July 2018
Volume 59, Issue 9
Open Access
ARVO Annual Meeting Abstract  |   July 2018
Loteprednol etabonate gel 0.5% vs prednisolone acetate suspension 1% for the treatment of inflammation post-cataract surgery in children
Author Affiliations & Notes
  • Bibiana Jin Jin Reiser
    The Vision Center, Children’s Hospital Los Angeles, Los Angeles, California, United States
    USC Roski Eye Institute, Los Angeles, California, United States
  • Jon I Williams
    Bausch + Lomb, Irvine, California, United States
  • Jason L Vittitow
    Bausch + Lomb, Bridgewater, New Jersey, United States
  • Footnotes
    Commercial Relationships   Bibiana Jin Reiser, Bausch + Lomb (F), Retrophin (F); Jon Williams, Bausch + Lomb (E); Jason Vittitow, Bausch + Lomb (E)
  • Footnotes
    Support  None
Investigative Ophthalmology & Visual Science July 2018, Vol.59, 2666. doi:https://doi.org/
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      Bibiana Jin Jin Reiser, Jon I Williams, Jason L Vittitow; Loteprednol etabonate gel 0.5% vs prednisolone acetate suspension 1% for the treatment of inflammation post-cataract surgery in children. Invest. Ophthalmol. Vis. Sci. 2018;59(9):2666. doi: https://doi.org/.

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

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Purpose : To compare loteprednol etabonate (LE) ophthalmic gel, 0.5% with prednisolone acetate ophthalmic suspension (PA), 1% for the treatment of postoperative inflammation following cataract surgery in children.

Methods : This was a phase 4, multicenter, double-masked, parallel-group, non-inferiority study. Subjects ≤11 years of age who had undergone routine uncomplicated cataract surgery were randomized 1:1 to LE or PA, with dosing immediately following surgery, the evening of surgery, QID for 14 days, BID for 7 days, then QD for 7 days. Assessments were performed on postoperative day 1, 7, 14, 28, 42, and 90. The primary efficacy endpoint was mean grade anterior chamber inflammation (ACI; cells and flare, each graded on a 0-4 scale) on Day 14, with non-inferiority criterion being an upper 95% confidence interval (CI) for the treatment difference of <0.35. Secondary endpoints included the proportions of subjects with grades 0-4 ACI, posterior synechiae, and precipitates on the implant/cornea. Safety/tolerability assessments included adverse events (AEs), intraocular pressure (IOP), ocular signs, and ocular symptoms.

Results : The ITT population comprised 105 subjects (LE n=53, PA n=52, of whom 29 and 24 subjects, respectively, were ≤ 3 years of age). LE met the criterion for non-inferiority to PA: at day 14, the LS mean difference between treatments for ACI was 0.006 (95% CI:-0.281, 0.292). The distribution of ACI scores did not differ between treatments at any on-treatment visit (P>0.05); on Days 7, 14, and 28, 49.1% vs 58.3%, 69.2% vs 67.4%, and 89.7% vs 81.8% of LE- and PA-treated subjects had grade 0 ACI. There were few subjects with synechiae or corneal/implant precipitates in either group. Safety/tolerability findings were unremarkable. Mean IOP decreased in both treatment groups at all postoperative visits. Excluding day 1, IOP elevations ≥5 mm Hg occurred in 4/43 and 6/38 study eyes in the LE- and PA-groups; 3 of the LE-treated eyes had IOP elevations ≥10 mm Hg. Ocular AEs occurring more than once included eye pain (LE n=5, PA n=2), eye lid edema (LE n=4, PA n=2), hyperemia (LE n=3) and discomfort (LE n=2, PA n=3) and were mostly mild to moderate in severity.

Conclusions : In this study of pediatric subjects undergoing cataract surgery, LE gel 0.5% was safe and effective in treating post- surgical inflammation with similar outcomes as compared to PA 1%.

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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