Allergic Conjunctivitis
Conditions
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.
Interventions
DRUGAC-170 0.05%
1 drop in each eye at 3 separate times during a 21 day period
DRUGAC-170 0.1%
1 drop in each eye at 3 separate times during a 21 day period
DRUGAC-170 0.24%
1 drop in each eye at 3 separate times during a 21 day period
DRUGAC-170 0%
1 drop in each eye at 3 separate times during a 21 day period
Sponsors
Aciex Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
10 Years to No maximum
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 or trial parameters. * Use of disallowed medications during the period indicated prior to the study enrollment or during the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Ocular Itching at Duration of Action (24 Hours Post-dose) | 3, 5, 7 minutes post-CAC | 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) | 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 (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 Duration of Action (24 Hours Post-dose) | 7, 15, 20 minutes post-CAC | 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) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Chemosis 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. 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) | 7, 15, 20 minutes post-CAC | 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) | 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. |
| Eyelid Swelling 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. 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) | 7, 15, 20 minutes post-CAC | 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) | 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. |
| Tearing 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. 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) | 7, 15, 20 minutes post-CAC | 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) | 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. |
| Rhinorrhea 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. 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) | 7, 15, 20 minutes post-CAC | 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) | 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. |
| 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. |
| Nasal Pruritus at Duration of Action (24 Hours Post-dose) | 7, 15, 20 minutes post-CAC | 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) | 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 Duration of Action (16 Hours Post-dose) | 7, 15, 20 minutes post-CAC | 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) | 7, 15, 20 minutes post-CAC | 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) | 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 Onset of Action (16 Hours Post-dose) | 7, 15, 20 minutes post-CAC | 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) | 7, 15, 20 minutes post-CAC | 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) | 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. |
| Nasal Composite Score at Duration of Action (16 Hours Post-dose) | 7, 15, 20 minutes post-CAC | 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) | 7, 15, 20 minutes post-CAC | 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) | 7, 15, 20 minutes post-CAC | 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 | 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.. |
| Nasal Pruritus 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. 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. |
| Ciliary Redness at Duration of Action (24 Hours Post-dose) | 7, 15, 20 minutes post-CAC | 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) | 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. |
| 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 Duration of Action (24 Hours Post-dose) | 7, 15, 20 minutes post-CAC | 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) | 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. |
Countries
United States
Participant flow
Recruitment details
Subjects were recruited from one site in the US.
Pre-assignment details
101 subjects were enrolled, 7 subjects discontinued, and 94 subjects completed the study. The 101 subjects that met all inclusion criteria and none of the exclusion criteria were randomized to receive AC-170 0.05%, AC-170 0.1%, AC-170 0.24% or AC-170 0%. Note: All solutions were early formulations and not the final to-be-marketed formulation.
Participants by arm
| Arm | Count |
|---|---|
| AC-170 0.05% AC-170 0.05%: 1 drop in each eye at 3 separate times during a 21 day period | 25 |
| AC-170 0.1% AC-170 0.1%: 1 drop in each eye at 3 separate times during a 21 day period | 26 |
| AC-170 0.24% AC-170 0.24%: 1 drop in each eye at 3 separate times during a 21 day period | 25 |
| AC-170 0% AC-170 0%: 1 drop in each eye at 3 separate times during a 21 day period | 25 |
| Total | 101 |
Baseline characteristics
| Characteristic | AC-170 0.05% | Total | AC-170 0% | AC-170 0.24% | AC-170 0.1% |
|---|---|---|---|---|---|
| Age, Continuous | 45.5 years STANDARD_DEVIATION 13.58 | 41.4 years STANDARD_DEVIATION 13.59 | 38.1 years STANDARD_DEVIATION 14.12 | 38.9 years STANDARD_DEVIATION 12.53 | 43.1 years STANDARD_DEVIATION 13.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 16 Participants | 5 Participants | 3 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 22 Participants | 85 Participants | 20 Participants | 22 Participants | 21 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 4 Participants | 1 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 24 Participants | 96 Participants | 23 Participants | 24 Participants | 25 Participants |
| Region of Enrollment United States | 25 participants | 101 participants | 25 participants | 25 participants | 26 participants |
| Sex: Female, Male Female | 17 Participants | 56 Participants | 14 Participants | 10 Participants | 15 Participants |
| Sex: Female, Male Male | 8 Participants | 45 Participants | 11 Participants | 15 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 6 / 25 | 3 / 26 | 4 / 25 | 2 / 25 |
| serious Total, serious adverse events | 0 / 25 | 0 / 26 | 0 / 25 | 0 / 25 |
Outcome results
Primary
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
Population: Intent to Treat (ITT)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AC-170 0.05% | Conjunctival Redness at Duration of Action (16 Hours Post-dose) | 7 minutes post-CAC | 1.62 units on a scale | Standard Deviation 0.634 |
| AC-170 0.05% | Conjunctival Redness at Duration of Action (16 Hours Post-dose) | 20 minutes post-CAC | 1.63 units on a scale | Standard Deviation 0.696 |
| AC-170 0.05% | Conjunctival Redness at Duration of Action (16 Hours Post-dose) | 15 minutes post-CAC | 1.68 units on a scale | Standard Deviation 0.606 |
| AC-170 0.1% | Conjunctival Redness at Duration of Action (16 Hours Post-dose) | 7 minutes post-CAC | 1.59 units on a scale | Standard Deviation 0.624 |
| AC-170 0.1% | Conjunctival Redness at Duration of Action (16 Hours Post-dose) | 20 minutes post-CAC | 1.58 units on a scale | Standard Deviation 0.721 |
| AC-170 0.1% | Conjunctival Redness at Duration of Action (16 Hours Post-dose) | 15 minutes post-CAC | 1.65 units on a scale | Standard Deviation 0.711 |
| AC-170 0.24% | Conjunctival Redness at Duration of Action (16 Hours Post-dose) | 15 minutes post-CAC | 1.61 units on a scale | Standard Deviation 0.545 |
| AC-170 0.24% | Conjunctival Redness at Duration of Action (16 Hours Post-dose) | 7 minutes post-CAC | 1.45 units on a scale | Standard Deviation 0.489 |
| AC-170 0.24% | Conjunctival Redness at Duration of Action (16 Hours Post-dose) | 20 minutes post-CAC | 1.56 units on a scale | Standard Deviation 0.634 |
| AC-170 0% | Conjunctival Redness at Duration of Action (16 Hours Post-dose) | 7 minutes post-CAC | 1.79 units on a scale | Standard Deviation 0.359 |
| AC-170 0% | Conjunctival Redness at Duration of Action (16 Hours Post-dose) | 20 minutes post-CAC | 1.88 units on a scale | Standard Deviation 0.403 |
| AC-170 0% | Conjunctival Redness at Duration of Action (16 Hours Post-dose) | 15 minutes post-CAC | 1.91 units on a scale | Standard Deviation 0.426 |
Primary
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.
Time frame: 7, 15, 20 minutes post-CAC
Population: Intent to Treat (ITT)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AC-170 0.05% | Conjunctival Redness at Duration of Action (24 Hours Post-dose) | 7 minutes post-CAC | 1.43 units on a scale | Standard Deviation 0.635 |
| AC-170 0.05% | Conjunctival Redness at Duration of Action (24 Hours Post-dose) | 20 minutes post-CAC | 1.61 units on a scale | Standard Deviation 0.617 |
| AC-170 0.05% | Conjunctival Redness at Duration of Action (24 Hours Post-dose) | 15 minutes post-CAC | 1.63 units on a scale | Standard Deviation 0.617 |
| AC-170 0.1% | Conjunctival Redness at Duration of Action (24 Hours Post-dose) | 7 minutes post-CAC | 1.38 units on a scale | Standard Deviation 0.668 |
| AC-170 0.1% | Conjunctival Redness at Duration of Action (24 Hours Post-dose) | 20 minutes post-CAC | 1.54 units on a scale | Standard Deviation 0.677 |
| AC-170 0.1% | Conjunctival Redness at Duration of Action (24 Hours Post-dose) | 15 minutes post-CAC | 1.59 units on a scale | Standard Deviation 0.663 |
| AC-170 0.24% | Conjunctival Redness at Duration of Action (24 Hours Post-dose) | 15 minutes post-CAC | 1.85 units on a scale | Standard Deviation 0.608 |
| AC-170 0.24% | Conjunctival Redness at Duration of Action (24 Hours Post-dose) | 7 minutes post-CAC | 1.71 units on a scale | Standard Deviation 0.628 |
| AC-170 0.24% | Conjunctival Redness at Duration of Action (24 Hours Post-dose) | 20 minutes post-CAC | 1.79 units on a scale | Standard Deviation 0.713 |
| AC-170 0% | Conjunctival Redness at Duration of Action (24 Hours Post-dose) | 7 minutes post-CAC | 1.70 units on a scale | Standard Deviation 0.505 |
