A Multi-Center, Evaluation of the Onset and Duration of Action of AC-170 0.24% Compared to Vehicle

A Multi-Center, Double-Masked, Randomized, Vehicle-Controlled, Evaluation of the Onset and Duration of Action of AC-170 0.24% Ophthalmic Solution (Formula AFH-002) Compared to Vehicle (Formula AFH-001) in the Conjunctival Allergen Challenge (CAC) Model of Acute Allergic Conjunctivitis

The purpose of this study is to evaluate the onset and duration of action of AC-170 0.24% compared to vehicle in the prevention of the signs and symptoms of allergic conjunctivitis in the conjunctival allergen challenge (CAC) model.

Study Overview

• Status: Completed
• Conditions: Allergic Conjunctivitis
• Intervention / Treatment: Drug: AC-170 0.24%; Drug: AC-170 0%

• Study Type: Interventional
• Enrollment (Actual): 101
• Phase: Phase 3

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 (Child, Adult, Older Adult)
• 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 trial parameters
• use of disallowed medication during the period indicated prior to the enrollment or during the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AC-170 0.24%	Drug: AC-170 0.24%; 1 drop in each eye at 2 separate times during a 14 day period
Placebo Comparator: AC-170 0%	Drug: AC-170 0%; 1 drop in each eye at 2 separate times during a 14 day period

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ocular Itching at Duration of Action (8 Hours + 30 Minutes Post-Dose)	A treatment efficacy CAC was performed 8 hours + 30 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 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 (8 Hours + 30 Minutes Post-Dose)	A treatment efficacy CAC was performed 8 hours + 30 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 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
Tolerability of Study Medication at Visit 3A	Tolerability was assessed upon instillation of study medication, at 1 minute and 2 minutes post study medication instillation. Drop comfort was assessed using a 0-to 10 scale where 0=very comfortable and 10=very uncomfortable.	upon instillation, 1 minute and 2 minutes post instillation
Ciliary Redness at Duration of Action (8 Hours + 30 Minutes Post-Dose)	A treatment efficacy CAC was performed 8 hours + 30 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 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 (8 Hours + 30 Minutes Post-Dose)	A treatment efficacy CAC was performed 8 hours + 30 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 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 (8 Hours + 30 Minutes Post-Dose)	A treatment efficacy CAC was performed 8 hours + 30 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
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 (8 Hours + 30 Minutes Post-Dose)	A treatment efficacy CAC was performed 8 hours + 30 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
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 (8 Hours + 30 Minutes Post-Dose)	A treatment efficacy CAC was performed 8 hours + 30 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
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 (8 Hours + 30 Minutes Post-Dose)	A treatment efficacy CAC was performed 8 hours + 30 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
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 (8 Hours + 30 Minutes Post-Dose)	A treatment efficacy CAC was performed 8 hours + 30 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
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 (8 Hours + 30 Minutes Post-Dose)	A treatment efficacy CAC was performed 8 hours + 30 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 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 Duration of Action (8 Hours + 30 Minutes Post-Dose)	A treatment efficacy CAC was performed 8 hours + 30 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 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
Percentage of Participants With At Least One Nasal Symptom at Duration of Action (8 Hours + 30 Minutes Post-Dose)	A treatment efficacy CAC was performed 8 hours + 30 minutes after drop instillation. For Nasal Composite Score the Total Composite Score ranges from 0 to 16, higher scores represent greater severity. Patients needed to have at least one of the nasal symptoms present (Rhinorrhea + Nasal Pruritus + Ear or Palate Pruritus + Nasal Congestion) each symptom was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Composite score for each time point was analyzed.	7, 15, 20 minutes post-CAC
Percentage of Participants With At Least One Nasal Symptom at Onset of Action (15 Minutes Post-Dose)	A treatment efficacy CAC was performed 15 minutes after drop instillation. For Nasal Composite Score the Total Composite Score ranges from 0 to 16, higher scores represent greater severity. Patients needed to have at least one of the nasal symptoms present (Rhinorrhea + Nasal Pruritus + Ear or Palate Pruritus + Nasal Congestion) each symptom was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Composite score for each time point was analyzed.	7, 15, 20 minutes post-CAC

Collaborators and Investigators

• Sponsor: Aciex Therapeutics, Inc.
• Investigators: Principal Investigator: Eugene McLaurin, MD, Total Eye Care, PA; Principal Investigator: Mark Bergmann, MD, Eye Care Associates of Greater Cincinnati

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Actual): October 1, 2013
• Study Completion (Actual): October 1, 2013

Study Registration Dates

• First Submitted: June 17, 2013
• First Submitted That Met QC Criteria: June 17, 2013
• First Posted (Estimate): June 19, 2013

Study Record Updates

• Last Update Posted (Actual): November 9, 2017
• Last Update Submitted That Met QC Criteria: October 11, 2017
• Last Verified: October 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; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Allergic Agents; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Histamine H1 Antagonists, Non-Sedating; Cetirizine
• Other Study ID Numbers: 13-100-0002