{"id":"https://openalex.org/W2965629330","doi":"https://doi.org/10.1089/jop.2018.0154","title":"Effect of OTX-101, a Novel Nanomicellar Formulation of Cyclosporine A, on Conjunctival Staining in Patients with Keratoconjunctivitis Sicca: A Pooled Analysis of Phase 2b/3 and 3 Clinical Trials","display_name":"Effect of OTX-101, a Novel Nanomicellar Formulation of Cyclosporine A, on Conjunctival Staining in Patients with Keratoconjunctivitis Sicca: A Pooled Analysis of Phase 2b/3 and 3 Clinical Trials","publication_year":2019,"publication_date":"2019-08-02","ids":{"openalex":"https://openalex.org/W2965629330","doi":"https://doi.org/10.1089/jop.2018.0154","mag":"2965629330","pmid":"https://pubmed.ncbi.nlm.nih.gov/31373837"},"language":"en","primary_location":{"id":"doi:10.1089/jop.2018.0154","doi":"https://doi.org/10.1089/jop.2018.0154","is_oa":false,"landing_page_url":"https://doi.org/10.1089/jop.2018.0154","pdf_url":null,"source":{"id":"https://openalex.org/S192126995","display_name":"Journal of Ocular Pharmacology and Therapeutics","issn_l":"1080-7683","issn":["1080-7683","1557-7732","8756-3320"],"is_oa":false,"is_in_doaj":false,"is_core":true,"listed_in":["cwts-core","dongbi-d","doyens","jufo-1","medline","norway-1","poland-70","russia-white-list-1"],"host_organization":"https://openalex.org/P4310320443","host_organization_name":"Mary Ann Liebert, Inc.","host_organization_lineage":["https://openalex.org/P4310320443","https://openalex.org/P4310320017"],"host_organization_lineage_names":["Mary Ann Liebert, Inc.","SAGE Publishing"],"type":"journal"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Journal of Ocular Pharmacology and Therapeutics","raw_type":"journal-article"},"volume":null,"type":"article","is_traditional":true,"indexed_in":["crossref","pubmed"],"open_access":{"is_oa":false,"oa_status":"closed","oa_url":null,"any_repository_has_fulltext":false},"authorships":[{"author_position":"first","author":{"id":"https://openalex.org/A5089917783","display_name":"Robert John Smyth-Medina","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I4210088116","display_name":"North Valley Eye Medical Group","ror":"https://ror.org/0084hyx75","country_code":"US","type":"healthcare","lineage":["https://openalex.org/I4210088116"]}],"countries":["US"],"is_corresponding":true,"raw_author_name":"Robert Smyth-Medina","raw_affiliation_strings":["North Valley Eye Medical Group, Inc., Mission Hills, California"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"North Valley Eye Medical Group, Inc., Mission Hills, California","institution_ids":["https://openalex.org/I4210088116"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5058956431","display_name":"Josh Johnston","orcid":null,"observed_orcids":[]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Josh Johnston","raw_affiliation_strings":["Georgia Eye Partners, Atlanta, Georgia"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Georgia Eye Partners, Atlanta, Georgia","institution_ids":[]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5079582456","display_name":"Douglas K. Devries","orcid":"https://orcid.org/0000-0002-1808-616X","observed_orcids":["https://orcid.org/0000-0002-1808-616X"]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Douglas K. Devries","raw_affiliation_strings":["Eye Care Associates of Nevada, Sparks, Nevada"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Eye Care Associates of Nevada, Sparks, Nevada","institution_ids":[]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5109432508","display_name":"April Jasper","orcid":null,"observed_orcids":[]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"April Jasper","raw_affiliation_strings":["Advanced Eyecare Specialists, West Palm Beach, Florida"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Advanced Eyecare Specialists, West Palm