| AC-170 0% | Conjunctival Redness at Duration of Action (24 Hours Post-dose) | 20 minutes post-CAC | 1.76 units on a scale | Standard Deviation 0.575 |
| AC-170 0% | Conjunctival Redness at Duration of Action (24 Hours Post-dose) | 15 minutes post-CAC | 1.90 units on a scale | Standard Deviation 0.489 |
Primary
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
Population: Intent to Treat (ITT)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AC-170 0.05% | Conjunctival Redness at Onset of Action (15 Minutes Post-dose) | 7 minutes post-CAC | 1.44 units on a scale | Standard Deviation 0.663 |
| AC-170 0.05% | Conjunctival Redness at Onset of Action (15 Minutes Post-dose) | 20 minutes post-CAC | 1.83 units on a scale | Standard Deviation 0.648 |
| AC-170 0.05% | Conjunctival Redness at Onset of Action (15 Minutes Post-dose) | 15 minutes post-CAC | 1.81 units on a scale | Standard Deviation 0.67 |
| AC-170 0.1% | Conjunctival Redness at Onset of Action (15 Minutes Post-dose) | 7 minutes post-CAC | 1.45 units on a scale | Standard Deviation 0.812 |
| AC-170 0.1% | Conjunctival Redness at Onset of Action (15 Minutes Post-dose) | 20 minutes post-CAC | 1.67 units on a scale | Standard Deviation 0.868 |
| AC-170 0.1% | Conjunctival Redness at Onset of Action (15 Minutes Post-dose) | 15 minutes post-CAC | 1.67 units on a scale | Standard Deviation 0.821 |
| AC-170 0.24% | Conjunctival Redness at Onset of Action (15 Minutes Post-dose) | 15 minutes post-CAC | 1.83 units on a scale | Standard Deviation 0.68 |
| AC-170 0.24% | Conjunctival Redness at Onset of Action (15 Minutes Post-dose) | 7 minutes post-CAC | 1.66 units on a scale | Standard Deviation 0.718 |
| AC-170 0.24% | Conjunctival Redness at Onset of Action (15 Minutes Post-dose) | 20 minutes post-CAC | 1.79 units on a scale | Standard Deviation 0.717 |
| AC-170 0% | Conjunctival Redness at Onset of Action (15 Minutes Post-dose) | 7 minutes post-CAC | 1.88 units on a scale | Standard Deviation 0.541 |
| AC-170 0% | Conjunctival Redness at Onset of Action (15 Minutes Post-dose) | 20 minutes post-CAC | 1.97 units on a scale | Standard Deviation 0.622 |
| AC-170 0% | Conjunctival Redness at Onset of Action (15 Minutes Post-dose) | 15 minutes post-CAC | 1.96 units on a scale | Standard Deviation 0.589 |
Primary
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
Population: Intent to Treat (ITT)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AC-170 0.05% | Ocular Itching at Duration of Action (16 Hours Post-dose) | 3 minutes post-CAC | 1.91 units on a scale | Standard Deviation 0.924 |
| AC-170 0.05% | Ocular Itching at Duration of Action (16 Hours Post-dose) | 7 minutes post-CAC | 1.86 units on a scale | Standard Deviation 0.907 |
| AC-170 0.05% | Ocular Itching at Duration of Action (16 Hours Post-dose) | 5 minutes post-CAC | 2.01 units on a scale | Standard Deviation 1.019 |
| AC-170 0.1% | Ocular Itching at Duration of Action (16 Hours Post-dose) | 3 minutes post-CAC | 2.00 units on a scale | Standard Deviation 0.771 |
| AC-170 0.1% | Ocular Itching at Duration of Action (16 Hours Post-dose) | 7 minutes post-CAC | 1.87 units on a scale | Standard Deviation 0.913 |
| AC-170 0.1% | Ocular Itching at Duration of Action (16 Hours Post-dose) | 5 minutes post-CAC | 2.04 units on a scale | Standard Deviation 0.889 |
| AC-170 0.24% | Ocular Itching at Duration of Action (16 Hours Post-dose) | 5 minutes post-CAC | 1.74 units on a scale | Standard Deviation 0.843 |
| AC-170 0.24% | Ocular Itching at Duration of Action (16 Hours Post-dose) | 3 minutes post-CAC | 1.65 units on a scale | Standard Deviation 0.963 |
| AC-170 0.24% | Ocular Itching at Duration of Action (16 Hours Post-dose) | 7 minutes post-CAC | 1.75 units on a scale | Standard Deviation 0.91 |
| AC-170 0% | Ocular Itching at Duration of Action (16 Hours Post-dose) | 3 minutes post-CAC | 2.48 units on a scale | Standard Deviation 0.54 |
| AC-170 0% | Ocular Itching at Duration of Action (16 Hours Post-dose) | 7 minutes post-CAC | 2.27 units on a scale | Standard Deviation 0.777 |
| AC-170 0% | Ocular Itching at Duration of Action (16 Hours Post-dose) | 5 minutes post-CAC | 2.55 units on a scale | Standard Deviation 0.55 |
Primary
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.
Time frame: 3, 5, 7 minutes post-CAC
Population: Intent to Treat (ITT)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AC-170 0.05% | Ocular Itching at Duration of Action (24 Hours Post-dose) | 3 minutes post-CAC | 1.99 units on a scale | Standard Deviation 0.849 |
| AC-170 0.05% | Ocular Itching at Duration of Action (24 Hours Post-dose) | 7 minutes post-CAC | 1.77 units on a scale | Standard Deviation 0.774 |
| AC-170 0.05% | Ocular Itching at Duration of Action (24 Hours Post-dose) | 5 minutes post-CAC | 2.00 units on a scale | Standard Deviation 0.711 |
| AC-170 0.1% | Ocular Itching at Duration of Action (24 Hours Post-dose) | 3 minutes post-CAC | 1.78 units on a scale | Standard Deviation 0.873 |
| AC-170 0.1% | Ocular Itching at Duration of Action (24 Hours Post-dose) | 7 minutes post-CAC | 1.78 units on a scale | Standard Deviation 0.988 |
| AC-170 0.1% | Ocular Itching at Duration of Action (24 Hours Post-dose) | 5 minutes post-CAC | 1.92 units on a scale | Standard Deviation 0.883 |
| AC-170 0.24% | Ocular Itching at Duration of Action (24 Hours Post-dose) | 5 minutes post-CAC | 2.17 units on a scale | Standard Deviation 0.819 |
| AC-170 0.24% | Ocular Itching at Duration of Action (24 Hours Post-dose) | 3 minutes post-CAC | 1.90 units on a scale | Standard Deviation 0.804 |
| AC-170 0.24% | Ocular Itching at Duration of Action (24 Hours Post-dose) | 7 minutes post-CAC | 1.97 units on a scale | Standard Deviation 0.833 |
| AC-170 0% | Ocular Itching at Duration of Action (24 Hours Post-dose) | 3 minutes post-CAC | 2.24 units on a scale | Standard Deviation 0.575 |
| AC-170 0% | Ocular Itching at Duration of Action (24 Hours Post-dose) | 7 minutes post-CAC | 2.08 units on a scale | Standard Deviation 0.702 |
| AC-170 0% | Ocular Itching at Duration of Action (24 Hours Post-dose) | 5 minutes post-CAC | 2.24 units on a scale | Standard Deviation 0.686 |
Primary
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
Population: Intent to Treat (ITT)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AC-170 0.05% | Ocular Itching at Onset of Action (15 Minutes Post-dose) | 3 minutes post-CAC | 1.05 units on a scale | Standard Deviation 0.804 |
| AC-170 0.05% | Ocular Itching at Onset of Action (15 Minutes Post-dose) | 7 minutes post-CAC | 1.01 units on a scale | Standard Deviation 0.789 |
| AC-170 0.05% | Ocular Itching at Onset of Action (15 Minutes Post-dose) | 5 minutes post-CAC | 1.19 units on a scale | Standard Deviation 0.778 |
| AC-170 0.1% | Ocular Itching at Onset of Action (15 Minutes Post-dose) | 3 minutes post-CAC | 0.84 units on a scale | Standard Deviation 0.8 |
| AC-170 0.1% | Ocular Itching at Onset of Action (15 Minutes Post-dose) | 7 minutes post-CAC | 1.07 units on a scale | Standard Deviation 0.929 |
| AC-170 0.1% | Ocular Itching at Onset of Action (15 Minutes Post-dose) | 5 minutes post-CAC | 1.09 units on a scale | Standard Deviation 0.941 |
| AC-170 0.24% | Ocular Itching at Onset of Action (15 Minutes Post-dose) | 5 minutes post-CAC | 1.07 units on a scale | Standard Deviation 0.84 |
| AC-170 0.24% | Ocular Itching at Onset of Action (15 Minutes Post-dose) | 3 minutes post-CAC | 0.91 units on a scale | Standard Deviation 0.81 |
| AC-170 0.24% | Ocular Itching at Onset of Action (15 Minutes Post-dose) | 7 minutes post-CAC | 0.97 units on a scale | Standard Deviation 0.843 |
| AC-170 0% | Ocular Itching at Onset of Action (15 Minutes Post-dose) | 3 minutes post-CAC | 1.94 units on a scale | Standard Deviation 0.87 |
| AC-170 0% | Ocular Itching at Onset of Action (15 Minutes Post-dose) | 7 minutes post-CAC | 1.94 units on a scale | Standard Deviation 0.893 |
| AC-170 0% | Ocular Itching at Onset of Action (15 Minutes Post-dose) | 5 minutes post-CAC | 2.09 units on a scale | Standard Deviation 0.85 |
Secondary
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.
Time frame: 7, 15, 20 minutes post-CAC
Population: Intent to Treat (ITT)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AC-170 0.05% | Chemosis at Duration of Action (16 Hours Post-dose) | 7 minutes post-CAC | 0.71 units on a scale | Standard Deviation 0.553 |
| AC-170 0.05% | Chemosis at Duration of Action (16 Hours Post-dose) | 20 minutes post-CAC | 0.92 units on a scale | Standard Deviation 0.644 |
| AC-170 0.05% | Chemosis at Duration of Action (16 Hours Post-dose) | 15 minutes post-CAC | 0.93 units on a scale | Standard Deviation 0.557 |
| AC-170 0.1% | Chemosis at Duration of Action (16 Hours Post-dose) | 7 minutes post-CAC | 0.58 units on a scale | Standard Deviation 0.406 |
| AC-170 0.1% | Chemosis at Duration of Action (16 Hours Post-dose) | 20 minutes post-CAC | 0.72 units on a scale | Standard Deviation 0.583 |
| AC-170 0.1% | Chemosis at Duration of Action (16 Hours Post-dose) | 15 minutes post-CAC | 0.70 units on a scale | Standard Deviation 0.545 |
| AC-170 0.24% | Chemosis at Duration of Action (16 Hours Post-dose) | 15 minutes post-CAC | 0.60 units on a scale | Standard Deviation 0.354 |
| AC-170 0.24% | Chemosis at Duration of Action (16 Hours Post-dose) | 7 minutes post-CAC | 0.53 units on a scale | Standard Deviation 0.292 |
| AC-170 0.24% | Chemosis at Duration of Action (16 Hours Post-dose) | 20 minutes post-CAC | 0.71 units on a scale | Standard Deviation 0.46 |
| AC-170 0% | Chemosis at Duration of Action (16 Hours Post-dose) | 7 minutes post-CAC | 0.72 units on a scale | Standard Deviation 0.532 |
| AC-170 0% | Chemosis at Duration of Action (16 Hours Post-dose) | 20 minutes post-CAC | 1.00 units on a scale | Standard Deviation 0.65 |
| AC-170 0% | Chemosis at Duration of Action (16 Hours Post-dose) | 15 minutes post-CAC | 0.99 units on a scale | Standard Deviation 0.575 |
Secondary
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.
