Abstract | PURPOSE: 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:
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Authors | Thomas 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 |
Journal | American journal of ophthalmology
(Am J Ophthalmol)
Vol. 150
Issue 1
Pg. 122-127.e5
(Jul 2010)
ISSN: 1879-1891 [Electronic] United States |
PMID | 20488431
(Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Copyright | 2010 Elsevier Inc. All rights reserved. |
Chemical References |
- Anti-Allergic Agents
- Ophthalmic Solutions
- Piperidines
- Pyridines
- bepotastine besilate
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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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