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Influence of Three Different Formulations of Lachrymal Substitutes on Tear Film Thickness and Other Signs and Symptoms in Patients With Moderate to Severe Dry Eye Syndrome

Primary Purpose

Dry Eye Syndromes

Status

Completed

Phase

Phase 4

Locations

Austria

Study Type

Interventional

Intervention

Thealoz Duo Eye Drops

Optive Eye Drops

Systane Ultra Eye Drops

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, ametropia < 6 Dpt.
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 study medications or Fluorescein.
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, haematological 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 sterilised.
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.
Subject is a ward of court.

Sites / Locations

Department of Clinical Pharmacology, Medical University of Vienna

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

Experimental: Patients with dry eye syndrome 1

Experimental: Patients with dry eye syndrome 2

Experimental: Patients with dry eye syndrome 3

Arm Description

40 Patients with dry eye syndrome

Outcomes

Primary Outcome Measures

Change in tear film thickness as measured with Optical Coherence Tomography (OCT)

Tear film thickness as measured with Optical Coherence Tomography (OCT) predose and at defined time points after the first instillation, as well as on each study day

Secondary Outcome Measures

Tear Break Up Time (BUT)

Subjective evaluation of ocular comfort with questionnaire

Schirmer I test

OSDI score

Corneal fluorescein staining (Oxford grading scale)

Conjunctival hyperemia score

Efficacy assessment of eye drops by the patient with questionnaire

Efficacy of eye drops will be performed by the patient by choosing one of the following options: Very satisfactory Satisfactory Not very satisfactory Unsatisfactory

Efficacy assessment of eye drops by the investigator with questionnaire

Efficacy of eye drops will be performed by the investigator by choosing one of the following options: Very satisfactory Satisfactory Not very satisfactory Unsatisfactory

Full Information

NCT ID

NCT02986750

First Posted

December 1, 2016

Last Updated

August 19, 2019

Sponsor

Medical University of Vienna

1. Study Identification

Unique Protocol Identification Number

NCT02986750

Brief Title

Influence of Three Different Formulations of Lachrymal Substitutes on Tear Film Thickness and Other Signs and Symptoms 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 13, 2016 (Actual)

Primary Completion Date

March 23, 2017 (Actual)

Study Completion Date

March 23, 2017 (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. However, exact information about influence on tear film thickness and corneal residence time of topical lubricants is still sparse, therefore no ideal treatment regimen has been found. Recently a new method for assessment of tear film thickness based on ultra-high resolution optical coherence tomography (OCT) has become available. The aim of the present study is to assess the influence on tear film thickness of three different formulations of topical lubricants, in particular Thealoz Duo® Eye Drops, Optive® Eye Drops and Systane Ultra® Eye Drops in patients with moderate to severe dry eye disease. In addition, standard tests for dry eye syndrome, such as the ocular surface disease index (OSDI©), Schirmer I test, corneal fluorescein staining and determination of tear break up time (BUT) will be performed to compare the product effects.

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

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

120 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Experimental: Patients with dry eye syndrome 1

Arm Type

Experimental

Arm Description

40 Patients with dry eye syndrome

Arm Title

Experimental: Patients with dry eye syndrome 2

Arm Type

Active Comparator

Arm Description

40 Patients with dry eye syndrome

Arm Title

Experimental: Patients with dry eye syndrome 3

Arm Type

Active Comparator

Arm Description

40 Patients with dry eye syndrome

Intervention Type

Device

Intervention Name(s)

Thealoz Duo Eye Drops

Intervention Description

Manufacturer: Laboratoires Thea, France

Intervention Type

Device

Intervention Name(s)

Optive Eye Drops

Intervention Description

Manufacturer: Allergan Pharmaceuticals, Ireland

Intervention Type

Device

Intervention Name(s)

Systane Ultra Eye Drops

Intervention Description

Manufacturer: Alcon Pharma GmbH

Primary Outcome Measure Information:

Title

Change in tear film thickness as measured with Optical Coherence Tomography (OCT)

Description

Tear film thickness as measured with Optical Coherence Tomography (OCT) predose and at defined time points after the first instillation, as well as on each study day

Time Frame

10 weeks; at baseline, 10 minutes, 20 minutes, 40 minutes, 60 minutes, 120 minutes and 240 minutes after instillation of eye drops as well as 4 weeks and 8 weeks after the first instillation

Secondary Outcome Measure Information:

Title

Tear Break Up Time (BUT)

Time Frame

10 weeks

Title

Subjective evaluation of ocular comfort with questionnaire

Time Frame

10 weeks

Title

Schirmer I test

Time Frame

10 weeks

Title

OSDI score

Time Frame

10 weeks

Title

Corneal fluorescein staining (Oxford grading scale)

Time Frame

10 weeks

Title

Conjunctival hyperemia score

Time Frame

10 weeks

Title

Efficacy assessment of eye drops by the patient with questionnaire

Description

Efficacy of eye drops will be performed by the patient by choosing one of the following options: Very satisfactory Satisfactory Not very satisfactory Unsatisfactory

Time Frame

10 weeks

Title

Efficacy assessment of eye drops by the investigator with questionnaire

Description

Efficacy of eye drops will be performed by the investigator by choosing one of the following options: Very satisfactory Satisfactory Not very satisfactory Unsatisfactory

Time Frame

10 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, ametropia < 6 Dpt. 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 study medications or Fluorescein. 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, haematological 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 sterilised. 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. Subject is a ward of court.

Facility Information:

Facility Name

Department of Clinical Pharmacology, Medical University of Vienna

City

Vienna

ZIP/Postal Code

1090

Country

Austria

12. IPD Sharing Statement

Learn more about this trial

Influence of Three Different Formulations of Lachrymal Substitutes on Tear Film Thickness and Other Signs and Symptoms in Patients With Moderate to Severe Dry Eye Syndrome

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