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Loteprednol Etabonate Ophthalmic Gel 0.5% Following Cataract Surgery: Integrated Analysis of Two Clinical Studies

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Abstract

Introduction

We aimed to evaluate the safety and efficacy of loteprednol etabonate (LE) gel 0.5% compared with vehicle in the treatment of postoperative inflammation and pain following cataract surgery, using the integrated analysis of data from two identical, prospective, multicenter, randomized, double-masked, parallel-group, vehicle-controlled trials.

Methods

Patients with anterior chamber cell (ACC) inflammation ≥ grade 2 (6–15 cells) 1 day post-surgery were randomized to receive 1 or 2 drops of LE gel 0.5% or vehicle 4 times per day instilled in the study eye for 14 days. Primary outcome measures included the proportion of patients with complete resolution of ACC and grade 0 (no) pain on postoperative Day 8. Safety endpoints included adverse events (AEs), changes from baseline in intraocular pressure (IOP) and visual acuity (VA), biomicroscopy, and funduscopy findings. Gel comfort was graded by patients according to drop sensation.

Results

The intent-to-treat population included 813 patients (409 LE gel 0.5% and 404 vehicle). At postoperative Day 8, 30.8% and 15.1% of patients randomized to LE gel 0.5% or vehicle, respectively, had complete resolution of ACC, while 74.3% and 43.8% of patients, respectively, had grade 0 pain (P < 0.001 for both). Tolerability assessments for ocular itching, photophobia, and tearing favored LE gel 0.5% compared with vehicle at different time points beginning at Day 3. Two patients in the LE gel 0.5% group and 1 patient in the vehicle group exhibited a transient treatment-emergent increase in IOP ≥ 10 mmHg. Treatment-related AEs were generally mild to moderate and occurred less frequently with LE gel 0.5% than with vehicle. Reports of treatment-related blurred vision were rare (n = 2, vehicle).

Conclusion

LE gel 0.5% was efficacious and well tolerated in the treatment of postoperative pain and inflammation following ocular surgery, with minimal risk of IOP elevation.

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Acknowledgments

Bausch and Lomb, Inc. sponsored the two original studies in this pooled analysis and were responsible for the design and conduct of the study as well as data collection, management, and analysis of study data, and together with lead investigators, interpretation of the data, and preparation, review and approval of the manuscript. Bausch and Lomb, Inc. also funded the article publication charges for this study. The authors wish to thank Carol Tozzi, PhD, of Churchill Communications (Maplewood, NJ) for writing assistance (developing a first draft). This assistance was funded by Bausch and Lomb, Inc. The authors retained full control of the manuscript content.

Conflict of interest

T. Comstock is an employee of Bausch and Lomb, Inc. R. Rajpal is a consultant and speaker for Bausch and Lomb and has received grant support, honorarium and support for travel to meetings.

Compliance with ethics guidelines

All patients were required to provide written informed consent. Ethical approval was obtained from Schulman Associates IRB, Incorporated (Cincinnati, Ohio). Both studies were conducted in accordance with the World Medical Association Declaration of Helsinki (revised edition, 2004), relevant ICH Harmonized Tripartite Guidelines for Good Clinical Practice 1996, HIPAA guidelines, and applicable local regulations. All procedures followed were in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and with the Helsinki Declaration of 1975, as revised in 2000 and 2008.

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Authors and Affiliations

  1. See Clearly Vision Group, 8138 Watson Street, McLean, VA, 22102, USA

    Rajesh K. Rajpal

  2. Eye Care, Flushing, NY, USA

    Raymond Fong

  3. Bausch and Lomb Inc., Rochester, NY, USA

    Timothy L. Comstock

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  1. Rajesh K. Rajpal
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  2. Raymond Fong
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Correspondence to Rajesh K. Rajpal.

Additional information

Clinicaltrials.gov NCT 01010633 and NCT 01060072.

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Rajpal, R.K., Fong, R. & Comstock, T.L. Loteprednol Etabonate Ophthalmic Gel 0.5% Following Cataract Surgery: Integrated Analysis of Two Clinical Studies. Adv Ther 30, 907–923 (2013). https://doi.org/10.1007/s12325-013-0059-7

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