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.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bitop AG
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Patient questionnaire
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Non-inclusion criteria
- •Contraindications according to the package leaflet/summary of product characteristics
- •currently wearing contact lenses
结局指标
主要结局
Patient questionnaire
时间窗: 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)
Visual Analogue Scale
时间窗: 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.
Assessment of the redness of the eye
时间窗: 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
时间窗: 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.
Tolerability: The degree of irritation of the tested eye is being measured using a visual analogue scale.
时间窗: 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.
时间窗: 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.
次要结局
未报告次要终点