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document
Efficacy of bepotastine besilate ophthalmic solution 1.5 % for seasonal allergic conjunctivitis : a randomized , placebo-controlled , natural exposure , clinical trial . Allergic conjunctivitis ( AC ) affects an estimated 20 % of the population in the Western world , with a large fraction suffering due to seasonal or perennial allergen exposures . Bepotastine besilate ophthalmic solution ( BBOS ) 1.5 % , a dual-acting histamine ( H ( 1 ) ) receptor antagonist and mast cell stabilizer , is indicated for itching associated with AC . This study was designed to evaluate the efficacy and safety of BBOS 1.5 % for reducing ocular itching associated with AC in subjects enrolled in a natural exposure trial . Eligible subjects in a multicenter , double-masked , randomized , parallel-group , placebo-controlled , natural exposure clinical trial were randomly assigned to either BBOS 1.5 % or placebo eyedrops on a 1:1 basis and instilled 1 drop of the test agent into both eyes twice daily for 2 weeks . The mean change from baseline in instantaneous and reflective ocular itching scores at the end of 2 weeks of treatment were evaluated based on subject-assessed severity of instantaneous and reflective itching . Subject-reported adverse events ( AEs ) were also recorded for safety . Treatment with BBOS 1.5 % significantly reduced instantaneous and reflective ocular itching scores from baseline compared with placebo over the 2-week study period ( p = 0.007 and p = 0.005 , respectively ) . BBOS 1.5 % was well tolerated , and AEs were generally transient and mild . This clinical study indicates BBOS 1.5 % effectively and safely treated ocular itching in a natural exposure allergy study and is a useful treatment option for the management of ocular itching associated with AC . ( ClinicalTrials.gov identifier number : NCT01174823 . )
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Intervention_Pharmacological
bepotastine besilate ophthalmic solution
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Intervention_Control
placebo-controlled
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Intervention_Pharmacological
Bepotastine besilate ophthalmic solution ( BBOS )
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Intervention_Pharmacological
dual-acting histamine
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Intervention_Control
placebo-controlled
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Intervention_Pharmacological
BBOS
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Intervention_Control
placebo eyedrops
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Outcome_Physical
seasonal allergic conjunctivitis
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Outcome_Physical
reflective ocular itching scores
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Outcome_Adverse-effects
Subject-reported adverse events ( AEs )
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Outcome_Other
instantaneous and reflective ocular itching scores
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Outcome_Other
tolerated
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Outcome_Adverse-effects
AEs
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Outcome_Other
effectively
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Outcome_Other
safely
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Outcome_Physical
ocular itching
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Participant_Condition
seasonal allergic conjunctivitis
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Participant_Condition
ocular itching
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Participant_Condition
AC
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Participant_Condition
natural exposure trial