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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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ClinicalTrials.gov Identifier: NCT03519815
Recruitment Status : Completed
First Posted : May 9, 2018
Last Update Posted : February 19, 2019
Sponsor:
Information provided by (Responsible Party):
Daniela Nosch, University of Applied Sciences and Arts Northwestern Switzerland

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

Condition or disease Intervention/treatment Phase
Dry Eye Device: Ectoin® Eye Spray - Colloidal Device: Liposomal eye spray Tears Again® Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : June 1, 2018
Actual Primary Completion Date : October 30, 2018
Actual Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Diseases Tears

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




Primary Outcome Measures :
  1. 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.

  2. Difference in tear film quality [ Time Frame: 10min ]
    non-invasive tear film break up time (NIBUT)

  3. Difference in tear film osmolarity [ Time Frame: 10min ]
    osmolarity measurement

  4. Difference in conjunctival bulbar redness [ Time Frame: 10min ]
    grading of conjunctival bulbar redness


Secondary Outcome Measures :
  1. 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.

  2. Difference in tear film quality [ Time Frame: 10 +/- 3 days ]
    non-invasive tear film break up time (NIBUT)

  3. Difference in tear film osmolarity [ Time Frame: 10 +/- 3 days ]
    osmolarity measurement

  4. Difference in conjunctival bulbar redness [ Time Frame: 10 +/- 3 days ]
    grading of conjunctival bulbar redness



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03519815


Locations
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Switzerland
Institute of Optometry, FHNW
Olten, Solothurn, Switzerland, 4600
Sponsors and Collaborators
University of Applied Sciences and Arts Northwestern Switzerland
Investigators
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Principal Investigator: Daniela S Nosch, PhD University of Applied Sciences and Arts Northwestern Switzerland

Publications of Results:
Other Publications:
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Responsible Party: Daniela Nosch, Prof. Dr., University of Applied Sciences and Arts Northwestern Switzerland
ClinicalTrials.gov Identifier: NCT03519815     History of Changes
Other Study ID Numbers: 2018-00462
First Posted: May 9, 2018    Key Record Dates
Last Update Posted: February 19, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Daniela Nosch, University of Applied Sciences and Arts Northwestern Switzerland:
dry eye
eye spray

Additional relevant MeSH terms:
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Keratoconjunctivitis Sicca
Dry Eye Syndromes
Eye Diseases
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases