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, information about 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 optical coherence tomography (OCT) has become available. The aim of the present study is to assess corneal residence time of three different formulations of topical lubricants, in particular Thealoz Duo® Eye Drops, Hyabak® Eye Drops and Hydrabak® Eye Drops in patients with moderate 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..
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
60
Eye Drops
Eye Drops
Eye Drops
Department of Clinical Pharmacology
Vienna, Vienna, Austria
Tear film thickness
Change in tear film thickness as measured with OCT. Total time frame is 4 hours
Time frame: Change in tear film thickness from predose to 10 ± 3 minutes, 20 ± 3 minutes, 40 ± 5 minutes, 60 ± 5 minutes, 120 ± 10 minutes and 240 ± 10 minutes after instillation
Tear Break Up Time
Total time frame is 14 days
Time frame: change from screening to the last OCT measurement
Subjective evaluation of ocular comfort
Ocular comfort will be assessed immediately after instillation and at the end of the study day. Total time frame is 4 hours.
Time frame: change after instillation and after the last OCT measurement
Schirmer I test
Total time frame is 14 days
Time frame: change from screening to after the last OCT measurement
Visual Acuity
Total time frame is 14 days.
Time frame: change from screening to after the last OCT measurement
Intraocular Pressure
Total time frame is 14 days
Time frame: change from screening to after the last OCT measurement
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