title: Prolonged effectiveness of bepotastine besilate ophthalmic solution for the treatment of ocular symptoms of allergic conjunctivitis.
abstract: OBJECTIVE
  This clinical trial evaluated the safety and effectiveness of bepotastine besilate ophthalmic solutions 1.0% and 1.5% compared with placebo for the treatment of ocular itching and conjunctival hyperemia (redness) using the conjunctival allergen challenge (CAC) model of allergic conjunctivitis when dosed 16 h before a CAC test.
  
  
  METHODS
  Subjects with a history of allergic conjunctivitis were assigned to receive placebo or bepotastine besilate ophthalmic solution 1.0% or 1.5% in a single-center, randomized, placebo-controlled clinical trial. Eligible subjects (n=107) aged 10 years and older with a history of allergic conjunctivitis who had a reproducible positive reaction to a CAC were enrolled and dosed with test agent. The primary trial objectives included assessment of ocular itching and conjunctival redness at 16 h after instillation of test agent. Reductions in several CAC-induced secondary symptoms and signs of allergic conjunctivitis were also evaluated for tearing, ciliary and episcleral redness, eyelid swelling, chemosis, and mucous discharge.
  
  
  RESULTS
  Bepotastine besilate ophthalmic solution 1.5% demonstrated clinical effectiveness and statistical significance in comparison to placebo for the reduction in CAC-induced ocular itching 16 h after drug administration. Bepotastine besilate ophthalmic solution 1.0% also achieved statistical significance in comparison to placebo for reducing ocular itching at all time points 16 h after dosing. Statistically significant reduction (P≤0.05) was additionally seen in this CAC test for the secondary ocular efficacy variable of allergen-induced tearing for bepotastine besilate ophthalmic solution 1.5%. No clinical benefit was seen for reducing the coprimary efficacy variable of conjunctival redness with the CAC model of allergic conjunctivitis.
  
  
  CONCLUSIONS
  Bepotastine besilate ophthalmic solution 1.5% produced predefined clinically meaningful reduction in CAC-induced ocular itching and tearing in a single-site trial and was more effective than bepotastine besilate ophthalmic solution 1.0% and placebo for reducing ocular itching in a CAC test 16 h after dosing.
authors.affiliation: ISTA Pharmaceuticals® Inc., Irvine, CA 92618-2301, USA. jwilliams@istavision.com
authors.forename: Jon I
authors.initials: JI
authors.lastname: Williams
authors.forename: Kathryn S
authors.initials: KS
authors.lastname: Kennedy
authors.forename: James A
authors.initials: JA
authors.lastname: Gow
authors.forename: Gail L
authors.initials: GL
authors.lastname: Torkildsen
authors.forename: Mark B
authors.initials: MB
authors.lastname: Abelson
authors.forename: Paul J
authors.initials: PJ
authors.lastname: Gomes
authors.forename: Timothy R
authors.initials: TR
authors.lastname: McNamara
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D018926:Anti-Allergic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002648:Child; D003228:Conjunctiva / Q000187:drug effects; D003233:Conjunctivitis, Allergic / Q000188:drug therapy* / Q000276:immunology / Q000473:pathology; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D006940:Hyperemia / Q000188:drug therapy / Q000209:etiology; D008297:Male; D008875:Middle Aged; D009883:Ophthalmic Solutions; D010880:Piperidines / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D011446:Prospective Studies; D011537:Pruritus / Q000188:drug therapy / Q000209:etiology; D011725:Pyridines / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D013997:Time Factors; D055815:Young Adult
chemical_list: D018926:Anti-Allergic Agents; D009883:Ophthalmic Solutions; D010880:Piperidines; D011725:Pyridines; C511534:bepotastine besilate