Beach, Florida","institution_ids":[]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5060348734","display_name":"Shane R. Kannarr","orcid":null,"observed_orcids":[]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Shane R. Kannarr","raw_affiliation_strings":["Kannarr Eye Care, Pittsburg, Kansas"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Kannarr Eye Care, Pittsburg, Kansas","institution_ids":[]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5087354864","display_name":"Barry A. Schechter","orcid":"https://orcid.org/0000-0003-2964-8348","observed_orcids":["https://orcid.org/0000-0003-2964-8348"]},"institutions":[{"id":"https://openalex.org/I4210109135","display_name":"Florida Eye Microsurgical Institute","ror":"https://ror.org/01t3v1178","country_code":"US","type":"healthcare","lineage":["https://openalex.org/I4210109135"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Barry A. Schechter","raw_affiliation_strings":["Florida Eye Microsurgical Institute, Inc., Boynton Beach, Florida"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Florida Eye Microsurgical Institute, Inc., Boynton Beach, Florida","institution_ids":["https://openalex.org/I4210109135"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5009776123","display_name":"Bridgitte Shen Lee","orcid":"https://orcid.org/0000-0002-1354-9401","observed_orcids":["https://orcid.org/0000-0002-1354-9401"]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Bridgitte Shen Lee","raw_affiliation_strings":["Vision Optique, Houston, Texas"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Vision Optique, Houston, Texas","institution_ids":[]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5003989352","display_name":"George Kuttiparichel Varghese","orcid":"https://orcid.org/0000-0002-5327-2697","observed_orcids":["https://orcid.org/0000-0002-5327-2697"]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"George Varghese","raw_affiliation_strings":["Sun Pharmaceutical Industries, Inc., Princeton, New Jersey"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Sun Pharmaceutical Industries, Inc., Princeton, New Jersey","institution_ids":[]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5110287374","display_name":"Abayomi Ogundele","orcid":null,"observed_orcids":[]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Abayomi Ogundele","raw_affiliation_strings":["Sun Pharmaceutical Industries, Inc., Princeton, New Jersey"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Sun Pharmaceutical Industries, Inc., Princeton, New Jersey","institution_ids":[]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5108264813","display_name":"C. H. Darby","orcid":null,"observed_orcids":[]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Charles H. Darby","raw_affiliation_strings":["Sun Pharma Advanced Research Company, Ltd., Princeton, New Jersey"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Sun Pharma Advanced Research Company, Ltd., Princeton, New Jersey","institution_ids":[]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5088888181","display_name":"Paul M Karpecki","orcid":"https://orcid.org/0000-0003-1390-2532","observed_orcids":["https://orcid.org/0000-0003-1390-2532"]},"institutions":[{"id":"https://openalex.org/I143302722","display_name":"University of Kentucky","ror":"https://ror.org/02k3smh20","country_code":"US","type":"education","lineage":["https://openalex.org/I143302722"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Paul Karpecki","raw_affiliation_strings":["Kentucky Eye Institute, Lexington, Kentucky"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Kentucky Eye Institute, Lexington, Kentucky","institution_ids":["https://openalex.org/I143302722"]}]},{"author_position":"last","author":{"id":"https://openalex.org/A5009517012","display_name":"Jodi