Impact of Tixel Treatment on Symptoms and Signs in Patients With Dry Eye Disease
ConditionDry Eye Disease (DED)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAston University
About this trial
This study will examine how a standard Tixel treatment versus a sham treatment for eye wrinkles affects the symptoms and signs of Dry Eye Disease.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Mild to Moderate Periorbital wrinkles
OSDI score of at least 23
Noninvasive Tear film break up time (NIBUT) ≤ 10 seconds
No other eye or skin or immune problems
Disqualifiers
Pregnancy and/or breastfeeding
Lesions in the periorbital area
Acute severe blepharitis
Acute conjunctivitis
Trial design
Design model
Parallel
Treatments tested in this trial
Thermo-mechanical action based peri-orbital fractional skin treatment
DeviceParticipants will receive three Tixel® treatments at 2-weeks intervals
Sham treatment
DeviceParticipants will receive three sham treatments at 2-weeks intervals
Treatment groups
36 Participants
are divided into 2 treatment groupsGroup A: Tixel treatmentExperimental treatment 1 intervention
Group B: Sham treatmentSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
To assess the safety of periorbital Tixel treatments in patients with dry eye through the reporting of adverse events (AE) and serious adverse events (SAE) exclusively.
SAFETY, number of AEs Any safety related event during the study will be recorded and analyzed
Time frame
Through study completion, an average of 4 monthsSecondary outcomes
1
To evaluate the impact of the treatment on symptoms and signs of dry eyes and compare the findings with those of a control group.
NIBUT Seconds OSDI Score Topography mm/ D Slit Lamp examination Standardized Patient Evaluation of Eye Dryness (SPEED) Questionnaire Lid margin profile Tear Sampling Analysis Ocular tear biomarkers Meibography Corneal staining with fluorescein Conjunctival staining with lissamine green
Time frame
Through study completion, an average of 4 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov