drugset / Trial / NCT04776096

Efficacy and Toxicity of Bepotastine 1,5% PF vs Olopatadine 0,2% With BAK on Allergic Conjunctivitis Treatment

NCT04776096

Phase 4 Completed 97 enrolled Laboratorios Poen
RandomizedParallel-groupDouble-blindTreatment

Summary

The present study will be carried out to evaluate the antiallergic efficacy of Bepotastine besilate 1.5% free of preservatives versus standard treatment with 0.2% Olopatadine hydrochloride with 0.1% benzalkonium chloride as preservative in adult patients diagnosed with allergic conjunctivitis. The antiallergic efficacy will be evaluated by the reduction of ocular signs and symptoms and by the resolution of non-ocular symptoms (rhinorrhea, congestion, and nasal pruritus), as well as the effect of the preservative and its relationship with the cytotoxicity of the ocular surface. Also will evaluate the safety of both products.

Timeline

Start
2021-03-10
Primary completion
2022-08-18
Completion
2022-08-18

Drugs

EvaluationDrugModalityDoseRoute
Subject Bepotastine Small molecule 1.5 %
Comparator Olopatadine Other / unclassified 0.2 %

Indications