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Completed

NCT Number: NCT01134328

Efficacy of AC-150 for the Treatment of Allergic Conjunctivitis in the Enviro-CAC™ Model

The purpose of this study is to evaluate the efficacy of AC-150 compared to vehicle and its components in the prevention of the signs and symptoms of allergic conjunctivitis in Enviro-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

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 study enrollment or during the study.

Treatment and study plan

AC-150 Combo

Drug

1 drop in each eye for up to 14 days

AC-150A 0.1%

Drug

1 drop in each eye once per day for up to 14 days

AC-150B 0.005%

Drug

1 drop in each eye once per day for up to 14 days

Vehicle

Drug

1 drop in each eye once per day for up to 14 days

Primary outcomes

  1. 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.

  2. 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.

  3. Ocular Itching at 8 Hours Post-dose at Visit 4A

    Time frame: 3, 5, 7 minutes post-CAC

    A treatment efficacy CAC was performed 8 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.

  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.

  5. 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.

  6. Conjunctival Redness at 8 Hours Post-dose at Visit 4A

    Time frame: 7, 15, 20 minutes post-CAC

    A treatment efficacy CAC was performed 8 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. Ciliary Redness at 8 Hours Post-dose at Visit 4A

    Time frame: 7, 15, 20 minutes post-CAC

    A treatment efficacy CAC was performed 8 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.

  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. 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.

  6. Episcleral Redness at 8 Hours Post-dose at Visit 4A

    Time frame: 7, 15, 20 minutes post-CAC

    A treatment efficacy CAC was performed 8 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.

  7. Total 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. Total redness was defined as the sum of the conjunctival, ciliary and episcleral redness scores, and was, thus, on a 0-12 scale, making the threshold for clinical significance a treatment difference of 3.0 units. Higher scores represent greater severity.

  8. Total 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. Total redness was defined as the sum of the conjunctival, ciliary and episcleral redness scores, and was, thus, on a 0-12 scale, making the threshold for clinical significance a treatment difference of 3.0 units. Higher scores represent greater severity.

  9. Total Redness at 8 Hours Post-Dose at Visit 4A

    Time frame: 7, 15, 20 minutes post-CAC

    A treatment efficacy CAC was performed 8 hours after drop instillation. Total redness was defined as the sum of the conjunctival, ciliary and episcleral redness scores, and was, thus, on a 0-12 scale, making the threshold for clinical significance a treatment difference of 3.0 units. Higher scores represent greater severity.

  10. Lid 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. Lid swelling was assessed by the patient on a 0-3 scale (0=none to 3=severe). Average of lid swelling score over both eyes was analyzed.

  11. Lid Swelling 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. Lid swelling was assessed by the patient on a 0-3 scale (0=none to 3=severe). Average of lid swelling score over both eyes was analyzed.

  12. Lid Swelling at 8 Hours Post-dose at Visit 4A

    Time frame: 7, 15, 20 minutes post-CAC

    A treatment efficacy CAC was performed 8 hours after drop instillation. Lid swelling was assessed by the patient on a 0-3 scale (0=none to 3=severe). Average of lid swelling score over both eyes was analyzed.

  13. 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.

  14. 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 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.

  15. Ear or Palate Pruritus at 8 Hours Post-dose at Visit 4A

    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.

  16. Tolerability of Study Medication at Visit 2B

    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.

  17. Tolerability of Study Medication at Visit 3

    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 Multi-Center, Randomized, Double-Masked Evaluation of the Efficacy of Cetirizine 0.1%/Fluticasone 0.005% Ophthalmic Solution Compared to Its Components and Vehicle in a Modified Conjunctival Allergen Challenge (CAC) Model During Pollen Season

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Jun 2, 2010
Registry last updated
Sep 14, 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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