Efficacy of AC-170 for the Treatment of Allergic Conjunctivitis in the 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 efficacy of different concentrations of AC-170 compared to vehicle in the prevention of the signs and symptoms of allergic conjunctivitis in the conjunctival allergen challenge (CAC) Model.

Official Title
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A Single Center, Double-Masked, Randomized, Vehicle-Controlled, Parallel-Group Study Evaluating the Efficacy of Three Different Concentrations of Cetirizine (0.05%, 0.1%, and 0.24%) Ophthalmic Solution Versus Vehicle in the Treatment of Allergic Conjunctivitis in the Conjunctival Allergen Challenge Model (CAC)

Conditions
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Allergic Conjunctivitis

Intervention / Treatment
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* Drug: AC-170 0.05%
* Drug: AC-170 0.1%
* Drug: AC-170 0.24%
* Drug: AC-170 0%


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Positive bilateral conjunctival allergen challenge (CAC) reaction 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 the 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AC-170 0.05%<br> | Drug: AC-170 0.05%<br>* 1 drop in each eye at 3 separate times during a 21 day period<br>|
| Experimental: AC-170 0.1%<br> | Drug: AC-170 0.1%<br>* 1 drop in each eye at 3 separate times during a 21 day period<br>|
| Experimental: AC-170 0.24%<br> | Drug: AC-170 0.24%<br>* 1 drop in each eye at 3 separate times during a 21 day period<br>|
| Placebo Comparator: AC-170 0%<br> | Drug: AC-170 0%<br>* 1 drop in each eye at 3 separate times during a 21 day period<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ocular Itching at Duration of Action (16 Hours Post-dose) | A treatment efficacy CAC was performed 16 hours after drop instillation. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed. | 3, 5, 7 minutes post-CAC | 
| Ocular Itching at Duration of Action (24 Hours Post-dose) | A treatment efficacy CAC was performed 24 hours after drop instillation. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed. | 3, 5, 7 minutes post-CAC | 
| Ocular Itching at Onset of Action (15 Minutes Post-dose) | A treatment efficacy CAC was performed 15 minutes after drop instillation. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed. | 3, 5, 7 minutes post-CAC | 
| Conjunctival Redness at Duration of Action (16 Hours Post-dose) | A treatment efficacy CAC was performed 16 hours after drop instillation. Conjunctival Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of conjunctival redness score over both eyes was analyzed. | 7, 15, 20 minutes post-CAC | 
| Conjunctival Redness at Duration of Action (24 Hours Post-dose) | A treatment efficacy CAC was performed 24 hours after drop instillation. Conjunctival Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of conjunctival redness score over both eyes was analyzed. | 7, 15, 20 minutes post-CAC | 
| Conjunctival Redness at Onset of Action (15 Minutes Post-dose) | A treatment efficacy CAC was performed 15 minutes after drop instillation. Conjunctival Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of conjunctival redness score over both eyes was analyzed. | 7, 15, 20 minutes post-CAC | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ciliary Redness at Duration of Action (16 Hours Post-dose) | A treatment efficacy CAC was performed 16 hours after drop instillation. Ciliary Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ciliary redness score over both eyes was analyzed. | 7, 15, 20 minutes post-CAC | 
| Ciliary Redness at Duration of Action (24 Hours Post-dose) | A treatment efficacy CAC was performed 24 hours after drop instillation. Ciliary Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ciliary redness score over both eyes was analyzed. | 7, 15, 20 minutes post-CAC | 
| Ciliary Redness at Onset of Action (15 Minutes Post-dose) | A treatment efficacy CAC was performed 15 minutes after drop instillation. Ciliary Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ciliary redness score over both eyes was analyzed. | 7, 15, 20 minutes post-CAC | 
| Episcleral Redness at Duration of Action (16 Hours Post-dose) | A treatment efficacy CAC was performed 16 hours after drop instillation. Episcleral Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of episcleral redness score over both eyes was analyzed. | 7, 15, 20 minutes post-CAC | 
