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
Overview
- Phase
- Phase 2
- Intervention
- AC-150 Combo
- Conditions
- Allergic Conjunctivitis
- Sponsor
- Aciex Therapeutics, Inc.
- Enrollment
- 83
- Locations
- 1
- Primary Endpoint
- Ocular Itching at Onset of Action (15 Minutes Post-dose)
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
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.
Investigators
Eligibility 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 study enrollment or during the study.
Arms & Interventions
AC-150 Combo
Intervention: AC-150 Combo
AC-150A 0.1%
Intervention: AC-150A 0.1%
AC-150B 0.005%
Intervention: AC-150B 0.005%
Vehicle
Intervention: Vehicle
Outcomes
Primary Outcomes
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.
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 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.
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.
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 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
- Ciliary Redness at Onset of Action (15 Minutes Post-dose)(7, 15, 20 minutes post-CAC)
- Ciliary Redness at Duration of Action (16 Hours Post-dose)(7, 15, 20 minutes post-CAC)
- Ciliary Redness at 8 Hours Post-dose at Visit 4A(7, 15, 20 minutes post-CAC)
- Episcleral Redness at Onset of Action (15 Minutes Post-dose)(7, 15, 20 minutes post-CAC)
- Episcleral Redness at Duration of Action (16 Hours Post-dose)(7, 15, 20 minutes post-CAC)
- Episcleral Redness at 8 Hours Post-dose at Visit 4A(7, 15, 20 minutes post-CAC)
- Total Redness at Onset of Action (15 Minutes Post-dose)(7, 15, 20 minutes post-CAC)
- Total Redness at Duration of Action (16 Hours Post-dose)(7, 15, 20 minutes post-CAC)
- Total Redness at 8 Hours Post-Dose at Visit 4A(7, 15, 20 minutes post-CAC)
- Lid Swelling at Onset of Action (15 Minutes Post-dose)(7, 15, 20 minutes post-CAC)
- Lid Swelling Duration of Action (16 Hours Post-dose)(7, 15, 20 minutes post-CAC)
- Lid Swelling at 8 Hours Post-dose at Visit 4A(7, 15, 20 minutes post-CAC)
- Ear or Palate Pruritus at Onset of Action (15 Minutes Post-dose)(7, 15, 20 minutes post-CAC)
- Ear or Palate Pruritus at Duration of Action (16 Hours Post-dose)(7, 15, 20 minutes post-CAC)
- Ear or Palate Pruritus at 8 Hours Post-dose at Visit 4A(7, 15, 20 minutes post-CAC)
- Tolerability of Study Medication at Visit 2B(upon instillation, 1 minute and 2 minutes post instillation)
- Tolerability of Study Medication at Visit 3(upon instillation, 1 minute and 2 minutes post instillation)