Back to resultsA Multi-Center Study Evaluating the Onset and Duration of Action of AC-170 0.24% Compared to Vehicle in the Conjunctival Allergen Challenge (CAC)
Primary Purpose
Allergic Conjunctivitis
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
AC-170 0.24%
AC-170 0%
Sponsored by
About this trial
This is an interventional treatment trial for Allergic Conjunctivitis
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 medication during the period indicated prior to the enrollment or during the study
Sites / Locations
- Ora, Inc.
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
AC-170 0.24%
AC-170 0%
Arm Description
Outcomes
Primary Outcome Measures
Ocular Itching at Duration of Action (16 Hours + 1 Hour Post-dose)
A treatment efficacy Conjunctival Allergen Challenge (CAC) was performed 16 hours + 1 hour 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.
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.
Conjunctival Redness at Duration of Action (16 Hours + 1 Hour Post-dose)
A treatment efficacy CAC was performed 16 hours + 1 hour 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.
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.
Secondary Outcome Measures
Ciliary Redness at Duration of Action (16 Hours + 1 Hour Post-dose)
A treatment efficacy CAC was performed 16 hours + 1 hour 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.
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.
Episcleral Redness at Duration of Action (16 Hours + 1 Hour Post-dose)
A treatment efficacy CAC was performed 16 hours + 1 hour 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.
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.
Chemosis at Duration of Action (16 Hours + 1 Hour Post-dose)
A treatment efficacy CAC was performed 16 hours + 1 hour 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.
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.
Eyelid Swelling at Duration of Action (16 Hours + 1 Hour Post-dose)
A treatment efficacy CAC was performed 16 hours + 1 hour 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.
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.
Tearing at Duration of Action (16 Hours + 1 Hour Post-dose)
A treatment efficacy CAC was performed 16 hours + 1 hour 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.
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.
Rhinorrhea at Duration of Action (16 Hours +1 Hour Post-dose)
A treatment efficacy CAC was performed 16 hours + 1 hour 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.
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.
Nasal Pruritis at Duration of Action (16 Hours + 1 Hour Post-dose)
A treatment efficacy CAC was performed 16 hours + 1 hour 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.
Nasal Pruritis 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.
Ear or Palate Pruritis at Duration of Action (16 Hours + 1 Hour Post-dose)
A treatment efficacy CAC was performed 16 hours + 1 hour 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.
Ear or Palate Pruritis 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.
Nasal Congestion at Duration of Action (16 Hours + 1 Hour Post-dose)
A treatment efficacy CAC was performed 16 hours + 1 hour 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.
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.
Number of Participants With At Least One of the Nasal Symptoms Present (Rhinorrhea + Nasal Pruritus + Ear or Palate Pruritus + Nasal Congestion) at Duration of Action (16 Hours + 1 Hour Post-dose)
A treatment efficacy CAC was performed 16 hours + 1 hour 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.
Number of Participants With At Least One of the Nasal Symptoms Present (Rhinorrhea + Nasal Pruritus + Ear or Palate Pruritus + Nasal Congestion) 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.
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.
Full Information
NCT ID
NCT01551056
First Posted
March 8, 2012
Last Updated
October 6, 2017
Sponsor
Aciex Therapeutics, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01551056
Brief Title
A Multi-Center Study Evaluating the Onset and Duration of Action of AC-170 0.24% Compared to Vehicle in the Conjunctival Allergen Challenge (CAC)
Official Title
A Multi-Center, Double-Masked, Randomized, Vehicle-Controlled, Evaluation of the Onset and Duration of Action of Cetirizine 0.24% Ophthalmic Solution (Formula AFH-002) Compared to Vehicle (Formula AFH-001) in the Conjunctival Allergen Challenge (CAC) Model of Acute Allergic Conjunctivitis
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aciex Therapeutics, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Conjunctivitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
91 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AC-170 0.24%
Arm Type
Experimental
Arm Title
AC-170 0%
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
AC-170 0.24%
Intervention Description
1 drop in each eye at 2 separate times during a 14 day period
Intervention Type
Drug
Intervention Name(s)
AC-170 0%
Intervention Description
1 drop in each eye at 2 separate times during a 14 day period
Primary Outcome Measure Information:
Title
Ocular Itching at Duration of Action (16 Hours + 1 Hour Post-dose)
Description
A treatment efficacy Conjunctival Allergen Challenge (CAC) was performed 16 hours + 1 hour 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.
Time Frame
3, 5, 7 minutes post-CAC
Title
Ocular Itching at Onset of Action (15 Minutes Post-dose)
Description
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.
Time Frame
3, 5, 7 minutes post-CAC
Title
Conjunctival Redness at Duration of Action (16 Hours + 1 Hour Post-dose)
Description
A treatment efficacy CAC was performed 16 hours + 1 hour 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.
Time Frame
7, 15, 20 minutes post-CAC
Title
Conjunctival Redness at Onset of Action (15 Minutes Post-dose)
Description
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.
