{"id":107405,"date":"2022-08-11T18:57:05","date_gmt":"2022-08-11T22:57:05","guid":{"rendered":"https:\/\/med.virginia.edu\/cell-biology\/?p=107405"},"modified":"2026-05-22T17:01:16","modified_gmt":"2026-05-22T21:01:16","slug":"lacripep-for-the-treatment-of-primary-sjogrens-associated-ocular-surface-disease-results-of-the-first-in-human-study","status":"publish","type":"post","link":"https:\/\/med.virginia.edu\/cell-biology\/2022\/08\/11\/lacripep-for-the-treatment-of-primary-sjogrens-associated-ocular-surface-disease-results-of-the-first-in-human-study\/","title":{"rendered":"Lacripep for the Treatment of Primary Sj\u00f6gren’s-Associated Ocular Surface Disease: Results of the First-In-Human Study"},"content":{"rendered":"

UVA Author:<\/strong> Gordon Laurie
\nCitation:<\/strong> Tauber J, Laurie GW, Parsons EC, Odrich MG; Lacripep study group*; Lacripep study group*. Lacripep for the Treatment of Primary Sj\u00f6gren’s-Associated Ocular Surface Disease: Results of the First-In-Human Study. Cornea. 2022 Aug 3. doi: 10.1097\/ICO.0000000000003091. Epub ahead of print.<\/p>\n

DOI:<\/strong> https:\/\/pubmed.ncbi.nlm.nih.gov\/35942530\/<\/a>
\nPub-Med Number<\/strong>: 35942530<\/p>\n

\n

Abstract<\/h2>\n
\n

Purpose:\u00a0<\/strong>The purpose of this study was to assess the safety, tolerability, dosing, and efficacy of the active 19 amino acid fragment of lacritin (Lacripep), a broad regulator of ocular surface homeostasis, in the treatment of ocular surface disease associated with primary Sj\u00f6gren’s syndrome.<\/p>\n

Methods:\u00a0<\/strong>Two hundred four subjects were randomized to receive vehicle, 22 \u03bcM Lacripep, or 44 \u03bcM Lacripep 3 times daily for 28 days, preceded by a 14-day run-in and followed by 14-day washout. Outcome measures were corneal fluorescein staining (CFS), lissamine conjunctival staining, Schirmer with anesthesia, tear break-up time, SANDE scoring, and visual analog scale assessment of symptoms.<\/p>\n

Results:\u00a0<\/strong>This study established the safety and tolerability of topical treatment with Lacripep in patients with primary Sj\u00f6gren’s syndrome. There were few adverse events: Only mild irritation was found in less than 3 percent of patients dosed with Lacripep. Total CFS and Eye Dryness Score were not significantly changed at day 28. Post hoc analysis of patients with Eye Dryness Severity scores of 60 or greater at baseline revealed significant improvements in inferior CFS at 14 and 28 days and complaints of burning and stinging at 14 days. Significant improvement in regional lissamine conjunctival staining was seen at 14 and 28 days.<\/p>\n

Conclusions:\u00a0<\/strong>This first-in-human study of Lacripep in patients with primary Sj\u00f6gren’s syndrome demonstrated clinically significant improvements in specific signs and symptoms on which to base future studies. This study established safety and tolerability and potential metrics of efficacy in patients with moderate to severe disease. Further work on appropriate dosing and concentration is ongoing.<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

