Nctid:
NCT06616480
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"=>"2023-03-03", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-09", "completionDateStruct"=>{"date"=>"2024-06-20", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2024-09-25", "studyFirstSubmitDate"=>"2024-09-20", "studyFirstSubmitQcDate"=>"2024-09-25", "lastUpdatePostDateStruct"=>{"date"=>"2024-09-27", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-27", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2024-03-28", "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"=>"The percentage of iris color change after wearing lenses ,The proportion of contact lens corrected eyesight"}], "primaryOutcomes"=>[{"measure"=>"Efficacy evaluation indexes", "timeFrame"=>"after wearing lenses for 7 days", "description"=>"The proportion of contact lens-corrected eyesight, 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 len"}]}, "oversightModule"=>{"isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Myopia"]}, "descriptionModule"=>{"briefSummary"=>"This project is an open, parallel, randomly controlled, and non-inferiority clinical trial of DSFNC1 soft hydrophilic contact lenses with SiHy color soft hydrophilic contact lenses."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n1. Age ≥ 18 years old, gender is not limited;\n2. Soft hydrophilic contact lenses to be worn range from 0.00 to -12.00D;\n3. Both eyes were normal with no other abnormality or disease other than refractive error;\n4. Best-corrected eyesight ≥ 1.0 in both eyes with frame lenses;\n5. Astigmatism ≤ 2.0D;\n6. T5ar film break-up time (BUT) \\>5s in both eyes\n7. Those who are able to complete a minimum of 90 days of follow-up and are able to wear contact lenses as required by the protocol;\n8. Ability to understand the purpose of the trial, to participate voluntarily and to have Informed Consent signed by the subject himself/herself or his/her legal guardian.\n\nExclusion Criteria:\n\n1. Persons with any systemic condition that contraindicates the wearing of contact lenses, or who are receiving treatment that interferes with vision or the wearing of contact lenses;\n2. Those who had worn hard contact lenses within 4 weeks or soft contact lenses within 7 days prior to enrollment in this trial;\n3. People who are allergic to contact lens, and people with systemic allergic diseases;\n4. Patients with conical corneas or other irregular corneas;\n5. Those who have to wear soft hydrophilic contact lenses for a long period of time under special circumstances such as dryness, severe dust or volatile chemicals;\n6. Those who are pregnant, breastfeeding, or planning a pregnancy at the time of enrollment;\n7. Those who were eligible for enrollment in only one eye;\n8. Concurrent participation in other clinical trials or participation in a soft contact lens clinical trial of soft hydrophilic contact lenses within 10 days prior to enrollment in this trial\n9. Participants who have participated in a clinical trial of a drug or a medical device other than a contact lens within 3 months prior to enrollment in this trial;\n10. Other conditions that, in the judgment of the investigator, make wearing soft contact lenses unsuitable or preclude enrollment."}, "identificationModule"=>{"nctId"=>"NCT06616480", "briefTitle"=>"A Study to Evaluate the Safety and Efficacy of DSFNC1 Soft Hydrophilic Contact Lenses and SiHy Color Soft Hydrophilic Contact Lenses", "organization"=>{"class"=>"INDUSTRY", "fullName"=>"BenQ Materials Corporation"}, "officialTitle"=>"Multicenter, Open, Parallel, Randomized Controlled Comparison on the Safety and Efficacy Clinical Study of DSFNC1 Soft Hydrophilic Contact Lenses With SiHy Color Soft Hydrophilic Contact Lenses", "orgStudyIdInfo"=>{"id"=>"DSFNC1 202303"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"BenQ Materials DSFNC1 lenses", "description"=>"BenQ Materials contact lens wears for daily disposable", "interventionNames"=>["Device: BenQ Materials DSFNC1 soft hydrophilic contact lenses"]}, {"type"=>"ACTIVE_COMPARATOR", "label"=>"Visco SiHy Color lens", "interventionNames"=>["Device: Visco SiHy Color soft hydrophilic contact lenses"]}], "interventions"=>[{"name"=>"BenQ Materials DSFNC1 soft hydrophilic contact lenses", "type"=>"DEVICE", "description"=>"Test lenses were to be worn for approximately 90 days.", "armGroupLabels"=>["BenQ Materials DSFNC1 lenses"]}, {"name"=>"Visco SiHy Color soft hydrophilic contact lenses", "type"=>"DEVICE", "description"=>"Control lenses were to be worn for approximately 90 days", "armGroupLabels"=>["Visco SiHy Color 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"}}}}
