Loteprednol etabonate (submicron) ophthalmic gel 0.38% dosed three times daily following cataract surgery: integrated analysis of two Phase III clinical studies
Autor: | Heleen H DeCory, Megan E. Cavet, Jason L Vittitow, Raymond Fong |
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Rok vydání: | 2019 |
Předmět: |
Intraocular pressure
medicine.medical_specialty Visual acuity genetic structures medicine.medical_treatment Population Intraocular lens 03 medical and health sciences 0302 clinical medicine Blurred vision Ophthalmology Medicine Adverse effect education Original Research education.field_of_study business.industry postoperative inflammation Clinical Ophthalmology cataract surgery Cataract surgery integrated analysis eye diseases loteprednol etabonate Tolerability submicron 030221 ophthalmology & optometry medicine.symptom postoperative pain business 030217 neurology & neurosurgery |
Zdroj: | Clinical Ophthalmology (Auckland, N.Z.) |
ISSN: | 1177-5483 |
Popis: | Raymond Fong,1 Megan E Cavet,2 Heleen H DeCory,2 Jason L Vittitow31Manhattan Eye, Ear and Throat Hospital and Lenox Hill Hospital, New York, NY, USA; 2Medical Affairs, Bausch + Lomb, Rochester, NY, USA; 3Clinical Affairs, Bausch + Lomb, Bridgewater, NJ, USAPurpose: To evaluate the efficacy and safety of a submicron formulation of loteprednol etabonate (LE) gel 0.38% instilled three times daily (TID) compared with vehicle for the treatment of inflammation and pain following cataract surgery with intraocular lens implantation, integrated across two multicenter, double-masked, randomized, parallel-group, Phase III studies.Patients and methods: Subjects ≥18 years of age with anterior chamber (AC) cells ≥grade 2 (6–15 cells) on day 1 after cataract surgery were randomized to receive 1 drop of LE gel 0.38% TID, twice daily (not reported/analyzed herein), or vehicle instilled in the study eye for 14 days. Primary endpoints were the proportion of subjects with resolution of AC cells and grade 0 (no) pain at postoperative day 8. Safety outcomes included adverse events (AEs), ocular signs, fundoscopy results, visual acuity, intraocular pressure (IOP), and tolerability (drop comfort and ocular symptoms).Results: The integrated intent-to-treat population included 742 subjects (LE gel 0.38% TID, n=371; vehicle, n=371). Significantly more subjects in the LE gel 0.38% TID group compared with the vehicle group had complete resolution of AC cells (29.6% vs 15.1%) and grade 0 pain (74.4% vs 48.8%) at day 8 (P75%) of subjects in each treatment group reported no drop discomfort. There were no reports of blurred vision with LE gel.Conclusion: The results of this integrated analysis indicate that LE (submicron) gel 0.38% administered TID is safe and effective for the treatment of ocular inflammation and pain following cataract surgery, with minimal risk of IOP elevation.Keywords: cataract surgery, postoperative pain, postoperative inflammation, loteprednol etabonate, submicron, integrated analysis |
Databáze: | OpenAIRE |
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