Drugs / Loteprednol Etabonate
Loteprednol Etabonate
also known as
KPI-121 · lotemax · Lotemax gel · FML · KPI-121 0.25% Ophthalmic Suspension · Lot · Lotemax (loteprednol etabonate) 0.5%
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | LOTEMAX | — | 2018-07-20 | fda.gov ↗ |
| Approved | US (FDA) | LOTEMAX | — | 1998-03-09 | fda.gov ↗ |
Trials 33 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 15 trials | ||||||
| Phase 1 | NCT05353101 | Jul 2020 → Jun 2021 | vernal keratoconjunctivitis | Second Affiliated Hospital of Nanchang University | Completed | No outcome recorded |
| Phase 1 | NCT03531697 | Apr 2018 → Sep 2019 | — | Sandoz | Completed | No outcome recorded |
| Phase 1 | NCT03098953 | Apr → May 2017 | — | Bausch & Lomb Incorporated | Completed | No outcome recorded |
| Phase 1 | NCT03063489 | Feb → May 2015 | asthenopia | Bausch Health Americas, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01736527 | Jan 2013 | — | Bausch & Lomb Incorporated | Completed | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT01817582 | May 2013 → Jan 2014 | dry eye syndrome | Bausch & Lomb Incorporated | Completed | No outcome recorded |
| Phase 2 | NCT00560638 | Nov 2005 → Feb 2006 | dry eye syndrome | Bausch & Lomb Incorporated | Completed | No outcome recorded |
| Phase 311 trials | ||||||
| Phase 3 | NCT03596723 | Jul → Sep 2018 | — | Kala Pharmaceuticals, Inc. | Terminated | No outcome recorded |
| Phase 3 | NCT02786901 | Jun 2016 → Jun 2017 | cataract | Bausch & Lomb Incorporated | Completed | No outcome recorded |
| Phase 3 | NCT02208297 | Sep 2014 → Mar 2015 | cataract | Bausch & Lomb Incorporated | Completed | No outcome recorded |
| Phase 3 | NCT01996839 | Dec 2013 → May 2014 | cataract | Bausch & Lomb Incorporated | Completed | No outcome recorded |
| Phase 3 | NCT01475643 | Jun 2013 → Jun 2017 | cataract | Bausch & Lomb Incorporated | Completed | No outcome recorded |
| Phase 3 | NCT01435460 | Aug 2010 → Apr 2011 | conjunctivitis | Bausch & Lomb Incorporated | Completed | No outcome recorded |
| Phase 3 | NCT01060072 | Feb → Sep 2010 | — | Bausch & Lomb Incorporated | Completed | No outcome recorded |
| Phase 3 | NCT01010633 | Nov 2009 → Jun 2010 | — | Bausch & Lomb Incorporated | Completed | No outcome recorded |
| Phase 3 | NCT01028027 | Oct 2009 → Feb 2010 | blepharitis, conjunctivitis, keratitis | Bausch & Lomb Incorporated | Completed | No outcome recorded |
| Phase 3 | NCT00699153 | Jun 2008 → May 2009 | — | Bausch & Lomb Incorporated | Completed | No outcome recorded |
| Phase 3 | NCT00645671 | Mar 2008 → Mar 2009 | — | Bausch & Lomb Incorporated | Completed | No outcome recorded |
| Phase 49 trials | ||||||
| Phase 4 | NCT07496060 | Aug 2025 → Jan 2026 | anterior uveitis | Fayoum University | Completed | No outcome recorded |
| Phase 4 | NCT05136443 | Nov 2021 → Sep 2023 | corneal edema, corneal endothelial dystrophy | Price Vision Group | Completed | No outcome recorded |
| Phase 4 | NCT04075227 | Oct 2015 → Mar 2019 | conjunctival pterygium, steroid-induced glaucoma | Wannisa Suphachearabhan | Completed | No outcome recorded |
| Phase 4 | NCT01437982 | Aug 2010 → Oct 2015 | giant papillary conjunctivitis | Bausch & Lomb Incorporated | Completed | No outcome recorded |
| Phase 4 | NCT00447577 | Jan → Jun 2007 | keratoconjunctivitis | Bausch & Lomb Incorporated | Completed | No outcome recorded |
| Phase 4 | NCT00420628 | Nov 2006 → Jan 2009 | chalazion | Bausch & Lomb Incorporated | Completed | No outcome recorded |
| Phase 4 | NCT00407043 | Nov 2006 → Sep 2007 | dry eye syndrome | Ophthalmic Consultants of Long Island | Completed | No outcome recorded |
