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

Laboratorios Poen

Status and phase

Completed

Phase 4

Conditions

Allergic Conjunctivitis

Treatments

Drug: Olopatadine Hydrochloride 0.2% BAK

Drug: Bepotastine Besilate 1.5% PF

Study type

Interventional

Funder types

Industry

Identifiers

NCT04776096

ANTILERG001-19

Details and patient eligibility

About

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.

Enrollment

97 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients older than 18 years old.
Clinical diagnosis of allergic conjunctivitis and active allergy with at least 2 points on itching and hyperemia scale.
Patients with history of allergic conjunctivitis.
Patients who accept no to wear contact lens during the duration of the trial.
Patients who accept no to use any other medication by any delivery route.
Patients with intraocular pressure controlled (less than 18 mmhg)

Exclusion criteria

Patients who have undergone refractive surgery within the 6 months prior to the start of the study
Patient with ocular or systemic active diseases
Patients who are participating in another trial
Patients who have used eye medication in the last 15 days and/or who have received anti-inflammatory drugs (corticosteroids and/or NSAIDs) and/or antihistamines by mouth or intravenous.
Patients hypersensitive to any component of the products: Bepotastine besilate, sodium chloride, monosodium phosphate dihydrate, sodium hydroxide, Olopatadine hydrochloride, benzalkonium chloride, dibasic sodium phosphate, hydrochloric acid, edetate disodium or povidone K29 / 32.
Women who are breastfeeding and pregnant.