Efficacy of AC-150 for the Treatment of Allergic Conjunctivitis in the Enviro-CAC™ Model
- Conditions
- Allergic Conjunctivitis
- Interventions
- Drug: AC-150 ComboDrug: AC-150B 0.005%Drug: AC-150A 0.1%Drug: Vehicle
- Registration Number
- NCT01134328
- Lead Sponsor
- Aciex Therapeutics, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 83
- 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 or trial parameters.
- Use of disallowed medications during the period indicated prior to study enrollment or during the study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description AC-150 Combo AC-150 Combo - AC-150B 0.005% AC-150B 0.005% - AC-150A 0.1% AC-150A 0.1% - Vehicle Vehicle -
- Primary Outcome Measures
Name Time Method Ocular Itching at 8 Hours Post-dose at Visit 4A 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.
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 (16 Hours Post-dose) 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.
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.
Conjunctival Redness at Duration of Action (16 Hours Post-dose) 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 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 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.
Ciliary Redness at Duration of Action (16 Hours Post-dose) 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.
Ciliary Redness at 8 Hours Post-dose at Visit 4A 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.
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.
Episcleral Redness at Duration of Action (16 Hours Post-dose) 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.
Episcleral Redness at 8 Hours Post-dose at Visit 4A 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.
Total 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. 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.
Total Redness at Duration of Action (16 Hours Post-dose) 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.
Total Redness at 8 Hours Post-Dose at Visit 4A 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.
Lid 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. 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.
Lid Swelling Duration of Action (16 Hours Post-dose) 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.
Lid Swelling at 8 Hours Post-dose at Visit 4A 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.
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.
Ear or Palate Pruritus at Duration of Action (16 Hours 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.
Ear or Palate Pruritus at 8 Hours Post-dose at Visit 4A 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.
Tolerability of Study Medication at Visit 2B 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.
Tolerability of Study Medication at Visit 3 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.
Trial Locations
- Locations (1)
Ora, Inc
🇺🇸Andover, Massachusetts, United States