PMID- 32826644 OWN - NLM STAT- MEDLINE DCOM- 20211022 LR - 20230912 IS - 1536-4798 (Electronic) IS - 0277-3740 (Linking) VI - 40 IP - 5 DP - 2021 May 1 TI - Safety of KPI-121 Ophthalmic Suspension 0.25% in Patients With Dry Eye Disease: A Pooled Analysis of 4 Multicenter, Randomized, Vehicle-Controlled Studies. PG - 564-570 LID - 10.1097/ICO.0000000000002452 [doi] AB - PURPOSE: The safety of KPI-121 0.25%, an ophthalmic nanoparticle suspension of loteprednol etabonate, was evaluated in subjects with dry eye disease (DED) in one phase 2 and three phase 3 randomized trials of similar design. METHODS: Adults with DED received KPI-121 0.25% or vehicle drops 4 times daily (QID) for >/=2 weeks; 1430 subjects received KPI-121 0.25% and 1438 subjects received vehicle drops. Main safety assessments were adverse events (AEs) and intraocular pressure (IOP). As a common side effect associated with the use of ocular corticosteroids is elevated IOP, subjects with a history of or current diagnosis of glaucoma were excluded. RESULTS: Instillation site pain was the most common AE, reported by 5.2% of subjects in the KPI-121 0.25% group and 4.4% of subjects in the vehicle group; other AEs were reported by 5 mm Hg that resulted in an IOP of >/=21 mm Hg in either eye during use of the study product. CONCLUSIONS: KPI-121 ophthalmic suspension 0.25% seemed to be safe and well tolerated when dosed QID for 2 to 4 weeks in those DED subjects included in the 4 trials. CI - Copyright (c) 2020 The Author(s). Published by Wolters Kluwer Health, Inc. FAU - Korenfeld, Michael AU - Korenfeld M AD - Comprehensive Eye Care, Ltd, Washington, MO. FAU - Nichols, Kelly K AU - Nichols KK AD - School of Optometry, University of Alabama, Birmingham, AL. FAU - Goldberg, Damien AU - Goldberg D AD - Wolstan and Goldberg Eye Associates, Torrance, CA. FAU - Evans, David AU - Evans D AD - Total Eye Care, PA, Memphis, TN. FAU - Sall, Ken AU - Sall K AD - Sall Research Medical Center, Artesia, CA. FAU - Foulks, Gary AU - Foulks G AD - Department of Ophthalmology, University of Louisville, Louisville, KY; and. FAU - Coultas, Susan AU - Coultas S AD - Kala Pharmaceuticals, Inc, Watertown, MA. FAU - Brazzell, Kim AU - Brazzell K AD - Kala Pharmaceuticals, Inc, Watertown, MA. LA - eng SI - ClinicalTrials.gov/NCT02188160 PT - Clinical Trial, Phase II PT - Clinical Trial, Phase III PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PL - United States TA - Cornea JT - Cornea JID - 8216186 RN - 0 (Anti-Allergic Agents) RN - 0 (Ophthalmic Solutions) RN - 0 (Suspensions) RN - YEH1EZ96K6 (Loteprednol Etabonate) SB - IM MH - Administration, Ophthalmic MH - Adolescent MH - Adult MH - Aged MH - Aged, 80 and over MH - Anti-Allergic Agents/*administration & dosage/adverse effects MH - Double-Blind Method MH - Drug-Related Side Effects and Adverse Reactions/diagnosis/etiology MH - Dry Eye Syndromes/*drug therapy MH - Eye Pain/chemically induced MH - Female MH - Humans MH - Intraocular Pressure/drug effects MH - Loteprednol Etabonate/*administration & dosage/adverse effects MH - Male MH - Middle Aged MH - Nanoparticles MH - Ophthalmic Solutions MH - Suspensions MH - Tonometry, Ocular MH - Visual Acuity/drug effects MH - Young Adult EDAT- 2020/08/23 06:00 MHDA- 2023/02/25 06:00 CRDT- 2020/08/23 06:00 PHST- 2020/04/23 00:00 [received] PHST- 2020/05/30 00:00 [accepted] PHST- 2020/08/23 06:00 [pubmed] PHST- 2023/02/25 06:00 [medline] PHST- 2020/08/23 06:00 [entrez] AID - 00003226-202105000-00004 [pii] AID - 10.1097/ICO.0000000000002452 [doi] PST - ppublish SO - Cornea. 2021 May 1;40(5):564-570. doi: 10.1097/ICO.0000000000002452.