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Bepotastine besilate ophthalmic solution 1.5% for alleviating nasal symptoms in patients with allergic conjunctivitis.

ABSTRACT: Background:Bepotastine besilate ophthalmic solution (BBOS) 1.5% is a topical antihistamine for the treatment of ocular itching associated with allergic conjunctivitis (AC). Allergic rhinitis and AC are common comorbid conditions. We explored the efficacy of BBOS 1.5% in alleviating nasal symptoms in an integrated analysis of two Phase III conjunctival allergen challenge (CAC) studies and a Phase IV environmental allergen study. Methods:In the Phase III trials, a CAC was performed 15 minutes, 8 hours, and 16 hours following ocular instillation of BBOS 1.5% (n=78) or placebo (n=79), and subjects evaluated nasal symptoms. In the environmental study, subjects instilled BBOS 1.5% (n=123) or placebo (n=122) twice daily and nasal symptoms were evaluated over 2 weeks. Results:In the Phase III trials, BBOS 1.5% had reduced CAC-induced nasal congestion and pruritus at 15 minutes and 8 hours postdosing and rhinorrhea and a non-ocular composite-symptom score (sum of nasal scores plus ear or palate pruritus) at all time points postdosing (all P?0.01 vs placebo). In the Phase IV environmental study, BBOS 1.5% reduced sneezing and nasal pruritus over 2 weeks and median number of days to improvement of nasal pruritus and total nasal symptom score (sum for rhinorrhea, sneezing, nasal pruritus, and nasal congestion; P?0.04 vs placebo). Additionally, investigator-reported improvement in overall ocular (pruritus, hyperemia, tearing) and nasal symptoms was greater with BBOS 1.5% vs placebo (P?0.03). Conclusion:Results of these exploratory analyses indicate that topical ocular BBOS 1.5% reduced nasal symptoms, supporting its use for alleviating rhinitis symptoms associated with AC.

SUBMITTER: Cavet ME

PROVIDER: S-EPMC5870655 | biostudies-literature | 2018

REPOSITORIES: biostudies-literature

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Bepotastine besilate ophthalmic solution 1.5% for alleviating nasal symptoms in patients with allergic conjunctivitis.

Cavet Megan E ME Gomes Paul J PJ Carr Warner W WW Williams Jon I JI

Journal of asthma and allergy 20180323

<h4>Background</h4>Bepotastine besilate ophthalmic solution (BBOS) 1.5% is a topical antihistamine for the treatment of ocular itching associated with allergic conjunctivitis (AC). Allergic rhinitis and AC are common comorbid conditions. We explored the efficacy of BBOS 1.5% in alleviating nasal symptoms in an integrated analysis of two Phase III conjunctival allergen challenge (CAC) studies and a Phase IV environmental allergen study.<h4>Methods</h4>In the Phase III trials, a CAC was performed ...[more]

PMID: 29615844

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Project description:BACKGROUND:The purpose of this study was to determine the efficacy of besifloxacin ophthalmic suspension 0.6% when used in the treatment of bacterial conjunctivitis infections due to Pseudomonas aeruginosa. METHODS:We undertook a post hoc analysis of clinical outcomes in patients with bacterial conjunctivitis due to P. aeruginosa across four prospective, multicenter, double-masked, randomized, controlled, clinical studies of besifloxacin ophthalmic suspension 0.6%. Efficacy outcomes included bacterial eradication and clinical resolution of the baseline infection at follow-up visits. Bacterial eradication was defined as the absence of ocular bacterial species present at or above threshold at baseline, while clinical resolution was defined as grade 0 ocular discharge and bulbar conjunctival injection. Safety outcomes included the incidence of adverse events, changes in visual acuity, and biomicroscopy and ophthalmoscopy findings. Patient outcomes were summarized and bacterial eradication and clinical resolution rates integrated. RESULTS:Of 1317 patients with culture-confirmed bacterial conjunctivitis across four clinical studies, nine (0.7%) were infected with P. aeruginosa at baseline, and of these, five were randomized to treatment with besifloxacin ophthalmic suspension 0.6%. Bacterial eradication of the baseline infection was observed at both follow-up visits in all five patients. Clinical resolution was achieved in two of five patients by the first follow-up visit and four of five patients by the second follow-up visit. There were no adverse events reported in these patients. There were no clinically meaningful biomicroscopy findings or changes in ophthalmoscopy or visual acuity. CONCLUSION:The incidence of bacterial conjunctivitis due to P. aeruginosa was low. Treatment of patients with P. aeruginosa infections with besifloxacin ophthalmic suspension 0.6% led to bacterial eradication of P. aeruginosa by the first follow-up visit and high rates of clinical resolution.

Dataset Information

Bepotastine besilate ophthalmic solution 1.5% for alleviating nasal symptoms in patients with allergic conjunctivitis.

Publications

Bepotastine besilate ophthalmic solution 1.5% for alleviating nasal symptoms in patients with allergic conjunctivitis.

Similar Datasets

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