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

NCT04776096 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 97

Last updated 2022-12-15

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Laboratorios Poen

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Argentina

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04776096 on ClinicalTrials.gov