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Abstract #16793 Published in IGR 9-1
A double-masked, randomized, parallel comparison of a fixed combination of bimatoprost 0.03%/timolol 0.5% with non-fixed combination use in patients with glaucoma or ocular hypertension
Hommer AEuropean Journal of Ophthalmology 2007; 17: 53-62
PURPOSE: To compare the safety and efficacy of the fixed combination product with non-fixed combination use of the same active ingredients in separate bottles (bimatoprost once-daily [qd], and timolol twice-daily [bid]). A bimatoprost 0.03% qd treatment arm was used for validation of the study. METHOD: This was a double-masked, randomized, parallel study in 445 patients with open-angle glaucoma or ocular hypertension. They were randomized in a ratio of 2:2:1 to receive bilateral treatment with the fixed combination, non-fixed combination treatment, or bimatoprost alone. RESULTS: Comparing the fixed combination and non-fixed combination, the non-inferiority margin of 1.5 mmHg was met at all three timepoints for mean intraocular pressure (IOP), and a margin of 1.0 mmHg for mean diurnal IOP. The incidence of conjunctival hyperemia was statistically significantly lower (p = 0.014) in the fixed combination group (8.5%, 15/176) compared with the bimatoprost group (18.9%, 17/90) and the non-fixed combination group (12.5%, 22/176). CONCLUSIONS: The fixed combination of bimatoprost 0.03%/timolol 0.5% administered once daily was comparable in ocular hypotensive efficacy to the non-fixed combination. The lower propensity of the fixed combination to elicit conjunctival hyperemia suggests a superior comparative benefit/risk assessment of the fixed combination in the treatment of elevated IOP. Members of the Ganfort(R) Investigators Group I were as follows: Investigators-W. Benton Boone, MD, Inglewood, CA; James D. Branch, MD, Winston-Salem, NC; Luca Brigatti, MD, Rochester, NY; William C. Christie, MD, Pittsburgh, PA; William S. Clifford, MD, Garden City, KS; David L. Cooke, MD, St. Joseph, MI; Joel Corwin, MD, Ventura, CA; William F. Davitt III, MD, El Paso, TX; Jason Burns, MD, Jorge De La Chapa, DO, San Antonio, TX; Donald Digby, MD, Greensboro, NC; Mark DiSclafani, MD, Bradenton, FL; Martin Dorner, MD, Bocholt, Germany; Anton Hommer, MD, Vienna, Austria; Barry Katzman, MD, San Diego, CA; Hartwig Koch-Schweitzer, MD, Mettingen, Germany; Theodore Krupin, MD, Chicago, IL; Mark A. Latina, MD, Reading, MA; Charles Lederer, MD, Kansas City, MO; Martin R. Leopold, MD, Fishkill, NY; Mark Lesk, MD, Montreal, Quebec, Canada; Arash Mansouri, MD, Fredericksburg, VA; David Manusow, MD, Winnipeg, Manitoba, Canada; Paul Murphy, MD, Saskatoon, Saskatchewan, Canada; Katherine Ochsner, MD, Wilmington, NC; Peter Otto, MD, Berlin, Germany, Norbert Pfeiffer, MD, Mainz, Germany; Roberto Piemontesi, MD, Saskatoon, Saskatchewan, Canada; Eugene Protzko, MD, Bel Air, MD; Jay Rubin, MD, San Antonio, TX; Roman Rybiczka, MD, Wien, Austria; Sonja Scholzel, MD, Berlin, Germany; Sriram Sonty, MD, Calumet City, IL; Robert H. Stewart, MD, Houston, TX; Joseph Tauber, MD, Kansas City, MO; and Thomas R. Walters, MD, Austin, TX. Organizational Center-Amy L. Batoosingh, Izabella Bossowska, MD, Connie Chou, PhD, Alison Ingram, and Gary D. Novack, PhD.
Dr. A. Hommer, Department of Ophthalmology, Hera Hospital, Vienna, Austria
Classification:
11.13.4 Betablocker and prostaglandin (Part of: 11 Medical treatment > 11.13 Combination therapy)
11.13.5 Other (Part of: 11 Medical treatment > 11.13 Combination therapy)
