Clinical Study to Evaluate the Efficacy of Ectoin® Containing Eye Spray for Treatment of Dry Eye Disease

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Dry Eye

Intervention / Treatment
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* Device: Ectoin® Eye Spray - Colloidal
* Device: Liposomal eye spray Tears Again®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Minimum age 18 years OSDI Score of at least 18 NIBUT smaller or equal to 10s in at least one eye Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ectoin Eye Spray<br>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 | Device: Ectoin® Eye Spray - Colloidal<br>* eye spray to be applied to the closed eye lid<br>|
| Active Comparator: Liponit Eye Spray<br>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 | Device: Liposomal eye spray Tears Again®<br>* eye spray to be applied to the closed eye lid<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in subjective variables 10min after application and after the treatment period with the eye sprays, in comparison to baseline measurements (visit 1). | ocular surface disease index (OSDI) questionnaire, VAS questionnaire for evaluation of dry eye symptoms and tolerability of the eye spray. | 10min | 
| Difference in tear film quality | non-invasive tear film break up time (NIBUT) | 10min | 
| Difference in tear film osmolarity | osmolarity measurement | 10min | 
| Difference in conjunctival bulbar redness | grading of conjunctival bulbar redness | 10min | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in subjective variables after the treatment period between the two eye sprays. | ocular surface disease index (OSDI) questionnaire, VAS questionnaire for evaluation of dry eye symptoms and tolerability of the eye spray. | 10 +/- 3 days | 
| Difference in tear film quality | non-invasive tear film break up time (NIBUT) | 10 +/- 3 days | 
| Difference in tear film osmolarity | osmolarity measurement | 10 +/- 3 days | 
| Difference in conjunctival bulbar redness | grading of conjunctival bulbar redness | 10 +/- 3 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dry eye, eye spray