Clinical Study to Evaluate the Efficacy of Ectoin® Containing Eye Spray for Treatment of Dry Eye Disease
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
1 other identifier
interventional
36
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2018
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 16, 2018
CompletedFirst Posted
Study publicly available on registry
May 9, 2018
CompletedStudy Start
First participant enrolled
June 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2018
CompletedFebruary 19, 2019
February 1, 2019
5 months
April 16, 2018
February 18, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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 Outcomes (4)
Difference in subjective variables after the treatment period between the two eye sprays.
10 +/- 3 days
Difference in tear film quality
10 +/- 3 days
Difference in tear film osmolarity
10 +/- 3 days
Difference in conjunctival bulbar redness
10 +/- 3 days
Study Arms (2)
Ectoin Eye Spray
ACTIVE COMPARATOREye 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
ACTIVE COMPARATOREye 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
Interventions
eye spray to be applied to the closed eye lid
Eligibility Criteria
You may qualify if:
- Minimum age 18 years
- OSDI Score of at least 18
- NIBUT smaller or equal to 10s in at least one eye
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Institute of Optometry, FHNW
Olten, Canton of Solothurn, 4600, Switzerland
Related Publications (5)
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.
PMID: 20096622BACKGROUNDCraig 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;15(4):802-812. doi: 10.1016/j.jtos.2017.08.003. Epub 2017 Aug 8.
PMID: 28797892RESULTDausch 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. doi: 10.1055/s-2006-927266. German.
PMID: 17199193RESULTLee 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. doi: 10.1055/s-2004-813715. German.
PMID: 15499517RESULTKhaireddin 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.
PMID: 19757354RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Daniela S Nosch, PhD
University of Applied Sciences and Arts Northwestern Switzerland
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof. Dr.
Study Record Dates
First Submitted
April 16, 2018
First Posted
May 9, 2018
Study Start
June 1, 2018
Primary Completion
October 30, 2018
Study Completion
December 31, 2018
Last Updated
February 19, 2019
Record last verified: 2019-02
Data Sharing
- IPD Sharing
- Will not share