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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)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01551056
First Posted: March 12, 2012
Last Update Posted: November 7, 2017
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.
Information provided by (Responsible Party):
Aciex Therapeutics, Inc.
March 8, 2012
March 12, 2012
June 27, 2017
October 3, 2017
November 7, 2017
March 2012
June 2012   (Final data collection date for primary outcome measure)
  • 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.
  • 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 ]
Complete list of historical versions of study NCT01551056 on ClinicalTrials.gov Archive Site
  • 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.
Not Provided
Not Provided
Not Provided
 
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)
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
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Allergic Conjunctivitis
  • 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
  • Experimental: AC-170 0.24%
    Intervention: Drug: AC-170 0.24%
  • Placebo Comparator: AC-170 0%
    Intervention: Drug: AC-170 0%
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
91
June 2012
June 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
10 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01551056
11-100-0012
No
Not Provided
Not Provided
Aciex Therapeutics, Inc.
Aciex Therapeutics, Inc.
Not Provided
Principal Investigator: Jack Greiner, DO Charles River Eye Associates
Principal Investigator: Gail Torkildsen Andover Eye Associates
Principal Investigator: Stacey Ackerman, MD Philadelphia Eye Associates
Aciex Therapeutics, Inc.
October 2017

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