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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01332188
First Posted: April 11, 2011
Last Update Posted: August 30, 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 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.

Condition Intervention Phase
Allergic Conjunctivitis Drug: AC-170 0.05% Drug: AC-170 0.1% Drug: AC-170 0.24% Drug: AC-170 0% Phase 2 Phase 3

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

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 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.

  • 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.

  • 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 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.

  • 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.

  • 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 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.

  • 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.

  • 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 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.

  • 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.

  • 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 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.

  • 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.

  • 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 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.

  • 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.

  • 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 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.

  • 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.

  • 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 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.

  • 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.

  • 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 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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..


Enrollment: 101
Study Start Date: April 2011
Study Completion Date: October 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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

  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 medications during the period indicated prior to the study 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): NCT01332188


Locations
United States, Massachusetts
Ora, Inc.
Andover, Massachusetts, United States, 01810
Sponsors and Collaborators
Aciex Therapeutics, Inc.
Investigators
Principal Investigator: Gail L Torkildsen, MD Andover Eye Associates
  More Information

Responsible Party: Aciex Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT01332188     History of Changes
Other Study ID Numbers: 11-100-0004
First Submitted: April 7, 2011
First Posted: April 11, 2011
Results First Submitted: June 28, 2017
Results First Posted: August 30, 2017
Last Update Posted: August 30, 2017
Last Verified: July 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