Clinical Study to Evaluate the Efficacy of Ectoin® Containing Eye Spray for Treatment of Dry Eye Disease
- Conditions
- Dry Eye
- Interventions
- Device: Ectoin® Eye Spray - ColloidalDevice: Liposomal eye spray Tears Again®
- Registration Number
- NCT03519815
- Brief Summary
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
- Detailed Description
"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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 36
- Minimum age 18 years
- OSDI Score of at least 18
- NIBUT smaller or equal to 10s in at least one eye
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ectoin Eye Spray Ectoin® Eye Spray - Colloidal 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 Liponit Eye Spray Liposomal eye spray Tears Again® 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
- Primary Outcome Measures
Name Time Method Difference in tear film osmolarity 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). 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 10min non-invasive tear film break up time (NIBUT)
Difference in conjunctival bulbar redness 10min grading of conjunctival bulbar redness
- Secondary Outcome Measures
Name Time Method Difference in tear film quality 10 +/- 3 days non-invasive tear film break up time (NIBUT)
Difference in subjective variables after the treatment period between the two eye sprays. 10 +/- 3 days ocular surface disease index (OSDI) questionnaire, VAS questionnaire for evaluation of dry eye symptoms and tolerability of the eye spray.
Difference in conjunctival bulbar redness 10 +/- 3 days grading of conjunctival bulbar redness
Difference in tear film osmolarity 10 +/- 3 days osmolarity measurement
Trial Locations
- Locations (1)
Institute of Optometry, FHNW
🇨🇭Olten, Solothurn, Switzerland