Luchs","orcid":"https://orcid.org/0000-0003-4634-9542","observed_orcids":["https://orcid.org/0000-0003-4634-9542"]},"institutions":[{"id":"https://openalex.org/I139290212","display_name":"Hofstra University","ror":"https://ror.org/03pm18j10","country_code":"US","type":"education","lineage":["https://openalex.org/I139290212"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Jodi Luchs","raw_affiliation_strings":["Hofstra Northwell School of Medicine, Hempstead, New York"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Hofstra Northwell School of Medicine, Hempstead, New York","institution_ids":["https://openalex.org/I139290212"]}]}],"institutions":[],"countries_distinct_count":1,"institutions_distinct_count":4,"corresponding_author_ids":["https://openalex.org/A5089917783"],"corresponding_institution_ids":["https://openalex.org/I4210088116"],"apc_list":null,"apc_paid":null,"fwci":2.6581,"has_fulltext":false,"cited_by_count":18,"citation_normalized_percentile":{"value":0.88425542,"is_in_top_1_percent":false,"is_in_top_10_percent":false},"cited_by_percentile_year":{"min":95,"max":97},"biblio":{"volume":"35","issue":"7","first_page":"388","last_page":"394"},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T10997","display_name":"Ocular Surface and Contact Lens","score":0.9994999766349792,"subfield":{"id":"https://openalex.org/subfields/2731","display_name":"Ophthalmology"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},"topics":[{"id":"https://openalex.org/T10997","display_name":"Ocular Surface and Contact Lens","score":0.9994999766349792,"subfield":{"id":"https://openalex.org/subfields/2731","display_name":"Ophthalmology"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},{"id":"https://openalex.org/T10920","display_name":"Advanced Drug Delivery Systems","score":0.00039999998989515007,"subfield":{"id":"https://openalex.org/subfields/3003","display_name":"Pharmaceutical Science"},"field":{"id":"https://openalex.org/fields/30","display_name":"Pharmacology, Toxicology and Pharmaceutics"},"domain":{"id":"https://openalex.org/domains/1","display_name":"Life Sciences"}},{"id":"https://openalex.org/T13467","display_name":"Drug-Induced Ocular Toxicity","score":9.999999747378752e-05,"subfield":{"id":"https://openalex.org/subfields/2731","display_name":"Ophthalmology"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}}],"keywords":[{"id":"https://openalex.org/keywords/cyclosporine","display_name":"cyclosporine","score":0.9890000224113464},{"id":"https://openalex.org/keywords/dry-eye-disease","display_name":"dry eye","score":0.9950000047683716},{"id":"https://openalex.org/keywords/conjunctival-staining","display_name":"conjunctival staining","score":0.925000011920929},{"id":"https://openalex.org/keywords/ocular-drug-delivery","display_name":"ocular drug delivery","score":0.8299999833106995},{"id":"https://openalex.org/keywords/treatment-related-adverse-events","display_name":"treatment-related adverse events","score":0.6520000100135803}],"concepts":[{"id":"https://openalex.org/C71924100","wikidata":"https://www.wikidata.org/wiki/Q11190","display_name":"Medicine","level":0,"score":0.7706986665725708},{"id":"https://openalex.org/C2778715236","wikidata":"https://www.wikidata.org/wiki/Q55622662","display_name":"Discontinuation","level":2,"score":0.6058607697486877},{"id":"https://openalex.org/C74864618","wikidata":"https://www.wikidata.org/wiki/Q2332446","display_name":"Staining","level":2,"score":0.5324479341506958},{"id":"https://openalex.org/C197934379","wikidata":"https://www.wikidata.org/wiki/Q2047938","display_name":"Adverse effect","level":2,"score":0.5139614939689636},{"id":"https://openalex.org/C126322002","wikidata":"https://www.wikidata.org/wiki/Q11180","display_name":"Internal