Time frame: 7, 15, 20 minutes post-CAC
Population: Intent to Treat (ITT)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AC-170 0.05% | Chemosis at Duration of Action (24 Hours Post-dose) | 7 minutes post-CAC | 0.68 units on a scale | Standard Deviation 0.478 |
| AC-170 0.05% | Chemosis at Duration of Action (24 Hours Post-dose) | 20 minutes post-CAC | 0.90 units on a scale | Standard Deviation 0.647 |
| AC-170 0.05% | Chemosis at Duration of Action (24 Hours Post-dose) | 15 minutes post-CAC | 0.87 units on a scale | Standard Deviation 0.612 |
| AC-170 0.1% | Chemosis at Duration of Action (24 Hours Post-dose) | 7 minutes post-CAC | 0.52 units on a scale | Standard Deviation 0.279 |
| AC-170 0.1% | Chemosis at Duration of Action (24 Hours Post-dose) | 20 minutes post-CAC | 0.71 units on a scale | Standard Deviation 0.419 |
| AC-170 0.1% | Chemosis at Duration of Action (24 Hours Post-dose) | 15 minutes post-CAC | 0.64 units on a scale | Standard Deviation 0.396 |
| AC-170 0.24% | Chemosis at Duration of Action (24 Hours Post-dose) | 15 minutes post-CAC | 0.77 units on a scale | Standard Deviation 0.433 |
| AC-170 0.24% | Chemosis at Duration of Action (24 Hours Post-dose) | 7 minutes post-CAC | 0.55 units on a scale | Standard Deviation 0.298 |
| AC-170 0.24% | Chemosis at Duration of Action (24 Hours Post-dose) | 20 minutes post-CAC | 0.84 units on a scale | Standard Deviation 0.572 |
| AC-170 0% | Chemosis at Duration of Action (24 Hours Post-dose) | 7 minutes post-CAC | 0.68 units on a scale | Standard Deviation 0.399 |
| AC-170 0% | Chemosis at Duration of Action (24 Hours Post-dose) | 20 minutes post-CAC | 0.90 units on a scale | Standard Deviation 0.568 |
| AC-170 0% | Chemosis at Duration of Action (24 Hours Post-dose) | 15 minutes post-CAC | 0.81 units on a scale | Standard Deviation 0.532 |
Secondary
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.
Time frame: 7, 15, 20 minutes post-CAC
Population: Intent to Treat (ITT)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AC-170 0.05% | Chemosis at Onset of Action (15 Minutes Post-dose) | 7 minutes post-CAC | 0.49 units on a scale | Standard Deviation 0.232 |
| AC-170 0.05% | Chemosis at Onset of Action (15 Minutes Post-dose) | 20 minutes post-CAC | 0.71 units on a scale | Standard Deviation 0.403 |
| AC-170 0.05% | Chemosis at Onset of Action (15 Minutes Post-dose) | 15 minutes post-CAC | 0.74 units on a scale | Standard Deviation 0.423 |
| AC-170 0.1% | Chemosis at Onset of Action (15 Minutes Post-dose) | 7 minutes post-CAC | 0.43 units on a scale | Standard Deviation 0.293 |
| AC-170 0.1% | Chemosis at Onset of Action (15 Minutes Post-dose) | 20 minutes post-CAC | 0.53 units on a scale | Standard Deviation 0.363 |
| AC-170 0.1% | Chemosis at Onset of Action (15 Minutes Post-dose) | 15 minutes post-CAC | 0.52 units on a scale | Standard Deviation 0.314 |
| AC-170 0.24% | Chemosis at Onset of Action (15 Minutes Post-dose) | 15 minutes post-CAC | 0.79 units on a scale | Standard Deviation 0.456 |
| AC-170 0.24% | Chemosis at Onset of Action (15 Minutes Post-dose) | 7 minutes post-CAC | 0.54 units on a scale | Standard Deviation 0.277 |
| AC-170 0.24% | Chemosis at Onset of Action (15 Minutes Post-dose) | 20 minutes post-CAC | 0.76 units on a scale | Standard Deviation 0.399 |
| AC-170 0% | Chemosis at Onset of Action (15 Minutes Post-dose) | 7 minutes post-CAC | 0.74 units on a scale | Standard Deviation 0.427 |
| AC-170 0% | Chemosis at Onset of Action (15 Minutes Post-dose) | 20 minutes post-CAC | 0.88 units on a scale | Standard Deviation 0.555 |
| AC-170 0% | Chemosis at Onset of Action (15 Minutes Post-dose) | 15 minutes post-CAC | 0.80 units on a scale | Standard Deviation 0.554 |
Secondary
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
Population: Intent to Treat (ITT)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AC-170 0.05% | Ciliary Redness at Duration of Action (16 Hours Post-dose) | 7 minutes post-CAC | 1.47 units on a scale | Standard Deviation 0.708 |
| AC-170 0.05% | Ciliary Redness at Duration of Action (16 Hours Post-dose) | 20 minutes post-CAC | 1.60 units on a scale | Standard Deviation 0.703 |
| AC-170 0.05% | Ciliary Redness at Duration of Action (16 Hours Post-dose) | 15 minutes post-CAC | 1.60 units on a scale | Standard Deviation 0.707 |
| AC-170 0.1% | Ciliary Redness at Duration of Action (16 Hours Post-dose) | 7 minutes post-CAC | 1.53 units on a scale | Standard Deviation 0.758 |
| AC-170 0.1% | Ciliary Redness at Duration of Action (16 Hours Post-dose) | 20 minutes post-CAC | 1.65 units on a scale | Standard Deviation 0.878 |
| AC-170 0.1% | Ciliary Redness at Duration of Action (16 Hours Post-dose) | 15 minutes post-CAC | 1.65 units on a scale | Standard Deviation 0.842 |
| AC-170 0.24% | Ciliary Redness at Duration of Action (16 Hours Post-dose) | 15 minutes post-CAC | 1.52 units on a scale | Standard Deviation 0.732 |
| AC-170 0.24% | Ciliary Redness at Duration of Action (16 Hours Post-dose) | 7 minutes post-CAC | 1.34 units on a scale | Standard Deviation 0.684 |
| AC-170 0.24% | Ciliary Redness at Duration of Action (16 Hours Post-dose) | 20 minutes post-CAC | 1.53 units on a scale | Standard Deviation 0.788 |
| AC-170 0% | Ciliary Redness at Duration of Action (16 Hours Post-dose) | 7 minutes post-CAC | 1.81 units on a scale | Standard Deviation 0.527 |
| AC-170 0% | Ciliary Redness at Duration of Action (16 Hours Post-dose) | 20 minutes post-CAC | 1.95 units on a scale | Standard Deviation 0.573 |
| AC-170 0% | Ciliary Redness at Duration of Action (16 Hours Post-dose) | 15 minutes post-CAC | 1.99 units on a scale | Standard Deviation 0.523 |
Secondary
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.
Time frame: 7, 15, 20 minutes post-CAC
Population: Intent to Treat (ITT)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AC-170 0.05% | Ciliary Redness at Duration of Action (24 Hours Post-dose) | 7 minutes post-CAC | 1.36 units on a scale | Standard Deviation 0.73 |
| AC-170 0.05% | Ciliary Redness at Duration of Action (24 Hours Post-dose) | 20 minutes post-CAC | 1.50 units on a scale | Standard Deviation 0.617 |
| AC-170 0.05% | Ciliary Redness at Duration of Action (24 Hours Post-dose) | 15 minutes post-CAC | 1.49 units on a scale | Standard Deviation 0.596 |
| AC-170 0.1% | Ciliary Redness at Duration of Action (24 Hours Post-dose) | 7 minutes post-CAC | 1.22 units on a scale | Standard Deviation 0.686 |
| AC-170 0.1% | Ciliary Redness at Duration of Action (24 Hours Post-dose) | 20 minutes post-CAC | 1.47 units on a scale | Standard Deviation 0.701 |
| AC-170 0.1% | Ciliary Redness at Duration of Action (24 Hours Post-dose) | 15 minutes post-CAC | 1.47 units on a scale | Standard Deviation 0.723 |
| AC-170 0.24% | Ciliary Redness at Duration of Action (24 Hours Post-dose) | 15 minutes post-CAC | 1.74 units on a scale | Standard Deviation 0.716 |
| AC-170 0.24% | Ciliary Redness at Duration of Action (24 Hours Post-dose) | 7 minutes post-CAC | 1.50 units on a scale | Standard Deviation 0.633 |
| AC-170 0.24% | Ciliary Redness at Duration of Action (24 Hours Post-dose) | 20 minutes post-CAC | 1.65 units on a scale | Standard Deviation 0.736 |
| AC-170 0% | Ciliary Redness at Duration of Action (24 Hours Post-dose) | 7 minutes post-CAC | 1.55 units on a scale | Standard Deviation 0.582 |
| AC-170 0% | Ciliary Redness at Duration of Action (24 Hours Post-dose) | 20 minutes post-CAC | 1.65 units on a scale | Standard Deviation 0.599 |
| AC-170 0% | Ciliary Redness at Duration of Action (24 Hours Post-dose) | 15 minutes post-CAC | 1.77 units on a scale | Standard Deviation 0.544 |
Secondary
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
Population: Intent to Treat (ITT). Number of analyzed subjects differ due to subject discontinuation during the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AC-170 0.05% | Ciliary Redness at Onset of Action (15 Minutes Post-dose) | 7 minutes post-CAC | 1.24 units on a scale | Standard Deviation 0.689 |
| AC-170 0.05% | Ciliary Redness at Onset of Action (15 Minutes Post-dose) | 20 minutes post-CAC | 1.65 units on a scale | Standard Deviation 0.647 |
| AC-170 0.05% | Ciliary Redness at Onset of Action (15 Minutes Post-dose) | 15 minutes post-CAC | 1.59 units on a scale | Standard Deviation 0.749 |
| AC-170 0.1% | Ciliary Redness at Onset of Action (15 Minutes Post-dose) | 7 minutes post-CAC | 1.24 units on a scale | Standard Deviation 0.867 |
| AC-170 0.1% | Ciliary Redness at Onset of Action (15 Minutes Post-dose) | 20 minutes post-CAC | 1.52 units on a scale | Standard Deviation 0.952 |
| AC-170 0.1% | Ciliary Redness at Onset of Action (15 Minutes Post-dose) | 15 minutes post-CAC | 1.51 units on a scale | Standard Deviation 0.861 |
| AC-170 0.24% | Ciliary Redness at Onset of Action (15 Minutes Post-dose) | 15 minutes post-CAC | 1.64 units on a scale | Standard Deviation 0.669 |
| AC-170 0.24% | Ciliary Redness at Onset of Action (15 Minutes Post-dose) | 7 minutes post-CAC | 1.27 units on a scale | Standard Deviation 0.858 |
| AC-170 0.24% | Ciliary Redness at Onset of Action (15 Minutes Post-dose) | 20 minutes post-CAC | 1.73 units on a scale | Standard Deviation 0.622 |
| AC-170 0% | Ciliary Redness at Onset of Action (15 Minutes Post-dose) | 7 minutes post-CAC | 1.67 units on a scale | Standard Deviation 0.628 |
| AC-170 0% | Ciliary Redness at Onset of Action (15 Minutes Post-dose) | 20 minutes post-CAC | 1.79 units on a scale | Standard Deviation 0.644 |
| AC-170 0% | Ciliary Redness at Onset of Action (15 Minutes Post-dose) | 15 minutes post-CAC | 1.77 units on a scale | Standard Deviation 0.661 |
Secondary
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.