| Episcleral Redness at Duration of Action (24 Hours Post-dose) | A treatment efficacy CAC was performed 24 hours after drop instillation. Episcleral Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of episcleral redness score over both eyes was analyzed. | 7, 15, 20 minutes post-CAC | 
| Episcleral Redness at Onset of Action (15 Minutes Post-dose) | A treatment efficacy CAC was performed 15 minutes after drop instillation. Episcleral Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of episcleral redness score over both eyes was analyzed. | 7, 15, 20 minutes post-CAC | 
| Chemosis at Duration of Action (16 Hours Post-dose) | A treatment efficacy CAC was performed 16 hours after drop instillation. Chemosis was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of chemosis score over both eyes was analyzed. | 7, 15, 20 minutes post-CAC | 
| Chemosis at Duration of Action (24 Hours Post-dose) | A treatment efficacy CAC was performed 24 hours after drop instillation. Chemosis was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of chemosis score over both eyes was analyzed. | 7, 15, 20 minutes post-CAC | 
| Chemosis at Onset of Action (15 Minutes Post-dose) | A treatment efficacy CAC was performed 15 minutes after drop instillation. Chemosis was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of chemosis score over both eyes was analyzed. | 7, 15, 20 minutes post-CAC | 
| Eyelid Swelling at Duration of Action (16 Hours Post-dose) | A treatment efficacy CAC was performed 16 hours after drop instillation. Eyelid swelling was assessed by the patient on a 0-3 scale (0=none to 3=severe). Average of eyelid swelling score over both eyes was analyzed. | 7, 15, 20 minutes post-CAC | 
| Eyelid Swelling at Duration of Action (24 Hours Post-dose) | A treatment efficacy CAC was performed 24 hours after drop instillation. Eyelid swelling was assessed by the patient on a 0-3 scale (0=none to 3=severe). Average of eyelid swelling score over both eyes was analyzed. | 7, 15, 20 minutes post-CAC | 
| Eyelid Swelling at Onset of Action (15 Minutes Post-dose) | A treatment efficacy CAC was performed 15 minutes after drop instillation. Eyelid swelling was assessed by the patient on a 0-3 scale (0=none to 3=severe). Average of eyelid swelling score over both eyes was analyzed. | 7, 15, 20 minutes post-CAC | 
| Tearing at Duration of Action (16 Hours Post-dose) | A treatment efficacy CAC was performed 16 hours after drop instillation. Tearing was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of tearing score over both eyes was analyzed. | 7, 15, 20 minutes post-CAC | 
| Tearing at Duration of Action (24 Hours Post-dose) | A treatment efficacy CAC was performed 24 hours after drop instillation. Tearing was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of tearing score over both eyes was analyzed. | 7, 15, 20 minutes post-CAC | 
| Tearing at Onset of Action (15 Minutes Post-dose) | A treatment efficacy CAC was performed 15 minutes after drop instillation. Tearing was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of tearing score over both eyes was analyzed. | 7, 15, 20 minutes post-CAC | 
| Rhinorrhea at Duration of Action (16 Hours Post-dose) | A treatment efficacy CAC was performed 16 hours after drop instillation. Rhinorrhea was assessed by the patient on a 0-4 scale (0=none to 4=severe). Rhinorrhea score for each time point was analyzed. | 7, 15, 20 minutes post-CAC | 
| Rhinorrhea at Duration of Action (24 Hours Post-dose) | A treatment efficacy CAC was performed 24 hours after drop instillation. Rhinorrhea was assessed by the patient on a 0-4 scale (0=none to 4=severe). Rhinorrhea score for each time point was analyzed. | 7, 15, 20 minutes post-CAC | 
| Rhinorrhea at Onset of Action (15 Minutes Post-dose) | A treatment efficacy CAC was performed 15 minutes after drop instillation. Rhinorrhea was assessed by the patient on a 0-4 scale (0=none to 4=severe). Rhinorrhea score for each time point was analyzed. | 7, 15, 20 minutes post-CAC | 
| Nasal Pruritus at Duration of Action (16 Hours Post-dose) | A treatment efficacy CAC was performed 16 hours after drop instillation. Nasal Pruritus was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Pruritus score for each time point was analyzed. | 7, 15, 20 minutes post-CAC | 
