contacts
1 site in 1 country.
Germany1 site
Facharzt für HNO-Heilkunde, Allergologie
Aachen, North Rhine-Westphalia, 52074
About this study
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.
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.
Read the 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
- Being tested
- Ectoin® Allergy Eye Drops 2%, Ectoin® Eye Spray Colloidal, Tears Again® eye spray
- Keywords
- According to section 23b Medical Devices Act, environmental disorder eye, allergen exposure, Ectoin® Allergy Eye Drops 2%, Ectoin® Eye Spray Colloidal, Ectoin
- Medical subject headings
- Eye Manifestations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ectoin® Allergy Eye Drops 2%Device
A one-time application of 1-2 drops in the more affected eye will be investigated.
Ectoin® Eye Spray ColloidalDevice
A one-time application of 1-2 drops in the more affected eye will be investigated.
Tears Again® eye sprayDevice
A one-time application of 1-2 drops in the more affected eye will be investigated.
| Study group | Role | What they receive |
|---|---|---|
| Ectoin® Allergy Eye Drops 2% | Active comparator | 20 Patients:
- Ectoin® Allergy Eye Drops 2% (bitop AG) Receives: Device: Ectoin® Allergy Eye Drops 2% |
| Ectoin® Eye Spray Colloidal | Active comparator | 20 Patients:
-Ectoin® Eye Spray Colloidal (bitop AG) Receives: Device: Ectoin® Eye Spray Colloidal |
| Tears Again® Eye Spray | Active comparator | 20 Patients:
- Tears Again® Eye Spray (Optima Pharmazeutische GmbH) Receives: Device: Tears Again® eye spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 12 hours after the application of medical product.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2019
- Study start1 Jan 2019
- Primary completion28 Jun 2019
- Study completion28 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eye ManifestationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bitop AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ralph Mösges, Dr., Study director, ClinCompetence
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04021225
- Sponsor's protocol ID
- btph-015-2018-AAT04-EES09
- Status last verified
- Aug 2020
- First submitted
- 7 May 2019
- Last updated
- 11 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04021225
- Acronym / sponsor ID
- btph-015-2018-AAT04-EES09
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Bitop AGIndustry (pharma, biotech, devices)
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 28 Jun 2019 (actual)
- Study completion
- 28 Jun 2019 (actual)
- First posted
- 16 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ectoin® Allergy Eye Drops 2% | Active comparator | Device: Ectoin® Allergy Eye Drops 2%20 Patients: - Ectoin® Allergy Eye Drops 2% (bitop AG) |
| Ectoin® Eye Spray Colloidal | Active comparator | Device: Ectoin® Eye Spray Colloidal20 Patients: -Ectoin® Eye Spray Colloidal (bitop AG) |
| Tears Again® Eye Spray | Active comparator | Device: Tears Again® eye spray20 Patients: - Tears Again® Eye Spray (Optima Pharmazeutische GmbH) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- -
- Non-inclusion criteria
- Contraindications according to the package leaflet/summary of product characteristics
- currently wearing contact lenses
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ectoin® Allergy Eye Drops 2%A one-time application of 1-2 drops in the more affected eye will be investigated. | Device | Ectoin® Allergy Eye Drops 2% |
| Ectoin® Eye Spray ColloidalA one-time application of 1-2 drops in the more affected eye will be investigated. | Device | Ectoin® Eye Spray Colloidal |
| Tears Again® eye sprayA one-time application of 1-2 drops in the more affected eye will be investigated. | Device | Tears Again® Eye Spray |
Primary outcome
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)
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.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ralph Mösges, Dr. study director
ClinCompetence
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ectoin® Allergy Eye Drops 2%, Ectoin® Eye Spray Colloidal and Tears Again® eye spray in people with Eye Manifestations, run by Bitop AG at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2020.