Back to resultsEfficacy of AC-170 for the Treatment of Allergic Conjunctivitis in the Conjunctival Allergen Challenge (CAC) Model (AC-170)
Primary Purpose
Allergic Conjunctivitis
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
AC-170 0.05%
AC-170 0.1%
AC-170 0.24%
AC-170 0%
Sponsored by
About this trial
This is an interventional treatment trial for Allergic Conjunctivitis
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 the study enrollment or during the study.
Sites / Locations
- Ora, Inc.
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
AC-170 0.05%
AC-170 0.1%
AC-170 0.24%
AC-170 0%
Arm Description
Outcomes
Primary Outcome Measures
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.
Ocular Itching at Duration of Action (24 Hours Post-dose)
A treatment efficacy CAC was performed 24 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)
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 (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.
Conjunctival Redness at Duration of Action (24 Hours Post-dose)
A treatment efficacy CAC was performed 24 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 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.
Secondary Outcome Measures
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.
Ciliary Redness at Duration of Action (24 Hours Post-dose)
A treatment efficacy CAC was performed 24 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 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.
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.
Episcleral Redness at Duration of Action (24 Hours Post-dose)
A treatment efficacy CAC was performed 24 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 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.
Chemosis at Duration of Action (16 Hours Post-dose)
A treatment efficacy CAC was performed 16 hours 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.
Chemosis at Duration of Action (24 Hours Post-dose)
A treatment efficacy CAC was performed 24 hours 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.
Chemosis at Onset of Action (15 Minutes Post-dose)
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.
Eyelid Swelling at Duration of Action (16 Hours Post-dose)
A treatment efficacy CAC was performed 16 hours 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.
Eyelid Swelling at Duration of Action (24 Hours Post-dose)
A treatment efficacy CAC was performed 24 hours 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.
Eyelid Swelling at Onset of Action (15 Minutes Post-dose)
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.
Tearing at Duration of Action (16 Hours Post-dose)
A treatment efficacy CAC was performed 16 hours 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.
Tearing at Duration of Action (24 Hours Post-dose)
A treatment efficacy CAC was performed 24 hours 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.
Tearing at Onset of Action (15 Minutes Post-dose)
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.
Rhinorrhea at Duration of Action (16 Hours Post-dose)
A treatment efficacy CAC was performed 16 hours 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.
Rhinorrhea at Duration of Action (24 Hours Post-dose)
A treatment efficacy CAC was performed 24 hours 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.
Rhinorrhea at Onset of Action (15 Minutes Post-dose)
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.
Nasal Pruritus at Duration of Action (16 Hours Post-dose)
A treatment efficacy CAC was performed 16 hours 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 Duration of Action (24 Hours Post-dose)
A treatment efficacy CAC was performed 24 hours 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)
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 Duration of Action (16 Hours Post-dose)
A treatment efficacy CAC was performed 16 hours 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 (24 Hours Post-dose)
A treatment efficacy CAC was performed 24 hours 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 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.
Nasal Congestion at Onset of Action (16 Hours Post-dose)
A treatment efficacy CAC was performed 16 hours 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 Congestion at Duration of Action (24 Hours Post-dose)
A treatment efficacy CAC was performed 24 hours 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 Congestion at Onset of Action (15 Minutes Post-dose)
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.
Nasal Composite Score at Duration of Action (16 Hours Post-dose)
A nasal composite score was summed for each patient based on the presence of at least one of the following four nasal symptoms on a 0-4 scale (0=none to 4=severe): rhinorrhea; nasal pruritus; ear or palate pruritus; and nasal congestion. The percentage of subjects with at least one nasal symptom present was calculated for each time point.
Nasal Composite Score at Duration of Action (24 Hours Post-dose)
A nasal composite score was summed for each patient based on the presence of at least one of the following four nasal symptoms on a 0-4 scale (0=none to 4=severe): rhinorrhea; nasal pruritus; ear or palate pruritus; and nasal congestion. The percentage of subjects with at least one nasal symptom present was calculated for each time point.
Nasal Composite Score at Onset of Action (15 Minutes Post-dose)
A nasal composite score was summed for each patient based on the presence of at least one of the following four nasal symptoms on a 0-4 scale (0=none to 4=severe): rhinorrhea; nasal pruritus; ear or palate pruritus; and nasal congestion. The percentage of subjects with at least one nasal symptom present was calculated for each time point.
