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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Enrollment
120
Manufacturer: Laboratoires Thea, France
Manufacturer: Allergan Pharmaceuticals, Ireland
Manufacturer: Alcon Pharma GmbH
Department of Clinical Pharmacology, Medical University of Vienna
Vienna, Austria
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
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
Tear Break Up Time (BUT)
Time frame: 10 weeks
Subjective evaluation of ocular comfort with questionnaire
Time frame: 10 weeks
Schirmer I test
Time frame: 10 weeks
OSDI score
Time frame: 10 weeks
Corneal fluorescein staining (Oxford grading scale)
Time frame: 10 weeks
Conjunctival hyperemia score
Time frame: 10 weeks
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
Time frame: 10 weeks
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
Time frame: 10 weeks
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