Nctid:
NCT06225973
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-20"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D015352", "term"=>"Dry Eye Syndromes"}, {"id"=>"D007638", "term"=>"Keratoconjunctivitis Sicca"}, {"id"=>"D005128", "term"=>"Eye Diseases"}], "ancestors"=>[{"id"=>"D007766", "term"=>"Lacrimal Apparatus Diseases"}, {"id"=>"D007637", "term"=>"Keratoconjunctivitis"}, {"id"=>"D003231", "term"=>"Conjunctivitis"}, {"id"=>"D003229", "term"=>"Conjunctival Diseases"}, {"id"=>"D007634", "term"=>"Keratitis"}, {"id"=>"D003316", "term"=>"Corneal Diseases"}], "browseLeaves"=>[{"id"=>"M18040", "name"=>"Dry Eye Syndromes", "asFound"=>"Dry Eye Disease", "relevance"=>"HIGH"}, {"id"=>"M10664", "name"=>"Keratoconjunctivitis Sicca", "asFound"=>"Dry Eye Disease", "relevance"=>"HIGH"}, {"id"=>"M8271", "name"=>"Eye Diseases", "asFound"=>"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"}]}, "interventionBrowseModule"=>{"browseLeaves"=>[{"id"=>"M12814", "name"=>"Ophthalmic Solutions", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Pharmaceutical Solutions", "abbrev"=>"PhSol"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE2"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"TRIPLE", "whoMasked"=>["PARTICIPANT", "CARE_PROVIDER", "INVESTIGATOR"], "maskingDescription"=>"The Sponsor, Investigators and study staff will be masked during the randomization process and throughout the study. The study site will have the capacity to unmask participants in an emergency.\n\nFollowing completion of the study, the randomization code will be unmasked once all data has been entered into the study database for every subject and the database has been locked."}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"PARALLEL"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>880}}, "statusModule"=>{"overallStatus"=>"ACTIVE_NOT_RECRUITING", "startDateStruct"=>{"date"=>"2024-02-06", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-07", "completionDateStruct"=>{"date"=>"2024-12", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-07-08", "studyFirstSubmitDate"=>"2024-01-17", "studyFirstSubmitQcDate"=>"2024-01-17", "lastUpdatePostDateStruct"=>{"date"=>"2024-07-10", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-26", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2024-12", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"To evaluate the efficacy of TL-925 compared to vehicle on tear production", "timeFrame"=>"Baseline to Day 29", "description"=>"Percentage of subjects who achieve ≥10 mm improvement in Schirmer's test score"}]}, "oversightModule"=>{"isFdaRegulatedDrug"=>true, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Dry Eye Disease"]}, "descriptionModule"=>{"briefSummary"=>"In this prospective, phase 2b, multicenter, randomized, double-masked, vehicle-controlled, parallel-arm study, approximately 880 subjects with moderate to severe dry eye disease (DED) will be randomly assigned (1:1) to receive either TL-925 or vehicle as topical ophthalmic eye drops administered bilaterally BID.\n\nThe study will comprise two phases: a two-week screening phase/run-in and a six-week double-masked treatment phase."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* A diagnosis of dry eye disease for at least 6 months\n* An unanesthetized Schirmer's test score (STS) of ≤ 10mm and ≥ 1mm in the study eye\n* Female subjects of childbearing potential and their male partners must both use a highly effective contraception method during the study\n\nExclusion Criteria:\n\n* Any clinically significant slit lamp finding\n* Any ongoing ocular infection (bacterial, viral or fungal) or active ocular inflammation\n* Best-corrected visual acuity ≥0.7 logarithm of the minimum angle of resolution\n* Any keratorefractive surgery within the last 12 months\n* Any intraocular or extraocular surgery within 3 months\n* Any blepharoplasty or corneal transplant in either eye\n* Any form of punctual, or intracanalicular occlusion in either eye\n* History or presence of any ocular disorder that may interfere with study results"}, "identificationModule"=>{"nctId"=>"NCT06225973", "briefTitle"=>"A Study of TL-925 Ophthalmic Emulsion as a Treatment for Dry Eye Disease", "organization"=>{"class"=>"INDUSTRY", "fullName"=>"Telios Pharma, Inc."