Submicron loteprednol etabonate ophthalmic gel 0.38% for the treatment of inflammation and pain after cataract surgery.

Abstract

PURPOSE:

To assess the safety and efficacy of a 0.38% submicron formulation of loteprednol etabonate (LE) gel for the treatment of postoperative inflammation and pain after cataract surgery.

SETTING:

Forty-five United States ophthalmology practices.

DESIGN:

Double-masked vehicle-controlled randomized parallel group study.

METHODS:

Patients 18 years of age or older with anterior chamber cells grade 2 or higher on day 1 after uncomplicated cataract surgery were randomized to 14 days of treatment with LE gel 2 times a day, LE gel 3 times a day, or vehicle. Hierarchical primary endpoints were the proportion of patients with resolution of anterior chamber cells and grade 0 (no) pain at postoperative day 8. Safety outcomes included adverse events, intraocular pressure (IOP), biomicroscopy, visual acuity, ophthalmoscopy, and tolerability (drop comfort and ocular symptoms).

RESULTS:

The intent-to-treat population included 514 patients. Significantly more patients in the LE gel 2 times a day and 3 times a day groups compared with the vehicle group had complete resolution of anterior chamber cells (26.9% and 28.7% versus 9.3%) and reported grade 0 pain (73.7% and 73.1% versus 47.7%) on day 8 (P < .001 vs vehicle for all). The safety findings were unremarkable, with 1 patient experiencing an IOP increase of 10 mm Hg or higher while on LE gel. More than 75% of patients in each group reported no drop discomfort.

CONCLUSION:

In this study, submicron loteprednol etabonate gel 0.38% appeared safe and effective in the treatment of postoperative inflammation and pain whether instilled 2 times or 3 times a day.

• Authors: Raymond Fong, Bruce E Silverstein, James H Peace, Jon I Williams, Jason L Vittitow
• Journal: Journal of cataract and refractive surgery (J Cataract Refract Surg) Vol. 44 Issue 10 Pg. 1220-1229 (Oct 2018) ISSN: 1873-4502 [Electronic] United States
• PMID: 30193927 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial)
• Copyright: Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved.

Chemical References

• Anti-Allergic Agents
• Gels
• Loteprednol Etabonate

Topics

• Adult
• Aged
• Aged, 80 and over
• Anti-Allergic Agents (adverse effects, therapeutic use)
• Double-Blind Method
• Eye Pain (drug therapy, etiology)
• Female
• Gels
• Humans
• Inflammation (drug therapy, etiology)
• Intraocular Pressure
• Loteprednol Etabonate (adverse effects, therapeutic use)
• Male
• Microscopy, Acoustic
• Middle Aged
• Ophthalmoscopy
• Phacoemulsification (adverse effects)
• Postoperative Complications
• Treatment Outcome
• Visual Acuity (physiology)