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

Phase 4

Completed

• Conditions: Allergic Conjunctivitis
• Interventions: Drug: Bepotastine Besilate 1.5% PF; Drug: Olopatadine Hydrochloride 0.2% BAK

• Registration Number: NCT04776096
• Lead Sponsor: Laboratorios Poen

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-02-25
• Study First Submitted QC: 2021-02-26
• Study First Posted: 2021-03-01
• Study Start: 2021-03-10
• Primary Completion: 2022-08-18
• Study Completion: 2022-08-18
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-14
• Last Update Posted: 2022-12-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 97

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bepotastine besilate 1,5% preservative free	Bepotastine Besilate 1.5% PF	Bepotastine besilate 1,5% in preservative-free bottle, administered once a day during the morning.
Olopatadine hydrochloride 0,2% with BAK	Olopatadine Hydrochloride 0.2% BAK	Olopatadine hydrochloride 0,2% with BAK as preservative, administered once a day during the morning.

Primary Outcome Measures

Name	Time	Method
Ocular itching	Baseline, Day 15, Day 30, Day 45, Day 60	Change of 1 point of scale 0-3 (none, mild, moderate, severe) in at least 1 visit between gruops.

Secondary Outcome Measures

Name	Time	Method
Eye burning	Baseline, Day 15, Day 30, Day 45, Day 60	Differences between treatments. Scale 0-3 (none, mild, moderate, severe)
Eye lacrimation	Baseline, Day 15, Day 30, Day 45, Day 60	Differences between treatments. Scale 0-3 (none, mild, moderate, severe)
Foreign body sensation	Baseline, Day 15, Day 30, Day 45, Day 60	Differences between treatments. Scale 0-3 (none, mild, moderate, severe)
Rhinorrhea	Baseline, Day 15, Day 30, Day 45, Day 60	Differences between treatments. Scale 0-3 (none, mild, moderate, severe)
Nasal congestion	Baseline, Day 15, Day 30, Day 45, Day 60	Differences between treatments. Scale 0-3 (none, mild, moderate, severe)
Nasal pruritus	Baseline, Day 15, Day 30, Day 45, Day 60	Differences between treatments. Scale 0-3 (none, mild, moderate, severe)
Visual Acuity	Baseline and Day 60	Improve from baseline.
Meniscus height	Baseline, Day 15, Day 30, Day 45, Day 60	Differences between treatments.
Conjunctival hyperemia	Baseline, Day 15, Day 30, Day 45, Day 60	Differences between treatments. Scale 0-3 (none, mild, moderate, severe)
Eye discharge	Baseline, Day 15, Day 30, Day 45, Day 60	Differences between treatments. Scale 0-3 (none, mild, moderate, severe)
Eyelid swelling	Baseline, Day 15, Day 30, Day 45, Day 60	Differences between treatments. Scale 0-3 (none, mild, moderate, severe)
Chemosis	Baseline, Day 15, Day 30, Day 45, Day 60	Differences between treatments. Scale 0-3 (none, mild, moderate, severe)
Conjuctival impression cytology	Baseline, Day 30, Day 60	Differences between treatments. Nelson classification.
Adverse reactions	Baseline, Day 15, Day 30, Day 45, Day 60.

Trial Locations

Locations (4)

Hospital Santa Lucía; 🇦🇷 Caba, Argentina

Hospital de Alta Complejidad El Cruce - Nestor Kirchner; 🇦🇷 Caba, Argentina

Instituto Oftalmológico Pedro Lagleyze; 🇦🇷 Caba, Argentina

Hospital Churruca - Visca; 🇦🇷 Caba, Argentina