{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,5]],"date-time":"2026-10-05T22:28:25Z","timestamp":1791239305826,"version":"4.1.0"},"reference-count":22,"publisher":"Elsevier BV","license":[{"start":{"date-parts":[[2026,7,1]],"date-time":"2026-07-01T00:00:00Z","timestamp":1782864000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/tdm\/userlicense\/1.0\/"},{"start":{"date-parts":[[2026,7,1]],"date-time":"2026-07-01T00:00:00Z","timestamp":1782864000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/legal\/tdmrep-license"}],"content-domain":{"domain":["clinicalkey.com","clinicalkey.com.au","clinicalkey.es","clinicalkey.fr","clinicalkey.jp","elsevier.com","sciencedirect.com"],"crossmark-restriction":true},"short-container-title":["The Ocular Surface"],"published-print":{"date-parts":[[2026,7]]},"DOI":"10.1016\/j.jtos.2026.03.004","type":"journal-article","created":{"date-parts":[[2026,3,25]],"date-time":"2026-03-25T07:58:07Z","timestamp":1774425487000},"page":"249-251","update-policy":"https:\/\/doi.org\/10.1016\/elsevier_cm_policy","source":"Crossref","is-referenced-by-count":1,"special_numbering":"C","title":["Pipeline: Design of therapeutic trials in Ocular Surface Disease"],"prefix":"10.1016","volume":"41","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-9699-8543","authenticated-orcid":false,"given":"Gary D.","family":"Novack","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"78","reference":[{"key":"10.1016\/j.jtos.2026.03.004_bib1","doi-asserted-by":"crossref","first-page":"163","DOI":"10.1016\/S1542-0124(12)70311-7","article-title":"Pipeline: regression to the mean","volume":"7","author":"Novack","year":"2009","journal-title":"Ocul Surf"},{"key":"10.1016\/j.jtos.2026.03.004_bib2","doi-asserted-by":"crossref","first-page":"193","DOI":"10.1016\/j.jtos.2012.05.002","article-title":"Pipeline: how should we display our data? What is the best number?","volume":"10","author":"Novack","year":"2012","journal-title":"Ocul Surf"},{"key":"10.1016\/j.jtos.2026.03.004_bib3","doi-asserted-by":"crossref","first-page":"1759","DOI":"10.1080\/03007995.2016.1210107","article-title":"Lifitegrast clinical efficacy for treatment of signs and symptoms of dry eye disease across three randomized controlled trials","volume":"32","author":"Holland","year":"2016","journal-title":"Curr Med Res Opin"},{"key":"10.1016\/j.jtos.2026.03.004_bib4","doi-asserted-by":"crossref","first-page":"2423","DOI":"10.1016\/j.ophtha.2015.08.001","article-title":"Lifitegrast ophthalmic solution 5.0% versus placebo for treatment of dry eye disease: results of the randomized phase III OPUS-2 study","volume":"122","author":"Tauber","year":"2015","journal-title":"Ophthalmology"},{"key":"10.1016\/j.jtos.2026.03.004_bib5","doi-asserted-by":"crossref","first-page":"53","DOI":"10.1016\/j.ophtha.2016.09.025","article-title":"Lifitegrast for the treatment of dry eye disease: results of a phase III, randomized, double-masked, placebo-controlled trial (OPUS-3)","volume":"124","author":"Holland","year":"2017","journal-title":"Ophthalmology"},{"key":"10.1016\/j.jtos.2026.03.004_bib6","doi-asserted-by":"crossref","first-page":"267","DOI":"10.1016\/j.jclinepi.2013.08.015","article-title":"Systematic review of the hawthorne effect: new concepts are needed to study research participation effects","volume":"67","author":"McCambridge","year":"2014","journal-title":"J Clin Epidemiol"},{"key":"10.1016\/j.jtos.2026.03.004_bib7","first-page":"CD009729","article-title":"Over the counter (OTC) artificial tear drops for dry eye syndrome","volume":"2","author":"Pucker","year":"2016","journal-title":"Cochrane Database Syst Rev"},{"key":"10.1016\/j.jtos.2026.03.004_bib8","doi-asserted-by":"crossref","first-page":"265","DOI":"10.1016\/j.jtos.2018.02.001","article-title":"Compared to what? The placebo effect in dry eye therapy","volume":"16","author":"Novack","year":"2018","journal-title":"Ocul Surf"},{"key":"10.1016\/j.jtos.2026.03.004_bib9","doi-asserted-by":"crossref","first-page":"192","DOI":"10.1016\/j.ophtha.2018.09.046","article-title":"Dry eye research-still regressing?","volume":"126","author":"Seitzman","year":"2019","journal-title":"Ophthalmology"},{"key":"10.1016\/j.jtos.2026.03.004_bib10","doi-asserted-by":"crossref","first-page":"20","DOI":"10.1016\/S1542-0124(12)70004-6","article-title":"Challenges and pitfalls in clinical trials of treatments for dry eye","volume":"1","author":"Foulks","year":"2003","journal-title":"Ocul