Nctid:
NCT06615453
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-03"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000015352", "term"=>"Dry Eye Syndromes"}, {"id"=>"D000007638", "term"=>"Keratoconjunctivitis Sicca"}, {"id"=>"D000005128", "term"=>"Eye Diseases"}], "ancestors"=>[{"id"=>"D000007766", "term"=>"Lacrimal Apparatus Diseases"}, {"id"=>"D000007637", "term"=>"Keratoconjunctivitis"}, {"id"=>"D000003231", "term"=>"Conjunctivitis"}, {"id"=>"D000003229", "term"=>"Conjunctival Diseases"}, {"id"=>"D000007634", "term"=>"Keratitis"}, {"id"=>"D000003316", "term"=>"Corneal Diseases"}], "browseLeaves"=>[{"id"=>"M8271", "name"=>"Eye Diseases", "asFound"=>"Eye Disease", "relevance"=>"HIGH"}, {"id"=>"M18040", "name"=>"Dry Eye Syndromes", "asFound"=>"Dry Eye Disease", "relevance"=>"HIGH"}, {"id"=>"M10664", "name"=>"Keratoconjunctivitis Sicca", "asFound"=>"Dry Eye Disease", "relevance"=>"HIGH"}, {"id"=>"M16355", "name"=>"Syndrome", "relevance"=>"LOW"}, {"id"=>"M10663", "name"=>"Keratoconjunctivitis", "relevance"=>"LOW"}, {"id"=>"M10786", "name"=>"Lacrimal Apparatus Diseases", "relevance"=>"LOW"}, {"id"=>"M6455", "name"=>"Conjunctivitis", "relevance"=>"LOW"}, {"id"=>"M6453", "name"=>"Conjunctival Diseases", "relevance"=>"LOW"}, {"id"=>"M10660", "name"=>"Keratitis", "relevance"=>"LOW"}, {"id"=>"M6539", "name"=>"Corneal Diseases", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Eye Diseases", "abbrev"=>"BC11"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"SINGLE", "whoMasked"=>["PARTICIPANT"]}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"PARALLEL"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>36}}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2024-09-17", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-09", "completionDateStruct"=>{"date"=>"2025-09", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-09-24", "studyFirstSubmitDate"=>"2024-09-19", "studyFirstSubmitQcDate"=>"2024-09-24", "lastUpdatePostDateStruct"=>{"date"=>"2024-09-26", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-26", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2025-09", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"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.", "timeFrame"=>"Through study completion, an average of 4 months", "description"=>"SAFETY, number of AEs Any safety related event during the study will be recorded and analyzed"}], "secondaryOutcomes"=>[{"measure"=>"To evaluate the impact of the treatment on symptoms and signs of dry eyes and compare the findings with those of a control group.", "timeFrame"=>"Through study completion, an average of 4 months", "description"=>"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"}]}, "oversightModule"=>{"isUsExport"=>false, "oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["Dry eye disese, Tixel treatment"], "conditions"=>["Dry Eye Disease (DED)"]}, "descriptionModule"=>{"briefSummary"=>"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."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n1. Mild to Moderate Periorbital wrinkles\n2. OSDI score of at least 23\n3. Noninvasive Tear film break up time (NIBUT) ≤ 10 seconds\n4. No other eye or skin or immune problems\n5. Willing and able to provide written informed consent.\n6. Willing to participate in all study activities and instructions.\n\nExclusion Criteria:\n\n1. Pregnancy and/or breastfeeding\n2. Lesions in the periorbital area\n3. Acute severe blepharitis\n4. Acute conjunctivitis\n5. Use of eye drops within 2 hours before examination\n6. Other concomitant anterior eye disease\n7. Has undergone outdoors/sunbed tanning during the last 4 weeks\n8. Is unwilling to follow the Tixel aftercare instructions after each of the three Tixel treatments.\n9. Active Herpes Simplex or tendency for Herpes Simplex in the periorbital area (meaning the subject has had the condition previously).\n10. Current skin cancer, malignant sites and/or advanced premalignant lesions or moles in the treatment area.\n11. An impaired immune system condition or use of immunosuppressive medication.\n12. Collagen disorders, keloid formation and/or abnormal wound healing.\n13. Previous invasive/ablative procedures in the areas to be treated within 3 months prior to initial treatment or plans for such treatment during the course of the Tixel2 device treatment, or before complete healing of such treatments has occurred.\n14. Any patient who takes or has taken any medications (including via topical application), herbal treatment (oral or topic), food supplements or vitamins, which may cause fragile skin or impaired skin healing during the last 3 months.\n15. Any patient who has used oral Isotretinoin (Accutane® or Roaccutan®) within 3 months prior to treatment or less.\n16. Any patient who has a history of bleeding coagulopathies or use of anticoagulants.\n17. Any patient who has tattoos or permanent makeup in the treated area.\n18. Any patient who has burned skin, blistered skin, irritated skin, or sensitive skin in any of the areas to be treated.\n19. Any patient who underwent thread lifting of the area to be treated in the last 3 months."}, "identificationModule"=>{"nctId"=>"NCT06615453", "acronym"=>"TIXEL-DED", "briefTitle"=>"Impact of Tixel Treatment on Symptoms and Signs in Patients with Dry Eye Disease", "organization"=>{"class"=>"OTHER", "fullName"=>"Aston University"}, "officialTitle"=>"A Prospective Study Assessing the Impact of Tixel Treatment of Peri Orbital Wrinkles on Symptoms and Signs in Patients with Dry Eye Disease", "orgStudyIdInfo"=>{"id"=>"HLS21162"}, "secondaryIdInfos"=>[{"id"=>"RECID HLS21162", "type"=>"OTHER", "domain"=>"Aston University"}]}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"Tixel treatment", "interventionNames"=>["Device: Thermo-mechanical action based peri-orbital fractional skin treatment"]}, {"type"=>"SHAM_COMPARATOR", "label"=>"Sham treatment", "interventionNames"=>["Device: Sham treatment"]}], "interventions"=>[{"name"=>"Thermo-mechanical action based peri-orbital fractional skin treatment", "type"=>"DEVICE", "description"=>"Participants will receive three Tixel® treatments at 2-weeks intervals", "armGroupLabels"=>["Tixel treatment"]}, {"name"=>"Sham treatment", "type"=>"DEVICE", "description"=>"Participants will receive three sham treatments at 2-weeks intervals", "armGroupLabels"=>["Sham treatment"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"B4 7ET", "city"=>"Birmingham", "status"=>"RECRUITING", "country"=>"United Kingdom", "contacts"=>[{"name"=>"Sunil Shah, MD", "role"=>"CONTACT", "email"=>"s.shah26@aston.ac.uk", "phone"=>"+44 121 711 2020"}], "facility"=>"Vision Science, School of Optometry", "geoPoint"=>{"lat"=>52.48142, "lon"=>-1.89983}}], "centralContacts"=>[{"name"=>"Sunil Shah, MD", "role"=>"CONTACT", "email"=>"s.shah26@aston.ac.uk", "phone"=>"+44 121 711 2020"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"UNDECIDED"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Aston University", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
