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

Primary Purpose

Allergic Conjunctivitis

Status
Completed
Phase
Phase 4
Locations
Argentina
Study Type
Interventional
Intervention
Bepotastine Besilate 1.5% PF
Olopatadine Hydrochloride 0.2% BAK
Sponsored by
Laboratorios Poen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Allergic Conjunctivitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital de Alta Complejidad El Cruce - Nestor Kirchner
  • Hospital Santa Lucía
  • Instituto Oftalmológico Pedro Lagleyze
  • Hospital Churruca - Visca

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Bepotastine besilate 1,5% preservative free

Olopatadine hydrochloride 0,2% with BAK

Arm Description

Bepotastine besilate 1,5% in preservative-free bottle, administered once a day during the morning.

Olopatadine hydrochloride 0,2% with BAK as preservative, administered once a day during the morning.

Outcomes

Primary Outcome Measures

Ocular itching
Change of 1 point of scale 0-3 (none, mild, moderate, severe) in at least 1 visit between gruops.

Secondary Outcome Measures

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

Full Information

First Posted
February 25, 2021
Last Updated
December 14, 2022
Sponsor
Laboratorios Poen
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1. Study Identification

Unique Protocol Identification Number
NCT04776096
Brief Title
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

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
March 10, 2021 (Actual)
Primary Completion Date
August 18, 2022 (Actual)
Study Completion Date
August 18, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Laboratorios Poen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Conjunctivitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
MULTICENTRIC, DOUBLE BLIND, RANDOMIZED, CONTROLLED, 60 DAYS, GROUP PARALLEL GROUPS, TO SHOW SUPERIORITY.
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
97 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bepotastine besilate 1,5% preservative free
Arm Type
Experimental
Arm Description
Bepotastine besilate 1,5% in preservative-free bottle, administered once a day during the morning.
Arm Title
Olopatadine hydrochloride 0,2% with BAK
Arm Type
Active Comparator
Arm Description
Olopatadine hydrochloride 0,2% with BAK as preservative, administered once a day during the morning.
Intervention Type
Drug
Intervention Name(s)
Bepotastine Besilate 1.5% PF
Other Intervention Name(s)
TRALER LC
Intervention Description
Bepotastine besilate 1,5% Preservative free ophthalmic solution
Intervention Type
Drug
Intervention Name(s)
Olopatadine Hydrochloride 0.2% BAK
Intervention Description
Olopatadine hydrochloride 0.2% with BAK as preservative
Primary Outcome Measure Information:
Title
Ocular itching
Description
Change of 1 point of scale 0-3 (none, mild, moderate, severe) in at least 1 visit between gruops.
Time Frame
Baseline, Day 15, Day 30, Day 45, Day 60
Secondary Outcome Measure Information:
Title
Eye burning
Description
Differences between treatments. Scale 0-3 (none, mild, moderate, severe)
Time Frame
Baseline, Day 15, Day 30, Day 45, Day 60
Title
Eye lacrimation
Description
Differences between treatments. Scale 0-3 (none, mild, moderate, severe)
Time Frame
Baseline, Day 15, Day 30, Day 45, Day 60
Title
Foreign body sensation
Description
Differences between treatments. Scale 0-3 (none, mild, moderate, severe)
Time Frame
Baseline, Day 15, Day 30, Day 45, Day 60
Title
Rhinorrhea
Description
Differences between treatments. Scale 0-3 (none, mild, moderate, severe)
Time Frame
Baseline, Day 15, Day 30, Day 45, Day 60
Title
Nasal congestion
Description
Differences between treatments. Scale 0-3 (none, mild, moderate, severe)
Time Frame
Baseline, Day 15, Day 30, Day 45, Day 60
Title
Nasal pruritus
Description
Differences between treatments. Scale 0-3 (none, mild, moderate, severe)
Time Frame
Baseline, Day 15, Day 30, Day 45, Day 60
Title
Eyelid swelling
Description
Differences between treatments. Scale 0-3 (none, mild, moderate, severe)
Time Frame
Baseline, Day 15, Day 30, Day 45, Day 60
Title
Visual Acuity
Description
Improve from baseline.
Time Frame
Baseline and Day 60
Title
Meniscus height
Description
Differences between treatments.
Time Frame
Baseline, Day 15, Day 30, Day 45, Day 60
Title
Conjunctival hyperemia
Description
Differences between treatments. Scale 0-3 (none, mild, moderate, severe)
Time Frame
Baseline, Day 15, Day 30, Day 45, Day 60
Title
Chemosis
Description
Differences between treatments. Scale 0-3 (none, mild, moderate, severe)
Time Frame
Baseline, Day 15, Day 30, Day 45, Day 60
Title
Eye discharge
Description
Differences between treatments. Scale 0-3 (none, mild, moderate, severe)
Time Frame
Baseline, Day 15, Day 30, Day 45, Day 60
Title
Conjuctival impression cytology
Description
Differences between treatments. Nelson classification.
Time Frame
Baseline, Day 30, Day 60
Title
Adverse reactions
Time Frame
Baseline, Day 15, Day 30, Day 45, Day 60.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Hospital de Alta Complejidad El Cruce - Nestor Kirchner
City
Caba
ZIP/Postal Code
B1888
Country
Argentina
Facility Name
Hospital Santa Lucía
City
Caba
ZIP/Postal Code
C1232AAC
Country
Argentina
Facility Name
Instituto Oftalmológico Pedro Lagleyze
City
Caba
ZIP/Postal Code
C1416 DJI
Country
Argentina
Facility Name
Hospital Churruca - Visca
City
Caba
ZIP/Postal Code
C1437
Country
Argentina

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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