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Influence of Lachrymal Substitute Gels on Tear Film Thickness in Patients With Moderate to Severe Dry Eye Syndrome

NCT ID: NCT02585453

Last Updated: 2015-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2015-11-30

Brief Summary

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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 the tear film thickness and the 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 tear film thickness and corneal residence time of three different formulations of topical lubricants, in particular Thealoz Duo® Eye Drops, Hylo® Gel Eye Drops and Systane® Gel 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 and determination of tear break up time (BUT) will be performed.

Detailed Description

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Conditions

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Dry Eye Syndromes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Investigators

Study Groups

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Patients with dry eye syndrome 1

20 Patients with dry eye syndrome

Group Type EXPERIMENTAL

Thealoz Duo Gel

Intervention Type DEVICE

Manufacturer: Laboratoires Thea, France

Patients with dry eye syndrome 2

20 Patients with dry eye syndrome

Group Type ACTIVE_COMPARATOR

Hylo-Gel

Intervention Type DEVICE

Manufacturer: Ursapharm, Saarbrücken, Germany

Patients with dry eye syndrome 3

20 Patients with dry eye syndrome

Group Type ACTIVE_COMPARATOR

Systane Gel Drops

Intervention Type DEVICE

Manufacturer: Alcon Pharma GmbH, Fort Worth, TX, USA

Interventions

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Thealoz Duo Gel

Manufacturer: Laboratoires Thea, France

Intervention Type DEVICE

Hylo-Gel

Manufacturer: Ursapharm, Saarbrücken, Germany

Intervention Type DEVICE

Systane Gel Drops

Manufacturer: Alcon Pharma GmbH, Fort Worth, TX, USA

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Men and women aged over 18 years
2. Signed and dated written informed consent
3. History of dry eye syndrome for at least 3 months
4. Tear Break Up Time (BUT) ≤ 10 seconds or Schirmer I test ≤ 5 mm and ≥ 2mm
5. OSDI ≥ 22
6. Normal ophthalmic findings except dry eye syndrome, ametropia \< 6 Dpt.
7. No administration of topical lubricants 12-24 hours before the screening examination

Exclusion Criteria

1. Presence of an ocular pathology judged by the investigator as incompatible with the study.
2. Any other clinical relevant ocular abnormality except DES.
3. History of allergy, known hypersensitivity to one of the components: the study medications or Fluorescein.
4. History of known clinically relevant allergy.
5. 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, neoplastic, haematological disease; severe psychiatric illness, etc.).
6. History of a recent acute illness with a recovery period within the 2 weeks before the inclusion visit (Day 0).
7. Pregnancy, lactation.
8. Pre-menopausal woman who is not using a reliable birth control method (oral contraceptives or coil) or is not surgically sterilised.
9. Participation in any high-speed or water-sports during the study without ocular protection (goggles or glasses).
10. Subject unable to understand the study instructions or unlikely to comply with the study schedule and treatment.
11. 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.
12. Subject is a ward of court.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

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Gerhard Garhofer

Assoc. Prof. PD Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Clinical Pharmacology, Medical University of Vienna

Vienna, , Austria

Site Status

Countries

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Austria

Other Identifiers

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LT2258-PIV-0614

Identifier Type: -

Identifier Source: org_study_id