A Single-Center,Evaluation of the Onset and Duration of Action of AC-170 0.24% Compared to Vehicle
- Conditions
- Allergic Conjunctivitis
- Interventions
- Drug: AC-170 0%Drug: AC-170 0.24%
- Registration Number
- NCT01685242
- Lead Sponsor
- Aciex Therapeutics, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
- positive bilateral conjunctival allergen challenge (CAC)reaction
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description AC-170 0% AC-170 0% - AC-170 0.24% AC-170 0.24% -
- Primary Outcome Measures
Name Time Method Conjunctival Redness at Duration of Action (8 Hours + 30 Minutes Post-dose) 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.
Conjunctival Redness at Onset of Action (15 Minutes Post-dose) 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) 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 (8 Hours + 30 Minutes Post-dose) 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.
- Secondary Outcome Measures
Name Time Method Ciliary Redness at Onset of Action (15 Minutes Post-dose) 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.
Eyelid Swelling at Onset of Action (15 Minutes Post-dose) 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.
Ear or Palate Pruritus at Duration of Action (8 Hours + 30 Minutes Post-dose) 7, 15, 20 minutes post-CAC A treatment efficacy CAC was performed 8 hours + 30 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.
Nasal Congestion at Onset of Action (15 Minutes Post-dose) 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.
Ciliary Redness at Duration of Action (8 Hours + 30 Minutes) 7, 15, 20 minutes post-CAC A treatment efficacy CAC was performed 8 hours + 30 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.
Rhinorrhea at Duration of Action (8 Hours + 30 Minutes Post-dose) 7, 15, 20 minutes post-CAC A treatment efficacy CAC was performed 8 hours + 30 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.
Chemosis at Duration of Action (8 Hours + 30 Minutes Post-dose) 7, 15, 20 minutes post-CAC A treatment efficacy CAC was performed 8 hours + 30 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.
Episcleral Redness at Duration of Action (8 Hours + 30 Minutes Post-dose) 7, 15, 20 minutes post-CAC A treatment efficacy CAC was performed 8 hours + 30 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.
Chemosis at Onset of Action (15 Minutes) 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.
Tearing at Duration of Action (8 Hours + 30 Minutes Post-dose) 7, 15, 20 minutes post-CAC A treatment efficacy CAC was performed 8 hours + 30 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.
Episcleral Redness at Onset of Action (15 Minutes Post-dose) 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.
Rhinorrhea at Onset of Action (15 Minutes Post-dose) 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.
Eyelid Swelling at Duration of Action (8 Hours + 30 Minutes Post-dose) 7, 15, 20 minutes post-CAC A treatment efficacy CAC was performed 8 hours + 30 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.
Tearing at Onset of Action (15 Minutes Post-dose) 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.
Nasal Pruritus at Duration of Action (8 Hours + 30 Minutes Post-dose) 7, 15, 20 minutes post-CAC A treatment efficacy CAC was performed 8 hours + 30 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.
Nasal Pruritus at Onset of Action (15 Minutes Post-dose) 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.
Ear or Palate Pruritus at Onset of Action (15 Minutes Post-dose) 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.
Nasal Congestion at Duration of Action (8 Hours + 30 Minutes Post-dose) 7, 15, 20 minutes post-CAC A treatment efficacy CAC was performed 8 hours + 30 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.
Nasal Composite Score at Duration of Action (8 Hours + 30 Minutes Post-dose) 7, 15, 20 minutes post-CAC A treatment efficacy CAC was performed 8 hours + 30 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.
Nasal Composite Score at Onset of Action (15 Minutes Post-dose) 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.
Tolerability of Study Medication at Visit 3A 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.
Trial Locations
- Locations (1)
Andover Eye Associates
🇺🇸Andover, Massachusetts, United States