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

Allergic Conjunctivitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04776096
• Other study ID #: ANTILERG001-19
• Status: Completed
• Phase: Phase 4
• Start date: March 10, 2021
• Est. completion date: August 18, 2022

Study information

• Verified date: December 2022
• Source: Laboratorios Poen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 97
• Est. completion date: August 18, 2022
• Est. primary completion date: August 18, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Allergic Conjunctivitis
• Conjunctivitis
• Conjunctivitis, Allergic

Intervention

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

Locations

Country	Name	City	State
Argentina	Hospital Churruca - Visca	Caba
Argentina	Hospital de Alta Complejidad El Cruce - Nestor Kirchner	Caba
Argentina	Hospital Santa Lucía	Caba
Argentina	Instituto Oftalmológico Pedro Lagleyze	Caba

Sponsors (1)

Lead Sponsor	Collaborator
Laboratorios Poen

Country where clinical trial is conducted

Argentina, 

Outcome

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