medicine","level":1,"score":0.41419267654418945},{"id":"https://openalex.org/C90924648","wikidata":"https://www.wikidata.org/wiki/Q120569","display_name":"Gastroenterology","level":1,"score":0.3974253535270691},{"id":"https://openalex.org/C118487528","wikidata":"https://www.wikidata.org/wiki/Q161437","display_name":"Ophthalmology","level":1,"score":0.3352692723274231},{"id":"https://openalex.org/C142724271","wikidata":"https://www.wikidata.org/wiki/Q7208","display_name":"Pathology","level":1,"score":0.26508694887161255}],"mesh":[{"descriptor_ui":"D006801","descriptor_name":"Humans","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D007166","descriptor_name":"Immunosuppressive Agents","qualifier_ui":"Q000008","qualifier_name":"administration & dosage","is_major_topic":true},{"descriptor_ui":"D007166","descriptor_name":"Immunosuppressive Agents","qualifier_ui":"Q000009","qualifier_name":"adverse effects","is_major_topic":false},{"descriptor_ui":"D007638","descriptor_name":"Keratoconjunctivitis Sicca","qualifier_ui":"Q000188","qualifier_name":"drug therapy","is_major_topic":true},{"descriptor_ui":"D008823","descriptor_name":"Micelles","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D013997","descriptor_name":"Time Factors","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D016032","descriptor_name":"Randomized Controlled Trials as Topic","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D016572","descriptor_name":"Cyclosporine","qualifier_ui":"Q000008","qualifier_name":"administration & dosage","is_major_topic":true},{"descriptor_ui":"D016572","descriptor_name":"Cyclosporine","qualifier_ui":"Q000009","qualifier_name":"adverse effects","is_major_topic":false},{"descriptor_ui":"D016896","descriptor_name":"Treatment Outcome","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D017322","descriptor_name":"Clinical Trials, Phase II as Topic","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D017326","descriptor_name":"Clinical Trials, Phase III as Topic","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D053758","descriptor_name":"Nanoparticles","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false}],"locations_count":2,"locations":[{"id":"doi:10.1089/jop.2018.0154","doi":"https://doi.org/10.1089/jop.2018.0154","is_oa":false,"landing_page_url":"https://doi.org/10.1089/jop.2018.0154","pdf_url":null,"source":{"id":"https://openalex.org/S192126995","display_name":"Journal of Ocular Pharmacology and Therapeutics","issn_l":"1080-7683","issn":["1080-7683","1557-7732","8756-3320"],"is_oa":false,"is_in_doaj":false,"is_core":true,"listed_in":["cwts-core","dongbi-d","doyens","jufo-1","medline","norway-1","poland-70","russia-white-list-1"],"host_organization":"https://openalex.org/P4310320443","host_organization_name":"Mary Ann Liebert, Inc.","host_organization_lineage":["https://openalex.org/P4310320443","https://openalex.org/P4310320017"],"host_organization_lineage_names":["Mary Ann Liebert, Inc.","SAGE Publishing"],"type":"journal"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Journal of Ocular Pharmacology and Therapeutics","raw_type":"journal-article"},{"id":"pmid:31373837","doi":null,"is_oa":false,"landing_page_url":"https://pubmed.ncbi.nlm.nih.gov/31373837","pdf_url":null,"source":{"id":"https://openalex.org/S4306525036","display_name":"PubMed","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":"https://openalex.org/I1299303238","host_organization_name":"National Institutes of Health","host_organization_lineage":["https://openalex.org/I1299303238"],"host_organization_lineage_names":[],"type":"repository"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Journal of ocular pharmacology and therapeutics : the official journal of the Association for Ocular Pharmacology and Therapeutics","raw_type":"Journal Article"}],"best_oa_location":null,"sustainable_development_goals":[{"id":"https://metadata.un.org/sdg/3","score":1.0,"display_name":"Good health and