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

NCT02986750 | Completed Phase 4

• 1 other identifier: LT2258-PIV-0216
• Study Type: interventional
• Target: 120
• 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 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.

Conditions

Dry Eye Syndromes

Outcome Measures

Primary Outcomes (1)

• 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

  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 Outcomes (8)

• Tear Break Up Time (BUT)

  10 weeks

• Subjective evaluation of ocular comfort with questionnaire

  10 weeks

• Schirmer I test

  10 weeks

• OSDI score

  10 weeks

• Corneal fluorescein staining (Oxford grading scale)

  10 weeks

Study Arms (3)

Experimental: Patients with dry eye syndrome 1

EXPERIMENTAL

40 Patients with dry eye syndrome

Device: Thealoz Duo Eye Drops

Experimental: Patients with dry eye syndrome 2

ACTIVE COMPARATOR

40 Patients with dry eye syndrome

Device: Optive Eye Drops

Experimental: Patients with dry eye syndrome 3

ACTIVE COMPARATOR

40 Patients with dry eye syndrome

Device: Systane Ultra Eye Drops

Interventions

Thealoz Duo Eye Drops DEVICE

Manufacturer: Laboratoires Thea, France

Experimental: Patients with dry eye syndrome 1

Optive Eye Drops DEVICE

Manufacturer: Allergan Pharmaceuticals, Ireland

Experimental: Patients with dry eye syndrome 2

Systane Ultra Eye Drops DEVICE

Manufacturer: Alcon Pharma GmbH

Experimental: 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 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, neoplasic, 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: December 1, 2016
• First Posted: December 8, 2016
• Study Start: February 13, 2016
• Primary Completion: March 23, 2017
• Study Completion: March 23, 2017
• Last Updated: August 20, 2019

Record last verified: 2019-08

Locations

AU (1)