A Multi-Center, Double-Masked, Randomized, Vehicle-Controlled, Evaluation of the Onset and Duration of Action of AC-170 0.24% Ophthalmic Solution (Formula AFH-002) Compared to Vehicle (Formula AFH-001) in the Conjunctival Allergen Challenge (CAC) Model of Acute Allergic Conjunctivitis
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Aciex Therapeutics, Inc.
- Enrollment
- 101
- Locations
- 1
- Primary Endpoint
- Ocular Itching at Duration of Action (8 Hours + 30 Minutes Post-Dose)
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 10 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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 trial parameters
- •use of disallowed medication during the period indicated prior to the enrollment or during the study
Arms & Interventions
AC-170 0.24%
Intervention: AC-170 0.24% (Drug)
AC-170 0%
Intervention: AC-170 0% (Drug)
Outcomes
Primary Outcomes
Ocular Itching at Duration of Action (8 Hours + 30 Minutes Post-Dose)
Time Frame: 3, 5, 7 minutes post-CAC
A treatment efficacy CAC was performed 8 hours + 30 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 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.
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 (8 Hours + 30 Minutes Post-Dose)
Time Frame: 7, 15, 20 minutes post-CAC
A treatment efficacy CAC was performed 8 hours + 30 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
- Ciliary Redness at Onset of Action (15 Minutes Post-Dose)(7, 15, 20 minutes post-CAC)
- Episcleral Redness at Duration of Action (8 Hours + 30 Minutes Post-Dose)(7, 15, 20 minutes post-CAC)
- Episcleral Redness at Onset of Action (15 Minutes Post-Dose)(7, 15, 20 minutes post-CAC)
- Chemosis at Duration of Action (8 Hours + 30 Minutes Post-Dose)(7, 15, 20 minutes post-CAC)
- Chemosis at Onset of Action (15 Minutes Post-Dose)(7, 15, 20 minutes post-CAC)
- Ciliary Redness at Duration of Action (8 Hours + 30 Minutes Post-Dose)(7, 15, 20 minutes post-CAC)
- Tearing at Onset of Action (15 Minutes Post-Dose)(7, 15, 20 minutes post-CAC)
- Rhinorrhea at Duration of Action (8 Hours + 30 Minutes Post-Dose)(7, 15, 20 minutes post-CAC)
- Rhinorrhea at Onset of Action (15 Minutes Post-Dose)(7, 15, 20 minutes post-CAC)
- Nasal Pruritus at Duration of Action (8 Hours + 30 Minutes Post-Dose)(7, 15, 20 minutes post-CAC)
- Nasal Pruritus at Onset of Action (15 Minutes Post-Dose)(7, 15, 20 minutes post-CAC)
- Ear or Palate Pruritus at Duration of Action (8 Hours + 30 Minutes Post-Dose)(7, 15, 20 minutes post-CAC)
- Ear or Palate Pruritus at Onset of Action (15 Minutes Post-Dose)(7, 15, 20 minutes post-CAC)
- Eyelid Swelling at Duration of Action (8 Hours + 30 Minutes Post-Dose)(7, 15, 20 minutes post-CAC)
- Eyelid Swelling at Onset of Action (15 Minutes Post-Dose)(7, 15, 20 minutes post-CAC)
- Tearing at Duration of Action (8 Hours + 30 Minutes Post-Dose)(7, 15, 20 minutes post-CAC)
- Nasal Congestion at Duration of Action (8 Hours + 30 Minutes Post-Dose)(7, 15, 20 minutes post-CAC)
- Nasal Congestion at Onset of Action (15 Minutes Post-Dose)(7, 15, 20 minutes post-CAC)
- Percentage of Participants With At Least One Nasal Symptom at Duration of Action (8 Hours + 30 Minutes Post-Dose)(7, 15, 20 minutes post-CAC)
- Percentage of Participants With At Least One Nasal Symptom at Onset of Action (15 Minutes Post-Dose)(7, 15, 20 minutes post-CAC)
- Tolerability of Study Medication at Visit 3A(upon instillation, 1 minute and 2 minutes post instillation)