Evaluation of the Onset and Duration of Action of RX-10045 in Allergic Conjunctivitis

Study Overview
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Brief Summary
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To purpose of this study is to establish the efficacy and safety of RX-10045 ophthalmic solution in alleviating the signs and symptoms of allergic conjunctivitis

Detailed Description
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Allergies are relatively common among the general population. Ocular signs and symptoms include itching, discomfort, redness, chemosis, tearing, and eyelid swelling. Allergic reactions can vary from a mild, self-limiting disease, to a debilitating condition that significantly impairs the quality of life of allergen-sensitive individuals. Currently approved treatments for ocular allergy reduce the signs and symptoms of the early phase reaction; however, evidence suggests that many patients suffer from the persistent late phase reaction. Manifestations of the late phase reaction occur 6 to 24 hours after allergen exposure and are characterized by an influx of acute inflammatory cells into the conjunctivae. Administration of anti-inflammatory agents decreases allergy signs and symptoms in both the early and late phase reactions. RX-10045 has been shown to be efficacious in multiple pre-clinical dry eye disease models and in a pre-clinical model of allergic conjunctivitis. The objective of this clinical study is to assess the safety and efficacy of RX-10045 ophthalmic solution for the treatment of the signs and symptoms of allergic conjunctivitis induced in the Conjunctival Allergen Challenge Model of allergic conjunctivitis at 15 minutes and 8 hours after medication instillation. It is anticipated that RX-10045 has therapeutic potential for the treatment of allergic conjunctivitis and an acceptable risk-benefit profile.

Official Title
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A Single-Center, Double-Masked, Randomized, Vehicle Controlled Evaluation of the Onset and Duration of Action of RX-10045 Ophthalmic Solution, 0.09% Compared to Vehicle in the Conjunctival Allergen Challenge (CAC) Model of Allergic Conjunctivitis

Conditions
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Allergic Conjunctivitis

Intervention / Treatment
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* Drug: RX-10045
* Drug: Vehicle for RX-10045 arm


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects MUST: Have a positive history of ocular allergies Have a positive bilateral conjunctival allergen challenge (CAC) reaction Exclusion Criteria: Subjects MUST NOT: Have known contraindications or sensitivities to study medication or its components Have any ocular condition that, in the opinion of the investigator, could affect the subject's safety or trial parameters Use a disallowed medication during the period indicated prior to the enrollment or during the study Be a female who is currently pregnant, planning a pregnancy, lactating, or not using a medically acceptable form of birth control

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RX-10045 active arm<br>RX-10045 Ophthalmic Solution, 0.09% | Drug: RX-10045<br>* RX-10045 Ophthalmic Solution, 0.09% At Visits 3A and 4, a trained study technician will instill one drop of the assigned, masked study treatment, into each eye.<br>|
| Placebo Comparator: Vehicle for RX-10045 arm<br>Vehicle of RX-10045 Ophthalmic Solution | Drug: Vehicle for RX-10045 arm<br>* Vehicle of RX-10045 Ophthalmic Solution At Visits 3A and 4, a trained study technician will instill one drop of the assigned, masked study treatment, into each eye.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ocular itching | Ocular itching at defined timepoints up to 2 weeks | Baseline to day 14 | 
| Conjunctival redness | Conjunctival redness evaluated by the investigator at defined timepoints up to 2 weeks | Baseline to day 14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ciliary and episcleral redness | Ciliary and episcleral redness evaluated by the investigator at defined timepoints up to 2 weeks | Baseline to day 14 | 
| Chemosis | Chemosis evaluated by the investigator at defined timepoints up to 2 weeks | Baseline to day 14 | 
| Eyelid swelling | Eyelid swelling evaluated by the subject at defined timepoints up to 2 weeks | Baseline to day 14 | 
| Tearing | Tearing evaluated by the subject at defined timepoints up to 2 weeks | Baseline to day 14 |