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

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

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.

Study Overview

• Status: Completed
• Conditions: Allergic Conjunctivitis
• Intervention / Treatment: Drug: AC-150 Combo; Drug: AC-150A 0.1%; Drug: AC-150B 0.005%; Drug: Vehicle

• Study Type: Interventional
• Enrollment (Actual): 83
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Andover, Massachusetts, United States, 01810
      • ORA, Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: AC-150 Combo	Drug: AC-150 Combo; 1 drop in each eye for up to 14 days
ACTIVE_COMPARATOR: AC-150A 0.1%	Drug: AC-150A 0.1%; 1 drop in each eye once per day for up to 14 days
ACTIVE_COMPARATOR: AC-150B 0.005%	Drug: AC-150B 0.005%; 1 drop in each eye once per day for up to 14 days
OTHER: Vehicle	Drug: Vehicle; 1 drop in each eye once per day for up to 14 days

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

Collaborators and Investigators

• Sponsor: Aciex Therapeutics, Inc.
• Investigators: Principal Investigator: Nicholas P Marsico, MD, East West Eye Institute

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (ACTUAL): July 1, 2010
• Study Completion (ACTUAL): July 1, 2010

Study Registration Dates

• First Submitted: May 28, 2010
• First Submitted That Met QC Criteria: June 1, 2010
• First Posted (ESTIMATE): June 2, 2010

Study Record Updates

• Last Update Posted (ACTUAL): September 14, 2017
• Last Update Submitted That Met QC Criteria: September 13, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity, Immediate; Eye Diseases; Hypersensitivity; Conjunctival Diseases; Conjunctivitis; Conjunctivitis, Allergic
• Other Study ID Numbers: 10-100-0005