Evaluation of the Efficacy of Topical Ophthalmic Steroids in a Modified Conjunctival Allergen Challenge (CAC) 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: 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 8 days between Visits 4 and 5. Prednisolone phosphate Tears Naturale II Ophthalmic Solution (Placebo) Duration: Approximately 19 days Controls: Artificial Tears (Tears Naturale® II)

Official Title
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A Phase 4, Randomized, Double-Masked, Single Center, Placebo-Controlled Adaptive Clinical Trial, Using Prednisolone Sodium Phosphate Ophthalmic Solution, 1%, in Subjects With Allergic Conjunctivitis to Evaluate a Modified Conjunctival Allergen Challenge (CAC) Model

Conditions
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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 8 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 8 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ocular Itching Change From Baseline to Day 11 | Ocular itching, as assessed by the participant, was measured on a 4-point scale 5 minutes after the conjunctival allergen challenge (CAC). 0 was best (no itching), and 4 was worst (worst itching). | 5 minutes post-CAC | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Conjunctival Redness Change From Baseline to Day 11 | Conjunctival Redness, as measured by the investigator, on a 4-point scale 7 minutes after the CAC. 0 was best (no redness), and 4 was worst (most redness) | 7 Minutes post-CAC | 
| Episcleral Redness Change From Baseline to Day 6 | Episcleral redness, as measured by the investigator, on a 4-point scale 7 minutes after the CAC.0 was best (least redness), and 4 was worst (most redness). | 7 minutes post-CAC | 
| Ciliary Redness Change From Baseline to Day 6 | Ciliary redness, as measured by the investigator, on a 4-point scale 7 minutes after the CAC. 0 was best (least redness), and 4 was worst (most redness). | 7 minutes post-CAC |