| Phase 4 | NCT00366691 | Feb 2006 → Sep 2007 | cataract | Medical University of South Carolina | Completed | No outcome recorded |
| Phase 4 | NCT00532961 | Feb → Apr 2005 | — | Bausch & Lomb Incorporated | Completed | No outcome recorded |
| Phase not applicable6 trials | ||||||
| — | NCT05542381 | Dec 2022 → May 2024 | age-related macular degeneration | Virginia Polytechnic Institute and State University | Completed | No outcome recorded |
| — | NCT02218827 | Sep 2014 → Sep 2015 | dry eye syndrome | Meir Medical Center | Unknown | No outcome recorded |
| — | NCT02322528 | Apr 2014 → Aug 2015 | Sjogren syndrome | University of Rochester | Completed | No outcome recorded |
| — | NCT01749241 | Sep 2012 → May 2015 | — | University of California, San Diego | Withdrawn | No outcome recorded |
| — | NCT01692652 | Aug 2012 → Mar 2013 | — | Yonsei University | Completed | No outcome recorded |
| — | NCT01695668 | Aug 2011 → Sep 2013 | dry eye syndrome | University of Michigan | Completed | No outcome recorded |
Also used as a comparator or background therapy in 24 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT04418999 Comparator | Sep 2020 → Dec 2021 | dry eye syndrome, eye allergy, keratoconus | Illinois College of Optometry | Completed | No outcome recorded |
| Phase 23 trials | ||||||
| Phase 2 | NCT02218489 Comparator | Jul 2014 → Dec 2015 | blepharitis | Kala Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT02188160 Comparator | Jun 2014 → Jan 2015 | dry eye syndrome | Kala Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT01107405 Comparator | Apr → May 2010 | conjunctivitis | Bausch & Lomb Incorporated | Completed | No outcome recorded |
| Phase 36 trials | ||||||
| Phase 3 | NCT05322148 Comparator | Jun → Nov 2022 | dry eye syndrome | Research Insight LLC | Completed | No outcome recorded |
| Phase 3 | NCT03616899 Comparator | Jul 2018 → Feb 2020 | dry eye syndrome | Kala Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT02793817 Comparator | Jun 2016 → Mar 2017 | — | Kala Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT02819284 Comparator | Jun 2016 → Sep 2017 | dry eye syndrome | Kala Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT02813265 Comparator | Jun 2016 → Oct 2017 | dry eye syndrome | Kala Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT02163824 Comparator | May → Dec 2014 | — | Kala Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 413 trials | ||||||
| Phase 4 | NCT07090044 Comparator | Aug 2021 → Dec 2022 | choroidal neovascularization, diabetic retinopathy, macular retinal edema, retinal vein occlusion | Retina Research Institute, LLC | Completed | No outcome recorded |
| Phase 4 | NCT07588074 Comparator | May → Jun 2021 | dry eye syndrome | Harrow Inc | Completed | No outcome recorded |
| Phase 4 | NCT04708821 Comparator | Apr → Sep 2021 | conjunctivitis | Clinical Research Center of Florida | Completed | No outcome recorded |
| Phase 4 | NCT04555694 Comparator | Oct 2020 → Feb 2022 | dry eye syndrome | Thomas Chester, OD | Completed | No outcome recorded |
| Phase 4 | NCT03123614 Comparator | Sep 2014 → Jul 2018 | corneal disorder, ocular hypertension | University of Utah | Completed | No outcome recorded |
| Phase 4 | NCT02120079 Comparator | Feb 2014 → Apr 2017 | dry eye syndrome | Tufts Medical Center | Completed | No outcome recorded |
| Phase 4 | NCT02028312 Comparator | Jan 2014 → Feb 2016 | dry eye syndrome | Edward Holland, MD | Withdrawn | No outcome recorded |