Time Frame
7, 15, 20 minutes post-CAC
Secondary Outcome Measure Information:
Title
Ciliary Redness at Duration of Action (16 Hours + 1 Hour Post-dose)
Description
A treatment efficacy CAC was performed 16 hours + 1 hour 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.
Time Frame
7, 15, 20 minutes post-CAC
Title
Ciliary Redness at Onset of Action (15 Minutes Post-dose)
Description
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.
Time Frame
7, 15, 20 minutes post-CAC
Title
Episcleral Redness at Duration of Action (16 Hours + 1 Hour Post-dose)
Description
A treatment efficacy CAC was performed 16 hours + 1 hour 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.
Time Frame
7, 15, 20 minutes post-CAC
Title
Episcleral Redness at Onset of Action (15 Minutes Post-dose)
Description
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.
Time Frame
7, 15, 20 minutes post-CAC
Title
Chemosis at Duration of Action (16 Hours + 1 Hour Post-dose)
Description
A treatment efficacy CAC was performed 16 hours + 1 hour 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.
Time Frame
7, 15, 20 minutes post-CAC
Title
Chemosis at Onset of Action (15 Minutes Post-dose)
Description
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.
Time Frame
7, 15, 20 minutes post-CAC
Title
Eyelid Swelling at Duration of Action (16 Hours + 1 Hour Post-dose)
Description
A treatment efficacy CAC was performed 16 hours + 1 hour 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.
Time Frame
7, 15, 20 minutes post-CAC
Title
Eyelid Swelling at Onset of Action (15 Minutes Post-dose)
Description
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.
Time Frame
7, 15, 20 minutes post-CAC
Title
Tearing at Duration of Action (16 Hours + 1 Hour Post-dose)
Description
A treatment efficacy CAC was performed 16 hours + 1 hour 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.
Time Frame
7, 15, 20 minutes post-CAC
Title
Tearing at Onset of Action (15 Minutes Post-dose)
Description
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.
Time Frame
7, 15, 20 minutes post-CAC
Title
Rhinorrhea at Duration of Action (16 Hours +1 Hour Post-dose)
Description
A treatment efficacy CAC was performed 16 hours + 1 hour 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.
Time Frame
7, 15, 20 minutes post-CAC
Title
Rhinorrhea at Onset of Action (15 Minutes Post-dose)
Description
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.
Time Frame
7, 15, 20 minutes post-CAC
Title
Nasal Pruritis at Duration of Action (16 Hours + 1 Hour Post-dose)
Description
A treatment efficacy CAC was performed 16 hours + 1 hour 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.
Time Frame
7, 15, 20 minutes post-CAC
Title
Nasal Pruritis at Onset of Action (15 Minutes Post-dose)
Description
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.
Time Frame
7, 15, 20 minutes post-CAC
Title
Ear or Palate Pruritis at Duration of Action (16 Hours + 1 Hour Post-dose)
Description
A treatment efficacy CAC was performed 16 hours + 1 hour 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.
Time Frame
7, 15, 20 minutes post-CAC
Title
Ear or Palate Pruritis at Onset of Action (15 Minutes Post-dose)
Description
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.
Time Frame
7, 15, 20 minutes post-CAC
Title
Nasal Congestion at Duration of Action (16 Hours + 1 Hour Post-dose)
Description
A treatment efficacy CAC was performed 16 hours + 1 hour 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.
Time Frame
7, 15, 20 minutes post-CAC
Title
Nasal Congestion at Onset of Action (15 Minutes Post-dose)
Description
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.
Time Frame
7, 15, 20 minutes post-CAC
Title
Number of Participants With At Least One of the Nasal Symptoms Present (Rhinorrhea + Nasal Pruritus + Ear or Palate Pruritus + Nasal Congestion) at Duration of Action (16 Hours + 1 Hour Post-dose)
Description
A treatment efficacy CAC was performed 16 hours + 1 hour 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.
Time Frame
7, 15, 20 minutes post-CAC
Title
Number of Participants With At Least One of the Nasal Symptoms Present (Rhinorrhea + Nasal Pruritus + Ear or Palate Pruritus + Nasal Congestion) at Onset of Action (15 Minutes Post-dose)
Description
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.
Time Frame
7, 15, 20 minutes post-CAC
Title
Tolerability of Study Medication at Visit 3A
Description
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.
Time Frame
upon instillation, 1 minute and 2 minutes post instillation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
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 medication during the period indicated prior to the enrollment or during the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jack Greiner, DO
Organizational Affiliation
Charles River Eye Associates
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gail Torkildsen
Organizational Affiliation
Andover Eye Associates
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Stacey Ackerman, MD
Organizational Affiliation
Philadelphia Eye Associates
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ora, Inc.
City
Andover
State/Province
Massachusetts
ZIP/Postal Code
01810
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Multi-Center Study Evaluating the Onset and Duration of Action of AC-170 0.24% Compared to Vehicle in the Conjunctival Allergen Challenge (CAC)
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