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Multicenter clinical evaluation of bepotastine besilate ophthalmic solutions 1.0% and 1.5% to treat allergic conjunctivitis.

AbstractPURPOSE:
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 < or = .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.
AuthorsThomas T Macejko, Mark T Bergmann, Jon I Williams, James A Gow, Paul J Gomes, Timothy R McNamara, Mark B Abelson, Bepotastine Besilate Ophthalmic Solutions Clinical Study Group
JournalAmerican journal of ophthalmology (Am J Ophthalmol) Vol. 150 Issue 1 Pg. 122-127.e5 (Jul 2010) ISSN: 1879-1891 [Electronic] United States
PMID20488431 (Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
Copyright2010 Elsevier Inc. All rights reserved.
Chemical References
  • Anti-Allergic Agents
  • Ophthalmic Solutions
  • Piperidines
  • Pyridines
  • bepotastine besilate
Topics
  • Adolescent
  • Adult
  • Anti-Allergic Agents (administration & dosage, adverse effects)
  • Child
  • Conjunctiva (blood supply)
  • Conjunctivitis, Allergic (drug therapy, physiopathology)
  • Double-Blind Method
  • Female
  • Humans
  • Hyperemia (drug therapy)
  • Male
  • Middle Aged
  • Ophthalmic Solutions (administration & dosage, adverse effects)
  • Piperidines (administration & dosage, adverse effects)
  • Prospective Studies
  • Pyridines (administration & dosage, adverse effects)
  • Treatment Outcome
  • Visual Acuity

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