NCT04776096

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

PHASE IV, MULTICENTRIC, DOUBLE-BLIND, RANDOMIZED, CONTROLLED,60 DAYS, PARALLEL GROUPS, SUPERIORITY STUDY, TO COMPARE THE EFFECTIVENESS AND TOXICITY OF BEPOTASTINE 1.5% PF vs. OLOPATADINE 0.2% WITH BAK IN TREATMENT OF ALLERGIC CONJUNCTIVITIS

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 97 (actual)
• Sponsor: Laboratorios Poen · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Allergic Conjunctivitis

Interventions

Type	Name	Description
DRUG	Bepotastine Besilate 1.5% PF	Bepotastine besilate 1,5% Preservative free ophthalmic solution
DRUG	Olopatadine Hydrochloride 0.2% BAK	Olopatadine hydrochloride 0.2% with BAK as preservative

Timeline

• Start date: 2021-03-10
• Primary completion: 2022-08-18
• Completion: 2022-08-18
• First posted: 2021-03-01
• Last updated: 2022-12-15

Locations

4 sites across 1 country: Argentina