Time frame: 7, 15, 20 minutes post-CAC
Population: Intent to Treat (ITT)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AC-170 0.05% | Ear or Palate Pruritus at Duration of Action (16 Hours Post-dose) | 7 minutes post-CAC | 0.4 units on a scale | Standard Deviation 0.87 |
| AC-170 0.05% | Ear or Palate Pruritus at Duration of Action (16 Hours Post-dose) | 20 minutes post-CAC | 0.8 units on a scale | Standard Deviation 1.11 |
| AC-170 0.05% | Ear or Palate Pruritus at Duration of Action (16 Hours Post-dose) | 15 minutes post-CAC | 0.9 units on a scale | Standard Deviation 1.09 |
| AC-170 0.1% | Ear or Palate Pruritus at Duration of Action (16 Hours Post-dose) | 7 minutes post-CAC | 0.4 units on a scale | Standard Deviation 0.57 |
| AC-170 0.1% | Ear or Palate Pruritus at Duration of Action (16 Hours Post-dose) | 20 minutes post-CAC | 0.9 units on a scale | Standard Deviation 0.91 |
| AC-170 0.1% | Ear or Palate Pruritus at Duration of Action (16 Hours Post-dose) | 15 minutes post-CAC | 0.8 units on a scale | Standard Deviation 0.9 |
| AC-170 0.24% | Ear or Palate Pruritus at Duration of Action (16 Hours Post-dose) | 15 minutes post-CAC | 0.5 units on a scale | Standard Deviation 0.77 |
| AC-170 0.24% | Ear or Palate Pruritus at Duration of Action (16 Hours Post-dose) | 7 minutes post-CAC | 0.3 units on a scale | Standard Deviation 0.74 |
| AC-170 0.24% | Ear or Palate Pruritus at Duration of Action (16 Hours Post-dose) | 20 minutes post-CAC | 0.8 units on a scale | Standard Deviation 0.93 |
| AC-170 0% | Ear or Palate Pruritus at Duration of Action (16 Hours Post-dose) | 7 minutes post-CAC | 0.5 units on a scale | Standard Deviation 0.87 |
| AC-170 0% | Ear or Palate Pruritus at Duration of Action (16 Hours Post-dose) | 20 minutes post-CAC | 1.2 units on a scale | Standard Deviation 1.31 |
| AC-170 0% | Ear or Palate Pruritus at Duration of Action (16 Hours Post-dose) | 15 minutes post-CAC | 1.0 units on a scale | Standard Deviation 1.1 |
Secondary
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.
Time frame: 7, 15, 20 minutes post-CAC
Population: Intent to Treat (ITT)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AC-170 0.05% | Ear or Palate Pruritus at Duration of Action (24 Hours Post-dose) | 7 minutes post-CAC | 0.6 units on a scale | Standard Deviation 0.89 |
| AC-170 0.05% | Ear or Palate Pruritus at Duration of Action (24 Hours Post-dose) | 20 minutes post-CAC | 0.8 units on a scale | Standard Deviation 1.11 |
| AC-170 0.05% | Ear or Palate Pruritus at Duration of Action (24 Hours Post-dose) | 15 minutes post-CAC | 0.7 units on a scale | Standard Deviation 0.96 |
| AC-170 0.1% | Ear or Palate Pruritus at Duration of Action (24 Hours Post-dose) | 7 minutes post-CAC | 0.3 units on a scale | Standard Deviation 0.46 |
| AC-170 0.1% | Ear or Palate Pruritus at Duration of Action (24 Hours Post-dose) | 20 minutes post-CAC | 0.7 units on a scale | Standard Deviation 0.74 |
| AC-170 0.1% | Ear or Palate Pruritus at Duration of Action (24 Hours Post-dose) | 15 minutes post-CAC | 0.6 units on a scale | Standard Deviation 0.65 |
| AC-170 0.24% | Ear or Palate Pruritus at Duration of Action (24 Hours Post-dose) | 15 minutes post-CAC | 0.7 units on a scale | Standard Deviation 0.98 |
| AC-170 0.24% | Ear or Palate Pruritus at Duration of Action (24 Hours Post-dose) | 7 minutes post-CAC | 0.4 units on a scale | Standard Deviation 0.76 |
| AC-170 0.24% | Ear or Palate Pruritus at Duration of Action (24 Hours Post-dose) | 20 minutes post-CAC | 0.7 units on a scale | Standard Deviation 0.9 |
| AC-170 0% | Ear or Palate Pruritus at Duration of Action (24 Hours Post-dose) | 7 minutes post-CAC | 0.5 units on a scale | Standard Deviation 0.96 |
| AC-170 0% | Ear or Palate Pruritus at Duration of Action (24 Hours Post-dose) | 20 minutes post-CAC | 0.7 units on a scale | Standard Deviation 1.07 |
| AC-170 0% | Ear or Palate Pruritus at Duration of Action (24 Hours Post-dose) | 15 minutes post-CAC | 0.8 units on a scale | Standard Deviation 1.19 |
Secondary
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
Population: Intent to Treat (ITT)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AC-170 0.05% | Ear or Palate Pruritus at Onset of Action (15 Minutes Post-dose) | 7 minutes post-CAC | 0.6 units on a scale | Standard Deviation 0.99 |
| AC-170 0.05% | Ear or Palate Pruritus at Onset of Action (15 Minutes Post-dose) | 20 minutes post-CAC | 0.7 units on a scale | Standard Deviation 1.01 |
| AC-170 0.05% | Ear or Palate Pruritus at Onset of Action (15 Minutes Post-dose) | 15 minutes post-CAC | 08 units on a scale | Standard Deviation 0.95 |
| AC-170 0.1% | Ear or Palate Pruritus at Onset of Action (15 Minutes Post-dose) | 7 minutes post-CAC | 0.2 units on a scale | Standard Deviation 0.52 |
| AC-170 0.1% | Ear or Palate Pruritus at Onset of Action (15 Minutes Post-dose) | 20 minutes post-CAC | 0.5 units on a scale | Standard Deviation 0.77 |
| AC-170 0.1% | Ear or Palate Pruritus at Onset of Action (15 Minutes Post-dose) | 15 minutes post-CAC | 0.4 units on a scale | Standard Deviation 0.76 |
| AC-170 0.24% | Ear or Palate Pruritus at Onset of Action (15 Minutes Post-dose) | 15 minutes post-CAC | 0.3 units on a scale | Standard Deviation 0.58 |
| AC-170 0.24% | Ear or Palate Pruritus at Onset of Action (15 Minutes Post-dose) | 7 minutes post-CAC | 0.3 units on a scale | Standard Deviation 0.56 |
| AC-170 0.24% | Ear or Palate Pruritus at Onset of Action (15 Minutes Post-dose) | 20 minutes post-CAC | 0.3 units on a scale | Standard Deviation 0.58 |
| AC-170 0% | Ear or Palate Pruritus at Onset of Action (15 Minutes Post-dose) | 7 minutes post-CAC | 0.4 units on a scale | Standard Deviation 0.76 |
| AC-170 0% | Ear or Palate Pruritus at Onset of Action (15 Minutes Post-dose) | 20 minutes post-CAC | 0.7 units on a scale | Standard Deviation 1.07 |
| AC-170 0% | Ear or Palate Pruritus at Onset of Action (15 Minutes Post-dose) | 15 minutes post-CAC | 0.7 units on a scale | Standard Deviation 1.07 |
Secondary
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
Population: Intent to Treat (ITT)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AC-170 0.05% | Episcleral Redness at Duration of Action (16 Hours Post-dose) | 7 minutes post-CAC | 1.68 units on a scale | Standard Deviation 0.602 |
| AC-170 0.05% | Episcleral Redness at Duration of Action (16 Hours Post-dose) | 20 minutes post-CAC | 1.80 units on a scale | Standard Deviation 0.629 |
| AC-170 0.05% | Episcleral Redness at Duration of Action (16 Hours Post-dose) | 15 minutes post-CAC | 1.81 units on a scale | Standard Deviation 0.639 |
| AC-170 0.1% | Episcleral Redness at Duration of Action (16 Hours Post-dose) | 7 minutes post-CAC | 1.74 units on a scale | Standard Deviation 0.69 |
| AC-170 0.1% | Episcleral Redness at Duration of Action (16 Hours Post-dose) | 20 minutes post-CAC | 1.73 units on a scale | Standard Deviation 0.797 |
| AC-170 0.1% | Episcleral Redness at Duration of Action (16 Hours Post-dose) | 15 minutes post-CAC | 1.77 units on a scale | Standard Deviation 0.757 |
| AC-170 0.24% | Episcleral Redness at Duration of Action (16 Hours Post-dose) | 15 minutes post-CAC | 1.69 units on a scale | Standard Deviation 0.605 |
| AC-170 0.24% | Episcleral Redness at Duration of Action (16 Hours Post-dose) | 7 minutes post-CAC | 1.57 units on a scale | Standard Deviation 0.497 |
| AC-170 0.24% | Episcleral Redness at Duration of Action (16 Hours Post-dose) | 20 minutes post-CAC | 1.69 units on a scale | Standard Deviation 0.647 |
| AC-170 0% | Episcleral Redness at Duration of Action (16 Hours Post-dose) | 7 minutes post-CAC | 1.90 units on a scale | Standard Deviation 0.439 |
| AC-170 0% | Episcleral Redness at Duration of Action (16 Hours Post-dose) | 20 minutes post-CAC | 1.97 units on a scale | Standard Deviation 0.458 |
| AC-170 0% | Episcleral Redness at Duration of Action (16 Hours Post-dose) | 15 minutes post-CAC | 2.02 units on a scale | Standard Deviation 0.484 |
Secondary
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.
