Tolerability of loteprednol/tobramycin versus dexamethasone/tobramycin in healthy volunteers: results of a 4-week, randomized, double-masked, parallel-group study

ABSTRACT

Objective: To compare the ocular comfort and tolerability of loteprednol etabonate 0.5%/tobramycin 0.3% (LE/T; Zylet^*) with dexamethasone 0.1%/tobramycin 0.3% (DM/T; TobraDex^†) in healthy volunteers.

* Zylet is a registered trademark of Bausch &Lomb, Inc., Tampa FL, USA

† TobraDex is a registered trademark of Alcon Laboratories, Inc., Fort Worth, TX, USA

Research design and methods: In this multicenter, randomized, double-masked, parallel-group study, healthy volunteers (n = 306) were randomized to receive LE/T or DM/T four times per day for 28 days. Subjects recorded subjective ratings for seven comfort/tolerability parameters using an electronic patient diary (EPD). The primary endpoint was the difference at week 4 from the ratings of an artificial tear at baseline in comfort/tolerability parameters between treatment groups, using a noninferiority paradigm.

Clinical trials registration: ClinicalTrials.gov, NCT 00532961.

Results: The 97.5% confidence intervals for the lower bound were within –10 for all of the seven comfort/tolerability parameters evaluated (pain, stinging/burning, irritation, itchiness, foreign-body sensation, dryness, and light sensitivity). Secondary analysis revealed small but significant within-treatment differences in pain favoring LE/T over tears and in light sensitivity favoring tears over DM/T (p < 0.01). Small between-treatment differences in the changes from baseline tear ratings to individual study visits favored LE/T for pain, stinging/burning, irritation, itchiness, foreign-body sensation, and light sensitivity at visit 4 (p ≤ 0.04); for pain, stinging/burning, and foreign-body sensation at visit 5 (p ≤ 0.03), and for dryness and light sensitivity at visit 6 (p ≤ 0.05).

Conclusions: LE/T satisfied all conditions of noninferi-ority to DM/T in comfort and tolerability. Subjects receiving LE/T were more likely to report better ocular comfort/tolerability ratings relative to baseline artificial tears than subjects receiving DM/T.

Limitations: The study population consisted of healthy volunteers.

Key words: :

• Dexamethasone
• Ester steroid
• Ketone steroid
• Loteprednol etabonate
• Ocular inflammation
• Tobramycin

Acknowledgments

Declaration of interest: This research was sponsored by Bausch & Lomb, Inc., Rochester, NY, USA. J.B. and E.H. were clinical investigators in this study. D.U., M.P., and T.C. are employed by Bausch & Lomb, Inc. The authors gratefully acknowledge the participation of the following additional principal investigators and clinical sites in this study (all USA): Stacey Ackerman, Philadelphia, PA; Bruce Anderson, Tampa, FL; John Bokosky, San Diego, CA; Ronald Cedrone, Portland, ME; Michael Goldstein, Boston, MA; Mark Juzych, Detroit, MI; Paul Karpecki, Kansas City, MO; Michael Korenfeld, Washington, MO; Jonathan Lass, Cleveland, OH; Daniel A. Long, Gretna, LA; Douglas Lorenz, Las Vegas, NV; Jonathan I. Macy, Los Angeles, CA; Joseph Napolitano, Rochelle Park, NJ; Don Perez-Ortiz, Tampa, FL; Walter S. Ramsey, Charleston, WV; Michael Rotberg, Charlotte, NC; Mary Jo Stiegemeier, Beachwood, OH. The authors thank Melvin F. Simoyi of The Scienomics Group for his assistance in preparation of the manuscript.

Notes

* Zylet is a registered trademark of Bausch &Lomb, Inc., Tampa FL, USA

† TobraDex is a registered trademark of Alcon Laboratories, Inc., Fort Worth, TX, USA

* Zylet is a registered trademark of Bausch &Lomb, Inc., Tampa FL, USA

TobraDex is a registered trademark of Alcon, Inc., Fort Worth, TX, USA