Tolerability of Study Medication at Visit 3A
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..
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01332188
Brief Title
Efficacy of AC-170 for the Treatment of Allergic Conjunctivitis in the Conjunctival Allergen Challenge (CAC) Model
Acronym
AC-170
Official Title
A Single Center, Double-Masked, Randomized, Vehicle-Controlled, Parallel-Group Study Evaluating the Efficacy of Three Different Concentrations of Cetirizine (0.05%, 0.1%, and 0.24%) Ophthalmic Solution Versus Vehicle in the Treatment of Allergic Conjunctivitis in the Conjunctival Allergen Challenge Model (CAC)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
October 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aciex Therapeutics, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the efficacy of different concentrations of AC-170 compared to vehicle in the prevention of the signs and symptoms of allergic conjunctivitis in the conjunctival allergen challenge (CAC) Model.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Conjunctivitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
101 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AC-170 0.05%
Arm Type
Experimental
Arm Title
AC-170 0.1%
Arm Type
Experimental
Arm Title
AC-170 0.24%
Arm Type
Experimental
Arm Title
AC-170 0%
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
AC-170 0.05%
Intervention Description
1 drop in each eye at 3 separate times during a 21 day period
Intervention Type
Drug
Intervention Name(s)
AC-170 0.1%
Intervention Description
1 drop in each eye at 3 separate times during a 21 day period
Intervention Type
Drug
Intervention Name(s)
AC-170 0.24%
Intervention Description
1 drop in each eye at 3 separate times during a 21 day period
Intervention Type
Drug
Intervention Name(s)
AC-170 0%
Intervention Description
1 drop in each eye at 3 separate times during a 21 day period
Primary Outcome Measure Information:
Title
Ocular Itching at Duration of Action (16 Hours Post-dose)
Description
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
Title
Ocular Itching at Duration of Action (24 Hours Post-dose)
Description
A treatment efficacy CAC was performed 24 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
Title
Ocular Itching at Onset of Action (15 Minutes Post-dose)
Description
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
Title
Conjunctival Redness at Duration of Action (16 Hours Post-dose)
Description
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
Title
Conjunctival Redness at Duration of Action (24 Hours Post-dose)
Description
A treatment efficacy CAC was performed 24 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
Title
Conjunctival Redness at Onset of Action (15 Minutes Post-dose)
Description
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
Secondary Outcome Measure Information:
Title
Ciliary Redness at Duration of Action (16 Hours Post-dose)
Description
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
Title
Ciliary Redness at Duration of Action (24 Hours Post-dose)
Description
A treatment efficacy CAC was performed 24 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
Title
Ciliary Redness at Onset of Action (15 Minutes Post-dose)
Description
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
Title
Episcleral Redness at Duration of Action (16 Hours Post-dose)
Description
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
Title
Episcleral Redness at Duration of Action (24 Hours Post-dose)
Description
A treatment efficacy CAC was performed 24 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
Title
Episcleral Redness at Onset of Action (15 Minutes Post-dose)
Description
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
Title
Chemosis at Duration of Action (16 Hours Post-dose)
Description
A treatment efficacy CAC was performed 16 hours 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.
Time Frame
7, 15, 20 minutes post-CAC
Title
Chemosis at Duration of Action (24 Hours Post-dose)
Description
A treatment efficacy CAC was performed 24 hours 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.
Time Frame
7, 15, 20 minutes post-CAC
Title
Chemosis at Onset of Action (15 Minutes Post-dose)
Description
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.
Time Frame
7, 15, 20 minutes post-CAC
Title
Eyelid Swelling at Duration of Action (16 Hours Post-dose)
Description
A treatment efficacy CAC was performed 16 hours 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.
Time Frame
7, 15, 20 minutes post-CAC
Title
Eyelid Swelling at Duration of Action (24 Hours Post-dose)
Description
A treatment efficacy CAC was performed 24 hours 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.
Time Frame
7, 15, 20 minutes post-CAC
Title
Eyelid Swelling at Onset of Action (15 Minutes Post-dose)
Description
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.
Time Frame
7, 15, 20 minutes post-CAC
Title
Tearing at Duration of Action (16 Hours Post-dose)
Description
A treatment efficacy CAC was performed 16 hours 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.