| Phase 4 | NCT01853696 Comparator | Mar 2013 → Jan 2015 | Fuchs' endothelial dystrophy, corneal edema | Cornea Research Foundation of America | Completed | No outcome recorded |
| Phase 4 | NCT01724892 Comparator | Nov 2012 → Sep 2013 | corneal disorder | Khon Kaen University | Completed | No outcome recorded |
| Phase 4 | NCT01443442 Comparator | Oct 2011 → Sep 2012 | conjunctivitis | Southern California College of Optometry at Marshall B. Ketchum University | Completed | No outcome recorded |
| Phase 4 | NCT00705159 Comparator | Jun 2008 → Mar 2010 | conjunctivitis | Bausch & Lomb Incorporated | Completed | No outcome recorded |
| Phase 4 | NCT00689078 Comparator | May → Jun 2008 | conjunctivitis | ORA, Inc. | Completed | No outcome recorded |
| Phase 4 | NCT00781300 Comparator | Mar → Nov 2006 | ocular hypertension, open-angle glaucoma | Federal University of São Paulo | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT02245516 Comparator | Jul → Dec 2014 | diabetic macular edema, retinal vein occlusion | Kala Pharmaceuticals, Inc. | Completed | No outcome recorded |
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 59 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | loteprednol etabonate | “The purpose of this study is to compare the effectiveness of the NSAID ketorolac tromethamine ophthalmic solution 0.4% with the steroid loteprednol etabonate ophthalmic...” NCT00366691 ↗45“Topical loteprednol etabonate 0.5% (Lotemax, Bausch and Lomb) has been shown to be safe and efficacious in treatment of inflammatory ocular disorders, but has not been...” NCT01695668 ↗ “Lotemax (loteprednol etabonate) 0.5% will be applied topically to both eyes for 6 weeks with the following regimen: four times a day for 2 weeks, twice daily for 2 weeks, and...” NCT02120079 ↗ “The purpose of this work was to evaluate the effect of loteprednol etabonate (LE) before the initiation of topical cyclosporine A (tCsA) therapy in patients with...” PMID 25083776 ↗ Sep 2014 “To assess the levels of loteprednol etabonate (LE) in tear fluid following a single topical instillation of LE ophthalmic gel 0.5% formulation to healthy volunteers.” NCT01736527 ↗ “Loteprednol etabonate and tobramycin ophthalmic suspension administered to study eye 4 times a day (QID) for 14 days.” NCT01028027 ↗ “A Randomized, Single-blind, Cross-over Study of Loteprednol Etabonate in Adults Undergoing Bilateral Cataract Surgery” NCT03531697 ↗ |
| Known as | FML | “Loteprednol Etabonate (FML) topical treatment 1 drop 4 times daily for 1 month” NCT02218827 ↗ |
| Known as | KPI-121 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02813265 ↗ |
| Known as | KPI-121 0.25% Ophthalmic Suspension | “KPI-121 0.25% Ophthalmic Suspension” NCT02163824 ↗ |
| Known as | Lot | “The patients were allocated equally into 2 groups by block randomization to receive either loteprednol etabonate (Lot) or dexamethasone (Dex) for 1 month after the surgery.” PMID 25555173 ↗ Jan 2015 |
| Known as | lotemax | “topical loteprednol etabonate (lotemax 0.5%) with warm compress & ocular massage” NCT01692652 ↗5“Loteprednol Etabonate Ophthalmic Gel [Lotemax]” NCT05542381 ↗ |
| Known as | Lotemax (loteprednol etabonate) 0.5% | “Lotemax (loteprednol etabonate) 0.5%” NCT02120079 ↗ |
| Known as | Lotemax gel | “Formulated LE into a gel (loteprednol etabonate ophthalmic gel, \[Lotemax® gel\])” NCT03063489 ↗1“Lotemax® Gel (loteprednol etabonate ophthalmic gel 0.5%)” NCT02028312 ↗ |
| Modality | Other / unclassified | “loteprednol etabonate (LE), a C-20 ester-based corticosteroid” PMID 22627057 ↗ May 2012 |
| Route | Other | “loteprednol etabonate ophthalmic suspension 0.5%” NCT00366691 ↗ |