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

NCT02585453 | Completed Phase 4

• 1 other identifier: LT2258-PIV-0614
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Dry Eye Syndromes

Outcome Measures

Primary Outcomes (1)

• Tear Film thickness as measured with optical coherence tomography (OCT)

  360 minutes

Secondary Outcomes (3)

• Tear Break Up Time

  1 month

• Schirmer 1 test

  1 month

• Subjective evaluation of ocular comfort

  1 month

Study Arms (3)

Patients with dry eye syndrome 1

EXPERIMENTAL

20 Patients with dry eye syndrome

Device: Thealoz Duo Gel

Patients with dry eye syndrome 2

ACTIVE COMPARATOR

20 Patients with dry eye syndrome

Device: Hylo-Gel

Patients with dry eye syndrome 3

ACTIVE COMPARATOR

20 Patients with dry eye syndrome

Device: Systane Gel Drops

Interventions

Thealoz Duo Gel DEVICE

Manufacturer: Laboratoires Thea, France

Patients with dry eye syndrome 1

Hylo-Gel DEVICE

Manufacturer: Ursapharm, Saarbrücken, Germany

Patients with dry eye syndrome 2

Systane Gel Drops DEVICE

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

Patients with dry eye syndrome 3

Eligibility Criteria

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

You may qualify if:

• 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 12-24 hours before the screening examination

You may not qualify if:

• 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, neoplastic, haematological disease; severe psychiatric illness, etc.).
• 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.

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Department of Clinical Pharmacology, Medical University of Vienna

Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof. PD Dr.

Study Record Dates

• First Submitted: April 26, 2015
• First Posted: October 23, 2015
• Study Start: April 1, 2015
• Primary Completion: September 1, 2015
• Study Completion: November 1, 2015
• Last Updated: December 3, 2015

Record last verified: 2015-12

Locations

AU (1)