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NCT Number: NCT04776096

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

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.

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Key information

Conditions

Allergic Conjunctivitis Conjunctival Diseases Conjunctivitis Conjunctivitis, Allergic Eye Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital Churruca - Visca, CABA, Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bepotastine Besilate 1.5% PF

Drug

Bepotastine besilate 1,5% Preservative free ophthalmic solution

Other names: TRALER LC

Olopatadine Hydrochloride 0.2% BAK

Drug

Olopatadine hydrochloride 0.2% with BAK as preservative

Primary outcomes

  1. 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 outcomes

  1. Eye burning

    Time frame: Baseline, Day 15, Day 30, Day 45, Day 60

    Differences between treatments. Scale 0-3 (none, mild, moderate, severe)

  2. Eye lacrimation

    Time frame: Baseline, Day 15, Day 30, Day 45, Day 60

    Differences between treatments. Scale 0-3 (none, mild, moderate, severe)

  3. Foreign body sensation

    Time frame: Baseline, Day 15, Day 30, Day 45, Day 60

    Differences between treatments. Scale 0-3 (none, mild, moderate, severe)

  4. Rhinorrhea

    Time frame: Baseline, Day 15, Day 30, Day 45, Day 60

    Differences between treatments. Scale 0-3 (none, mild, moderate, severe)

  5. Nasal congestion

    Time frame: Baseline, Day 15, Day 30, Day 45, Day 60

    Differences between treatments. Scale 0-3 (none, mild, moderate, severe)

  6. Nasal pruritus

    Time frame: Baseline, Day 15, Day 30, Day 45, Day 60

    Differences between treatments. Scale 0-3 (none, mild, moderate, severe)

  7. Eyelid swelling

    Time frame: Baseline, Day 15, Day 30, Day 45, Day 60

    Differences between treatments. Scale 0-3 (none, mild, moderate, severe)

  8. Visual Acuity

    Time frame: Baseline and Day 60

    Improve from baseline.

  9. Meniscus height

    Time frame: Baseline, Day 15, Day 30, Day 45, Day 60

    Differences between treatments.

  10. Conjunctival hyperemia

    Time frame: Baseline, Day 15, Day 30, Day 45, Day 60

    Differences between treatments. Scale 0-3 (none, mild, moderate, severe)

  11. Chemosis

    Time frame: Baseline, Day 15, Day 30, Day 45, Day 60

    Differences between treatments. Scale 0-3 (none, mild, moderate, severe)

  12. Eye discharge

    Time frame: Baseline, Day 15, Day 30, Day 45, Day 60

    Differences between treatments. Scale 0-3 (none, mild, moderate, severe)

  13. Conjuctival impression cytology

    Time frame: Baseline, Day 30, Day 60

    Differences between treatments. Nelson classification.

  14. Adverse reactions

    Time frame: Baseline, Day 15, Day 30, Day 45, Day 60.

Sponsors and collaborators

Lead sponsor

Laboratorios Poen

Industry

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 1, 2021
Registry last updated
Dec 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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