Multicenter Clinical Evaluation of Bepotastine Besilate Ophthalmic Solutions 1.0% and 1.5% to Treat Allergic Conjunctivitis

• Published in: American journal of ophthalmology 2010-07, Vol.150 (1), p.122-127.e5
• Main Authors: Macejko, Thomas T, Bergmann, Mark T, Williams, Jon I, Gow, James A, Gomes, Paul J, McNamara, Timothy R, Abelson, Mark B
• Format: Article
• Language: English
• Subjects: Adolescent; Adult; Anti-Allergic Agents - administration & dosage; Anti-Allergic Agents - adverse effects; Biological and medical sciences; Cataracts; Child; Clinical trials; Conjunctiva - blood supply; Conjunctivitis, Allergic - drug therapy; Conjunctivitis, Allergic - physiopathology; Double-Blind Method; Drug dosages; Female; Health insurance; Health Insurance Portability & Accountability Act 1996-US; Humans; Hyperemia - drug therapy; Male; Medical sciences; Middle Aged; Miscellaneous; Ophthalmic Solutions - administration & dosage; Ophthalmic Solutions - adverse effects; Ophthalmology; Pharmaceutical industry; Piperidines - administration & dosage; Piperidines - adverse effects; Prospective Studies; Pyridines - administration & dosage; Pyridines - adverse effects; Standard deviation; Surgery; Treatment Outcome; Visual Acuity
• ISSN: 0002-9394; 1879-1891
• DOI: 10.1016/j.ajo.2010.02.007

Purpose To evaluate the effectiveness of bepotastine besilate ophthalmic solutions 1.0% and 1.5% compared with placebo at reducing ocular itching and conjunctival hyperemia in the conjunctival allergen challenge (CAC) model of allergic conjunctivitis. Design Prospective, double-masked, randomized, placebo-controlled, phase 3 CAC clinical trial. Methods This multicenter trial enrolled 130 subjects with a clinical history of allergic conjunctivitis who were randomized to bepotastine besilate ophthalmic solution 1.0%, 1.5%, or 0.0% (placebo). One drop of test agent was instilled bilaterally before a CAC test evaluating responses at 15 minutes, 8 hours, or 16 hours after test agent instillation. Primary efficacy outcomes were unit improvements relative to placebo in mean scores for ocular itching and conjunctival hyperemia, each graded on 0- to 4-unit scales. Results Reductions of 1.2 units or more in mean ocular itching scores at all time points for both bepotastine besilate ophthalmic solutions 1.0% and 1.5% were observed at onset of action and 8-hour duration-of-action CAC tests ( P < .0001). Statistically significant reductions in conjunctival hyperemia ( P ≤ .0125) were observed for bepotastine besilate ophthalmic formulations only at the onset of action CAC test. Conclusions Bepotastine besilate ophthalmic solutions 1.0% and 1.5% both substantially decreased CAC-induced ocular itching for at least 8 hours after dosing. Reductions in conjunctival hyperemia after a CAC, although statistically significant for bepotastine besilate ophthalmic solutions 1.0% and 1.5% compared with placebo when assessed at 15 minutes after dosing, were modest.