{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,20]],"date-time":"2026-07-20T11:20:53Z","timestamp":1784546453651,"version":"3.55.0"},"reference-count":18,"publisher":"SAGE Publications","issue":"7","license":[{"start":{"date-parts":[[2019,9,1]],"date-time":"2019-09-01T00:00:00Z","timestamp":1567296000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Journal of Ocular Pharmacology and Therapeutics"],"published-print":{"date-parts":[[2019,9,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Purpose:<\/jats:title>\n                    <jats:p>Keratoconjunctivitis sicca (KCS), a multifactorial disease, is the most common ocular condition for patients seeking medical treatment and is characterized by ocular burning, stinging, and dryness. This pooled analysis examined the effect of OTX-101 0.09% versus vehicle on the total and individual conjunctival staining in patients with KCS from phase 2b\/3 and phase 3 studies.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods:<\/jats:title>\n                    <jats:p>In these randomized, multicenter, double-masked, and vehicle-controlled studies, patients received 1 drop of OTX-101 0.09% or vehicle in both eyes twice daily. The time points for the pooled analysis were baseline (day 0) and study days 28, 56, and 84\/early discontinuation. Conjunctival staining was graded on a 0- to 3-point scale per zone and averaged over both eyes at each assessment. Pooled safety assessments included adverse event (AE) reporting.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>\n                      The total mean (standard deviation) conjunctival staining scores at baseline were 5.4 (1.7) for OTX-101 (\n                      <jats:italic toggle=\"yes\">n<\/jats:italic>\n                      \u2009=\u2009523) and 5.5 (1.7) for vehicle (\n                      <jats:italic toggle=\"yes\">n<\/jats:italic>\n                      \u2009=\u2009525). OTX-101 versus vehicle significantly reduced the total conjunctival staining scores (\n                      <jats:italic toggle=\"yes\">P<\/jats:italic>\n                      \u2009=\u20090.0316, &lt;0.0001, and 0.0002) for days 28, 56, and 84, respectively. The most common treatment-related AE was instillation site pain (21.8% OTX-101 vs. 4.0% vehicle); most AEs were mild in nature.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions:<\/jats:title>\n                    <jats:p>Treatment with OTX-101 versus vehicle significantly improved the conjunctival staining in KCS as early as 4 weeks, and the improvement was maintained through 12 weeks. OTX-101 was effective and well tolerated for use in KCS.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1089\/jop.2018.0154","type":"journal-article","created":{"date-parts":[[2019,8,2]],"date-time":"2019-08-02T16:50:06Z","timestamp":1564764606000},"page":"388-394","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":19,"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"],"prefix":"10.1177","volume":"35","author":[{"given":"Robert","family":"Smyth-Medina","sequence":"first","affiliation":[{"name":"North Valley Eye Medical Group, Inc., Mission Hills, California."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Josh","family":"Johnston","sequence":"additional","affiliation":[{"name":"Georgia Eye Partners, Atlanta, Georgia."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Douglas K.","family":"Devries","sequence":"additional","affiliation":[{"name":"Eye Care Associates of Nevada, Sparks, Nevada."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"April","family":"Jasper","sequence":"additional","affiliation":[{"name":"Advanced Eyecare Specialists, West Palm Beach, Florida."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shane R.","family":"Kannarr","sequence":"additional","affiliation":[{"name":"Kannarr Eye Care, Pittsburg, Kansas."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Barry A.","family":"Schechter","sequence":"additional","affiliation":[{"name":"Florida Eye Microsurgical Institute, Inc., Boynton Beach, Florida."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bridgitte","family":"Shen Lee","sequence":"additional","affiliation":[{"name":"Vision Optique, Houston, Texas."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"George","family":"Varghese","sequence":"additional","affiliation":[{"name":"Sun Pharmaceutical Industries, Inc., Princeton, New Jersey."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Abayomi","family":"Ogundele","sequence":"additional","affiliation":[{"name":"Sun Pharmaceutical Industries, Inc., Princeton, New Jersey."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Charles H.","family":"Darby","sequence":"additional","affiliation":[{"name":"Sun Pharma Advanced Research Company, Ltd., Princeton, New Jersey."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paul","family":"Karpecki","sequence":"additional","affiliation":[{"name":"Kentucky Eye Institute, Lexington, Kentucky."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jodi","family":"Luchs","sequence":"additional","affiliation":[{"name":"Hofstra Northwell School of Medicine, Hempstead, New York."}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2019,9,5]]},"reference":[{"key":"e_1_3_4_2_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jtos.2017.05.008"},{"key":"e_1_3_4_3_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jtos.2017.05.003"},{"key":"e_1_3_4_4_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jtos.2017.05.011"},{"key":"e_1_3_4_5_2","doi-asserted-by":"publisher","DOI":"10.1001\/archopht.118.11.1489"},{"key":"e_1_3_4_6_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jtos.2017.05.006"},{"key":"e_1_3_4_7_2","doi-asserted-by":"publisher","DOI":"10.1167\/iovs.13-11681"},{"key":"e_1_3_4_8_2","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0076121"},{"key":"e_1_3_4_9_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0161-6420(99)00176-1"},{"key":"e_1_3_4_10_2","doi-asserted-by":"publisher","DOI":"10.2147\/OPTH.S101627"},{"key":"e_1_3_4_11_2","volume-title":"Full Prescribing Information","author":"CEQUA\u2122 (cyclosporine opthalmic solution 0.09%)","year":"2018","unstructured":"CEQUA\u2122 (cyclosporine opthalmic solution 0.09%). 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