UVA Author: Gordon Laurie Citation: Tauber J, Laurie GW, Parsons EC, Odrich MG; Lacripep study group*; Lacripep study group*. Lacripep for the Treatment of Primary Sj\u00f6gren’s-Associated Ocular Surface Disease: Results of the First-In-Human Study. Cornea. 2022 Aug 3. doi: 10.1097\/ICO.0000000000003091. Epub ahead of print. DOI: https:\/\/pubmed.ncbi.nlm.nih.gov\/35942530\/ Pub-Med Number: 35942530 Abstract Purpose:\u00a0The purpose of this study […]<\/p>\n","protected":false},"author":1740,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":"","_links_to":"","_links_to_target":""},"categories":[13],"tags":[22],"class_list":["post-107405","post","type-post","status-publish","format-standard","hentry","category-featured-publications","tag-intranet"],"acf":false,"yoast_head":"\nLacripep for the Treatment of Primary Sj\u00f6gren's-Associated Ocular Surface Disease: Results of the First-In-Human Study - Department of Cell Biology<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/med.virginia.edu\/cell-biology\/2022\/08\/11\/lacripep-for-the-treatment-of-primary-sjogrens-associated-ocular-surface-disease-results-of-the-first-in-human-study\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Lacripep for the Treatment of Primary Sj\u00f6gren's-Associated Ocular Surface Disease: Results of the First-In-Human Study - Department of Cell Biology\" \/>\n<meta property=\"og:description\" content=\"UVA Author: Gordon Laurie Citation: Tauber J, Laurie GW, Parsons EC, Odrich MG; Lacripep study group*; Lacripep study group*. Lacripep for the Treatment of Primary Sj\u00f6gren’s-Associated Ocular Surface Disease: Results of the First-In-Human Study. Cornea. 2022 Aug 3. doi: 10.1097\/ICO.0000000000003091. Epub ahead of print. DOI: https:\/\/pubmed.ncbi.nlm.nih.gov\/35942530\/ Pub-Med Number: 35942530 Abstract Purpose:\u00a0The purpose of this study […]\" \/>\n<meta property=\"og:url\" content=\"https:\/\/med.virginia.edu\/cell-biology\/2022\/08\/11\/lacripep-for-the-treatment-of-primary-sjogrens-associated-ocular-surface-disease-results-of-the-first-in-human-study\/\" \/>\n<meta property=\"og:site_name\" content=\"Department of Cell Biology\" \/>\n<meta property=\"article:published_time\" content=\"2022-08-11T22:57:05+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2026-05-22T21:01:16+00:00\" \/>\n<meta name=\"author\" content=\"zkr7e@virginia.edu\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"zkr7e@virginia.edu\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"2 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/med.virginia.edu\\\/cell-biology\\\/2022\\\/08\\\/11\\\/lacripep-for-the-treatment-of-primary-sjogrens-associated-ocular-surface-disease-results-of-the-first-in-human-study\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/med.virginia.edu\\\/cell-biology\\\/2022\\\/08\\\/11\\\/lacripep-for-the-treatment-of-primary-sjogrens-associated-ocular-surface-disease-results-of-the-first-in-human-study\\\/\"},\"author\":{\"name\":\"zkr7e@virginia.edu\",\"@id\":\"https:\\\/\\\/med.virginia.edu\\\/cell-biology\\\/#\\\/schema\\\/person\\\/b4929a1d4683383a392718e12166cd7f\"},\"headline\":\"Lacripep for the Treatment of Primary Sj\u00f6gren’s-Associated Ocular Surface Disease: Results of the First-In-Human Study\",\"datePublished\":\"2022-08-11T22:57:05+00:00\",\"dateModified\":\"2026-05-22T21:01:16+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/med.virginia.edu\\\/cell-biology\\\/2022\\\/08\\\/11\\\/lacripep-for-the-treatment-of-primary-sjogrens-associated-ocular-surface-disease-results-of-the-first-in-human-study\\\/\"},\"wordCount\":322,\"keywords\":[\"Intranet\"],\"articleSection\":[\"Featured Publications\"],\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/med.virginia.edu\\\/cell-biology\\\/2022\\\/08\\\/11\\\/lacripep-for-the-treatment-of-primary-sjogrens-associated-ocular-surface-disease-results-of-the-first-in-human-study\\\/\",\"url\":\"https:\\\/\\\/med.virginia.edu\\\/cell-biology\\\/2022\\\/08\\\/11\\\/lacripep-for-the-treatment-of-primary-sjogrens-associated-ocular-surface-disease-results-of-the-first-in-human-study\\\/\",\"name\":\"Lacripep for the Treatment of Primary Sj\u00f6gren's-Associated Ocular Surface Disease: Results of the First-In-Human Study - Department of Cell