Time frame: 7, 15, 20 minutes post-CAC
Population: Intent to Treat (ITT)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AC-170 0.05% | Episcleral Redness at Duration of Action (24 Hours Post-dose) | 7 minutes post-CAC | 1.53 units on a scale | Standard Deviation 0.59 |
| AC-170 0.05% | Episcleral Redness at Duration of Action (24 Hours Post-dose) | 20 minutes post-CAC | 1.70 units on a scale | Standard Deviation 0.579 |
| AC-170 0.05% | Episcleral Redness at Duration of Action (24 Hours Post-dose) | 15 minutes post-CAC | 1.72 units on a scale | Standard Deviation 0.585 |
| AC-170 0.1% | Episcleral Redness at Duration of Action (24 Hours Post-dose) | 7 minutes post-CAC | 1.37 units on a scale | Standard Deviation 0.681 |
| AC-170 0.1% | Episcleral Redness at Duration of Action (24 Hours Post-dose) | 20 minutes post-CAC | 1.60 units on a scale | Standard Deviation 0.688 |
| AC-170 0.1% | Episcleral Redness at Duration of Action (24 Hours Post-dose) | 15 minutes post-CAC | 1.63 units on a scale | Standard Deviation 0.7 |
| AC-170 0.24% | Episcleral Redness at Duration of Action (24 Hours Post-dose) | 15 minutes post-CAC | 1.90 units on a scale | Standard Deviation 0.657 |
| AC-170 0.24% | Episcleral Redness at Duration of Action (24 Hours Post-dose) | 7 minutes post-CAC | 1.73 units on a scale | Standard Deviation 0.616 |
| AC-170 0.24% | Episcleral Redness at Duration of Action (24 Hours Post-dose) | 20 minutes post-CAC | 1.87 units on a scale | Standard Deviation 0.696 |
| AC-170 0% | Episcleral Redness at Duration of Action (24 Hours Post-dose) | 7 minutes post-CAC | 1.80 units on a scale | Standard Deviation 0.505 |
| AC-170 0% | Episcleral Redness at Duration of Action (24 Hours Post-dose) | 20 minutes post-CAC | 1.85 units on a scale | Standard Deviation 0.53 |
| AC-170 0% | Episcleral Redness at Duration of Action (24 Hours Post-dose) | 15 minutes post-CAC | 2.00 units on a scale | Standard Deviation 0.505 |
Secondary
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
Population: Intent to Treat (ITT)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AC-170 0.05% | Episcleral Redness at Onset of Action (15 Minutes Post-dose) | 7 minutes post-CAC | 1.52 units on a scale | Standard Deviation 0.644 |
| AC-170 0.05% | Episcleral Redness at Onset of Action (15 Minutes Post-dose) | 20 minutes post-CAC | 1.91 units on a scale | Standard Deviation 0.577 |
| AC-170 0.05% | Episcleral Redness at Onset of Action (15 Minutes Post-dose) | 15 minutes post-CAC | 1.86 units on a scale | Standard Deviation 0.652 |
| AC-170 0.1% | Episcleral Redness at Onset of Action (15 Minutes Post-dose) | 7 minutes post-CAC | 1.49 units on a scale | Standard Deviation 0.782 |
| AC-170 0.1% | Episcleral Redness at Onset of Action (15 Minutes Post-dose) | 20 minutes post-CAC | 1.72 units on a scale | Standard Deviation 0.861 |
| AC-170 0.1% | Episcleral Redness at Onset of Action (15 Minutes Post-dose) | 15 minutes post-CAC | 1.73 units on a scale | Standard Deviation 0.803 |
| AC-170 0.24% | Episcleral Redness at Onset of Action (15 Minutes Post-dose) | 15 minutes post-CAC | 1.98 units on a scale | Standard Deviation 0.698 |
| AC-170 0.24% | Episcleral Redness at Onset of Action (15 Minutes Post-dose) | 7 minutes post-CAC | 1.64 units on a scale | Standard Deviation 0.744 |
| AC-170 0.24% | Episcleral Redness at Onset of Action (15 Minutes Post-dose) | 20 minutes post-CAC | 1.88 units on a scale | Standard Deviation 0.644 |
| AC-170 0% | Episcleral Redness at Onset of Action (15 Minutes Post-dose) | 7 minutes post-CAC | 1.93 units on a scale | Standard Deviation 0.508 |
| AC-170 0% | Episcleral Redness at Onset of Action (15 Minutes Post-dose) | 20 minutes post-CAC | 2.04 units on a scale | Standard Deviation 0.598 |
| AC-170 0% | Episcleral Redness at Onset of Action (15 Minutes Post-dose) | 15 minutes post-CAC | 2.01 units on a scale | Standard Deviation 0.575 |
Secondary
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.
Time frame: 7, 15, 20 minutes post-CAC
Population: Intent to Treat (ITT)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AC-170 0.05% | Eyelid Swelling at Duration of Action (16 Hours Post-dose) | 7 minutes post-CAC | 0.6 units on a scale | Standard Deviation 0.75 |
| AC-170 0.05% | Eyelid Swelling at Duration of Action (16 Hours Post-dose) | 20 minutes post-CAC | 0.6 units on a scale | Standard Deviation 0.76 |
| AC-170 0.05% | Eyelid Swelling at Duration of Action (16 Hours Post-dose) | 15 minutes post-CAC | 0.7 units on a scale | Standard Deviation 0.79 |
| AC-170 0.1% | Eyelid Swelling at Duration of Action (16 Hours Post-dose) | 7 minutes post-CAC | 0.8 units on a scale | Standard Deviation 0.66 |
| AC-170 0.1% | Eyelid Swelling at Duration of Action (16 Hours Post-dose) | 20 minutes post-CAC | 0.8 units on a scale | Standard Deviation 0.73 |
| AC-170 0.1% | Eyelid Swelling at Duration of Action (16 Hours Post-dose) | 15 minutes post-CAC | 0.9 units on a scale | Standard Deviation 0.75 |
| AC-170 0.24% | Eyelid Swelling at Duration of Action (16 Hours Post-dose) | 15 minutes post-CAC | 0.8 units on a scale | Standard Deviation 0.54 |
| AC-170 0.24% | Eyelid Swelling at Duration of Action (16 Hours Post-dose) | 7 minutes post-CAC | 0.8 units on a scale | Standard Deviation 0.66 |
| AC-170 0.24% | Eyelid Swelling at Duration of Action (16 Hours Post-dose) | 20 minutes post-CAC | 0.7 units on a scale | Standard Deviation 0.56 |
| AC-170 0% | Eyelid Swelling at Duration of Action (16 Hours Post-dose) | 7 minutes post-CAC | 0.9 units on a scale | Standard Deviation 0.71 |
| AC-170 0% | Eyelid Swelling at Duration of Action (16 Hours Post-dose) | 20 minutes post-CAC | 1.0 units on a scale | Standard Deviation 0.85 |
| AC-170 0% | Eyelid Swelling at Duration of Action (16 Hours Post-dose) | 15 minutes post-CAC | 1.1 units on a scale | Standard Deviation 0.86 |
Secondary
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.
Time frame: 7, 15, 20 minutes post-CAC
Population: Intent to Treat (ITT)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AC-170 0.05% | Eyelid Swelling at Duration of Action (24 Hours Post-dose) | 7 minutes post-CAC | 0.7 units on a scale | Standard Deviation 0.6 |
| AC-170 0.05% | Eyelid Swelling at Duration of Action (24 Hours Post-dose) | 20 minutes post-CAC | 0.8 units on a scale | Standard Deviation 0.69 |
| AC-170 0.05% | Eyelid Swelling at Duration of Action (24 Hours Post-dose) | 15 minutes post-CAC | 0.8 units on a scale | Standard Deviation 0.7 |
| AC-170 0.1% | Eyelid Swelling at Duration of Action (24 Hours Post-dose) | 7 minutes post-CAC | 0.7 units on a scale | Standard Deviation 0.54 |
| AC-170 0.1% | Eyelid Swelling at Duration of Action (24 Hours Post-dose) | 20 minutes post-CAC | 0.8 units on a scale | Standard Deviation 0.76 |
| AC-170 0.1% | Eyelid Swelling at Duration of Action (24 Hours Post-dose) | 15 minutes post-CAC | 0.8 units on a scale | Standard Deviation 0.73 |
| AC-170 0.24% | Eyelid Swelling at Duration of Action (24 Hours Post-dose) | 15 minutes post-CAC | 0.9 units on a scale | Standard Deviation 0.82 |
| AC-170 0.24% | Eyelid Swelling at Duration of Action (24 Hours Post-dose) | 7 minutes post-CAC | 0.9 units on a scale | Standard Deviation 0.68 |
| AC-170 0.24% | Eyelid Swelling at Duration of Action (24 Hours Post-dose) | 20 minutes post-CAC | 0.9 units on a scale | Standard Deviation 0.72 |
| AC-170 0% | Eyelid Swelling at Duration of Action (24 Hours Post-dose) | 7 minutes post-CAC | 0.7 units on a scale | Standard Deviation 0.74 |
| AC-170 0% | Eyelid Swelling at Duration of Action (24 Hours Post-dose) | 20 minutes post-CAC | 0.9 units on a scale | Standard Deviation 0.85 |
| AC-170 0% | Eyelid Swelling at Duration of Action (24 Hours Post-dose) | 15 minutes post-CAC | 0.9 units on a scale | Standard Deviation 0.82 |
Secondary
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.
