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

Overview

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.

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: August 18, 2022

Interventions

  • Drug: Bepotastine Besilate 1.5% PF
    • Bepotastine besilate 1,5% Preservative free ophthalmic solution
  • Drug: Olopatadine Hydrochloride 0.2% BAK
    • Olopatadine hydrochloride 0.2% with BAK as preservative

Arms, Groups and Cohorts

  • Experimental: Bepotastine besilate 1,5% preservative free
    • Bepotastine besilate 1,5% in preservative-free bottle, administered once a day during the morning.
  • Active Comparator: Olopatadine hydrochloride 0,2% with BAK
    • Olopatadine hydrochloride 0,2% with BAK as preservative, administered once a day during the morning.

Clinical Trial Outcome Measures

Primary Measures

  • Ocular itching
    • Time Frame: 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 Measures

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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Laboratorios Poen
  • Provider of Information About this Clinical Study
    • Sponsor

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