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NCT02986750

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

Completed Phase 4 Last updated 20 August 2019
What this trial tests

Phase 4 trial testing Thealoz Duo Eye Drops in Dry Eye Syndromes in 120 participants. Completed in 23 March 2017.

Timeline
13 February 2016
Primary endpoint
23 March 2017
23 March 2017

Quick facts

Lead sponsorMedical University of Vienna
PhasePhase 4
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposebasic science
Enrollment120
Start date13 February 2016
Primary completion23 March 2017
Estimated completion23 March 2017
Sites1 location across Austria

Drugs / interventions tested

Conditions studied

Sponsor

Medical University of Vienna

Who can join

18 and older, any sex, with Dry Eye Syndromes. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Other recruiting trials for Dry Eye Syndromes

Currently open trials in the same condition.

Other Medical University of Vienna trials

Trials by the same sponsor.

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Data sources for this page

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