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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.
  Purpose
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.

Condition Intervention Phase
Allergic Conjunctivitis Drug: AC-170 0.24% Drug: AC-170 0% Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Aciex Therapeutics, Inc.:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 91
Study Start Date: March 2012
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   10 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01551056


Locations
United States, Massachusetts
Ora, Inc.
Andover, Massachusetts, United States, 01810
Sponsors and Collaborators
Aciex Therapeutics, Inc.
Investigators
Principal Investigator: Jack Greiner, DO Charles River Eye Associates
Principal Investigator: Gail Torkildsen Andover Eye Associates
Principal Investigator: Stacey Ackerman, MD Philadelphia Eye Associates
  More Information

Responsible Party: Aciex Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT01551056     History of Changes
Other Study ID Numbers: 11-100-0012
First Submitted: March 8, 2012
First Posted: March 12, 2012
Results First Submitted: June 27, 2017
Results First Posted: October 3, 2017
Last Update Posted: November 7, 2017
Last Verified: October 2017

Additional relevant MeSH terms:
Conjunctivitis
Conjunctivitis, Allergic
Conjunctival Diseases
Eye Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Cetirizine
Anti-Allergic Agents
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs