Phase III efficacy and safety study of besifloxacin ophthalmic suspension 0.6% in the treatment of bacterial conjunctivitis

ABSTRACT

Objective: To compare the clinical and antimicrobial efficacy of besifloxacin ophthalmic suspension 0.6% with that of vehicle in the treatment of bacterial conjunctivitis.

Research design and methods: This was a randomized, multicenter, double-masked, vehicle-controlled study. A total of 957 patients aged 1 year and older with bacterial conjunctivitis were randomized to treatment with besifloxacin ophthalmic suspension 0.6% or vehicle applied topically three times daily for 5 days.

Main outcome measures: Primary endpoints were clinical resolution and microbial eradication of baseline bacterial infection at Visit 2 (Day 5 ± 1). Secondary endpoints included clinical resolution and microbial eradication at Visit 3 (Day 8 or 9), individual clinical outcomes at follow-up visits, and safety.

Clinical trial registration: NCT number, NCT00347932.

Results: Three hundred and ninety patients had culture-confirmed bacterial conjunctivitis. Clinical resolution and microbial eradication were significantly greater with besifloxacin ophthalmic suspension than with vehicle at Visit 2 (45.2% vs. 33.0%, p = 0.0084; and 91.5% vs. 59.7%, p < 0.0001, respectively) and Visit 3 (84.4% vs. 69.1%, p = 0.0011; and 88.4% vs. 71.7%, p < 0.0001, respectively). Results for secondary endpoints of individual clinical outcomes were consistent with primary endpoints. Fewer eyes receiving besifloxacin ophthalmic suspension experienced adverse events than those receiving vehicle (9.2% vs. 13.9%; p = 0.0047).

Conclusions: Besifloxacin ophthalmic suspension produces clinical resolution and microbial eradication rates significantly better than vehicle and is safe for the treatment of bacterial conjunctivitis.

Limitations: A limitation of this study is the lack of a non-treatment control group.

Key words: :

• Antibiotic resistance
• Bacterial conjunctivitis
• Besifloxacin ophthalmic suspension
• Clinical resolution
• Fluoroquinolone antibiotics
• Microbial eradication

Acknowledgments

Declaration of interest: This work was sponsored by Bausch & Lomb, Rochester, NY, USA. All of the authors had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.

M.E.T. has been a principal investigator for Alcon, Allergan, Aventis, Bausch & Lomb, Chakshu, Insite, Incyte, Otsuka, Pfizer, QLT, Santen, and Sirion. W.H.H. has no financial or other affiliations to disclose. D.W.U., T.W.M., W.H., M.R.P., T.L.C., and L.S.B. are employees of Bausch & Lomb.

The following investigators participated in this study: M. Abrams (Cleveland, OH), W. Andrews, Jr. (Woodstock, GA), J. Aquavella (Rochester, NY), P. Arnold (Fort Collins, CO), W. Beck (Newton, KS), C. Brasher (Salt Lake City, UT), T. Lam (Salt Lake City, UT), C. Brown (Teaneck, NJ), D. Brown, III (Fort Myers, FL), S. Capoor (Lexington, KY), D. Cardona (Fresno, CA), S. Cooper (Shreveport, LA), A. Cottingham, Jr. (San Antonio, TX), J. Dao (Phoenix, AZ), P. Dawson (Houston, TX), J. De Leon (Paramount, CA), P. Donshik (Bloomfield, CT), R. Eiferman (Louisville, KY), D. Galiani (Philadelphia, PA), M. Kay (Philadelphia, PA), F. George (Jonesboro, AR), C. Gonzalez (Cudahy, CA), M. Gorovoy (Fort Myers, FL), N. Hamouche (Ames, IA), P. Hanlon (Rochester, NY), R. Harral (Jonesboro, AR), T. Henderson (Austin, TX), J. Hunter (Torrance, CA), D. Johnson (Wilmington, NC), P. Jorizzo (Medford, OR), B. Kanengiser (Piscataway, NJ), D. Kohl (Boca Raton, FL), F. Kushner (Daytona Beach, FL), H. Lemley (Morgantown, WV), K. Lindahl (Rochester, NY), E. Maguen (Los Angeles, CA), J. Markoff (Philadelphia, PA), T. Mauger (Columbus, OH), K. Merkley (Salt Lake City, UT), E. Mitchell (Memphis, TN), D. Ottman (Carmichael, CA), J. Perez-Becerra (San Antonio, TX), S. Powell (Oakland, MD), C. Rich (Raleigh, NC), J. Rubin (San Antonio, TX), V. Sanchez-Bal (Bellflower, CA), E. Schenkel (Easton, PA), D. Shulman (San Antonio, TX), S. Spector (West Palm Beach, FL), A. Sprague (Augusta, GA), M. Stiegemeier (Beachwood, OH), J. Sutherland (Waterloo, IA), M. Tachibana (Fountain Valley, CA), J. Tibbetts (Bangor, ME), J. Weston (Roseburg, OR), E. White (San Diego, CA), R. Yee (Houston, TX), and N. Zosa (Pico Rivera, CA).

The authors thank Jessica D. Herr, PharmD, of Churchill Communications, and Heleen H. DeCory, PhD, of Bausch & Lomb, Inc., for writing and editorial assistance.

Notes

* DuraSite is a registered trade name of InSite Vision, Alameda, CA, USA

* Vigamox is a registered trade name of Alcon Laboratories, Inc., Fort Worth, TX