NCT04776096

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
97

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 25, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 1, 2021

Completed
9 days until next milestone

Study Start

First participant enrolled

March 10, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 18, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 18, 2022

Completed
Last Updated

December 15, 2022

Status Verified

December 1, 2022

Enrollment Period

1.4 years

First QC Date

February 25, 2021

Last Update Submit

December 14, 2022

Conditions

Allergic Conjunctivitis

Outcome Measures

Primary Outcomes (1)

  • Ocular itching

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

    Baseline, Day 15, Day 30, Day 45, Day 60

Secondary Outcomes (14)

  • Eye burning

    Baseline, Day 15, Day 30, Day 45, Day 60

  • Eye lacrimation

    Baseline, Day 15, Day 30, Day 45, Day 60

  • Foreign body sensation

    Baseline, Day 15, Day 30, Day 45, Day 60

  • Rhinorrhea

    Baseline, Day 15, Day 30, Day 45, Day 60

  • Nasal congestion

    Baseline, Day 15, Day 30, Day 45, Day 60

  • +9 more secondary outcomes

Study Arms (2)

Bepotastine besilate 1,5% preservative free

EXPERIMENTAL

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

Drug: Bepotastine Besilate 1.5% PF

Olopatadine hydrochloride 0,2% with BAK

ACTIVE COMPARATOR

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

Drug: Olopatadine Hydrochloride 0.2% BAK

Interventions

Bepotastine Besilate 1.5% PFDRUG

Bepotastine besilate 1,5% Preservative free ophthalmic solution

Also known as: TRALER LC
Bepotastine besilate 1,5% preservative free
Olopatadine Hydrochloride 0.2% BAKDRUG

Olopatadine hydrochloride 0.2% with BAK as preservative

Olopatadine hydrochloride 0,2% with BAK

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Hospital de Alta Complejidad El Cruce - Nestor Kirchner

CABA, B1888, Argentina

Location

Hospital Santa Lucía

CABA, C1232AAC, Argentina

Location

Instituto Oftalmológico Pedro Lagleyze

CABA, C1416 DJI, Argentina

Location

Hospital Churruca - Visca

CABA, C1437, Argentina

Location

MeSH Terms

Conditions

Conjunctivitis, Allergic

Interventions

bepotastine besilateOlopatadine Hydrochloride

Condition Hierarchy (Ancestors)

ConjunctivitisConjunctival DiseasesEye DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

DibenzoxepinsHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: MULTICENTRIC, DOUBLE BLIND, RANDOMIZED, CONTROLLED, 60 DAYS, GROUP PARALLEL GROUPS, TO SHOW SUPERIORITY.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 25, 2021

First Posted

March 1, 2021

Study Start

March 10, 2021

Primary Completion

August 18, 2022

Study Completion

August 18, 2022

Last Updated

December 15, 2022

Record last verified: 2022-12

Locations

AR(4)