| Nasal Pruritus at Duration of Action (24 Hours Post-dose) | A treatment efficacy CAC was performed 24 hours after drop instillation. Nasal Pruritus was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Pruritus score for each time point was analyzed. | 7, 15, 20 minutes post-CAC | 
| Nasal Pruritus at Onset of Action (15 Minutes Post-dose) | A treatment efficacy CAC was performed 15 minutes after drop instillation. Nasal Pruritus was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Pruritus score for each time point was analyzed. | 7, 15, 20 minutes post-CAC | 
| Ear or Palate Pruritus at Duration of Action (16 Hours Post-dose) | A treatment efficacy CAC was performed 16 hours after drop instillation. Ear or Palate Pruritus was assessed by the patient on a single 0-4 scale (0=none to 4=severe). Ear or Palate Pruritus score for each time point was analyzed. | 7, 15, 20 minutes post-CAC | 
| Ear or Palate Pruritus at Duration of Action (24 Hours Post-dose) | A treatment efficacy CAC was performed 24 hours after drop instillation. Ear or Palate Pruritus was assessed by the patient on a single 0-4 scale (0=none to 4=severe). Ear or Palate Pruritus score for each time point was analyzed. | 7, 15, 20 minutes post-CAC | 
| Ear or Palate Pruritus at Onset of Action (15 Minutes Post-dose) | A treatment efficacy CAC was performed 15 minutes after drop instillation. Ear or Palate Pruritus was assessed by the patient on a single 0-4 scale (0=none to 4=severe). Ear or Palate Pruritus score for each time point was analyzed. | 7, 15, 20 minutes post-CAC | 
| Nasal Congestion at Onset of Action (16 Hours Post-dose) | A treatment efficacy CAC was performed 16 hours after drop instillation. Nasal Congestion was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Congestion score for each time point was analyzed. | 7, 15, 20 minutes post-CAC | 
| Nasal Congestion at Duration of Action (24 Hours Post-dose) | A treatment efficacy CAC was performed 24 hours after drop instillation. Nasal Congestion was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Congestion score for each time point was analyzed. | 7, 15, 20 minutes post-CAC | 
| Nasal Congestion at Onset of Action (15 Minutes Post-dose) | A treatment efficacy CAC was performed 15 minutes after drop instillation. Nasal Congestion was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Congestion score for each time point was analyzed. | 7, 15, 20 minutes post-CAC | 
| Nasal Composite Score at Duration of Action (16 Hours Post-dose) | A nasal composite score was summed for each patient based on the presence of at least one of the following four nasal symptoms on a 0-4 scale (0=none to 4=severe): rhinorrhea; nasal pruritus; ear or palate pruritus; and nasal congestion. The percentage of subjects with at least one nasal symptom present was calculated for each time point. | 7, 15, 20 minutes post-CAC | 
| Nasal Composite Score at Duration of Action (24 Hours Post-dose) | A nasal composite score was summed for each patient based on the presence of at least one of the following four nasal symptoms on a 0-4 scale (0=none to 4=severe): rhinorrhea; nasal pruritus; ear or palate pruritus; and nasal congestion. The percentage of subjects with at least one nasal symptom present was calculated for each time point. | 7, 15, 20 minutes post-CAC | 
| Nasal Composite Score at Onset of Action (15 Minutes Post-dose) | A nasal composite score was summed for each patient based on the presence of at least one of the following four nasal symptoms on a 0-4 scale (0=none to 4=severe): rhinorrhea; nasal pruritus; ear or palate pruritus; and nasal congestion. The percentage of subjects with at least one nasal symptom present was calculated for each time point. | 7, 15, 20 minutes post-CAC | 
| Tolerability of Study Medication at Visit 3A | Subjects were asked to rate the comfort of the drop in each eye upon instillation, at 1 minute, and at 2 minutes after instillation of study medication. The assessment used a 10-point scale with 0 as very comfortable and 10 as very uncomfortable. Higher scores represent a worse outcome.. | upon instillation, 1 minute and 2 minutes post instillation |