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

NCT ID: NCT04776096

Last Updated: 2022-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

97 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-10

Study Completion Date

2022-08-18

Brief Summary

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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.

Detailed Description

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Conditions

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Allergic Conjunctivitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

MULTICENTRIC, DOUBLE BLIND, RANDOMIZED, CONTROLLED, 60 DAYS, GROUP PARALLEL GROUPS, TO SHOW SUPERIORITY.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Bepotastine besilate 1,5% preservative free

Bepotastine besilate 1,5% in preservative-free bottle, administered once a day during the morning.

Group Type EXPERIMENTAL

Bepotastine Besilate 1.5% PF

Intervention Type DRUG

Bepotastine besilate 1,5% Preservative free ophthalmic solution

Olopatadine hydrochloride 0,2% with BAK

Olopatadine hydrochloride 0,2% with BAK as preservative, administered once a day during the morning.

Group Type ACTIVE_COMPARATOR

Olopatadine Hydrochloride 0.2% BAK

Intervention Type DRUG

Olopatadine hydrochloride 0.2% with BAK as preservative

Interventions

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Bepotastine Besilate 1.5% PF

Bepotastine besilate 1,5% Preservative free ophthalmic solution

Intervention Type DRUG

Olopatadine Hydrochloride 0.2% BAK

Olopatadine hydrochloride 0.2% with BAK as preservative

Intervention Type DRUG

Other Intervention Names

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TRALER LC

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Laboratorios Poen

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hospital de Alta Complejidad El Cruce - Nestor Kirchner

CABA, , Argentina

Site Status

Hospital Santa Lucía

CABA, , Argentina

Site Status

Instituto Oftalmológico Pedro Lagleyze

CABA, , Argentina

Site Status

Hospital Churruca - Visca

CABA, , Argentina

Site Status

Countries

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Argentina

Other Identifiers

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ANTILERG001-19

Identifier Type: -

Identifier Source: org_study_id