Biology\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/med.virginia.edu\\\/cell-biology\\\/#website\"},\"datePublished\":\"2022-08-11T22:57:05+00:00\",\"dateModified\":\"2026-05-22T21:01:16+00:00\",\"author\":{\"@id\":\"https:\\\/\\\/med.virginia.edu\\\/cell-biology\\\/#\\\/schema\\\/person\\\/b4929a1d4683383a392718e12166cd7f\"},\"breadcrumb\":{\"@id\":\"https:\\\/\\\/med.virginia.edu\\\/cell-biology\\\/2022\\\/08\\\/11\\\/lacripep-for-the-treatment-of-primary-sjogrens-associated-ocular-surface-disease-results-of-the-first-in-human-study\\\/#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/med.virginia.edu\\\/cell-biology\\\/2022\\\/08\\\/11\\\/lacripep-for-the-treatment-of-primary-sjogrens-associated-ocular-surface-disease-results-of-the-first-in-human-study\\\/\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/med.virginia.edu\\\/cell-biology\\\/2022\\\/08\\\/11\\\/lacripep-for-the-treatment-of-primary-sjogrens-associated-ocular-surface-disease-results-of-the-first-in-human-study\\\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\\\/\\\/med.virginia.edu\\\/cell-biology\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Lacripep for the Treatment of Primary Sj\u00f6gren’s-Associated Ocular Surface Disease: Results of the First-In-Human Study\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\\\/\\\/med.virginia.edu\\\/cell-biology\\\/#website\",\"url\":\"https:\\\/\\\/med.virginia.edu\\\/cell-biology\\\/\",\"name\":\"Department of Cell Biology\",\"description\":\"University of Virginia School of Medicine\",\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\\\/\\\/med.virginia.edu\\\/cell-biology\\\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"en-US\"},{\"@type\":\"Person\",\"@id\":\"https:\\\/\\\/med.virginia.edu\\\/cell-biology\\\/#\\\/schema\\\/person\\\/b4929a1d4683383a392718e12166cd7f\",\"name\":\"zkr7e@virginia.edu\",\"image\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\\\/\\\/secure.gravatar.com\\\/avatar\\\/eb05928a9c10d0bc86fc859e223e3e9cd7a535837367cf67c524db2a42f795d0?s=96&d=mm&r=g\",\"url\":\"https:\\\/\\\/secure.gravatar.com\\\/avatar\\\/eb05928a9c10d0bc86fc859e223e3e9cd7a535837367cf67c524db2a42f795d0?s=96&d=mm&r=g\",\"contentUrl\":\"https:\\\/\\\/secure.gravatar.com\\\/avatar\\\/eb05928a9c10d0bc86fc859e223e3e9cd7a535837367cf67c524db2a42f795d0?s=96&d=mm&r=g\",\"caption\":\"zkr7e@virginia.edu\"},\"url\":\"https:\\\/\\\/med.virginia.edu\\\/cell-biology\\\/author\\\/zkr7evirginia-edu\\\/\"}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"Lacripep for the Treatment of Primary Sj\u00f6gren's-Associated Ocular Surface Disease: Results of the First-In-Human Study - Department of Cell Biology","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/med.virginia.edu\/cell-biology\/2022\/08\/11\/lacripep-for-the-treatment-of-primary-sjogrens-associated-ocular-surface-disease-results-of-the-first-in-human-study\/","og_locale":"en_US","og_type":"article","og_title":"Lacripep for the Treatment of Primary Sj\u00f6gren's-Associated Ocular Surface Disease: Results of the First-In-Human Study - Department of Cell Biology","og_description":"UVA Author: Gordon Laurie Citation: Tauber J, Laurie GW, Parsons EC, Odrich MG; Lacripep study group*; Lacripep study group*. Lacripep for the Treatment of Primary Sj\u00f6gren’s-Associated Ocular Surface Disease: Results of the First-In-Human Study. Cornea. 2022 Aug 3. doi: 10.1097\/ICO.0000000000003091. Epub ahead of print. DOI: https:\/\/pubmed.ncbi.nlm.nih.gov\/35942530\/ Pub-Med Number: 35942530 Abstract Purpose:\u00a0The purpose of this study […]","og_url":"https:\/\/med.virginia.edu\/cell-biology\/2022\/08\/11\/lacripep-for-the-treatment-of-primary-sjogrens-associated-ocular-surface-disease-results-of-the-first-in-human-study\/","og_site_name":"Department of Cell Biology","article_published_time":"2022-08-11T22:57:05+00:00","article_modified_time":"2026-05-22T21:01:16+00:00","author":"zkr7e@virginia.edu","twitter_card":"summary_large_image","twitter_misc":{"Written by":"zkr7e@virginia.edu","Est. reading time":"2 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/med.virginia.edu\/cell-biology\/2022\/08\/11\/lacripep-for-the-treatment-of-primary-sjogrens-associated-ocular-surface-disease-results-of-the-first-in-human-study\/#article","isPartOf":{"@id":"https:\/\/med.virginia.edu\/cell-biology\/2022\/08\/11\/lacripep-for-the-treatment-of-primary-sjogrens-associated-ocular-surface-disease-results-of-the-first-in-human-study\/"},"author":{"name":"zkr7e@virginia.edu","@id":"https:\/\/med.virginia.edu\/cell-biology\/#\/schema\/person\/b4929a1d4683383a392718e12166cd7f"},"headline":"Lacripep