Time frame: 7, 15, 20 minutes post-CAC
Population: Intent to Treat (ITT)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AC-170 0.05% | Eyelid Swelling at Onset of Action (15 Minutes Post-dose) | 7 minutes post-CAC | 0.4 units on a scale | Standard Deviation 0.56 |
| AC-170 0.05% | Eyelid Swelling at Onset of Action (15 Minutes Post-dose) | 20 minutes post-CAC | 0.5 units on a scale | Standard Deviation 0.71 |
| AC-170 0.05% | Eyelid Swelling at Onset of Action (15 Minutes Post-dose) | 15 minutes post-CAC | 0.5 units on a scale | Standard Deviation 0.68 |
| AC-170 0.1% | Eyelid Swelling at Onset of Action (15 Minutes Post-dose) | 7 minutes post-CAC | 0.5 units on a scale | Standard Deviation 0.7 |
| AC-170 0.1% | Eyelid Swelling at Onset of Action (15 Minutes Post-dose) | 20 minutes post-CAC | 0.6 units on a scale | Standard Deviation 0.58 |
| AC-170 0.1% | Eyelid Swelling at Onset of Action (15 Minutes Post-dose) | 15 minutes post-CAC | 0.6 units on a scale | Standard Deviation 0.65 |
| AC-170 0.24% | Eyelid Swelling at Onset of Action (15 Minutes Post-dose) | 15 minutes post-CAC | 0.6 units on a scale | Standard Deviation 0.65 |
| AC-170 0.24% | Eyelid Swelling at Onset of Action (15 Minutes Post-dose) | 7 minutes post-CAC | 0.5 units on a scale | Standard Deviation 0.49 |
| AC-170 0.24% | Eyelid Swelling at Onset of Action (15 Minutes Post-dose) | 20 minutes post-CAC | 0.5 units on a scale | Standard Deviation 0.49 |
| AC-170 0% | Eyelid Swelling at Onset of Action (15 Minutes Post-dose) | 7 minutes post-CAC | 0.7 units on a scale | Standard Deviation 0.81 |
| AC-170 0% | Eyelid Swelling at Onset of Action (15 Minutes Post-dose) | 20 minutes post-CAC | 0.7 units on a scale | Standard Deviation 0.84 |
| AC-170 0% | Eyelid Swelling at Onset of Action (15 Minutes Post-dose) | 15 minutes post-CAC | 0.8 units on a scale | Standard Deviation 0.89 |
Secondary
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.
Time frame: 7, 15, 20 minutes post-CAC
Population: Intent to Treat (ITT)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AC-170 0.05% | Nasal Composite Score at Duration of Action (16 Hours Post-dose) | 7 minutes post-CAC | 82.6 percentage of subjects |
| AC-170 0.05% | Nasal Composite Score at Duration of Action (16 Hours Post-dose) | 20 minutes post-CAC | 91.3 percentage of subjects |
| AC-170 0.05% | Nasal Composite Score at Duration of Action (16 Hours Post-dose) | 15 minutes post-CAC | 82.6 percentage of subjects |
| AC-170 0.1% | Nasal Composite Score at Duration of Action (16 Hours Post-dose) | 7 minutes post-CAC | 66.7 percentage of subjects |
| AC-170 0.1% | Nasal Composite Score at Duration of Action (16 Hours Post-dose) | 20 minutes post-CAC | 83.3 percentage of subjects |
| AC-170 0.1% | Nasal Composite Score at Duration of Action (16 Hours Post-dose) | 15 minutes post-CAC | 79.2 percentage of subjects |
| AC-170 0.24% | Nasal Composite Score at Duration of Action (16 Hours Post-dose) | 15 minutes post-CAC | 90.5 percentage of subjects |
| AC-170 0.24% | Nasal Composite Score at Duration of Action (16 Hours Post-dose) | 7 minutes post-CAC | 52.4 percentage of subjects |
| AC-170 0.24% | Nasal Composite Score at Duration of Action (16 Hours Post-dose) | 20 minutes post-CAC | 95.2 percentage of subjects |
| AC-170 0% | Nasal Composite Score at Duration of Action (16 Hours Post-dose) | 7 minutes post-CAC | 76.0 percentage of subjects |
| AC-170 0% | Nasal Composite Score at Duration of Action (16 Hours Post-dose) | 20 minutes post-CAC | 84.0 percentage of subjects |
| AC-170 0% | Nasal Composite Score at Duration of Action (16 Hours Post-dose) | 15 minutes post-CAC | 84.0 percentage of subjects |
Secondary
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.
Time frame: 7, 15, 20 minutes post-CAC
Population: Intent to Treat (ITT)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AC-170 0.05% | Nasal Composite Score at Duration of Action (24 Hours Post-dose) | 7 minutes post-CAC | 69.6 percentage of subjects |
| AC-170 0.05% | Nasal Composite Score at Duration of Action (24 Hours Post-dose) | 20 minutes post-CAC | 82.6 percentage of subjects |
| AC-170 0.05% | Nasal Composite Score at Duration of Action (24 Hours Post-dose) | 15 minutes post-CAC | 82.6 percentage of subjects |
| AC-170 0.1% | Nasal Composite Score at Duration of Action (24 Hours Post-dose) | 7 minutes post-CAC | 76.0 percentage of subjects |
| AC-170 0.1% | Nasal Composite Score at Duration of Action (24 Hours Post-dose) | 20 minutes post-CAC | 88.0 percentage of subjects |
| AC-170 0.1% | Nasal Composite Score at Duration of Action (24 Hours Post-dose) | 15 minutes post-CAC | 84.0 percentage of subjects |
| AC-170 0.24% | Nasal Composite Score at Duration of Action (24 Hours Post-dose) | 15 minutes post-CAC | 90.5 percentage of subjects |
| AC-170 0.24% | Nasal Composite Score at Duration of Action (24 Hours Post-dose) | 7 minutes post-CAC | 85.7 percentage of subjects |
| AC-170 0.24% | Nasal Composite Score at Duration of Action (24 Hours Post-dose) | 20 minutes post-CAC | 81.0 percentage of subjects |
| AC-170 0% | Nasal Composite Score at Duration of Action (24 Hours Post-dose) | 7 minutes post-CAC | 68.0 percentage of subjects |
| AC-170 0% | Nasal Composite Score at Duration of Action (24 Hours Post-dose) | 20 minutes post-CAC | 92.0 percentage of subjects |
| AC-170 0% | Nasal Composite Score at Duration of Action (24 Hours Post-dose) | 15 minutes post-CAC | 92.0 percentage of subjects |
Secondary
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.
Time frame: 7, 15, 20 minutes post-CAC
Population: Intent to Treat (ITT)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AC-170 0.05% | Nasal Composite Score at Onset of Action (15 Minutes Post-dose) | 7 minutes post-CAC | 52.2 percentage of subjects |
| AC-170 0.05% | Nasal Composite Score at Onset of Action (15 Minutes Post-dose) | 20 minutes post-CAC | 73.9 percentage of subjects |
| AC-170 0.05% | Nasal Composite Score at Onset of Action (15 Minutes Post-dose) | 15 minutes post-CAC | 82.6 percentage of subjects |
| AC-170 0.1% | Nasal Composite Score at Onset of Action (15 Minutes Post-dose) | 7 minutes post-CAC | 56 percentage of subjects |
| AC-170 0.1% | Nasal Composite Score at Onset of Action (15 Minutes Post-dose) | 20 minutes post-CAC | 52 percentage of subjects |
| AC-170 0.1% | Nasal Composite Score at Onset of Action (15 Minutes Post-dose) | 15 minutes post-CAC | 56 percentage of subjects |
| AC-170 0.24% | Nasal Composite Score at Onset of Action (15 Minutes Post-dose) | 15 minutes post-CAC | 47.6 percentage of subjects |
| AC-170 0.24% | Nasal Composite Score at Onset of Action (15 Minutes Post-dose) | 7 minutes post-CAC | 47.6 percentage of subjects |
| AC-170 0.24% | Nasal Composite Score at Onset of Action (15 Minutes Post-dose) | 20 minutes post-CAC | 52.4 percentage of subjects |
| AC-170 0% | Nasal Composite Score at Onset of Action (15 Minutes Post-dose) | 7 minutes post-CAC | 72 percentage of subjects |
| AC-170 0% | Nasal Composite Score at Onset of Action (15 Minutes Post-dose) | 20 minutes post-CAC | 84 percentage of subjects |
| AC-170 0% | Nasal Composite Score at Onset of Action (15 Minutes Post-dose) | 15 minutes post-CAC | 84 percentage of subjects |
Secondary
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.
Time frame: 7, 15, 20 minutes post-CAC
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AC-170 0.05% | Nasal Congestion at Duration of Action (24 Hours Post-dose) | 7 minutes post-CAC | 0.9 units on a scale | Standard Deviation 0.97 |
| AC-170 0.05% | Nasal Congestion at Duration of Action (24 Hours Post-dose) | 20 minutes post-CAC | 1.2 units on a scale | Standard Deviation 1 |
| AC-170 0.05% | Nasal Congestion at Duration of Action (24 Hours Post-dose) | 15 minutes post-CAC | 1.2 units on a scale | Standard Deviation 0.98 |
| AC-170 0.1% | Nasal Congestion at Duration of Action (24 Hours Post-dose) | 7 minutes post-CAC | 0.6 units on a scale | Standard Deviation 0.58 |
| AC-170 0.1% | Nasal Congestion at Duration of Action (24 Hours Post-dose) | 20 minutes post-CAC | 0.6 units on a scale | Standard Deviation 0.65 |
| AC-170 0.1% | Nasal Congestion at Duration of Action (24 Hours Post-dose) | 15 minutes post-CAC | 0.6 units on a scale | Standard Deviation 0.58 |
| AC-170 0.24% | Nasal Congestion at Duration of Action (24 Hours Post-dose) | 15 minutes post-CAC | 1.2 units on a scale | Standard Deviation 0.94 |
| AC-170 0.24% | Nasal Congestion at Duration of Action (24 Hours Post-dose) | 7 minutes post-CAC | 0.8 units on a scale | Standard Deviation 0.8 |
| AC-170 0.24% | Nasal Congestion at Duration of Action (24 Hours Post-dose) | 20 minutes post-CAC | 1.1 units on a scale | Standard Deviation 1.04 |
| AC-170 0% | Nasal Congestion at Duration of Action (24 Hours Post-dose) | 7 minutes post-CAC | 0.7 units on a scale | Standard Deviation 0.69 |
| AC-170 0% | Nasal Congestion at Duration of Action (24 Hours Post-dose) | 20 minutes post-CAC | 1.2 units on a scale | Standard Deviation 0.88 |
| AC-170 0% | Nasal Congestion at Duration of Action (24 Hours Post-dose) | 15 minutes post-CAC | 1.1 units on a scale | Standard Deviation 0.83 |
Secondary
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.
