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Notably, the signs and symptoms of dry eye syndrome can impact the daily quality of life for various age groups, including the elderly, and usually requires active treatment. The symptoms of dry eye syndrome include tear film instability, hyperosmolarity, ocular surface inflammation and damage, and neurosensory abnormalities. As treatments for dry eye are being developed, a standardized guideline is needed to increase the efficiency of drug development and improve the quality of clinical trial data. In this paper, we present general considerations for the pharmaceutical industry and clinical trial investigators designing clinical trials focused on the development of drugs to treat dry eye syndrome.<\/jats:p>","DOI":"10.24171\/j.phrp.2023.0031","type":"journal-article","created":{"date-parts":[[2023,4,26]],"date-time":"2023-04-26T06:31:38Z","timestamp":1682490698000},"page":"70-75","update-policy":"https:\/\/doi.org\/10.24171\/crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["Points to consider when developing drugs for dry eye syndrome"],"prefix":"10.24171","volume":"14","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-4092-6508","authenticated-orcid":true,"given":"Suyoung","family":"Bae","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8624-7327","authenticated-orcid":true,"given":"Hosun","family":"Seung","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0595-3399","authenticated-orcid":true,"given":"Ho Jung","family":"Oh","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"31909","reference":[{"volume-title":"The pharmaceutical and bio-pharma industry databook 2021 [Internet]","year":"2021","key":"ref1"},{"volume-title":"The pharmaceutical and bio-pharma industry databook 2022 [Internet]","year":"2022","key":"ref2"},{"volume-title":"Press release for reference: National Health Insurance Service, completion of agreement for usage-a medical fee \u2018type DA\u2019 181 items [Internet]","year":"2020","key":"ref3"},{"volume-title":"","year":"2020","key":"ref4"},{"key":"ref5","doi-asserted-by":"publisher","DOI":"10.1016\/j.jtos.2017.05.008"},{"volume-title":"Dry eye syndrome [Internet]","key":"ref6"},{"volume-title":"Dry eye syndrome [Internet]","key":"ref7"},{"key":"ref8","doi-asserted-by":"publisher","DOI":"10.5124\/jkma.2018.61.6.352"},{"key":"ref9","doi-asserted-by":"publisher","DOI":"10.1097\/icu.0000000000000569"},{"volume-title":"Dry eye syndrome [Internet]","year":"2022","key":"ref10"},{"volume-title":"Guideline on clinical trials for dry eye disease drugs [Internet]","year":"2022","key":"ref11"},{"volume-title":"Pharmaceutical Affairs Act [Internet]","year":"2022","key":"ref12"},{"volume-title":"Regulation on safety of pharmaceuticals, etc. [Internet]","year":"2022","key":"ref13"},{"volume-title":"","year":"2022","key":"ref14"},{"volume-title":"The extent of population exposure to assess clinical safety: for drugs intended for long-term treatment of non-life-threatening conditions [Internet]","year":"1995","key":"ref15"},{"volume-title":"Guideline on nonclinical evaluation of pharmaceuticals","year":"2017","key":"ref16"},{"volume-title":"","year":"2022","key":"ref17"},{"volume-title":"Analysis report of market and technology development for eye-drops [Internet]","year":"2020","key":"ref18"},{"volume-title":"Dry eye: developing drugs for treatment guidance for industry: draft guidance [Internet]","year":"2020","key":"ref19"}],"container-title":["Osong Public Health and Research Perspectives"],"original-title":[],"language":"en","link":[{"URL":"http:\/\/ophrp.org\/upload\/pdf\/j-phrp-2023-0031.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"http:\/\/ophrp.org\/journal\/view.php?doi=10.24171\/j.phrp.2023.0031","content-type":"unspecified","content-version":"vor","intended-application":"text-mining"},{"URL":"http:\/\/ophrp.org\/upload\/pdf\/j-phrp-2023-0031.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,4,28]],"date-time":"2023-04-28T05:51:16Z","timestamp":1682661076000},"score":1,"resource":{"primary":{"URL":"http:\/\/ophrp.org\/journal\/view.php?doi=10.24171\/j.phrp.2023.0031"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,4,30]]},"references-count":19,"journal-issue":{"issue":"2","published-print":{"date-parts":[[2023,4]]}},"URL":"https:\/\/doi.org\/10.24171\/j.phrp.2023.0031","relation":{},"ISSN":["2210-9099","2233-6052"],"issn-type":[{"type":"print","value":"2210-9099"},{"type":"electronic","value":"2233-6052"}],"subject":[],"published":{"date-parts":[[2023,4,30]]},"assertion":[{"value":"2023-02-06","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2023-03-30","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2023-04-26","order":2,"name":"published","label":"Published online","group":{"name":"publication_history","label":"Publication History"}},{"value":"2023-04-30","order":3,"name":"published","label":"Print publication","group":{"name":"publication_history","label":"Publication History"}}]}}