Surf"},{"key":"10.1016\/j.jtos.2026.03.004_bib21","doi-asserted-by":"crossref","first-page":"1050","DOI":"10.1016\/j.ajo.2011.11.003","article-title":"A phase 2 randomized, double-masked, placebo-controlled study of a novel integrin antagonist (SAR 1118) for the treatment of dry eye","volume":"153","author":"Semba","year":"2012","journal-title":"Am J Ophthalmol"},{"key":"10.1016\/j.jtos.2026.03.004_bib22","series-title":"Xiidra(R) package insert","year":"2022"},{"key":"10.1016\/j.jtos.2026.03.004_bib11","doi-asserted-by":"crossref","first-page":"135","DOI":"10.1016\/j.ajo.2025.09.035","article-title":"TFOS DEWS III: executive summary","volume":"282","author":"Perez","year":"2026","journal-title":"Am J Ophthalmol"},{"key":"10.1016\/j.jtos.2026.03.004_bib12","series-title":"Dry eye: developing drugs for treatment: guidance for industry","year":"2020"},{"key":"10.1016\/j.jtos.2026.03.004_bib13","doi-asserted-by":"crossref","first-page":"14","DOI":"10.1016\/j.ajo.2023.09.024","article-title":"United States regulatory approval of topical treatments for dry eye","volume":"258","author":"Cui","year":"2024","journal-title":"Am J Ophthalmol"},{"key":"10.1016\/j.jtos.2026.03.004_bib14","doi-asserted-by":"crossref","first-page":"516","DOI":"10.1016\/j.ophtha.2022.12.021","article-title":"NOV03 for dry eye disease associated with Meibomian gland dysfunction: results of the randomized phase 3 GOBI study","volume":"130","author":"Tauber","year":"2023","journal-title":"Ophthalmology"},{"key":"10.1016\/j.jtos.2026.03.004_bib15","series-title":"Miebo package insert","year":"2023"},{"key":"10.1016\/j.jtos.2026.03.004_bib16","article-title":"Acoltremon ophthalmic solution 0.003% for signs and symptoms of dry eye disease: results of phase 3 pivotal COMET-2 and COMET-3 studies","author":"Pattar","year":"2025","journal-title":"Ophthalmology"},{"key":"10.1016\/j.jtos.2026.03.004_bib17","doi-asserted-by":"crossref","first-page":"533","DOI":"10.1016\/j.jtos.2020.05.005","article-title":"Five variable that rule your life - home mortgage and biostatistical power","volume":"18","author":"Novack","year":"2020","journal-title":"Ocul Surf"},{"key":"10.1016\/j.jtos.2026.03.004_bib18","doi-asserted-by":"crossref","first-page":"1649","DOI":"10.1007\/s40123-025-01168-1","article-title":"Lissamine green in ophthalmology: a comprehensive review of diagnostic and clinical applications","volume":"14","author":"Barabino","year":"2025","journal-title":"Ophthalmol Ther"},{"key":"10.1016\/j.jtos.2026.03.004_bib19","first-page":"1","article-title":"Corneal fluorescein staining in FDA-reviewed dry eye registrational clinical trials: evidence of limited endpoint responsiveness","author":"Dabre","year":"2026","journal-title":"Ophthalmic Res"},{"key":"10.1016\/j.jtos.2026.03.004_bib20","doi-asserted-by":"crossref","first-page":"51","DOI":"10.1016\/j.jtos.2023.08.002","article-title":"Clinical trials submissions to the ocular surface","volume":"30","author":"Novack","year":"2023","journal-title":"Ocul Surf"}],"container-title":["The Ocular Surface"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S1542012426000340?httpAccept=text\/xml","content-type":"text\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S1542012426000340?httpAccept=text\/plain","content-type":"text\/plain","content-version":"vor","intended-application":"text-mining"}],"deposited":{"date-parts":[[2026,9,24]],"date-time":"2026-09-24T21:05:17Z","timestamp":1790283917000},"score":1,"resource":{"primary":{"URL":"https:\/\/linkinghub.elsevier.com\/retrieve\/pii\/S1542012426000340"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,7]]},"references-count":22,"alternative-id":["S1542012426000340"],"URL":"https:\/\/doi.org\/10.1016\/j.jtos.2026.03.004","relation":{},"ISSN":["1542-0124"],"issn-type":[{"value":"1542-0124","type":"print"}],"subject":[],"published":{"date-parts":[[2026,7]]},"assertion":[{"value":"Elsevier","name":"publisher","label":"This article is maintained by"},{"value":"Pipeline: Design of therapeutic trials in Ocular Surface Disease","name":"articletitle","label":"Article Title"},{"value":"The Ocular Surface","name":"journaltitle","label":"Journal Title"},{"value":"https:\/\/doi.org\/10.1016\/j.jtos.2026.03.004","name":"articlelink","label":"CrossRef DOI link to publisher maintained version"},{"value":"simple-article","name":"content_type","label":"Content Type"},{"value":"\u00a9 2026 Elsevier Inc. All rights are reserved, including those for text and data mining, AI training, and similar technologies.","name":"copyright","label":"Copyright"}]}}