Comparison of Ectoin® Containing Eye Drops and Ectoin® Containing Eye Spray With the Eye Spray Tears Again®

NCT04021225 | Completed DMC

• 1 other identifier: btph-015-2018-AAT04-EES09
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to gain knowledge on the duration of symptom relief of environmental disorders of the eye as might be present in allergy sufferers after allergen exposure following application of the study products. Additionally, the extent of symptom relief as well as tolerability of this topic treatment will be evaluated.

Conditions

Eye Manifestations

Keywords

According to section 23b Medical Devices Act; environmental disorder eye; allergen exposure; Ectoin® Allergy Eye Drops 2%; Ectoin® Eye Spray Colloidal; Ectoin

Outcome Measures

Primary Outcomes (6)

• Patient questionnaire

  Relief of environmental disorders of the eye will be assessed by determining the time to onset of action using a patient questionnaire. The extent of relief as the degree of effectiveness will be determined using the following variables: • Patient questionnaire The questions from the patient questionnaire are: * How do you rate your eyesight at this time? Unimpaired, impaired * Do you have difficulties reading normal printed material in the newspaper? (no, a little, strong, stopped trying)

  Change is being assessed between before the application of the medical product and 30 minutes after the application of the medical product.

• Assessment of the redness of the eye

  Relief of environmental disorders of the eye will be assessed by determining the time to onset of action using a patient questionnaire. The extent of relief as the degree of effectiveness will be determined using the following variables: • Digital analysis of the redness of the eye. The redness of the eye is evaluated by means of digital image analysis. The patient's more affected eye is photographed parallel to the entries on the VAS. To capture the images, the same construction for attaching the camera as well as fixed camera settings are used to create comparable conditions. Captured data analyzed by MATLAB V.9.5.

  Change is being assessed between before the application of the medical product and 30 minutes after the application of the medical product.

• Assessment of the redness of the eye by an external observer

  Relief of environmental disorders of the eye will be assessed by determining the time to onset of action using a patient questionnaire. The extent of relief as the degree of effectiveness will be determined using the following variables: • Assessment of the redness of the eye by an external observer Redness of eye evaluated by a physician.

  Change is being assessed between before the application of the medical product and 30 minutes after the application of the medical product.

• Visual Analogue Scale

  Relief of environmental disorders of the eye will be assessed by determining the time to onset of action using a patient questionnaire. The extent of relief as the degree of effectiveness will be determined using the following variables: • Visual Analogue Scale The evaluation of effectiveness data is collected by the patient using a visual analogue scale. To this end, the patient marks on a visual analog scale by a vertical line the extent of his discomfort between the endpoints most severe complaints = 100 and no complaints = 0.

  Change is being assessed between before the application of the medical product and 30 minutes after the application of the medical product.

• Tolerability: The degree of irritation of the tested eye is being measured using a visual analogue scale.

  It will be assessed using the following variables: • The patient questionnaires are: Please evaluate the degree of irritation of the tested eye (itching, foreign body sensation, lacrimation and/or swelling of the eyelid) after administration of the investigational medicinal product. The evaluation of effectiveness data is collected by the patient using a visual analogue scale. To this end, the patient marks on a visual analog scale by a vertical line the extent of his discomfort between the endpoints most severe complaints = 100 and no complaints = 0.

  Change is being assessed between 0 minutes and 30 minutes after the application of the medical product.

• Safety: All adverse reactions and adverse events that occur after signing the informed consent form must be reported, even if no investigational medicinal product was taken.

  It will be assessed using the following variables: • The occurrence of adverse events. Safety: Adverse events and serious adverse events evaluated by physicians. Any side effects that were not present before the visit, and any side effects that reoccur or worsen after the visit. Abnormal clinically relevant results from diagnostic procedures, including out-of-range laboratory testing, should be considered as an AE. If adverse reactions occur after the visit, the patient is encouraged to contact the doctor by telephone.

  Up to 12 hours after the application of medical product.

Study Arms (3)

Ectoin® Allergy Eye Drops 2%

ACTIVE COMPARATOR

20 Patients: \- Ectoin® Allergy Eye Drops 2% (bitop AG)

Device: Ectoin® Allergy Eye Drops 2%

Ectoin® Eye Spray Colloidal

ACTIVE COMPARATOR

20 Patients: -Ectoin® Eye Spray Colloidal (bitop AG)

Device: Ectoin® Eye Spray Colloidal

Tears Again® Eye Spray

ACTIVE COMPARATOR

20 Patients: \- Tears Again® Eye Spray (Optima Pharmazeutische GmbH)

Device: Tears Again® eye spray

Interventions

Ectoin® Allergy Eye Drops 2% DEVICE

A one-time application of 1-2 drops in the more affected eye will be investigated.

Ectoin® Allergy Eye Drops 2%

Ectoin® Eye Spray Colloidal DEVICE

A one-time application of 1-2 drops in the more affected eye will be investigated.

Ectoin® Eye Spray Colloidal

Tears Again® eye spray DEVICE

A one-time application of 1-2 drops in the more affected eye will be investigated.

Tears Again® Eye Spray

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed and dated informed consent form
• Male and female patients aged 18 to 75 years
• Patients have to suffer from allergen exposure induced environmental disorder of the eye

You may not qualify if:

• Contraindications according to the package leaflet/summary of product characteristics
• currently wearing contact lenses

Sponsors & Collaborators

• Bitop AG: lead

Study Sites (1)

Facharzt für HNO-Heilkunde, Allergologie

Aachen, North Rhine-Westphalia, 52074, Germany

Location

MeSH Terms

Conditions

Eye Manifestations

Condition Hierarchy (Ancestors)

Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ralph Mösges, Dr.

  ClinCompetence

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2019
• First Posted: July 16, 2019
• Study Start: January 1, 2019
• Primary Completion: June 28, 2019
• Study Completion: June 28, 2019
• Last Updated: August 11, 2020

Record last verified: 2020-08

Locations

DE (1)