well-being"}],"study_designs":[],"awards":[],"funders":[],"has_content":{"pdf":false,"grobid_xml":false},"content_urls":null,"referenced_works_count":17,"referenced_works":["https://openalex.org/W1523354060","https://openalex.org/W1992063412","https://openalex.org/W2021491704","https://openalex.org/W2023378519","https://openalex.org/W2052153606","https://openalex.org/W2077912787","https://openalex.org/W2084043416","https://openalex.org/W2086358431","https://openalex.org/W2106079454","https://openalex.org/W2115345791","https://openalex.org/W2381631717","https://openalex.org/W2541357500","https://openalex.org/W2737439597","https://openalex.org/W2737787547","https://openalex.org/W2739359388","https://openalex.org/W2739410682","https://openalex.org/W2892874106"],"related_works":["https://openalex.org/W2961022150","https://openalex.org/W2966827320","https://openalex.org/W3120095939","https://openalex.org/W2892874106","https://openalex.org/W3197101043","https://openalex.org/W6941207007","https://openalex.org/W2930314817","https://openalex.org/W2093934346","https://openalex.org/W1972952427","https://openalex.org/W4417520907"],"abstract_inverted_index":{"Abstract":[0],"Purpose:":[1],"Keratoconjunctivitis":[2],"sicca":[3],"(KCS),":[4],"a":[5,104],"multifactorial":[6],"disease,":[7],"is":[8,20],"the":[9,32,40,84,161,208,219],"most":[10,181,194],"common":[11,182],"ocular":[12,23],"condition":[13],"for":[14,83,141,150,173,232],"patients":[15,47,66],"seeking":[16],"medical":[17],"treatment":[18],"and":[19,26,42,53,63,91,96,111,147,171,177,218,229],"characterized":[21],"by":[22],"burning,":[24],"stinging,":[25],"dryness.":[27],"This":[28],"pooled":[29,85],"analysis":[30,86],"examined":[31],"effect":[33],"of":[34,70],"OTX-101":[35,71,142,156,190,203,226],"0.09%":[36,72],"versus":[37,157,204],"vehicle":[38,74,151,158,205],"on":[39,103],"total":[41,129,162],"individual":[43],"conjunctival":[44,133,163,209],"staining":[45,100,134,164,210],"in":[46,75,198,211,234],"with":[48,202],"KCS":[49,212],"from":[50],"phase":[51,54],"2b/3":[52],"3":[55],"studies.":[56],"Methods:":[57],"In":[58],"these":[59],"randomized,":[60],"multicenter,":[61],"double-masked,":[62],"vehicle-controlled":[64],"studies,":[65],"received":[67],"1":[68],"drop":[69],"or":[73],"both":[76,114],"eyes":[77,115],"twice":[78],"daily.":[79],"The":[80,128,180],"time":[81],"points":[82],"were":[87,138,196],"baseline":[88,137],"(day":[89],"0)":[90],"study":[92],"days":[93,174],"28,":[94,175],"56,":[95,176],"84/early":[97],"discontinuation.":[98],"Conjunctival":[99],"was":[101,185,221,227],"graded":[102],"0-":[105],"to":[106],"3-point":[107],"scale":[108],"per":[109],"zone":[110],"averaged":[112],"over":[113],"at":[116,136],"each":[117],"assessment.":[118],"Pooled":[119],"safety":[120],"assessments":[121],"included":[122],"adverse":[123],"event":[124],"(AE)":[125],"reporting.":[126],"Results:":[127],"mean":[130],"(standard":[131],"deviation)":[132],"scores":[135,165],"5.4":[139],"(1.7)":[140,149],"(":[143,152,166],"n":[144,153],"=":[145,154,168],"523)":[146],"5.5":[148],"525).":[155],"significantly":[159,206],"reduced":[160],"P":[167],"0.0316,":[169],"<0.0001,":[170],"0.0002)":[172],"84,":[178],"respectively.":[179],"treatment-related":[183],"AE":[184],"instillation":[186],"site":[187],"pain":[188],"(21.8%":[189],"vs.":[191],"4.0%":[192],"vehicle);":[193],"AEs":[195],"mild":[197],"nature.":[199],"Conclusions:":[200],"Treatment":[201],"improved":[207],"as":[213,215],"early":[214],"4":[216],"weeks,":[217],"improvement":[220],"maintained":[222],"through":[223],"12":[224],"weeks.":[225],"effective":[228],"well":[230],"tolerated":[231],"use":[233],"KCS.":[235]},"counts_by_year":[{"year":2026,"cited_by_count":3},{"year":2025,"cited_by_count":4},{"year":2022,"cited_by_count":4},{"year":2021,"cited_by_count":3},{"year":2020,"cited_by_count":4}],"updated_date":"2026-10-31T12:09:11.096373","created_date":"2019-08-13T00:00:00"}