protocolSection identificationModule nctId: NCT06349356, orgStudyIdInfo id: FDACSTIM0012023, secondaryIdInfos id: IRB00000533, type: OTHER, domain: WCG IRB, briefTitle: Prospective Evaluation of Efficacy and Safety of an Intense Pulsed Light Device to Treat Dry Eye Disease", statusModule overallStatus: RECRUITING, startDateStruct date: 2023-03-28, primaryCompletionDateStruct date: 2024-09-30, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Quantel Medical, class: INDUSTRY, descriptionModule briefSummary: The goal of this clinical trial is to evaluate the efficacy and safety of C.STIM, an intense pulsed light device to treat signs and symptoms of dry eye disease. The main question it aims to answer is:• Difference of the evolution of Tear Break-Up time (TBUT) between the 2 arms of the study (placebo and treated).Researchers will compare treated group and placebo to respond to the main question.Participants will assess to an inclusion visit (disease evaluation purpose) and then four IPL treatment visit to finish with the last visit (disease evaluation purpose)., conditionsModule conditions: Dry Eye Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: MULTI-CENTER, PROSPECTIVE, RANDOMIZED, SHAM-CONTROLLED, SUPERIORITY, NON-SIGNIFICANT RISK, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Intense pulsed light with C.STIM device, outcomesModule primaryOutcomes measure: Tear Break-Up Time evolution, secondaryOutcomes measure: dry eye signs and symptoms, secondaryOutcomes measure: dry eye signs and symptoms, secondaryOutcomes measure: dry eye signs and symptoms, secondaryOutcomes measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability], secondaryOutcomes measure: Meibum quality, secondaryOutcomes measure: Meibum Expressibility, secondaryOutcomes measure: Use of artificial tear drops, secondaryOutcomes measure: Use of artificial tear drops, secondaryOutcomes measure: Glaucoma, eligibilityModule sex: ALL, minimumAge: 22 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Visionary Consultants Inc., status: RECRUITING, city: Lexington, state: Kentucky, zip: 40517, country: United States, contacts name: Dr. KARPECKI, role: CONTACT, phone: 463-210-6618, email: karpecki@karpecki.com, geoPoint lat: 37.98869, lon: -84.47772, locations facility: Triangle Eye Consultants, status: ACTIVE_NOT_RECRUITING, city: Raleigh, state: North Carolina, zip: 27617, country: United States, geoPoint lat: 35.7721, lon: -78.63861, locations facility: Toyos Clinic, status: RECRUITING, city: Nashville, state: Tennessee, zip: 37215, country: United States, contacts name: Dr. TOYOS, role: CONTACT, phone: 615-327-4015, email: rostar80@gmail.com, geoPoint lat: 36.16589, lon: -86.78444, locations facility: Eye Centers of Racine & Kenosha, status: RECRUITING, city: Kenosha, state: Wisconsin, zip: 53142, country: United States, contacts name: Dr SINGH, role: CONTACT, phone: 312-371-4335, email: ipsingh@amazingeye.com, geoPoint lat: 42.58474, lon: -87.82119, hasResults: False