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Difference in the Frequency of Use of Lachrymal Substitutes in Patients With Moderate to Severe Dry Eye Syndrome

Primary Purpose

Dry Eye Syndromes

Status

Completed

Phase

Not Applicable

Locations

Austria

Study Type

Interventional

Intervention

Thealoz Duo eye drops and Thealoz Duo gel

Thealoz Duo gel

About this trial

This is an interventional basic science trial for Dry Eye Syndromes

Eligibility Criteria

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

Inclusion Criteria:

Men and women aged over 18 years
Signed and dated written informed consent.
History of dry eye syndrome for at least 3 months
Tear Break Up Time (BUT) ≤ 10 seconds or Schirmer I test ≤ 5 mm and ≥ 2mm
OSDI ≥ 22
Normal ophthalmic findings except dry eye syndrome
No administration of topical lubricants 24 hours before the screening examination

Exclusion Criteria:

Presence of an ocular pathology judged by the investigator as incompatible with the study.
Any other clinical relevant ocular abnormality except DES.
History of allergy, known hypersensitivity to one of the components: the administered medical device product, fluorescein or lissamine green
History of known clinically relevant allergy
Medical or surgical history judged by the investigator to be incompatible with the study participation (hepatic or renal insufficiency; all chronic severe organic disease: metabolic, endocrine, neoplasic, hematological disease; severe psychiatric illness, etc.).
History of a recent acute illness with a recovery period within the 2 weeks before the inclusion visit (Day 0).
Pregnancy, lactation.
Pre-menopausal woman who is not using a reliable birth control method (oral contraceptives or coil) or is not surgically sterilized.
Participation in any high-speed or water-sports during the study without ocular protection (goggles or glasses).
Subject unable to understand the study instructions or unlikely to comply with the study schedule and treatment.
Participation in another clinical study in the 4 weeks before the start of the present study or at the same time as the present study.

Sites / Locations

Department of Clinical Pharmacology, Medical University of Vienna

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Experimental: Patients with dry eye syndrome 1

Experimental: Patients with dry eye syndrome 2

Arm Description

20 patients with dry eye syndrome, they will receive intervention 1 for one week and then cross over to intervention 2

20 patients with dry eye syndrome, they will receive intervention 2 for one week and then cross over to intervention 1

Outcomes

Primary Outcome Measures

Number of drops of Thealoz Duo® eye drops and Thealoz Duo® gel instilled during the day (patient diary)

Number of drops of Thealoz Duo® eye drops and Thealoz Duo® gel instilled during the day during the observation period of one week for each medical device (patient diary)

Secondary Outcome Measures

Tear Break Up Time (BUT)

Schirmer I test

Conjunctival and corneal staining

OSDI questionnaire

Quality of life of patients (VAS)

Full Information

NCT ID

NCT02980913

First Posted

November 30, 2016

Last Updated

August 21, 2019

Sponsor

Medical University of Vienna

1. Study Identification

Unique Protocol Identification Number

NCT02980913

Brief Title

Difference in the Frequency of Use of Lachrymal Substitutes in Patients With Moderate to Severe Dry Eye Syndrome

Study Type

Interventional

2. Study Status

Record Verification Date

August 2019

Overall Recruitment Status

Completed

Study Start Date

February 11, 2016 (Actual)

Primary Completion Date

May 17, 2016 (Actual)

Study Completion Date

May 17, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Medical University of Vienna

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Dry eye syndrome is a highly prevalent ocular disease with an increasing incidence in the elderly population. Topically administered lubricants are the basis for treatment of this disease. Relief of symptoms in patients with moderate to severe dry eye disease is usually reached by the use of artificial tears during the day. Nighttime relief is often achieved by substances known to be more adhesive to the ocular surface, such as gels.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dry Eye Syndromes

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

45 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Experimental: Patients with dry eye syndrome 1

Arm Type

Experimental

Arm Description

20 patients with dry eye syndrome, they will receive intervention 1 for one week and then cross over to intervention 2

Arm Title

Experimental: Patients with dry eye syndrome 2

Arm Type

Experimental

Arm Description

20 patients with dry eye syndrome, they will receive intervention 2 for one week and then cross over to intervention 1

Intervention Type

Device

Intervention Name(s)

Thealoz Duo eye drops and Thealoz Duo gel

Other Intervention Name(s)

Intervention 1

Intervention Description

Thealoz Duo eye drops during the day + Thealoz Duo gel at night (1 drop before going to bed) for 7 days

Intervention Type

Device

Intervention Name(s)

Thealoz Duo gel

Other Intervention Name(s)

Intervention 2

Intervention Description

Thealoz Duo gel during the day and at night for 7 days

Primary Outcome Measure Information:

Title

Number of drops of Thealoz Duo® eye drops and Thealoz Duo® gel instilled during the day (patient diary)

Description

Number of drops of Thealoz Duo® eye drops and Thealoz Duo® gel instilled during the day during the observation period of one week for each medical device (patient diary)

Time Frame

4 weeks

Secondary Outcome Measure Information:

Title

Tear Break Up Time (BUT)

Time Frame

4 weeks

Title

Schirmer I test

Time Frame

4 weeks

Title

Conjunctival and corneal staining

Time Frame

4 weeks

Title

OSDI questionnaire

Time Frame

4 weeks

Title

Quality of life of patients (VAS)

Time Frame

4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Men and women aged over 18 years Signed and dated written informed consent. History of dry eye syndrome for at least 3 months Tear Break Up Time (BUT) ≤ 10 seconds or Schirmer I test ≤ 5 mm and ≥ 2mm OSDI ≥ 22 Normal ophthalmic findings except dry eye syndrome No administration of topical lubricants 24 hours before the screening examination Exclusion Criteria: Presence of an ocular pathology judged by the investigator as incompatible with the study. Any other clinical relevant ocular abnormality except DES. History of allergy, known hypersensitivity to one of the components: the administered medical device product, fluorescein or lissamine green History of known clinically relevant allergy Medical or surgical history judged by the investigator to be incompatible with the study participation (hepatic or renal insufficiency; all chronic severe organic disease: metabolic, endocrine, neoplasic, hematological disease; severe psychiatric illness, etc.). History of a recent acute illness with a recovery period within the 2 weeks before the inclusion visit (Day 0). Pregnancy, lactation. Pre-menopausal woman who is not using a reliable birth control method (oral contraceptives or coil) or is not surgically sterilized. Participation in any high-speed or water-sports during the study without ocular protection (goggles or glasses). Subject unable to understand the study instructions or unlikely to comply with the study schedule and treatment. Participation in another clinical study in the 4 weeks before the start of the present study or at the same time as the present study.

Facility Information:

Facility Name

Department of Clinical Pharmacology, Medical University of Vienna

City

Vienna

ZIP/Postal Code

1090

Country

Austria

12. IPD Sharing Statement

Citations:

PubMed Identifier

30155282

Citation

Fondi K, Wozniak PA, Schmidl D, Bata AM, Witkowska KJ, Popa-Cherecheanu A, Schmetterer L, Garhofer G. Effect of Hyaluronic Acid/Trehalose in Two Different Formulations on Signs and Symptoms in Patients with Moderate to Severe Dry Eye Disease. J Ophthalmol. 2018 Aug 1;2018:4691417. doi: 10.1155/2018/4691417. eCollection 2018.

Results Reference

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Difference in the Frequency of Use of Lachrymal Substitutes in Patients With Moderate to Severe Dry Eye Syndrome

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