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| ID | Type | Description | Link |
|---|---|---|---|
| RECID HLS21162 | Other Identifier | Aston University |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tixel treatment | Experimental |
| |
| Sham treatment | Sham Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thermo-mechanical action based peri-orbital fractional skin treatment | Device | Participants will receive three Tixel® treatments at 2-weeks intervals |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | Through study completion, an average of 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sunil Shah, MD | Contact | +44 121 711 2020 | s.shah26@aston.ac.uk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vision Science, School of Optometry | Recruiting | Birmingham | B4 7ET | United Kingdom |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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| Sham treatment | Device | Participants will receive three sham treatments at 2-weeks intervals |
|
| Through study completion, an average of 4 months |