Eye Manifestations Clinical Trial
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.
Verified date | August 2020 |
Source | Bitop AG |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 50 |
Est. completion date | June 28, 2019 |
Est. primary completion date | June 28, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Germany | Facharzt für HNO-Heilkunde, Allergologie | Aachen | NRW |
Lead Sponsor | Collaborator |
---|---|
Bitop AG |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | |
Primary | 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. | |
Primary | 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. | |
Primary | 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. | |
Primary | 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. | |
Primary | 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. |
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