{"doi":"10.2500/aap.2012.33.3570","title":"Integrated phase III trials of bepotastine besilate ophthalmic solution 1.5% for ocular itching associated with allergic conjunctivitis","abstract":null,"journal":"Allergy and Asthma Proceedings","year":2012,"id":689939,"datarank":0.3596842909197557,"base_score":2.3978952727983707,"endowment":2.3978952727983707,"self_citation_contribution":0.3596842909197557,"citation_network_contribution":0.0,"self_endowment_contribution":0.3596842909197557,"citer_contribution":0.0,"corpus_percentile":null,"corpus_rank":null,"citation_count":10,"citer_count":0,"citers_with_citation_signal":0,"citers_with_endowment":0,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":null,"is_data_producer":false,"deposit_databanks":null,"is_oa":false,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":null,"fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":1802441,"name":"Gail L. Torkildsen","orcid":null,"position":1,"is_corresponding":false},{"id":1802442,"name":"James A. Gow","orcid":null,"position":2,"is_corresponding":false},{"id":1802443,"name":"Timothy R. McNamara","orcid":null,"position":3,"is_corresponding":false},{"id":1802444,"name":"Paul J. Gomes","orcid":null,"position":4,"is_corresponding":false},{"id":1802445,"name":"Jon I. Williams","orcid":null,"position":5,"is_corresponding":false},{"id":1802446,"name":"for the Bepotastine Besilate Ophthalmic Solut","orcid":null,"position":6,"is_corresponding":false},{"id":1802440,"name":"Edward J. Meier","orcid":null,"position":0,"is_corresponding":false}],"reference_count":0,"raw_metadata":{"has_enrichment":true,"resolved":true,"title":"Integrated phase III trials of bepotastine besilate ophthalmic solution 1.5% for ocular itching associated with allergic conjunctivitis","abstract":"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).","is_dataset_classified":null,"base_score":2.3978952727983707,"endowment":2.3978952727983707,"datacite_reuse_total":0,"file_count":0,"downloads":0,"views":0,"has_version_chain":false,"is_dataset":false,"is_oa":false,"pmid":"22991696","pmcid":null,"openalex_id":"https://openalex.org/W69940183","authors":[],"funders":[],"total_grants":0,"fwci":2.1605,"citation_percentile":0.86525044,"influential_citations":0,"citation_trend":[{"year":2012,"count":1},{"year":2013,"count":4},{"year":2014,"count":1},{"year":2015,"count":1},{"year":2016,"count":1},{"year":2018,"count":2}],"oa_status":"closed","license":null,"oa_locations":[{"url":"http://www.ingentaconnect.com/content/ocean/aap/2012/00000033/00000003/art00009","host_type":"publisher"},{"url":"https://doi.org/10.2500/aap.2012.33.3570","host_type":"journal"},{"url":"https://pubmed.ncbi.nlm.nih.gov/22991696","host_type":"repository"}],"fields_of_study":["Ocular Surface and Contact Lens","Mast cells and histamine","Allergic Rhinitis and Sensitization","Medicine","Adolescent","Adult","Aged","Antipruritics","Child","Conjunctivitis, Allergic","Female","Humans","Male","Middle Aged","Ophthalmic Solutions","Piperidines","Pruritus","Pyridines","Treatment Outcome","Young Adult"],"mesh_terms":["Adolescent","Adult","Aged","Antipruritics","Child","Conjunctivitis, Allergic","Female","Humans","Male","Middle Aged","Ophthalmic Solutions","Piperidines","Pruritus","Pyridines","Treatment Outcome","Young Adult"],"keywords":["Itching","Medicine","Allergic conjunctivitis","Placebo","Clinical trial","Adverse effect","Dermatology","Allergy","Anesthesia","Internal medicine","Immunology","Pathology"],"sdg_mappings":[{"sdg_number":0,"sdg_label":"Good health and well-being"}],"linked_datasets":[],"clinical_trials":[],"software_tools":[],"database_accessions":[{"name":"nct"}],"source":"live","citation_network_status":"fetched"},"created_at":"2026-08-22T18:58:22.005625Z","pmid":null,"pmcid":null,"fwci":null,"citation_percentile":null,"influential_citations":0,"oa_status":null,"license":null,"views":0,"total_file_size_bytes":0,"version_count":0,"fair_f":null,"fair_a":null,"fair_i":null,"fair_r":null,"fair_zscore":null,"fair_rationale":null,"fair_model":null,"fair_agent_version":null,"fair_fulltext_source":null,"fair_has_llm":null,"fair_computed_at":null,"clinical_trials":[],"software_tools":[],"db_accessions":[],"linked_datasets":[],"topics":[]}