Loteprednol Ophthalmic Base Compared to Loteprednol Ophthalmic Suspension vs Placebo in an Allergen Challenge

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the efficacy of loteprednol etabonate ophthalmic base, compared to loteprednol etabonate ophthalmic suspension, and vehicle in the prevention of the signs and symptoms of allergic conjunctivitis in a modified Conjunctival Allergen Challenge model and in an environmental model during pollen season. Comparisons will be made following 2 weeks of dosing.

Official Title
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Efficacy of Loteprednol Etabonate Ophthalmic Base Compared to Loteprednol Etabonate Ophthalmic Suspension vs Placebo in a Modified Conjunctival Allergen Challenge(CAC) Model

Conditions
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Allergic Conjunctivitis

Intervention / Treatment
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* Drug: Loteprednol etabonate base (QD)
* Drug: Loteprednol etabonate base (BID)
* Drug: Loteprednol etabonate base (QID)
* Drug: Loteprednol etabonate suspension
* Drug: Vehicle of loteprednol etabonate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Positive history of ocular allergies and positive skin test reaction to cat hair, cat dander, grasses, ragweed, and/or trees within the past 24 months. Calculated best-corrected visual acuity of 0.70 logMAR or better in each eye as measured using the ETDRS chart. Positive bilateral conjunctival allergen challenge(CAC)reaction within 10 minutes of instillation of the last titration of allergen at visit 1. Positive bilateral CAC reaction in 1 out of 3 time points for the initial and re-challenge at visit 2. Exclusion Criteria: Known contraindications or sensitivities to the study medication or its components. Any ocular condition that, in the opinion of the investigator, could affect the subjects safety or trial parameters. Use of disallowed medications during the period indicated prior to study enrollment or during the study.

Ages Eligible for Study
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Minimum Age: 10 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Loteprednol etabonate base (QD)<br>Loteprednol etabonate ophthalmic base dosed once/day. | Drug: Loteprednol etabonate base (QD)<br>* Loteprednol Etabonate ophthalmic base once daily dosing for 2 weeks<br>|
| Active Comparator: Loteprednol etabonate base (BID)<br>Loteprednol etabonate ophthalmic base dosed two times/day | Drug: Loteprednol etabonate base (BID)<br>* Loteprednol etabonate ophthalmic base BID dosing for 2 weeks<br>|
| Active Comparator: Loteprednol etabonate base (QID)<br>Loteprednol etabonate ophthalmic base dosed four times/day. | Drug: Loteprednol etabonate base (QID)<br>* Loteprednol Etabonate ophthalmic base four times/day dosing for 2 week<br>|
| Active Comparator: Loteprednol etabonate suspension (QID)<br>Loteprednol etabonate ophthalmic suspension dosed four times/day | Drug: Loteprednol etabonate suspension<br>* Loteprednol etabonate ophthalmic suspension dosed four times daily for 2 weeks.<br>|
| Placebo Comparator: Vehicle of loteprednol etabonate<br>Vehicle of loteprednol etabonate, dosed either QD, BID, or QID | Drug: Vehicle of loteprednol etabonate<br>* Vehicle of loteprednol etabonate ophthalmic dosed once, twice or four times daily for 2 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ocular Itching | Evaluated by subject at 3, 5, and 7 min post challenge on a scale of 0-4 where 0=no itching and 4=incapacitating itch. | Visit 4 (8 hr re-challenge) | 
| Conjunctival Redness | Evaluated by investigator at 7, 15 and 20 minutes post challenge on a scale of 0-4 where 0= no redness and 4=extremely severe redness. | Visit 4 (8 hr re-challenge) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ocular Itching | Evaluated by the subject at 3, 5 and 7 min post-challenge on a scale of 0-4 where 0=no itching and 4=incapacitating itch. | Visit 3 (initial challenge) | 
| Conjunctival Redness | Evaluated by investigator at 7, 15 and 20 minutes post challenge on a scale of 0-4 where 0= no redness and 4=extremely severe redness. | Visit 3 (initial challenge) | 
| Ocular Itching | Evaluated by the subject at 3, 5 and 7 min post-challenge on a scale of 0-4 where 0=no itching and 4=incapacitating itch. | Visit 4 (initial challenge) | 
| Conjunctival Redness | Evaluated by investigator at 7, 15 and 20 minutes post challenge on a scale of 0-4 where 0= no redness and 4=extremely severe redness. | Visit 4 (initial challenge) |