Skip to main content
OpenTrials
Completed

NCT Number: NCT01551056

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 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Allergic Conjunctivitis Conjunctival Diseases Conjunctivitis Conjunctivitis, Allergic Eye Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases

Age range

10 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Ora, Inc.

Andover, Massachusetts, 01810, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AC-170 0.24%

Drug

1 drop in each eye at 2 separate times during a 14 day period

AC-170 0%

Drug

1 drop in each eye at 2 separate times during a 14 day period

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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 outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. 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.

  19. 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.

  20. 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.

  21. 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.

Sponsors and collaborators

Lead sponsor

Aciex Therapeutics, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Mar 12, 2012
Registry last updated
Nov 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.