Integrated phase III trials of bepotastine besilate ophthalmic solution 1.5% for ocular itching associated with allergic conjunctivitis
| Autor: | Edward J. Meier, Gail L. Torkildsen, James A. Gow, Timothy R. McNamara, Paul J. Gomes, Jon I. Williams, null for the Bepotastine Besilate Ophthalmic Solut |
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| Rok vydání: | 2012 |
| Předmět: |
Pulmonary and Respiratory Medicine
Adult Male medicine.medical_specialty Adolescent Pyridines Placebo law.invention Young Adult Randomized controlled trial Piperidines law medicine Immunology and Allergy Humans Dosing Adverse effect Child Antipruritic Aged Conjunctivitis Allergic business.industry Pruritus General Medicine Antipruritics Middle Aged medicine.disease Dermatology eye diseases Allergic conjunctivitis Clinical trial Treatment Outcome Itching Female medicine.symptom Ophthalmic Solutions business medicine.drug |
| Zdroj: | Allergy and asthma proceedings. 33(3) |
| ISSN: | 1539-6304 |
| Popis: | Allergic conjunctivitis is a clinical reaction to environmental allergens and is manifested by ocular itching caused by IgE-induced mast cell degranulation. Bepotastine besilate is a selective H(1)-antagonist with mast cell stabilizing properties. This report examines the reduction of ocular itching integrated from two conjunctival allergen challenge (CAC) clinical trials comparing bepotastine besilate ophthalmic solution (BBOS) 1.5% to placebo in subjects with a history of allergic conjunctivitis. Two phase III, double-masked, placebo-controlled, parallel-group, CAC clinical trials evaluated BBOS 1.5% versus placebo to reduce ocular itching. Eligible subjects were randomly assigned 1:1 to either BBOS 1.5% (n = 78) or placebo (n = 79). Ocular itching was graded by subjects using a standardized scale (0–4 U). Adverse events and ophthalmic clinical findings were recorded for safety. BBOS 1.5% was superior to placebo for reducing CAC-induced ocular itching (p < 0.0001) as early as 3 minutes post-CAC and for at least 8 hours after dosing. Post hoc analyses examining several populations also showed a significant improvement (p < 0.0001) for subjects with more severe itching response at screening and for the proportion of subjects with complete or nearly complete resolution of CAC-induced itching, both outcomes supporting the clinical benefit of BBOS 1.5%. Adverse events were generally transient and mild. BBOS 1.5% is safe and effective in the treatment of ocular itching associated with allergic conjunctivitis within 3 minutes of a CAC and with a sustained duration of action of at least 8 hours. (ClinicalTrials.gov numbers: NCT00424398 and NCT00586664). |
| Databáze: | OpenAIRE |
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