Clinical trial NCT04776096: Efficacy and Toxicity of Bepotastine 1,5% PF vs Olopatadine 0,2% With BAK on Allergic Conjunctivitis Treatment
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Allergic Conjunctivitis
Lead sponsor: Laboratorios Poen
Sponsor class: INDUSTRY
First posted: 2021-03-01
Enrollment: 97
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: MULTICENTRIC, DOUBLE BLIND, RANDOMIZED, CONTROLLED, 60 DAYS, GROUP PARALLEL GROUPS, TO SHOW SUPERIORITY.
Primary purpose: TREATMENT

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% 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Ocular itching
timeFrame: Baseline, Day 15, Day 30, Day 45, Day 60
Secondary outcomes:
measure: Eye burning
timeFrame: Baseline, Day 15, Day 30, Day 45, Day 60
measure: Eye lacrimation
timeFrame: Baseline, Day 15, Day 30, Day 45, Day 60
measure: Foreign body sensation
timeFrame: Baseline, Day 15, Day 30, Day 45, Day 60
measure: Rhinorrhea
timeFrame: Baseline, Day 15, Day 30, Day 45, Day 60
measure: Nasal congestion
timeFrame: Baseline, Day 15, Day 30, Day 45, Day 60
measure: Nasal pruritus
timeFrame: Baseline, Day 15, Day 30, Day 45, Day 60
measure: Eyelid swelling
timeFrame: Baseline, Day 15, Day 30, Day 45, Day 60
measure: Visual Acuity
timeFrame: Baseline and Day 60
measure: Meniscus height
timeFrame: Baseline, Day 15, Day 30, Day 45, Day 60
measure: Conjunctival hyperemia
timeFrame: Baseline, Day 15, Day 30, Day 45, Day 60
measure: Chemosis
timeFrame: Baseline, Day 15, Day 30, Day 45, Day 60
measure: Eye discharge
timeFrame: Baseline, Day 15, Day 30, Day 45, Day 60
measure: Conjuctival impression cytology
timeFrame: Baseline, Day 30, Day 60
measure: Adverse reactions
timeFrame: Baseline, Day 15, Day 30, Day 45, Day 60.
Other outcomes:
Locations:
city: Caba
country: Argentina
facility: Hospital de Alta Complejidad El Cruce - Nestor Kirchner
city: Caba
country: Argentina
facility: Hospital Santa Lucía
city: Caba
country: Argentina
facility: Instituto Oftalmológico Pedro Lagleyze
city: Caba
country: Argentina
facility: Hospital Churruca - Visca
Study officials:
References: