Prospective Randomized Study to Evaluate the Efficacy and Tolerability of Ectoin® Containing Eye Spray (EES09) and Comparison to the Liposomal Eye Spray Tears Again® (TA) in the Treatment of Dry Eye Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Difference in tear film osmolarity
研究概览
简要总结
Subjective and objective evaluation of the efficacy and tolerability of preservative-free "Ectoin® Eye Spray - Colloidal" and comparison of the efficacy and tolerability between "Ectoin® Eye Spray - Colloidal" and Tears Again® in patients with mild-moderate dry eye disease
详细描述
"Dry eye is a multifactorial disease of the ocular surface characterized by a loss of homeostasis of the tear film, and accompanied by ocular symptoms, in which tear film instability and hyperosmolarity, ocular surface inflammation and damage, and neuro- sensory abnormalities play etiological roles." (DEWS II Report, 2017).
For the treatment and prevention of dry eye disease (DED) there are a number of treatment modalities available, depending on the severity and classification (aqueous deficient / evaporative) of the disease. The liposomal eye spray Tears Again® (TA, Optima Medical Swiss AG - medical device with CE marking) represents an option to treat mild to moderate evaporative DED. A novel preservative-free eye spray, Ectoin® Eye Spray - Colloidal (EES09; bitop AG -medical device with CE marking), was developed, in which colloids (colloidal lecithin emulsion) serve as a carrier for Ectoin. Ectoin is known as a natural cell-protective and inflammatory-inhibiting molecule. The principle mode of action of Ectoin is based on the physical interaction of this compatible solute with water and the resulting effects of the Ectoin-Hydro-Complex on the tissue treated.
The aim of this study is to subjectively and objectively evaluate the efficacy and tolerability of preservative-free "Ectoin® Eye Spray - Colloidal" and to compare the efficacy and tolerability between "Ectoin® Eye Spray - Colloidal" and Tears Again® in patients with mild-moderate dry eye disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Minimum age 18 years
- •OSDI Score of at least 18
- •NIBUT smaller or equal to 10s in at least one eye
排除标准
- •Post-operative trauma or injury
- •Ocular disease with exception of DED
- •Hypersensitivity to any of the ingredients in the products used for this study
- •Contact lens wear 24h before or on the day of study visits
- •Use of eye drops / other eye sprays on the day of visit 1 or during the duration of the study period
研究组 & 干预措施
Ectoin Eye Spray
Eye Spray to be applied 3 times per day for the duration of 10 +/-3 days "Ectoin® Eye Spray - Colloidal" (EES09; bitop AG) - CE marked medical device
Ingredients: Ectoin®, Soy-Lecithin, Vitamin A, Vitamin E, water, physiological buffer system Indication: to treat mild to moderate dry eye disease
干预措施: Ectoin® Eye Spray - Colloidal (Device)
Liponit Eye Spray
Eye Spray to be applied 3 times per day for the duration of 10 +/-3 days
Liposomal eye spray: Tears Again® (TA, Optima Medical Swiss AG) - CE marked medical device Ingredients: Soy-Lecithin, Sodium Chloride, Ethanol, Phenoxyethanol, Vitamin A-Palmitate, Vitamin E, Aqua purificata Indication: to treat mild to moderate dry eye disease
干预措施: Liposomal eye spray Tears Again® (Device)
结局指标
主要结局
Difference in tear film osmolarity
时间窗: 10min
osmolarity measurement
Difference in subjective variables 10min after application and after the treatment period with the eye sprays, in comparison to baseline measurements (visit 1).
时间窗: 10min
ocular surface disease index (OSDI) questionnaire, VAS questionnaire for evaluation of dry eye symptoms and tolerability of the eye spray.
Difference in tear film quality
时间窗: 10min
non-invasive tear film break up time (NIBUT)
Difference in conjunctival bulbar redness
时间窗: 10min
grading of conjunctival bulbar redness
次要结局
- Difference in tear film quality(10 +/- 3 days)
- Difference in subjective variables after the treatment period between the two eye sprays.(10 +/- 3 days)
- Difference in conjunctival bulbar redness(10 +/- 3 days)
- Difference in tear film osmolarity(10 +/- 3 days)
研究者
Daniela Nosch
Prof. Dr.
University of Applied Sciences and Arts Northwestern Switzerland