Bepreve vs. Alrex in Subjects With Moderate to Severe Allergic Conjunctivitis

Study Overview
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Brief Summary
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Allergic conjunctivitis (AC) afflicts approximately 20% of the US population. Typically, patients manifest symptoms in the spring, summer and fall, when airborne allergens are at their peak. Patients may also be afflicted year-round, if sensitive to allergens such as dust mites or pet dander. Signs and symptoms of allergic conjunctivitis are conjunctival hyperemia, ocular itching, conjunctival and eyelid edema, papillary hypertrophy, tearing and burning. This is a randomized clinical study to evaluate the efficacy of Bepreve® (bepotastine besilate 1.5% ophthalmic solution) compared to Alrex® (loteprednol etabonate 0.2%) in the treatment of moderate to severe allergic conjunctivitis in patient over the age of 18 years. The study will be a two-week study with four visits. Ocular signs (eye redness( and symptoms (itching) will be monitored as outcome variables.

Detailed Description
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Investigator and Study Center: Judy Tong, OD Eye Care Center Southern California College of Optometry Test Product, Dose and Mode of Administration: Bepreve (bepotastine besilate ophthalmic solution) 1.5% bid ou vs. Alrex (loteprednol etabonate ophthalmic suspension) 0.2% qid ou Study Title: A Single-Center, Masked, Randomized Study Comparing Bepreve (bepotastine besilate) 1.5% - H1 Specific Antihistamine vs. Alrex (loteprednol etabonate) 0.2% - Corticosteroid in Subjects with Moderate to Severe Allergic Conjunctivitis Primary Objective(s): The primary objective of this study is to compare the efficacy of Bepreve (bepotastine besilate) 1.5% ophthalmic solution compared to Alrex (loteprednol etabonate) 0.2% in the treatment of moderate to severe allergic conjunctivitis in patients over the age of 18 years of age Study Design: Interventional, Randomized, Parallel Arm, Investigator Masked Study Population: Subjects over the age of 18 years of age with moderate to severe allergic conjunctivitis. Duration of Treatment: 14 days Efficacy Assessments: Itching, Bulbar conjunctival injection, Bulbar conjunctival chemosis Safety Assessments: N/A

Official Title
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A Single-Center, Masked, Randomized Study Comparing Bepreve (Bepotastine Besilate) 1.5% - H1 Specific Antihistamine vs. Alrex (Loteprednol Etabonate) 0.2% - Corticosteroid in Subjects With Moderate to Severe Allergic Conjunctivitis

Conditions
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Allergic Conjunctivitis

Intervention / Treatment
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* Drug: bepotastine besilate, 1.5%
* Drug: Loteprednol etabonate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Moderate to severe allergic subjects (≥ 2.5 on a 0.0 to 4.0 itching scale AND > grade 2.0 bulbar redness using validated (Efron) scale) Must be able to understand and sign an informed consent form that has been approved by the Institutional Review Board (IRB). Can comply with instillation of study drug Must be able to comply with the visit schedule and other requirements of the study. Exclusion Criteria: Subjects who use daily wear (5-7 days / week, 6-16 hours/day)25 disposable soft hydrogel or silicone hydrogel contact lenses will be included in the study if they have been consistently wearing the same brand and have been using the same care solution for one month or longer. They will be asked to not wear their soft contact lenses to the eligibility visit (three days of no lens wear) and be willing to discontinue lens wear during the two weeks of the study because of the incompatibility of medicated eye drop instillation with contact lens wear and the potential confounding effect of contact lenses and care solutions. Active inflammation of the cornea, iris, anterior chamber Active or suspected herpetic eye disease (simplex, vaccinia, varicella) Active or suspected mycobacterial or acanthamoeba infection Active for suspected fungal disorders of the eye Persistent and significant dry eye syndrome Known allergy, contraindications or hypersensitivity to loteprednol, bepotastine, or its components Pregnancy or breast-feeding Use of topical eye drops, topical or systemic antihistamines, topical, nasal or systemic corticosteroids, immunosuppressive or immunomodulating agents, decongestants, aspirin, or non-steroidal antiinflammatory (NSAIDs) during the two weeks prior to the study. Participation in any other study within 30 days of this study.

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
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Bepreve<br>1.5% bepotastine besilate, drops, twice per day, for two weeks | Drug: bepotastine besilate, 1.5%<br>* Topical ocular aqueous formulation, oen drop per instillation, twice per day for 14 days<br>* Other names: Bepreve;|
| Active Comparator: Alrex<br>treatment with 0.2 % loteprednol etabonate, drops, four times per day | Drug: Loteprednol etabonate<br>* Topical ocular aqueous formulation, one drop per instillation, four times per day for 14 days<br>* Other names: Alrex;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Ocular Itching at 14 Days | Ocular Itching Scale. Scale is 0 - 4 in 0.5 scale unit increments. 0 equals no Itch. 4 equals most severe itch. No calculation details are necessary as the change is calculated as the latest time point minus the earliest time point. | Change from Baseline in Ocular Itching at 14 Days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bepotastine besilate, Loteprednol etabonate, Conjunctivitis, Allergic