}, "officialTitle"=>"A Phase 2b, Multicenter, Randomized, Double-masked Vehicle-controlled Study to Evaluate the Efficacy and Safety of TL-925 Ophthalmic Emulsion 0.1% in Subjects With Moderate to Severe Dry Eye Disease", "orgStudyIdInfo"=>{"id"=>"TL-925-303"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"TL-925 Arm", "description"=>"TL-925 will be administered OU BID", "interventionNames"=>["Drug: TL-925"]}, {"type"=>"PLACEBO_COMPARATOR", "label"=>"Vehicle Arm", "description"=>"Vehicle will be administered OU BID", "interventionNames"=>["Other: Placebo"]}], "interventions"=>[{"name"=>"TL-925", "type"=>"DRUG", "description"=>"TL-925 is an eye drop.", "armGroupLabels"=>["TL-925 Arm"]}, {"name"=>"Placebo", "type"=>"OTHER", "description"=>"The composition of the vehicle is identical to the active formulation except for the exclusion of the active ingredient.", "armGroupLabels"=>["Vehicle Arm"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"85032", "city"=>"Phoenix", "state"=>"Arizona", "country"=>"United States", "facility"=>"Cornea and Cataract Consultants of Arizona", "geoPoint"=>{"lat"=>33.44838, "lon"=>-112.07404}}, {"zip"=>"91204", "city"=>"Glendale", "state"=>"California", "country"=>"United States", "facility"=>"Global Research Management", "geoPoint"=>{"lat"=>34.14251, "lon"=>-118.25508}}, {"zip"=>"91942", "city"=>"La Mesa", "state"=>"California", "country"=>"United States", "facility"=>"Nvision - La Mesa", "geoPoint"=>{"lat"=>32.76783, "lon"=>-117.02308}}, {"zip"=>"90505", "city"=>"Torrance", "state"=>"California", "country"=>"United States", "facility"=>"Nvision - Torrance", "geoPoint"=>{"lat"=>33.83585, "lon"=>-118.34063}}, {"zip"=>"60062", "city"=>"Northbrook", "state"=>"Illinois", "country"=>"United States", "facility"=>"Wyse Eyecare", "geoPoint"=>{"lat"=>42.12753, "lon"=>-87.82895}}, {"zip"=>"47203", "city"=>"Columbus", "state"=>"Indiana", "country"=>"United States", "facility"=>"Pankratz Eye", "geoPoint"=>{"lat"=>39.20144, "lon"=>-85.92138}}, {"zip"=>"40206", "city"=>"Louisville", "state"=>"Kentucky", "country"=>"United States", "facility"=>"Butchertown Clinical", "geoPoint"=>{"lat"=>38.25424, "lon"=>-85.75941}}, {"zip"=>"01810", "city"=>"Andover", "state"=>"Massachusetts", "country"=>"United States", "facility"=>"Andover Eye Associates - Andover", "geoPoint"=>{"lat"=>42.65843, "lon"=>-71.137}}, {"zip"=>"02767", "city"=>"Raynham", "state"=>"Massachusetts", "country"=>"United States", "facility"=>"Andover Eye Associates - Raynham", "geoPoint"=>{"lat"=>41.94871, "lon"=>-71.0731}}, {"zip"=>"01581", "city"=>"Westborough", "state"=>"Massachusetts", "country"=>"United States", "facility"=>"NEERA - Westborough", "geoPoint"=>{"lat"=>42.26954, "lon"=>-71.61618}}, {"zip"=>"01801", "city"=>"Woburn", "state"=>"Massachusetts", "country"=>"United States", "facility"=>"NEERA - Woburn", "geoPoint"=>{"lat"=>42.47926, "lon"=>-71.15228}}, {"zip"=>"27529", "city"=>"Garner", "state"=>"North Carolina", "country"=>"United States", "facility"=>"Oculus Research", "geoPoint"=>{"lat"=>35.71126, "lon"=>-78.61417}}, {"zip"=>"28451", "city"=>"Leland", "state"=>"North Carolina", "country"=>"United States", "facility"=>"Wilmington Eye", "geoPoint"=>{"lat"=>34.25628, "lon"=>-78.04471}}, {"zip"=>"16066", "city"=>"Cranberry Township", "state"=>"Pennsylvania", "country"=>"United States", "facility"=>"Scott and Christie EyeCare Associates", "geoPoint"=>{"lat"=>40.68496, "lon"=>-80.10714}}, {"zip"=>"37072", "city"=>"Goodlettsville", "state"=>"Tennessee", "country"=>"United States", "facility"=>"Advancing Vision Research", "geoPoint"=>{"lat"=>36.32311, "lon"=>-86.71333}}, {"zip"=>"38119", "city"=>"Memphis", "state"=>"Tennessee", "country"=>"United States", "facility"=>"Total Eye Care, PA", "geoPoint"=>{"lat"=>35.14953, "lon"=>-90.04898}}, {"zip"=>"37167", "city"=>"Smyrna", "state"=>"Tennessee", "country"=>"United States", "facility"=>"Advancing Vision Research", "geoPoint"=>{"lat"=>35.98284, "lon"=>-86.5186}}, {"zip"=>"24502", "city"=>"Lynchburg", "state"=>"Virginia", "country"=>"United States", "facility"=>"Piedmont Eye Center", "geoPoint"=>{"lat"=>37.41375, "lon"=>-79.14225}}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Telios Pharma, Inc.", "class"=>"INDUSTRY"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
