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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01551056
Recruitment Status : Completed
First Posted : March 12, 2012
Results First Posted : October 3, 2017
Last Update Posted : November 7, 2017
Sponsor:
Information provided by (Responsible Party):
Aciex Therapeutics, Inc.

Tracking Information
First Submitted Date  ICMJE March 8, 2012
First Posted Date  ICMJE March 12, 2012
Results First Submitted Date  ICMJE June 27, 2017
Results First Posted Date  ICMJE October 3, 2017
Last Update Posted Date November 7, 2017
Study Start Date  ICMJE March 2012
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 6, 2017)
  • Ocular Itching at Duration of Action (16 Hours + 1 Hour Post-dose) [ Time Frame: 3, 5, 7 minutes post-CAC ]
    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) [ 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.
  • Conjunctival Redness at Duration of Action (16 Hours + 1 Hour Post-dose) [ Time Frame: 7, 15, 20 minutes post-CAC ]
    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) [ 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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 8, 2012)
  • Ocular Itching at defined time points up to 2 weeks [ Time Frame: Baseline to day 14 ]
  • Ocular Redness at defined time points up to 2 weeks [ Time Frame: Baseline to day 14 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 6, 2017)
  • Ciliary Redness at Duration of Action (16 Hours + 1 Hour Post-dose) [ Time Frame: 7, 15, 20 minutes post-CAC ]
    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) [ 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.
  • Episcleral Redness at Duration of Action (16 Hours + 1 Hour Post-dose) [ Time Frame: 7, 15, 20 minutes post-CAC ]
    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) [ 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.
  • Chemosis at Duration of Action (16 Hours + 1 Hour Post-dose) [ Time Frame: 7, 15, 20 minutes post-CAC ]
    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) [ 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.
  • Eyelid Swelling at Duration of Action (16 Hours + 1 Hour Post-dose) [ Time Frame: 7, 15, 20 minutes post-CAC ]
    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) [ 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.
  • Tearing at Duration of Action (16 Hours + 1 Hour Post-dose) [ Time Frame: 7, 15, 20 minutes post-CAC ]
    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) [ 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.
  • Rhinorrhea at Duration of Action (16 Hours +1 Hour Post-dose) [ Time Frame: 7, 15, 20 minutes post-CAC ]
    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) [ 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.
  • Nasal Pruritis at Duration of Action (16 Hours + 1 Hour Post-dose) [ Time Frame: 7, 15, 20 minutes post-CAC ]
    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) [ 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.
  • Ear or Palate Pruritis at Duration of Action (16 Hours + 1 Hour Post-dose) [ Time Frame: 7, 15, 20 minutes post-CAC ]
    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) [ 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.
  • Nasal Congestion at Duration of Action (16 Hours + 1 Hour Post-dose) [ Time Frame: 7, 15, 20 minutes post-CAC ]
    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) [ 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.
  • 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) [ Time Frame: 7, 15, 20 minutes post-CAC ]
    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) [ Time Frame: 7, 15, 20 minutes post-CAC ]
    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 [ Time Frame: upon instillation, 1 minute and 2 minutes post instillation ]
    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.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Allergic Conjunctivitis
Intervention  ICMJE
  • Drug: AC-170 0.24%
    1 drop in each eye at 2 separate times during a 14 day period
  • Drug: AC-170 0%
    1 drop in each eye at 2 separate times during a 14 day period
Study Arms  ICMJE
  • Experimental: AC-170 0.24%
    Intervention: Drug: AC-170 0.24%
  • Placebo Comparator: AC-170 0%
    Intervention: Drug: AC-170 0%
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 10, 2012)
91
Original Estimated Enrollment  ICMJE
 (submitted: March 8, 2012)
90
Actual Study Completion Date  ICMJE June 2012
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 10 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01551056
Other Study ID Numbers  ICMJE 11-100-0012
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Aciex Therapeutics, Inc.
Study Sponsor  ICMJE Aciex Therapeutics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jack Greiner, DO Charles River Eye Associates
Principal Investigator: Gail Torkildsen Andover Eye Associates
Principal Investigator: Stacey Ackerman, MD Philadelphia Eye Associates
PRS Account Aciex Therapeutics, Inc.
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP