Treatment of allergic conjunctivitis with bepotastine besilate ophthalmic solution 1.5%

Abstract

Purpose

To examine the pooled per-protocol ocular end points from two conjunctival allergen challenge (CAC) clinical trials of the dual-action antihistamine bepotastine besilate ophthalmic solution (BBOS) 1.5%.

Methods

Two Phase III, placebo-controlled, double-masked, randomized clinical trials were conducted at a total of six separate centers using the CAC model of allergic conjunctivitis. The same study design was employed for both clinical trials, with subjects randomly assigned to either BBOS 1.5% (n=78) or placebo (n=79) treatment. Each subject received one eye drop of the test agent bilaterally at different study visits 15 minutes, 8 hours, or 16 hours prior to a CAC. Primary ocular end points included changes in ocular itching reported at 3, 5, and 7 minutes and conjunctival hyperemia assessed at 7, 15, and 20 minutes following each CAC. Secondary ocular end points included chemosis as well as episcleral and ciliary hyperemia judged by investigators, and tearing (scored as either absent or present) and eyelid swelling judged by subjects.

Results

A statistically significant reduction in ocular itching was observed for BBOS 1.5% treatment compared to placebo at all time points (P<0.0001), while measures for onset and 8-hour persistence of action also reached clinical significance (ie, ≥1.0 unit difference) at a majority of time points. In addition, a significant reduction in conjunctival hyperemia was achieved at a majority of time points during the onset of action CAC test. Secondary end points were also significantly improved compared to placebo, most prominently for reduced tearing at all study visits and reduced eyelid swelling at the onset of action and 8-hour study visits. Adverse events were generally mild and transient.

Conclusion

BBOS 1.5% rapidly reduced CAC-induced ocular itching with duration of effectiveness of at least 8 hours after dosing. Certain secondary signs of inflammation were also significantly reduced.

Keywords:

• allergen challenge
• antihistamine
• itching
• Bepreve

Acknowledgments

The authors would like to acknowledge the following individuals for their assistance in preparation of this manuscript: James T McLaughlin, of Ora (Andover, MA, USA) for manuscript preparation; Kathryn S Kennedy of Statistics and Data Corporation (Tempe, AZ, USA) for statistical analyses; and Mauricio Muñoz and Karen Gertz of Bausch + Lomb Pharmaceuticals (Irvine, CA, USA) for data review and verification. Portions of the data presented here have previously been presented at annual meetings of the American Academy of Ophthalmology, the American Academy of Allergy, Asthma and Immunology, and the Association for Research in Vision and Ophthalmology. The Bepotastine Besilate Ophthalmic Solutions Clinical Study Group comprises: Stacey L Ackerman, MD, Philadelphia Eye Associates, Philadelphia, PA, USA; Mark T Bergmann, MD, Eye Care Associates of Greater Cincinnati, Inc., Cincinnati, OH, USA; Jung T Dao, MD, Cornea Consultants of Arizona, Phoenix, AZ, USA; Fred K Kurata, MD, East West Eye Institute, Los Angeles, CA, USA; Thomas T Macejko, MD, Eye Care Associates of Greater Cincinnati, Inc., Fairfield, OH, USA; Eugene B McLaurin, MD, Total Eye Care, Memphis, TN, USA; Edward J Meier, MD, Eye Care Associates of Greater Cincinnati, Inc., Mason, OH, USA; Clifford M Michaelson, MD, Andover Eye Associates, Andover, MA, USA; Thomas K Mundorf, MD, Mundorf Eye Center, Charlotte, NC, USA; Eugene E Protzko, MD, Seidenberg Protzko Eye Associates, Bel Air, MD, USA; Tushina A Reddy, MD, Ophthalmic Associates, Las Vegas, NV, USA; and Gail L Torkildsen, MD, Andover Eye Associates, Andover, MA, USA.

Disclosure

JI Williams is an employee of Bausch + Lomb. PJ Gomes is an employee of Ora, Inc. The authors have no other conflicts of interest in this work.