Multicenter randomized phase 3 study of a sustained-release intracanalicular dexamethasone insert for treatment of ocular inflammation and pain after cataract surgery
| Autor: | Syd L, Tyson, Shamik, Bafna, Joseph P, Gira, Damien F, Goldberg, Jason J, Jones, Michael P, Jones, Janet K, Kim, Joseph M, Martel, Michael L, Nordlund, Ian K, Piovanetti-Perez, Inder Paul, Singh, Jamie Lynne, Metzinger, Deepa, Mulani, Swati, Sane, Jonathan H, Talamo, Michael H, Goldstein, David T, Vroman |
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| Rok vydání: | 2019 |
| Předmět: |
Male
medicine.medical_specialty medicine.medical_treatment Visual Acuity Phases of clinical research Cataract Extraction Placebo Dexamethasone law.invention 03 medical and health sciences Postoperative Complications 0302 clinical medicine Double-Blind Method Randomized controlled trial law Eye Pain Humans Medicine Prospective Studies Prospective cohort study Adverse effect Glucocorticoids Aged business.industry Cataract surgery Uveitis Anterior Sensory Systems Surgery Clinical trial Ophthalmology Treatment Outcome Delayed-Action Preparations 030221 ophthalmology & optometry Female Ophthalmic Solutions business 030217 neurology & neurosurgery Follow-Up Studies medicine.drug |
| Zdroj: | Journal of Cataract and Refractive Surgery. 45:204-212 |
| ISSN: | 0886-3350 |
| Popis: | To assess the efficacy and safety of a sustained-release intracanalicular dexamethasone insert for the treatment of postoperative ocular inflammation and pain in patients having cataract surgery.Twenty-one United States sites.Prospective multicenter randomized parallel-arm double-masked vehicle-controlled phase 3 study.Patients with planned clear corneal cataract surgery were randomized (1:1) to receive dexamethasone insert or placebo, and the treatment was placed in the canaliculus of the eye immediately after surgery (Day 1). The primary efficacy endpoints were complete absence of anterior chamber cells at Day 14 and complete absence of pain at Day 8.The study comprised 438 adult patients (216 in the treatment arm and 222 in the placebo arm). At Day 14, significantly more patients had an absence of anterior chamber cells in the dexamethasone insert arm compared with placebo (52.3% versus 31.1%; P .0001). At Day 8, significantly more patients had an absence of ocular pain in the dexamethasone insert arm compared with placebo (79.6% versus 61.3%; P .0001). The dexamethasone insert arm showed no increase compared with placebo in incidence of all adverse events or ocular adverse events. Twice as many placebo patients required rescue therapy, compared with treated patients at Day 14.Both primary endpoints were successfully met. In addition, patients receiving the dexamethasone insert experienced a decrease in inflammation after surgery as early as Day 4 through Day 45, and a decrease in pain as early as one day after surgery (Day 2) through Day 45. The dexamethasone insert was well-tolerated, and the adverse events profile was similar to placebo. |
| Databáze: | OpenAIRE |
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