Time frame: 7, 15, 20 minutes post-CAC
Population: Intent to Treat (ITT)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AC-170 0.05% | Nasal Congestion at Onset of Action (15 Minutes Post-dose) | 7 minutes post-CAC | 0.7 units on a scale | Standard Deviation 1.05 |
| AC-170 0.05% | Nasal Congestion at Onset of Action (15 Minutes Post-dose) | 20 minutes post-CAC | 1.1 units on a scale | Standard Deviation 1.14 |
| AC-170 0.05% | Nasal Congestion at Onset of Action (15 Minutes Post-dose) | 15 minutes post-CAC | 1.1 units on a scale | Standard Deviation 1.08 |
| AC-170 0.1% | Nasal Congestion at Onset of Action (15 Minutes Post-dose) | 7 minutes post-CAC | 0.4 units on a scale | Standard Deviation 0.58 |
| AC-170 0.1% | Nasal Congestion at Onset of Action (15 Minutes Post-dose) | 20 minutes post-CAC | 0.5 units on a scale | Standard Deviation 0.65 |
| AC-170 0.1% | Nasal Congestion at Onset of Action (15 Minutes Post-dose) | 15 minutes post-CAC | 0.5 units on a scale | Standard Deviation 0.65 |
| AC-170 0.24% | Nasal Congestion at Onset of Action (15 Minutes Post-dose) | 15 minutes post-CAC | 0.4 units on a scale | Standard Deviation 0.59 |
| AC-170 0.24% | Nasal Congestion at Onset of Action (15 Minutes Post-dose) | 7 minutes post-CAC | 0.4 units on a scale | Standard Deviation 0.59 |
| AC-170 0.24% | Nasal Congestion at Onset of Action (15 Minutes Post-dose) | 20 minutes post-CAC | 0.4 units on a scale | Standard Deviation 0.59 |
| AC-170 0% | Nasal Congestion at Onset of Action (15 Minutes Post-dose) | 7 minutes post-CAC | 0.8 units on a scale | Standard Deviation 0.78 |
| AC-170 0% | Nasal Congestion at Onset of Action (15 Minutes Post-dose) | 20 minutes post-CAC | 1.4 units on a scale | Standard Deviation 0.87 |
| AC-170 0% | Nasal Congestion at Onset of Action (15 Minutes Post-dose) | 15 minutes post-CAC | 1.4 units on a scale | Standard Deviation 0.86 |
Secondary
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.
Time frame: 7, 15, 20 minutes post-CAC
Population: Intent to Treat (ITT)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AC-170 0.05% | Nasal Congestion at Onset of Action (16 Hours Post-dose) | 7 minutes post-CAC | 1.2 units on a scale | Standard Deviation 0.99 |
| AC-170 0.05% | Nasal Congestion at Onset of Action (16 Hours Post-dose) | 20 minutes post-CAC | 1.5 units on a scale | Standard Deviation 1.05 |
| AC-170 0.05% | Nasal Congestion at Onset of Action (16 Hours Post-dose) | 15 minutes post-CAC | 1.4 units on a scale | Standard Deviation 1.04 |
| AC-170 0.1% | Nasal Congestion at Onset of Action (16 Hours Post-dose) | 7 minutes post-CAC | 0.5 units on a scale | Standard Deviation 0.65 |
| AC-170 0.1% | Nasal Congestion at Onset of Action (16 Hours Post-dose) | 20 minutes post-CAC | 0.8 units on a scale | Standard Deviation 0.99 |
| AC-170 0.1% | Nasal Congestion at Onset of Action (16 Hours Post-dose) | 15 minutes post-CAC | 0.6 units on a scale | Standard Deviation 0.76 |
| AC-170 0.24% | Nasal Congestion at Onset of Action (16 Hours Post-dose) | 15 minutes post-CAC | 1.0 units on a scale | Standard Deviation 1.19 |
| AC-170 0.24% | Nasal Congestion at Onset of Action (16 Hours Post-dose) | 7 minutes post-CAC | 0.8 units on a scale | Standard Deviation 1.18 |
| AC-170 0.24% | Nasal Congestion at Onset of Action (16 Hours Post-dose) | 20 minutes post-CAC | 1.0 units on a scale | Standard Deviation 1.14 |
| AC-170 0% | Nasal Congestion at Onset of Action (16 Hours Post-dose) | 7 minutes post-CAC | 0.8 units on a scale | Standard Deviation 0.78 |
| AC-170 0% | Nasal Congestion at Onset of Action (16 Hours Post-dose) | 20 minutes post-CAC | 1.3 units on a scale | Standard Deviation 1.21 |
| AC-170 0% | Nasal Congestion at Onset of Action (16 Hours Post-dose) | 15 minutes post-CAC | 1.2 units on a scale | Standard Deviation 0.85 |
Secondary
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.
Time frame: 7, 15, 20 minutes post-CAC
Population: Intent to Treat (ITT)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AC-170 0.05% | Nasal Pruritus at Duration of Action (16 Hours Post-dose) | 7 minutes post-CAC | 0.6 units on a scale | Standard Deviation 0.91 |
| AC-170 0.05% | Nasal Pruritus at Duration of Action (16 Hours Post-dose) | 20 minutes post-CAC | 0.7 units on a scale | Standard Deviation 0.99 |
| AC-170 0.05% | Nasal Pruritus at Duration of Action (16 Hours Post-dose) | 15 minutes post-CAC | 0.6 units on a scale | Standard Deviation 0.91 |
| AC-170 0.1% | Nasal Pruritus at Duration of Action (16 Hours Post-dose) | 7 minutes post-CAC | 0.2 units on a scale | Standard Deviation 0.37 |
| AC-170 0.1% | Nasal Pruritus at Duration of Action (16 Hours Post-dose) | 20 minutes post-CAC | 0.6 units on a scale | Standard Deviation 0.91 |
| AC-170 0.1% | Nasal Pruritus at Duration of Action (16 Hours Post-dose) | 15 minutes post-CAC | 0.4 units on a scale | Standard Deviation 0.65 |
| AC-170 0.24% | Nasal Pruritus at Duration of Action (16 Hours Post-dose) | 15 minutes post-CAC | 0.7 units on a scale | Standard Deviation 0.8 |
| AC-170 0.24% | Nasal Pruritus at Duration of Action (16 Hours Post-dose) | 7 minutes post-CAC | 0.5 units on a scale | Standard Deviation 0.65 |
| AC-170 0.24% | Nasal Pruritus at Duration of Action (16 Hours Post-dose) | 20 minutes post-CAC | 0.6 units on a scale | Standard Deviation 0.65 |
| AC-170 0% | Nasal Pruritus at Duration of Action (16 Hours Post-dose) | 7 minutes post-CAC | 0.4 units on a scale | Standard Deviation 0.71 |
| AC-170 0% | Nasal Pruritus at Duration of Action (16 Hours Post-dose) | 20 minutes post-CAC | 0.8 units on a scale | Standard Deviation 1.13 |
| AC-170 0% | Nasal Pruritus at Duration of Action (16 Hours Post-dose) | 15 minutes post-CAC | 0.8 units on a scale | Standard Deviation 1.01 |
Secondary
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.
Time frame: 7, 15, 20 minutes post-CAC
Population: Intent to Treat (ITT)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AC-170 0.05% | Nasal Pruritus at Duration of Action (24 Hours Post-dose) | 7 minutes post-CAC | 0.7 units on a scale | Standard Deviation 0.93 |
| AC-170 0.05% | Nasal Pruritus at Duration of Action (24 Hours Post-dose) | 20 minutes post-CAC | 0.5 units on a scale | Standard Deviation 0.9 |
| AC-170 0.05% | Nasal Pruritus at Duration of Action (24 Hours Post-dose) | 15 minutes post-CAC | 0.7 units on a scale | Standard Deviation 1.03 |
| AC-170 0.1% | Nasal Pruritus at Duration of Action (24 Hours Post-dose) | 7 minutes post-CAC | 0.4 units on a scale | Standard Deviation 0.64 |
| AC-170 0.1% | Nasal Pruritus at Duration of Action (24 Hours Post-dose) | 20 minutes post-CAC | 0.5 units on a scale | Standard Deviation 0.65 |
| AC-170 0.1% | Nasal Pruritus at Duration of Action (24 Hours Post-dose) | 15 minutes post-CAC | 0.4 units on a scale | Standard Deviation 0.58 |
| AC-170 0.24% | Nasal Pruritus at Duration of Action (24 Hours Post-dose) | 15 minutes post-CAC | 0.8 units on a scale | Standard Deviation 0.93 |
| AC-170 0.24% | Nasal Pruritus at Duration of Action (24 Hours Post-dose) | 7 minutes post-CAC | 0.4 units on a scale | Standard Deviation 0.58 |
| AC-170 0.24% | Nasal Pruritus at Duration of Action (24 Hours Post-dose) | 20 minutes post-CAC | 0.6 units on a scale | Standard Deviation 0.82 |
| AC-170 0% | Nasal Pruritus at Duration of Action (24 Hours Post-dose) | 7 minutes post-CAC | 0.4 units on a scale | Standard Deviation 0.82 |
| AC-170 0% | Nasal Pruritus at Duration of Action (24 Hours Post-dose) | 20 minutes post-CAC | 0.7 units on a scale | Standard Deviation 0.85 |
| AC-170 0% | Nasal Pruritus at Duration of Action (24 Hours Post-dose) | 15 minutes post-CAC | 0.6 units on a scale | Standard Deviation 0.99 |
Secondary
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.
Time frame: 7, 15, 20 minutes post-CAC
Population: Intent to Treat (ITT)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AC-170 0.05% | Nasal Pruritus at Onset of Action (15 Minutes Post-dose) | 7 minutes post-CAC | 0.4 units on a scale | Standard Deviation 0.99 |
| AC-170 0.05% | Nasal Pruritus at Onset of Action (15 Minutes Post-dose) | 20 minutes post-CAC | 0.4 units on a scale | Standard Deviation 0.95 |
| AC-170 0.05% | Nasal Pruritus at Onset of Action (15 Minutes Post-dose) | 15 minutes post-CAC | 0.4 units on a scale | Standard Deviation 0.84 |
| AC-170 0.1% | Nasal Pruritus at Onset of Action (15 Minutes Post-dose) | 7 minutes post-CAC | 0.2 units on a scale | Standard Deviation 0.37 |
| AC-170 0.1% | Nasal Pruritus at Onset of Action (15 Minutes Post-dose) | 20 minutes post-CAC | 0.4 units on a scale | Standard Deviation 0.64 |
| AC-170 0.1% | Nasal Pruritus at Onset of Action (15 Minutes Post-dose) | 15 minutes post-CAC | 0.3 units on a scale | Standard Deviation 0.56 |
| AC-170 0.24% | Nasal Pruritus at Onset of Action (15 Minutes Post-dose) | 15 minutes post-CAC | 0.2 units on a scale | Standard Deviation 0.44 |
| AC-170 0.24% | Nasal Pruritus at Onset of Action (15 Minutes Post-dose) | 7 minutes post-CAC | 0.3 units on a scale | Standard Deviation 0.56 |
| AC-170 0.24% | Nasal Pruritus at Onset of Action (15 Minutes Post-dose) | 20 minutes post-CAC | 0.3 units on a scale | Standard Deviation 0.66 |
| AC-170 0% | Nasal Pruritus at Onset of Action (15 Minutes Post-dose) | 7 minutes post-CAC | 0.4 units on a scale | Standard Deviation 0.65 |
| AC-170 0% | Nasal Pruritus at Onset of Action (15 Minutes Post-dose) | 20 minutes post-CAC | 0.4 units on a scale | Standard Deviation 0.65 |
| AC-170 0% | Nasal Pruritus at Onset of Action (15 Minutes Post-dose) | 15 minutes post-CAC | 0.4 units on a scale | Standard Deviation 0.58 |
Secondary
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.
