Evaluation of Prednisolone in a Modified Conjunctival Allergen Challenge Model

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the effectiveness of the modified Conjunctival Allergen Challenge (CAC) and observe how the produced allergic inflammation reacts to treatment with a proven ocular anti-inflammatory medication, Prednisolone, assessed by the following measures: Chronic Allergic Inflammation assessed using confocal microscopy Ocular itching Conjunctival redness

Detailed Description
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Prospective, single center, randomized, double-masked, placebo controlled study. Subjects will be randomized to one of the following treatment arms to dose four times per day (QID) for 4 days between Visits 3 and 4. Prednisolone phosphate Tears Naturale II Ophthalmic Solution (Placebo) Duration: Approximately 2 weeks Controls: Artificial Tears (Tears Naturale® II)

Official Title
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A Single-Center, Double-Masked, Randomized, Placebo-Controlled Evaluation of Prednisolone Sodium Phosphate Ophthalmic Solution, 1% Compared to Placebo in a Modified Conjunctival Allergen Challenge (CAC) Model

Conditions
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Chronic Allergic Conjunctivitis

Intervention / Treatment
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* Drug: Prednisolone Sodium Phosphate Ophthalmic Solution 1%
* Drug: Tears Naturale II Ophthalmic Solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least 18 years of age & either sex, any race Willing and able to follow all instructions Positive history of ocular allergies Reproducible positive ocular allergic reaction induced by conjunctival allergen challenge Exclusion Criteria: Have planned surgery during trial period Female currently pregnant, planning a pregnancy or lactating Use of disallowed medications Have ocular infections, or ocular conditions that could affect study parameters Have moderate to severe dry eye Have used an investigational drug or device within 30 days of start of study Female that is currently pregnant, planning a pregnancy or lactating

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prednisolone<br>Prednisolone Sodium Phosphate Ophthalmic Solution, 1% | Drug: Prednisolone Sodium Phosphate Ophthalmic Solution 1%<br>* One drop in each eye, four times/day for 4 days.<br>|
| Placebo Comparator: Placebo<br>Tears Naturale II Ophthalmic Solution, 1% | Drug: Tears Naturale II Ophthalmic Solution<br>* one drop in each eye, four times/ day (QID) for 4 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inflammation Change From Baseline to Day 6 | Ocular inflammation was measured by a masked clinician on a 4-point scale 90 minutes after the conjunctival allergen challenge (CAC) . 0 = best (little to no inflammation), 4 = worst (most inflammation). | 90 minutes post CAC | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ocular Itching Change From Baseline to Day 6 | Ocular itching was measured by subject on a scale of 0 to 4 where 0 = no itching and 4 = worst itching. This measurement was taken 7 minutes post CAC | 7 minutes post-CAC | 
| Ocular Redness Change From Baseline to Day 6 | Ocular redness was measured by the investigator on a 4-point scale 7 minutes post-CAC. 0 = best (no redness), 4 = worst (most redness). | 7 minutes post-CAC |