Status:
COMPLETED
Efficacy and Toxicity of Bepotastine 1,5% PF vs Olopatadine 0,2% With BAK on Allergic Conjunctivitis Treatment
Lead Sponsor:
Laboratorios Poen
Conditions:
Allergic Conjunctivitis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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% b...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 10 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 18 2022
Estimated Enrollment :
97 Patients enrolled
Trial Details
Trial ID
NCT04776096
Start Date
March 10 2021
End Date
August 18 2022
Last Update
December 15 2022
Active Locations (4)
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1
Hospital de Alta Complejidad El Cruce - Nestor Kirchner
CABA, Argentina, B1888
2
Hospital Santa Lucía
CABA, Argentina, C1232AAC
3
Instituto Oftalmológico Pedro Lagleyze
CABA, Argentina, C1416 DJI
4
Hospital Churruca - Visca
CABA, Argentina, C1437