for the Treatment of Primary Sj\u00f6gren’s-Associated Ocular Surface Disease: Results of the First-In-Human Study","datePublished":"2022-08-11T22:57:05+00:00","dateModified":"2026-05-22T21:01:16+00:00","mainEntityOfPage":{"@id":"https:\/\/med.virginia.edu\/cell-biology\/2022\/08\/11\/lacripep-for-the-treatment-of-primary-sjogrens-associated-ocular-surface-disease-results-of-the-first-in-human-study\/"},"wordCount":322,"keywords":["Intranet"],"articleSection":["Featured Publications"],"inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/med.virginia.edu\/cell-biology\/2022\/08\/11\/lacripep-for-the-treatment-of-primary-sjogrens-associated-ocular-surface-disease-results-of-the-first-in-human-study\/","url":"https:\/\/med.virginia.edu\/cell-biology\/2022\/08\/11\/lacripep-for-the-treatment-of-primary-sjogrens-associated-ocular-surface-disease-results-of-the-first-in-human-study\/","name":"Lacripep for the Treatment of Primary Sj\u00f6gren's-Associated Ocular Surface Disease: Results of the First-In-Human Study - Department of Cell Biology","isPartOf":{"@id":"https:\/\/med.virginia.edu\/cell-biology\/#website"},"datePublished":"2022-08-11T22:57:05+00:00","dateModified":"2026-05-22T21:01:16+00:00","author":{"@id":"https:\/\/med.virginia.edu\/cell-biology\/#\/schema\/person\/b4929a1d4683383a392718e12166cd7f"},"breadcrumb":{"@id":"https:\/\/med.virginia.edu\/cell-biology\/2022\/08\/11\/lacripep-for-the-treatment-of-primary-sjogrens-associated-ocular-surface-disease-results-of-the-first-in-human-study\/#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/med.virginia.edu\/cell-biology\/2022\/08\/11\/lacripep-for-the-treatment-of-primary-sjogrens-associated-ocular-surface-disease-results-of-the-first-in-human-study\/"]}]},{"@type":"BreadcrumbList","@id":"https:\/\/med.virginia.edu\/cell-biology\/2022\/08\/11\/lacripep-for-the-treatment-of-primary-sjogrens-associated-ocular-surface-disease-results-of-the-first-in-human-study\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/med.virginia.edu\/cell-biology\/"},{"@type":"ListItem","position":2,"name":"Lacripep for the Treatment of Primary Sj\u00f6gren’s-Associated Ocular Surface Disease: Results of the First-In-Human Study"}]},{"@type":"WebSite","@id":"https:\/\/med.virginia.edu\/cell-biology\/#website","url":"https:\/\/med.virginia.edu\/cell-biology\/","name":"Department of Cell Biology","description":"University of Virginia School of Medicine","potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/med.virginia.edu\/cell-biology\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"en-US"},{"@type":"Person","@id":"https:\/\/med.virginia.edu\/cell-biology\/#\/schema\/person\/b4929a1d4683383a392718e12166cd7f","name":"zkr7e@virginia.edu","image":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/secure.gravatar.com\/avatar\/eb05928a9c10d0bc86fc859e223e3e9cd7a535837367cf67c524db2a42f795d0?s=96&d=mm&r=g","url":"https:\/\/secure.gravatar.com\/avatar\/eb05928a9c10d0bc86fc859e223e3e9cd7a535837367cf67c524db2a42f795d0?s=96&d=mm&r=g","contentUrl":"https:\/\/secure.gravatar.com\/avatar\/eb05928a9c10d0bc86fc859e223e3e9cd7a535837367cf67c524db2a42f795d0?s=96&d=mm&r=g","caption":"zkr7e@virginia.edu"},"url":"https:\/\/med.virginia.edu\/cell-biology\/author\/zkr7evirginia-edu\/"}]}},"_links":{"self":[{"href":"https:\/\/med.virginia.edu\/cell-biology\/wp-json\/wp\/v2\/posts\/107405","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/med.virginia.edu\/cell-biology\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/med.virginia.edu\/cell-biology\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/med.virginia.edu\/cell-biology\/wp-json\/wp\/v2\/users\/1740"}],"replies":[{"embeddable":true,"href":"https:\/\/med.virginia.edu\/cell-biology\/wp-json\/wp\/v2\/comments?post=107405"}],"version-history":[{"count":1,"href":"https:\/\/med.virginia.edu\/cell-biology\/wp-json\/wp\/v2\/posts\/107405\/revisions"}],"predecessor-version":[{"id":107490,"href":"https:\/\/med.virginia.edu\/cell-biology\/wp-json\/wp\/v2\/posts\/107405\/revisions\/107490"}],"wp:attachment":[{"href":"https:\/\/med.virginia.edu\/cell-biology\/wp-json\/wp\/v2\/media?parent=107405"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/med.virginia.edu\/cell-biology\/wp-json\/wp\/v2\/categories?post=107405"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/med.virginia.edu\/cell-biology\/wp-json\/wp\/v2\/tags?post=107405"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}