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

February 18, 2019 updated by: Daniela Nosch, University of Applied Sciences and Arts Northwestern Switzerland

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • Solothurn
      • Olten, Solothurn, Switzerland, 4600
        • Institute of Optometry, FHNW

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Ectoin Eye Spray

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
eye spray to be applied to the closed eye lid
Active Comparator: Liponit Eye Spray

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®
eye spray to be applied to the closed eye lid

What is the study measuring?

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).
Time Frame: 10min
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
Time Frame: 10min
non-invasive tear film break up time (NIBUT)
10min
Difference in tear film osmolarity
Time Frame: 10min
osmolarity measurement
10min
Difference in conjunctival bulbar redness
Time Frame: 10min
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.
Time Frame: 10 +/- 3 days
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
Time Frame: 10 +/- 3 days
non-invasive tear film break up time (NIBUT)
10 +/- 3 days
Difference in tear film osmolarity
Time Frame: 10 +/- 3 days
osmolarity measurement
10 +/- 3 days
Difference in conjunctival bulbar redness
Time Frame: 10 +/- 3 days
grading of conjunctival bulbar redness
10 +/- 3 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Applied Sciences and Arts Northwestern Switzerland

Investigators

  • Principal Investigator: Daniela S Nosch, PhD, University of Applied Sciences and Arts Northwestern Switzerland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2018

Primary Completion (Actual)

October 30, 2018

Study Completion (Actual)

December 31, 2018

Study Registration Dates

First Submitted

April 16, 2018

First Submitted That Met QC Criteria

April 26, 2018

First Posted (Actual)

May 9, 2018

Study Record Updates

Last Update Posted (Actual)

February 19, 2019

Last Update Submitted That Met QC Criteria

February 18, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-00462

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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