July 2018
Volume 59, Issue 9
Open Access
ARVO Annual Meeting Abstract  |   July 2018
Safety and efficacy of a novel submicron loteprednol etabonate gel in the treatment of inflammation and pain post-cataract surgery
Author Affiliations & Notes
  • Jason L Vittitow
    Clinical Affairs, Bausch + Lomb, Bridgewater, New Jersey, United States
  • Thomas LoBue
    LoBue Laser & Eye Medical Center Inc., Murrietta, California, United States
  • Joseph Martel
    Martel Eye Medical Group, Rancho Cordova, California, United States
  • Footnotes
    Commercial Relationships   Jason Vittitow, Bausch + Lomb (E); Thomas LoBue, Bausch + Lomb (F); Joseph Martel, Bausch + Lomb (F)
  • Footnotes
    Support  None
Investigative Ophthalmology & Visual Science July 2018, Vol.59, 2235. doi:
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      Jason L Vittitow, Thomas LoBue, Joseph Martel; Safety and efficacy of a novel submicron loteprednol etabonate gel in the treatment of inflammation and pain post-cataract surgery. Invest. Ophthalmol. Vis. Sci. 2018;59(9):2235.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Purpose : Loteprednol etabonate (LE) ophthalmic gel 0.5% is indicated for the treatment of postsurgical inflammation and pain with QID administration. This study evaluated a new gel formulation with smaller (submicron) LE particles and a reduced drug concentration (0.38%) and dosing frequency in treating inflammation and pain post-cataract surgery.

Methods : This was a Phase 3, multicenter, double-masked, vehicle-controlled study in subjects ≥ 18 years of age undergoing uncomplicated cataract surgery. Subjects with postoperative anterior chamber cell (ACC) ≥ grade 2 (6-15 cells) were randomized to LE gel 0.38% BID, LE gel 0.38% TID, or vehicle for 14 days. Primary efficacy endpoints included the proportion of subjects with complete resolution of ACC and grade 0 (no) pain on postoperative day 8 and were analyzed hierarchically. Secondary efficacy endpoints included complete resolution of ACC and flare (individual and combined), grade 0 pain at each visit and rescue medication use. Safety outcomes included adverse events (AEs), ocular symptoms, intraocular pressure (IOP), visual acuity, and biomicroscopy and funduscopy findings.

Results : The ITT population included 600 subjects (LE gel TID, n=200; LE gel BID, n=201; vehicle, n=199). At day 8, a significantly greater proportion of subjects in the LE gel TID group (30.5%) but not the LE gel BID group (25.9%) compared to vehicle group (20.1%) had complete resolution of ACC (P=0.034 for LE gel TID vs vehicle). Further, a significantly greater proportion of subjects in the LE gel TID group (75.5%) compared to vehicle (49.7%) had complete resolution of pain (P=0.034). Secondary efficacy endpoints also favored LE gel TID. Fewer subjects in the LE gel TID and BID groups required rescue medication vs. vehicle (10.0% and 11.4% vs. 31.2%, P<0.0001 for both) prior to day 8, and fewer had ≥1 ocular AE in the study eye (7.5% and 5.9% vs. 10.1%). Additional safety findings in the LE groups were comparable to those in the vehicle group. Mean IOP decreased over the course of the study in all groups, with one subject in each LE group experiencing an IOP elevation ≥10 mm Hg at one or more post-baseline visit.

Conclusions : In this study, submicron LE gel 0.38% dosed TID was effective in resolving ocular inflammation and pain after cataract surgery with an acceptable safety profile.

This is an abstract that was submitted for the 2018 ARVO Annual Meeting, held in Honolulu, Hawaii, April 29 - May 3, 2018.

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