Study Evaluating the Efficacy and Safety of PRT-2761 for the Treatment of Acute and Chronic Allergic Conjunctivitis

Study Overview
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Brief Summary
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To evaluate the efficacy and safety of two concentrations of PRT-2761 as a topical ophthalmic solution for the treatment of the signs and symptoms of acute and chronic allergic conjunctivitis.

Official Title
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A Single-Center, Randomized, Double-Masked, Vehicle and Active-Controlled, Dose-Ranging Phase 2 Study Evaluating the Efficacy and Safety of PRT-2761 for the Treatment of Acute and Chronic Allergic Conjunctivitis Using the Conjunctival Allergen Challenge Model (Ora-CAC®)

Conditions
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Allergic Conjunctivitis

Intervention / Treatment
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* Drug: PRT-2761 0.5%
* Drug: PRT-2761 1%
* Drug: Patanol
* Drug: Pred-forte
* Drug: PRT-2761 0%


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: be at least 18 years old be willing and able to avoid all disallowed medications and contact lenses must have a pregnancy test if of childbearing potential must be able to read an eye chart from 10 feet away Exclusion Criteria: must not have any allergies to the study medications must not have any ocular or non ocular condition that investigator feels will interfere with study parameters must not have used an investigational drug or device in the past 30 days or concurrently enrolled in another investigational trial

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PRT-2761 0.5%<br> | Drug: PRT-2761 0.5%<br>* Six drops in each eye over a 17 day period.<br>|
| Experimental: PRT-2761 1%<br> | Drug: PRT-2761 1%<br>* Six drops in each eye over a 17 day period.<br>|
| Active Comparator: Patanol<br> | Drug: Patanol<br>* Six drops in each eye over a 17 day period.<br>|
| Active Comparator: Pred-forte<br> | Drug: Pred-forte<br>* Four drops in each eye over a 3 day period.<br>|
| Placebo Comparator: PRT-2761 0%<br> | Drug: PRT-2761 0%<br>* Six drops in each eye over a 17 day period.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ocular Itching at 5, 7, and 10 Minutes Post CAC on Day 1 | Ocular Itching was assessed by a trained investigator post-conjunctival allergen challenge (CAC) on a 0 to 4 scale (0=none (best/no itching) to 4=severe (worst/most itching). The ocular itching was averaged across all subjects at each time point. | post CAC exposure at 5, 7, and 10 minutes post CAC on Day 1 | 
| Ocular Itching at 5, 7, and 10 Minutes Post CAC on Day 15 | Ocular Itching was assessed by the subjects using a 0 to 4 point scale(0=none (best/no itching) to 4=severe (worst/most itching)). The ocular itching was averaged across all subjects at each time point. | post CAC exposure at 5, 7, and 10 minutes post CAC on Day 15 | 
| Conjunctival Redness at 7, 15, and 20 Minutes Post CAC on Day 1 | Conjunctival Redness was assessed by a trained investigator post-conjunctival allergen challenge (CAC) on a 0 to 4 scale (0=none (best/no redness) to 4=severe (worst/most redness)). The conjunctival redness was averaged across all subjects at each time point. | post CAC exposure at 7, 15, and 20 minutes post-CAC on Day 1. | 
| Conjunctival Redness at 7, 15, and 20 Minutes Post CAC on Day 15 | Conjunctival Redness was assessed by a trained investigator post-conjunctival allergen challenge (CAC) on a 0 to 4 scale (0=none (best/no redness) to 4=severe (worst/most redness)). The conjunctival redness was averaged across all subjects at each time point. | post CAC exposure at 7, 15, and 20 minutes post-CAC on Day 15. |