Nctid:
NCT06616519
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000009216", "term"=>"Myopia"}], "ancestors"=>[{"id"=>"D000012030", "term"=>"Refractive Errors"}, {"id"=>"D000005128", "term"=>"Eye Diseases"}], "browseLeaves"=>[{"id"=>"M12168", "name"=>"Myopia", "asFound"=>"Myopia", "relevance"=>"HIGH"}, {"id"=>"M14872", "name"=>"Refractive Errors", "relevance"=>"LOW"}, {"id"=>"M8271", "name"=>"Eye Diseases", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Eye Diseases", "abbrev"=>"BC11"}, {"name"=>"All Conditions", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"PARALLEL"}, "enrollmentInfo"=>{"type"=>"ACTUAL", "count"=>192}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"2021-05-18", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-09", "completionDateStruct"=>{"date"=>"2022-08-25", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2024-09-25", "studyFirstSubmitDate"=>"2024-09-19", "studyFirstSubmitQcDate"=>"2024-09-25", "lastUpdatePostDateStruct"=>{"date"=>"2024-09-27", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-27", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2022-05-01", "type"=>"ACTUAL"}}, "outcomesModule"=>{"otherOutcomes"=>[{"measure"=>"efficacy evaluation indexes", "timeFrame"=>"on the day of wearing the lens and after wearing lenses for 30 days and 90 days", "description"=>"Instant iris color change after wearing lenses Binocular CVA with lenses ≥ 1.0"}], "primaryOutcomes"=>[{"measure"=>"efficacy evaluation indexes", "timeFrame"=>"after wearing lenses for 7 days", "description"=>"Binocular CVA with lenses after wearing lenses, The percentage of changes in iris color"}], "secondaryOutcomes"=>[{"measure"=>"Time of Break up time (BUT)", "timeFrame"=>"on the day of wearing the lens and wearing lenses for 7 days,30 days and 90 days", "description"=>"Comparison of BUT time results between the experimental group and control group"}, {"measure"=>"Distance Uncorrected visual acuity (UCVA)", "timeFrame"=>"on the day of wearing the lens and wearing lenses for 7 days,30 days and 90 days", "description"=>"Comparison of distance uncorrected visual acuity results between the experimental group and control group"}, {"measure"=>"Fitness of the contact", "timeFrame"=>"on the day of wearing the lens and wearing lenses for 7 days,30 days and 90 days", "description"=>"the position of lens on the ocular surface, the coverage, tightness and movability of lens"}]}, "oversightModule"=>{"isUsExport"=>false, "oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Myopia"]}, "descriptionModule"=>{"briefSummary"=>"This project is an open, parallel, randomly controlled, and non-inferiority clinical trial of MSENCI soft hydrophilic contact lenses with Oxypure color soft hydrophilic contact lenses used as the control product."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n1. Age ≥ 18 years old, no gender limitation;\n2. Soft hydrophilic contact lenses worn should be from 0.00D to -12.00D;\n3. Subjects should have normal binocular conditions without any abnormality or diseases except for ametropia;\n4. The optimal binocular CVA with glasses ≥ 1.0;\n5. The astigmatism should be ≤1.5D;\n6. Binoculus BUT \\>5s;\n7. should accept follow-ups for at least 90 days and wear the contact lens as required in the protocol;\n8. should understand the purpose of the trial, volunteer to attend and sign the Informed Consent Form by the subjects themselves or their legal guardians.\n\n .\n\nExclusion Criteria:\n\n1. Patients who suffer from systemic diseases that prohibit contact lens use or receive treatment that may affect the vision or contact lens use;\n2. Patients who have worn hard contact lenses within 4 weeks or soft contact lenses within 7 days before being included in the trial;\n3. Patients who are allergic to contact lenses or suffer from systemic allergy;\n4. Patients who have keratoconus or other cornea irregularity;\n5. Patients who always stay at places that are dry, dust-heavy, having volatile chemicals or otherwise affect the use of soft hydrophilic contact lenses;\n6. People who are pregnant, during their lactation or prepare for the pregnancy while being included;\n7. People who have only a single eye qualified for the trial;\n8. People who have attended a clinical trial of medicine or medical devices other than contact lens within 3 months before being included in this trial;\n9. People who have attended a clinical trial of medicine or medical devices other than contact lens within 3 months before being included in this trial;\n10. Other cases where investigators determine the soft contact lens should not be used or the candidate should be excluded."}, "identificationModule"=>{"nctId"=>"NCT06616519", "briefTitle"=>"A Study to Evaluate the Safety and Efficacy of MSENC1 Soft Hydrophilic Contact Lenses and Oxypure Color Soft Hydrophilic Contact Lenses", "organization"=>{"class"=>"INDUSTRY", "fullName"=>"BenQ Materials Corporation"}, "officialTitle"=>"Multi-center, Open, Parallel, and Randomly Controlled Comparison Between MSENC1 Soft Hydrophilic Contact Lenses and Oxypure Color Soft Hydrophilic Contact Lenses in Their Safety and Efficacy", "orgStudyIdInfo"=>{"id"=>"MSENC1 202101"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"BenQ Materials MSENCI lenses", "description"=>"BenQ Materials Daily disposable contact lens wears for 1 month", "interventionNames"=>["Device: BenQ Materials MSENCI soft hydrophilic contact lenses"]}, {"type"=>"ACTIVE_COMPARATOR", "label"=>"Visco Oxypure lens", "interventionNames"=>["Device: Visco Oxypure Color soft hydrophilic contact lenses"]}], "interventions"=>[{"name"=>"BenQ Materials MSENCI soft hydrophilic contact lenses", "type"=>"DEVICE", "description"=>"Test lenses were to be worn for approximately 90 days.", "armGroupLabels"=>["BenQ Materials MSENCI lenses"]}, {"name"=>"Visco Oxypure Color soft hydrophilic contact lenses", "type"=>"DEVICE", "description"=>"Control lenses were to be worn for approximately 90 days", "armGroupLabels"=>["Visco Oxypure lens"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"33341", "city"=>"Taoyuan", "country"=>"China", "facility"=>"BenQ Materials Corporation"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"BenQ Materials Corporation", "class"=>"INDUSTRY"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