Time Frame
7, 15, 20 minutes post-CAC
Title
Tearing at Duration of Action (24 Hours Post-dose)
Description
A treatment efficacy CAC was performed 24 hours 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.
Time Frame
7, 15, 20 minutes post-CAC
Title
Tearing at Onset of Action (15 Minutes Post-dose)
Description
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.
Time Frame
7, 15, 20 minutes post-CAC
Title
Rhinorrhea at Duration of Action (16 Hours Post-dose)
Description
A treatment efficacy CAC was performed 16 hours 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.
Time Frame
7, 15, 20 minutes post-CAC
Title
Rhinorrhea at Duration of Action (24 Hours Post-dose)
Description
A treatment efficacy CAC was performed 24 hours 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.
Time Frame
7, 15, 20 minutes post-CAC
Title
Rhinorrhea at Onset of Action (15 Minutes Post-dose)
Description
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.
Time Frame
7, 15, 20 minutes post-CAC
Title
Nasal Pruritus at Duration of Action (16 Hours Post-dose)
Description
A treatment efficacy CAC was performed 16 hours 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.
Time Frame
7, 15, 20 minutes post-CAC
Title
Nasal Pruritus at Duration of Action (24 Hours Post-dose)
Description
A treatment efficacy CAC was performed 24 hours 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.
Time Frame
7, 15, 20 minutes post-CAC
Title
Nasal Pruritus at Onset of Action (15 Minutes Post-dose)
Description
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.
Time Frame
7, 15, 20 minutes post-CAC
Title
Ear or Palate Pruritus at Duration of Action (16 Hours Post-dose)
Description
A treatment efficacy CAC was performed 16 hours 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
Title
Ear or Palate Pruritus at Duration of Action (24 Hours Post-dose)
Description
A treatment efficacy CAC was performed 24 hours 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
Title
Ear or Palate Pruritus at Onset of Action (15 Minutes Post-dose)
Description
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
Title
Nasal Congestion at Onset of Action (16 Hours Post-dose)
Description
A treatment efficacy CAC was performed 16 hours 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.
Time Frame
7, 15, 20 minutes post-CAC
Title
Nasal Congestion at Duration of Action (24 Hours Post-dose)
Description
A treatment efficacy CAC was performed 24 hours 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.
Time Frame
7, 15, 20 minutes post-CAC
Title
Nasal Congestion at Onset of Action (15 Minutes Post-dose)
Description
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.
Time Frame
7, 15, 20 minutes post-CAC
Title
Nasal Composite Score at Duration of Action (16 Hours Post-dose)
Description
A nasal composite score was summed for each patient based on the presence of at least one of the following four nasal symptoms on a 0-4 scale (0=none to 4=severe): rhinorrhea; nasal pruritus; ear or palate pruritus; and nasal congestion. The percentage of subjects with at least one nasal symptom present was calculated for each time point.
Time Frame
7, 15, 20 minutes post-CAC
Title
Nasal Composite Score at Duration of Action (24 Hours Post-dose)
Description
A nasal composite score was summed for each patient based on the presence of at least one of the following four nasal symptoms on a 0-4 scale (0=none to 4=severe): rhinorrhea; nasal pruritus; ear or palate pruritus; and nasal congestion. The percentage of subjects with at least one nasal symptom present was calculated for each time point.
Time Frame
7, 15, 20 minutes post-CAC
Title
Nasal Composite Score at Onset of Action (15 Minutes Post-dose)
Description
A nasal composite score was summed for each patient based on the presence of at least one of the following four nasal symptoms on a 0-4 scale (0=none to 4=severe): rhinorrhea; nasal pruritus; ear or palate pruritus; and nasal congestion. The percentage of subjects with at least one nasal symptom present was calculated for each time point.
Time Frame
7, 15, 20 minutes post-CAC
Title
Tolerability of Study Medication at Visit 3A
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
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 the study enrollment or during the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gail L Torkildsen, MD
Organizational Affiliation
Andover Eye Associates
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ora, Inc.
City
Andover
State/Province
Massachusetts
ZIP/Postal Code
01810
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Efficacy of AC-170 for the Treatment of Allergic Conjunctivitis in the Conjunctival Allergen Challenge (CAC) Model
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