Safety of KPI-121 Ophthalmic Suspension 0.25% in Patients With Dry Eye Disease: A Pooled Analysis of 4 Multicenter, Randomized, Vehicle-Controlled Studies.
| Autor: | Korenfeld M; Comprehensive Eye Care, Ltd, Washington, MO., Nichols KK; School of Optometry, University of Alabama, Birmingham, AL., Goldberg D; Wolstan and Goldberg Eye Associates, Torrance, CA., Evans D; Total Eye Care, PA, Memphis, TN., Sall K; Sall Research Medical Center, Artesia, CA., Foulks G; Department of Ophthalmology, University of Louisville, Louisville, KY; and., Coultas S; Kala Pharmaceuticals, Inc, Watertown, MA., Brazzell K; Kala Pharmaceuticals, Inc, Watertown, MA. |
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| Jazyk: | angličtina |
| Zdroj: | Cornea [Cornea] 2021 May 01; Vol. 40 (5), pp. 564-570. |
| DOI: | 10.1097/ICO.0000000000002452 |
| Abstrakt: | 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 ≤0.8% of subjects in the KPI-121 group. IOP elevations, a side effect associated with the use of ophthalmic corticosteroids, were observed with low incidence: 0.6% and 0.2% of subjects in the KPI-121 and vehicle groups, respectively. An IOP elevation was defined as an increase from baseline of >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. (Copyright © 2020 The Author(s). Published by Wolters Kluwer Health, Inc.) |
| Databáze: | MEDLINE |
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