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

Primary Purpose

Dry Eye

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Ectoin® Eye Spray - Colloidal
Liposomal eye spray Tears Again®
Sponsored by
University of Applied Sciences and Arts Northwestern Switzerland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye focused on measuring dry eye, eye spray

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Institute of Optometry, FHNW

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Ectoin Eye Spray

Liponit Eye Spray

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
Difference in tear film quality
non-invasive tear film break up time (NIBUT)
Difference in tear film osmolarity
osmolarity measurement
Difference in conjunctival bulbar redness
grading of conjunctival bulbar redness

Secondary Outcome Measures

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.
Difference in tear film quality
non-invasive tear film break up time (NIBUT)
Difference in tear film osmolarity
osmolarity measurement
Difference in conjunctival bulbar redness
grading of conjunctival bulbar redness

Full Information

First Posted
April 16, 2018
Last Updated
February 18, 2019
Sponsor
University of Applied Sciences and Arts Northwestern Switzerland
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1. Study Identification

Unique Protocol Identification Number
NCT03519815
Brief Title
Clinical Study to Evaluate the Efficacy of Ectoin® Containing Eye Spray for Treatment of Dry Eye Disease
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
June 1, 2018 (Actual)
Primary Completion Date
October 30, 2018 (Actual)
Study Completion Date
December 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Applied Sciences and Arts Northwestern Switzerland

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye
Keywords
dry eye, eye spray

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ectoin Eye Spray
Arm Type
Active Comparator
Arm Description
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
Arm Title
Liponit Eye Spray
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Ectoin® Eye Spray - Colloidal
Intervention Description
eye spray to be applied to the closed eye lid
Intervention Type
Device
Intervention Name(s)
Liposomal eye spray Tears Again®
Intervention Description
eye spray to be applied to the closed eye lid
Primary Outcome Measure Information:
Title
Difference in subjective variables 10min after application and after the treatment period with the eye sprays, in comparison to baseline measurements (visit 1).
Description
ocular surface disease index (OSDI) questionnaire, VAS questionnaire for evaluation of dry eye symptoms and tolerability of the eye spray.
Time Frame
10min
Title
Difference in tear film quality
Description
non-invasive tear film break up time (NIBUT)
Time Frame
10min
Title
Difference in tear film osmolarity
Description
osmolarity measurement
Time Frame
10min
Title
Difference in conjunctival bulbar redness
Description
grading of conjunctival bulbar redness
Time Frame
10min
Secondary Outcome Measure Information:
Title
Difference in subjective variables after the treatment period between the two eye sprays.
Description
ocular surface disease index (OSDI) questionnaire, VAS questionnaire for evaluation of dry eye symptoms and tolerability of the eye spray.
Time Frame
10 +/- 3 days
Title
Difference in tear film quality
Description
non-invasive tear film break up time (NIBUT)
Time Frame
10 +/- 3 days
Title
Difference in tear film osmolarity
Description
osmolarity measurement
Time Frame
10 +/- 3 days
Title
Difference in conjunctival bulbar redness
Description
grading of conjunctival bulbar redness
Time Frame
10 +/- 3 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniela S Nosch, PhD
Organizational Affiliation
University of Applied Sciences and Arts Northwestern Switzerland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Optometry, FHNW
City
Olten
State/Province
Solothurn
ZIP/Postal Code
4600
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
20096622
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.
Results Reference
background
PubMed Identifier
28797892
Citation
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;15(4):802-812. doi: 10.1016/j.jtos.2017.08.003. Epub 2017 Aug 8.
Results Reference
result
PubMed Identifier
17199193
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. doi: 10.1055/s-2006-927266. German.
Results Reference
result
PubMed Identifier
15499517
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. doi: 10.1055/s-2004-813715. German.
Results Reference
result
PubMed Identifier
19757354
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.
Results Reference
result

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

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