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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Allergic Conjunctivitis

Intervention / Treatment
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* Drug: Bepotastine Besilate 1.5% PF
* Drug: Olopatadine Hydrochloride 0.2% BAK


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: MULTICENTRIC, DOUBLE BLIND, RANDOMIZED, CONTROLLED, 60 DAYS, GROUP PARALLEL GROUPS, TO SHOW SUPERIORITY.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bepotastine besilate 1,5% preservative free<br>Bepotastine besilate 1,5% in preservative-free bottle, administered once a day during the morning. | Drug: Bepotastine Besilate 1.5% PF<br>* Bepotastine besilate 1,5% Preservative free ophthalmic solution<br>* Other names: TRALER LC;|
| Active Comparator: Olopatadine hydrochloride 0,2% with BAK<br>Olopatadine hydrochloride 0,2% with BAK as preservative, administered once a day during the morning. | Drug: Olopatadine Hydrochloride 0.2% BAK<br>* Olopatadine hydrochloride 0.2% with BAK as preservative<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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