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 Details — Status: Completed

Administrative data

• NCT number: NCT03519815
• Other study ID #: 2018-00462
• Status: Completed
• Phase: N/A
• Start date: June 1, 2018
• Est. completion date: December 31, 2018

Study information

• Verified date: February 2019
• Source: University of Applied Sciences and Arts Northwestern Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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

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 information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: December 31, 2018
• Est. primary completion date: October 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dry Eye
• Dry Eye Syndromes
• Eye Diseases
• Keratoconjunctivitis Sicca

Intervention

Device:
• Ectoin® Eye Spray - Colloidal
eye spray to be applied to the closed eye lid
• Liposomal eye spray Tears Again®
eye spray to be applied to the closed eye lid

Locations

Country	Name	City	State
Switzerland	Institute of Optometry, FHNW	Olten	Solothurn

Sponsors (1)

Lead Sponsor	Collaborator
University of Applied Sciences and Arts Northwestern Switzerland

Country where clinical trial is conducted

Switzerland, 

References & Publications (5)

Craig JP, Nelson JD, Azar DT, Belmonte C, Bron AJ, Chauhan SK, de Paiva CS, Gomes JAP, Hammitt KM, Jones L, Nichols JJ, Nichols KK, Novack GD, Stapleton FJ, Willcox MDP, Wolffsohn JS, Sullivan DA. TFOS DEWS II Report Executive Summary. Ocul Surf. 2017 Oct — View Citation

Craig JP, Purslow C, Murphy PJ, Wolffsohn JS. Effect of a liposomal spray on the pre-ocular tear film. Cont Lens Anterior Eye. 2010 Apr;33(2):83-7. doi: 10.1016/j.clae.2009.12.007. Epub 2010 Jan 21. — View Citation

Dausch D, Lee S, Dausch S, Kim JC, Schwert G, Michelson W. [Comparative study of treatment of the dry eye syndrome due to disturbances of the tear film lipid layer with lipid-containing tear substitutes]. Klin Monbl Augenheilkd. 2006 Dec;223(12):974-83. G — View Citation

Khaireddin R, Schmidt KG. [Comparative investigation of treatments for evaporative dry eye]. Klin Monbl Augenheilkd. 2010 Feb;227(2):128-34. doi: 10.1055/s-0028-1109686. Epub 2009 Sep 15. German. — View Citation

Lee S, Dausch S, Maierhofer G, Dausch D. [A new therapy concept for the treatment of dry eye--the usefulness of phospholipid liposomes]. Klin Monbl Augenheilkd. 2004 Oct;221(10):825-36. German. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Difference in tear film quality	non-invasive tear film break up time (NIBUT)	10min
Primary	Difference in tear film osmolarity	osmolarity measurement	10min
Primary	Difference in conjunctival bulbar redness	grading of conjunctival bulbar redness	10min
Secondary	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
Secondary	Difference in tear film quality	non-invasive tear film break up time (NIBUT)	10 +/- 3 days
Secondary	Difference in tear film osmolarity	osmolarity measurement	10 +/- 3 days
Secondary	Difference in conjunctival bulbar redness	grading of conjunctival bulbar redness	10 +/- 3 days