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

Dry Eye Clinical Trial

Official title:
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

Clinical Trial 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

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03519815
Study type Interventional
Source University of Applied Sciences and Arts Northwestern Switzerland
Contact
Status Completed
Phase N/A
Start date June 1, 2018
Completion date December 31, 2018
View Details
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