Efficacy of AC-150 for the Treatment of Allergic Conjunctivitis in the Enviro-CAC™ Model

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy of AC-150 compared to vehicle and its components in the prevention of the signs and symptoms of allergic conjunctivitis in Enviro-CAC™ Model.

Official Title
-----------------
A Multi-Center, Randomized, Double-Masked Evaluation of the Efficacy of Cetirizine 0.1%/Fluticasone 0.005% Ophthalmic Solution Compared to Its Components and Vehicle in a Modified Conjunctival Allergen Challenge (CAC) Model During Pollen Season

Conditions
-----------------
Allergic Conjunctivitis

Intervention / Treatment
-----------------
* Drug: AC-150 Combo
* Drug: AC-150A 0.1%
* Drug: AC-150B 0.005%
* Drug: Vehicle


Participation Criteria
=================
Eligibility Criteria
-----------------
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 study enrollment or during the study.

Ages Eligible for Study
-----------------
Minimum Age: 10 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AC-150 Combo<br> | Drug: AC-150 Combo<br>* 1 drop in each eye for up to 14 days<br>|
| Active Comparator: AC-150A 0.1%<br> | Drug: AC-150A 0.1%<br>* 1 drop in each eye once per day for up to 14 days<br>|
| Active Comparator: AC-150B 0.005%<br> | Drug: AC-150B 0.005%<br>* 1 drop in each eye once per day for up to 14 days<br>|
| Other: Vehicle<br> | Drug: Vehicle<br>* 1 drop in each eye once per day for up to 14 days<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 8 Hours Post-dose at Visit 4A | A treatment efficacy CAC was performed 8 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 | 
| 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 | 
| 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 8 Hours Post-dose at Visit 4A | A treatment efficacy CAC was performed 8 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 8 Hours Post-dose at Visit 4A | A treatment efficacy CAC was performed 8 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 | 
| 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 | 
| 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 8 Hours Post-dose at Visit 4A | A treatment efficacy CAC was performed 8 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 | 
| Total Redness at Onset of Action (15 Minutes Post-dose) | A treatment efficacy CAC was performed 15 minutes after drop instillation. Total redness was defined as the sum of the conjunctival, ciliary and episcleral redness scores, and was, thus, on a 0-12 scale, making the threshold for clinical significance a treatment difference of 3.0 units. Higher scores represent greater severity. | 7, 15, 20 minutes post-CAC | 
| Total Redness at Duration of Action (16 Hours Post-dose) | A treatment efficacy CAC was performed 16 hours after drop instillation. Total redness was defined as the sum of the conjunctival, ciliary and episcleral redness scores, and was, thus, on a 0-12 scale, making the threshold for clinical significance a treatment difference of 3.0 units. Higher scores represent greater severity. | 7, 15, 20 minutes post-CAC | 
| Total Redness at 8 Hours Post-Dose at Visit 4A | A treatment efficacy CAC was performed 8 hours after drop instillation. Total redness was defined as the sum of the conjunctival, ciliary and episcleral redness scores, and was, thus, on a 0-12 scale, making the threshold for clinical significance a treatment difference of 3.0 units. Higher scores represent greater severity. | 7, 15, 20 minutes post-CAC | 
| Lid Swelling at Onset of Action (15 Minutes Post-dose) | A treatment efficacy CAC was performed 15 minutes after drop instillation. Lid swelling was assessed by the patient on a 0-3 scale (0=none to 3=severe). Average of lid swelling score over both eyes was analyzed. | 7, 15, 20 minutes post-CAC | 
| Lid Swelling Duration of Action (16 Hours Post-dose) | A treatment efficacy CAC was performed 16 hours after drop instillation. Lid swelling was assessed by the patient on a 0-3 scale (0=none to 3=severe). Average of lid swelling score over both eyes was analyzed. | 7, 15, 20 minutes post-CAC | 
| Lid Swelling at 8 Hours Post-dose at Visit 4A | A treatment efficacy CAC was performed 8 hours after drop instillation. Lid swelling was assessed by the patient on a 0-3 scale (0=none to 3=severe). Average of lid swelling score over both eyes 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 | 
| Ear or Palate Pruritus at Duration of Action (16 Hours 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 | 
| Ear or Palate Pruritus at 8 Hours Post-dose at Visit 4A | 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 | 
| Tolerability of Study Medication at Visit 2B | 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 | 
| Tolerability of Study Medication at Visit 3 | 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 |