Shaare Zedek Medical Center
Jerusalem, Israel
NCT Number: NCT04670263
Dry Eye disease signs and symptoms are reduced in patients who receive topical steroids and topical hyaluronic acid.
AdOM's Tear Film Imager measurements are reproducible and it can diagnose the dry eye disease state in a single, non-invasive measurement. The Tear Film Imager can provide objective accurate measurements of the dry eye treatment effectiveness.
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Notify Me18 year and older
All sexes
Interventional
Phase 2 / Phase 3
Jerusalem, Israel
80 subjects will be enrolled , 40 of which with positive signs and symptoms of Dry eye and 40 healthy subjects without sign and no symptoms of Dry eye. Healthy and Dry eye groups will be age- matched.
Over a period of 4 weeks, the subjects diagnosed with dry eye will be treated and as follows:
Both groups will be examined at baseline and 4 weeks after baseline measurement.
Treatment results will be measured by both traditional methods and by Tear Film Imager.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Tear Film Imager recording
Time frame: 1month
Tear film imager meuresmend will be assessed during the study visits
Time frame: 2 hours
The repeatability of TFI will be evaluated by comparing the reported parameters of the two TFI measurements on first visit
Time frame: 1month
The correlation between the clinician's measurements of Dry Eye and the corresponding Tear film imager reported parameters of interest will used to evaluate the association between the two assessments.
Time frame: from baseline to 1 month
Change from baseline of the lipid layer thickness as measured by the Tear film imager
Time frame: from baseline to 1 month
Change from baseline of the Muco-aqueous layer thickness as measured by Tear film imager
Adom Advanced Optical Technologies Ltd.
Industry
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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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