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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
83
1 drop in each eye for up to 14 days
1 drop in each eye once per day for up to 14 days
1 drop in each eye once per day for up to 14 days
Ora, Inc
Andover, Massachusetts, United States
Ocular Itching at Onset of Action (15 Minutes Post-dose)
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.
Time frame: 3, 5, 7 minutes post-CAC
Ocular Itching at Duration of Action (16 Hours Post-dose)
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.
Time frame: 3, 5, 7 minutes post-CAC
Ocular Itching at 8 Hours Post-dose at Visit 4A
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.
Time frame: 3, 5, 7 minutes post-CAC
Conjunctival Redness at Onset of Action (15 Minutes Post-dose)
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.
Time frame: 7, 15, 20 minutes post-CAC
Conjunctival Redness at Duration of Action (16 Hours Post-dose)
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.
Time frame: 7, 15, 20 minutes post-CAC
Conjunctival Redness at 8 Hours Post-dose at Visit 4A
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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
1 drop in each eye once per day for up to 14 days
Time frame: 7, 15, 20 minutes post-CAC
Ciliary Redness at Onset of Action (15 Minutes Post-dose)
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.
Time frame: 7, 15, 20 minutes post-CAC
Ciliary Redness at Duration of Action (16 Hours Post-dose)
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.
Time frame: 7, 15, 20 minutes post-CAC
Ciliary Redness at 8 Hours Post-dose at Visit 4A
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.
Time frame: 7, 15, 20 minutes post-CAC
Episcleral Redness at Onset of Action (15 Minutes Post-dose)
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.
Time frame: 7, 15, 20 minutes post-CAC
Episcleral Redness at Duration of Action (16 Hours Post-dose)
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.
Time frame: 7, 15, 20 minutes post-CAC
Episcleral Redness at 8 Hours Post-dose at Visit 4A
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.
Time frame: 7, 15, 20 minutes post-CAC
Total Redness at Onset of Action (15 Minutes Post-dose)
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.
Time frame: 7, 15, 20 minutes post-CAC
Total Redness at Duration of Action (16 Hours Post-dose)
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.
Time frame: 7, 15, 20 minutes post-CAC
Total Redness at 8 Hours Post-Dose at Visit 4A
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.
Time frame: 7, 15, 20 minutes post-CAC
Lid Swelling at Onset of Action (15 Minutes Post-dose)
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.
Time frame: 7, 15, 20 minutes post-CAC
Lid Swelling Duration of Action (16 Hours Post-dose)
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.
Time frame: 7, 15, 20 minutes post-CAC
Lid Swelling at 8 Hours Post-dose at Visit 4A
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.
Time frame: 7, 15, 20 minutes post-CAC
Ear or Palate Pruritus at Onset of Action (15 Minutes Post-dose)
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.
Time frame: 7, 15, 20 minutes post-CAC
Ear or Palate Pruritus at Duration of Action (16 Hours Post-dose)
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.
Time frame: 7, 15, 20 minutes post-CAC
Ear or Palate Pruritus at 8 Hours Post-dose at Visit 4A
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.
Time frame: 7, 15, 20 minutes post-CAC
Tolerability of Study Medication at Visit 2B
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.
Time frame: upon instillation, 1 minute and 2 minutes post instillation
Tolerability of Study Medication at Visit 3
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.
Time frame: upon instillation, 1 minute and 2 minutes post instillation