Efficacy of AC-170 for the Treatment of Allergic Conjunctivitis in the Conjunctival Allergen Challenge (CAC) Model (AC-170)

July 31, 2017 updated by: Aciex Therapeutics, Inc.

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

101

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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 or trial parameters.
  • Use of disallowed medications during the period indicated prior to the study enrollment or during the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ocular Itching at Onset of Action (15 Minutes Post-dose)
Time Frame: 3, 5, 7 minutes post-CAC
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)
Time Frame: 3, 5, 7 minutes post-CAC
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
Conjunctival Redness at Onset of Action (15 Minutes Post-dose)
Time Frame: 7, 15, 20 minutes post-CAC
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)
Time Frame: 7, 15, 20 minutes post-CAC
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
Ocular Itching at Duration of Action (24 Hours Post-dose)
Time Frame: 3, 5, 7 minutes post-CAC
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
Conjunctival Redness at Duration of Action (24 Hours Post-dose)
Time Frame: 7, 15, 20 minutes post-CAC
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ciliary Redness at Onset of Action (15 Minutes Post-dose)
Time Frame: 7, 15, 20 minutes post-CAC
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)
Time Frame: 7, 15, 20 minutes post-CAC
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
Episcleral Redness at Onset of Action (15 Minutes Post-dose)
Time Frame: 7, 15, 20 minutes post-CAC
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
Ear or Palate Pruritus at Onset of Action (15 Minutes Post-dose)
Time Frame: 7, 15, 20 minutes post-CAC
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
Eyelid Swelling at Onset of Action (15 Minutes Post-dose)
Time Frame: 7, 15, 20 minutes post-CAC
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 Onset of Action (15 Minutes Post-dose)
Time Frame: 7, 15, 20 minutes post-CAC
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 Onset of Action (15 Minutes Post-dose)
Time Frame: 7, 15, 20 minutes post-CAC
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 Onset of Action (15 Minutes Post-dose)
Time Frame: 7, 15, 20 minutes post-CAC
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
Nasal Congestion at Onset of Action (15 Minutes Post-dose)
Time Frame: 7, 15, 20 minutes post-CAC
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
Chemosis at Onset of Action (15 Minutes Post-dose)
Time Frame: 7, 15, 20 minutes post-CAC
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
Ciliary Redness at Duration of Action (24 Hours Post-dose)
Time Frame: 7, 15, 20 minutes post-CAC
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
Episcleral Redness at Duration of Action (16 Hours Post-dose)
Time Frame: 7, 15, 20 minutes post-CAC
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)
Time Frame: 7, 15, 20 minutes post-CAC
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
Chemosis at Duration of Action (16 Hours Post-dose)
Time Frame: 7, 15, 20 minutes post-CAC
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)
Time Frame: 7, 15, 20 minutes post-CAC
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
Eyelid Swelling at Duration of Action (16 Hours Post-dose)
Time Frame: 7, 15, 20 minutes post-CAC
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)
Time Frame: 7, 15, 20 minutes post-CAC
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
Tearing at Duration of Action (16 Hours Post-dose)
Time Frame: 7, 15, 20 minutes post-CAC
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)
Time Frame: 7, 15, 20 minutes post-CAC
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
Rhinorrhea at Duration of Action (16 Hours Post-dose)
Time Frame: 7, 15, 20 minutes post-CAC
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)
Time Frame: 7, 15, 20 minutes post-CAC
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
Nasal Pruritus at Duration of Action (16 Hours Post-dose)
Time Frame: 7, 15, 20 minutes post-CAC
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)
Time Frame: 7, 15, 20 minutes post-CAC
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
Ear or Palate Pruritus at Duration of Action (16 Hours Post-dose)
Time Frame: 7, 15, 20 minutes post-CAC
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)
Time Frame: 7, 15, 20 minutes post-CAC
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
Nasal Congestion at Onset of Action (16 Hours Post-dose)
Time Frame: 7, 15, 20 minutes post-CAC
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)
Time Frame: 7, 15, 20 minutes post-CAC
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 Composite Score at Duration of Action (16 Hours Post-dose)
Time Frame: 7, 15, 20 minutes post-CAC
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)
Time Frame: 7, 15, 20 minutes post-CAC
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)
Time Frame: 7, 15, 20 minutes post-CAC
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
Time Frame: upon instillation, 1 minute and 2 minutes post instillation
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

This is where you will find people and organizations involved with this study.

Sponsor

Aciex Therapeutics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

October 1, 2011

Study Registration Dates

First Submitted

April 7, 2011

First Submitted That Met QC Criteria

April 8, 2011

First Posted (Estimate)

April 11, 2011

Study Record Updates

Last Update Posted (Actual)

August 30, 2017

Last Update Submitted That Met QC Criteria

July 31, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11-100-0004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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