Department of Clinical Pharmacology
Vienna, State of Vienna, 1090, Austria
NCT Number: NCT01864330
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..
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Notify Me18 year and older
All sexes
Interventional
Phase 4
Vienna, State of Vienna, 1090, Austria
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Eye Drops
Eye Drops
Eye Drops
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
Change in tear film thickness as measured with OCT.
Total time frame is 4 hours
Time frame: change from screening to the last OCT measurement
Total time frame is 14 days
Time frame: change after instillation and after the last OCT measurement
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 from screening to after the last OCT measurement
Total time frame is 14 days
Time frame: change from screening to after the last OCT measurement
Total time frame is 14 days.
Time frame: change from screening to after the last OCT measurement
Total time frame is 14 days
Medical University of Vienna
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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