Alrex® Versus Patanol in the Treatment of Seasonal Allergic Conjunctivitis(SAC)

Study Overview
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Brief Summary
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This study is to evaluate the safety and efficacy of Alrex (LE ophthalmic suspension, 0.2%) versus Patanol (olopatadine hydrochloride ophthalmic solution, 0.1%) in the temporary relief of the signs and symptoms of Seasonal Allergic Conjunctivitis (SAC).

Official Title
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A Clinical Safety and Efficacy Evaluation of Alrex® (Loteprednol Etabonate Ophthalmic Suspension, 0.2%) Versus Patanol (Olopatadine Hydrochloride Ophthalmic Solution, 0.1%) in the Treatment of Seasonal Allergic Conjunctivitis (SAC)

Conditions
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Seasonal Allergic Conjunctivitis

Intervention / Treatment
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* Drug: Loteprednol etabonate 0.2%
* Drug: Olopatadine 0.1%


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects who are diagnosed with acute SAC and experience at least grade 4 ocular itching and at least grade 2 bulbar conjunctival injection (redness) in each eye due to seasonal allergy at Visit 1. Exclusion Criteria: Subjects who have a known hypersensitivity to the study medications or their components or contraindications to ocular corticosteroids. Subjects who use any of the disallowed medications throughout the duration of the study and during the period indicated prior to Visit 1. Subjects who have intraocular pressure (IOP) greater than 21 mm Hg in either eye or any type of glaucoma. Subjects who have a history of any severe/serious ocular pathology or medical condition that could result in the subject's inability to complete the study or affect the subject's safety or trial parameters.

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 |
| --- | --- |
| Experimental: Alrex<br>Ophthalmic formulation containing the active ingredient loteprednol etabonate, 0.2% | Drug: Loteprednol etabonate 0.2%<br>* 1 drop of Alrex 4 times daily (QID) in both eyes at approximately 4 hour intervals for 2 weeks.<br>* Other names: Alrex;|
| Active Comparator: Patanol<br>Ophthalmic solution containing olopatadine, 0.1% | Drug: Olopatadine 0.1%<br>* 1 drop of Patanol 2 times daily (BID)at intervals of 6-8 hours or more for 2 weeks.<br>* Other names: Patanol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bulbar Conjunctival Injection | Bulbar conjunctival injection (sign) evaluated using a grading scale from 0-3: where 0 = Absent and 3 = Severe | Change from baseline to day 15 (visit 3) | 
| Ocular Itching | Ocular itching (symptom) evaluated using a grading scale from 0-4 where 0 = Absent and 4 = Severe | Change from baseline to day 15 (visit 3) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bulbar Conjunctival Injection | Bulbar conjunctival injection (sign) evaluated using a grading scale from 0-3: where 0 = Absent and 3 = Severe | Change from baseline to day 8 (visit 2) | 
| Ocular Itching | Ocular itching (symptom) evaluated using a grading scale from 0-4 where 0 = Absent and 4 = Severe | Change from baseline to day 8 (visit 2) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ocular allergy