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Completed

NCT Number: NCT01332188

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

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.

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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 2 / 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 medications during the period indicated prior to the study enrollment or during the study.

Treatment and study plan

AC-170 0.05%

Drug

1 drop in each eye at 3 separate times during a 21 day period

AC-170 0.1%

Drug

1 drop in each eye at 3 separate times during a 21 day period

AC-170 0.24%

Drug

1 drop in each eye at 3 separate times during a 21 day period

AC-170 0%

Drug

1 drop in each eye at 3 separate times during a 21 day period

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. 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.

  19. 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.

  20. 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.

  21. 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.

  22. 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.

  23. 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.

  24. 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.

  25. 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.

  26. 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.

  27. 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.

  28. 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.

  29. 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.

  30. 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.

  31. 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..

Sponsors and collaborators

Lead sponsor

Aciex Therapeutics, Inc.

Industry

Registry information

Official study 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)

Acronym: AC-170

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Apr 11, 2011
Registry last updated
Aug 30, 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.

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