Time frame: 7, 15, 20 minutes post-CAC
Population: Intent to Treat (ITT)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AC-170 0.05% | Rhinorrhea at Duration of Action (16 Hours Post-dose) | 7 minutes post-CAC | 1.1 units on a scale | Standard Deviation 1.26 |
| AC-170 0.05% | Rhinorrhea at Duration of Action (16 Hours Post-dose) | 20 minutes post-CAC | 1.3 units on a scale | Standard Deviation 1.14 |
| AC-170 0.05% | Rhinorrhea at Duration of Action (16 Hours Post-dose) | 15 minutes post-CAC | 1.2 units on a scale | Standard Deviation 1.01 |
| AC-170 0.1% | Rhinorrhea at Duration of Action (16 Hours Post-dose) | 7 minutes post-CAC | 0.4 units on a scale | Standard Deviation 0.49 |
| AC-170 0.1% | Rhinorrhea at Duration of Action (16 Hours Post-dose) | 20 minutes post-CAC | 0.7 units on a scale | Standard Deviation 0.8 |
| AC-170 0.1% | Rhinorrhea at Duration of Action (16 Hours Post-dose) | 15 minutes post-CAC | 0.6 units on a scale | Standard Deviation 0.77 |
| AC-170 0.24% | Rhinorrhea at Duration of Action (16 Hours Post-dose) | 15 minutes post-CAC | 1.1 units on a scale | Standard Deviation 1.04 |
| AC-170 0.24% | Rhinorrhea at Duration of Action (16 Hours Post-dose) | 7 minutes post-CAC | 0.7 units on a scale | Standard Deviation 0.99 |
| AC-170 0.24% | Rhinorrhea at Duration of Action (16 Hours Post-dose) | 20 minutes post-CAC | 1.1 units on a scale | Standard Deviation 1.05 |
| AC-170 0% | Rhinorrhea at Duration of Action (16 Hours Post-dose) | 7 minutes post-CAC | 0.7 units on a scale | Standard Deviation 0.8 |
| AC-170 0% | Rhinorrhea at Duration of Action (16 Hours Post-dose) | 20 minutes post-CAC | 1.1 units on a scale | Standard Deviation 1.24 |
| AC-170 0% | Rhinorrhea at Duration of Action (16 Hours Post-dose) | 15 minutes post-CAC | 1.0 units on a scale | Standard Deviation 1.12 |
Secondary
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.
Time frame: 7, 15, 20 minutes post-CAC
Population: Intent to Treat (ITT)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AC-170 0.05% | Rhinorrhea at Duration of Action (24 Hours Post-dose) | 7 minutes post-CAC | 1.1 units on a scale | Standard Deviation 1.28 |
| AC-170 0.05% | Rhinorrhea at Duration of Action (24 Hours Post-dose) | 20 minutes post-CAC | 1.2 units on a scale | Standard Deviation 1.28 |
| AC-170 0.05% | Rhinorrhea at Duration of Action (24 Hours Post-dose) | 15 minutes post-CAC | 1.1 units on a scale | Standard Deviation 1.29 |
| AC-170 0.1% | Rhinorrhea at Duration of Action (24 Hours Post-dose) | 20 minutes post-CAC | 0.6 units on a scale | Standard Deviation 0.7 |
| AC-170 0.1% | Rhinorrhea at Duration of Action (24 Hours Post-dose) | 7 minutes post-CAC | 0.6 units on a scale | Standard Deviation 0.65 |
| AC-170 0.1% | Rhinorrhea at Duration of Action (24 Hours Post-dose) | 15 minutes post-CAC | 0.7 units on a scale | Standard Deviation 0.69 |
| AC-170 0.24% | Rhinorrhea at Duration of Action (24 Hours Post-dose) | 20 minutes post-CAC | 1.0 units on a scale | Standard Deviation 0.71 |
| AC-170 0.24% | Rhinorrhea at Duration of Action (24 Hours Post-dose) | 15 minutes post-CAC | 1.2 units on a scale | Standard Deviation 0.91 |
| AC-170 0.24% | Rhinorrhea at Duration of Action (24 Hours Post-dose) | 7 minutes post-CAC | 0.8 units on a scale | Standard Deviation 0.9 |
| AC-170 0% | Rhinorrhea at Duration of Action (24 Hours Post-dose) | 7 minutes post-CAC | 0.7 units on a scale | Standard Deviation 0.69 |
| AC-170 0% | Rhinorrhea at Duration of Action (24 Hours Post-dose) | 20 minutes post-CAC | 0.8 units on a scale | Standard Deviation 0.9 |
| AC-170 0% | Rhinorrhea at Duration of Action (24 Hours Post-dose) | 15 minutes post-CAC | 1.0 units on a scale | Standard Deviation 0.84 |
Secondary
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.
Time frame: 7, 15, 20 minutes post-CAC
Population: Intent to Treat (ITT)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AC-170 0.05% | Rhinorrhea at Onset of Action (15 Minutes Post-dose) | 7 minutes post-CAC | 0.6 units on a scale | Standard Deviation 1.2 |
| AC-170 0.05% | Rhinorrhea at Onset of Action (15 Minutes Post-dose) | 20 minutes post-CAC | 0.8 units on a scale | Standard Deviation 1.23 |
| AC-170 0.05% | Rhinorrhea at Onset of Action (15 Minutes Post-dose) | 15 minutes post-CAC | 0.9 units on a scale | Standard Deviation 1.25 |
| AC-170 0.1% | Rhinorrhea at Onset of Action (15 Minutes Post-dose) | 7 minutes post-CAC | 0.2 units on a scale | Standard Deviation 0.41 |
| AC-170 0.1% | Rhinorrhea at Onset of Action (15 Minutes Post-dose) | 20 minutes post-CAC | 0.4 units on a scale | Standard Deviation 0.71 |
| AC-170 0.1% | Rhinorrhea at Onset of Action (15 Minutes Post-dose) | 15 minutes post-CAC | 0.4 units on a scale | Standard Deviation 0.65 |
| AC-170 0.24% | Rhinorrhea at Onset of Action (15 Minutes Post-dose) | 15 minutes post-CAC | 0.5 units on a scale | Standard Deviation 0.75 |
| AC-170 0.24% | Rhinorrhea at Onset of Action (15 Minutes Post-dose) | 7 minutes post-CAC | 0.3 units on a scale | Standard Deviation 0.58 |
| AC-170 0.24% | Rhinorrhea at Onset of Action (15 Minutes Post-dose) | 20 minutes post-CAC | 0.5 units on a scale | Standard Deviation 0.68 |
| AC-170 0% | Rhinorrhea at Onset of Action (15 Minutes Post-dose) | 7 minutes post-CAC | 0.6 units on a scale | Standard Deviation 0.82 |
| AC-170 0% | Rhinorrhea at Onset of Action (15 Minutes Post-dose) | 20 minutes post-CAC | 0.6 units on a scale | Standard Deviation 0.7 |
| AC-170 0% | Rhinorrhea at Onset of Action (15 Minutes Post-dose) | 15 minutes post-CAC | 0.8 units on a scale | Standard Deviation 0.87 |
Secondary
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.
Time frame: 7, 15, 20 minutes post-CAC
Population: Intent to Treat (ITT)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AC-170 0.05% | Tearing at Duration of Action (16 Hours Post-dose) | 7 minutes post-CAC | 1.0 units on a scale | Standard Deviation 1.07 |
| AC-170 0.05% | Tearing at Duration of Action (16 Hours Post-dose) | 20 minutes post-CAC | 0.7 units on a scale | Standard Deviation 0.85 |
| AC-170 0.05% | Tearing at Duration of Action (16 Hours Post-dose) | 15 minutes post-CAC | 0.8 units on a scale | Standard Deviation 0.89 |
| AC-170 0.1% | Tearing at Duration of Action (16 Hours Post-dose) | 7 minutes post-CAC | 0.8 units on a scale | Standard Deviation 0.72 |
| AC-170 0.1% | Tearing at Duration of Action (16 Hours Post-dose) | 20 minutes post-CAC | 0.4 units on a scale | Standard Deviation 0.63 |
| AC-170 0.1% | Tearing at Duration of Action (16 Hours Post-dose) | 15 minutes post-CAC | 0.5 units on a scale | Standard Deviation 0.64 |
| AC-170 0.24% | Tearing at Duration of Action (16 Hours Post-dose) | 15 minutes post-CAC | 0.7 units on a scale | Standard Deviation 0.65 |
| AC-170 0.24% | Tearing at Duration of Action (16 Hours Post-dose) | 7 minutes post-CAC | 0.6 units on a scale | Standard Deviation 0.51 |
| AC-170 0.24% | Tearing at Duration of Action (16 Hours Post-dose) | 20 minutes post-CAC | 0.7 units on a scale | Standard Deviation 0.62 |
| AC-170 0% | Tearing at Duration of Action (16 Hours Post-dose) | 7 minutes post-CAC | 0.6 units on a scale | Standard Deviation 0.67 |
| AC-170 0% | Tearing at Duration of Action (16 Hours Post-dose) | 20 minutes post-CAC | 0.9 units on a scale | Standard Deviation 0.97 |
| AC-170 0% | Tearing at Duration of Action (16 Hours Post-dose) | 15 minutes post-CAC | 0.9 units on a scale | Standard Deviation 0.82 |
Secondary
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.
Time frame: 7, 15, 20 minutes post-CAC
Population: Intent to Treat (ITT)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AC-170 0.05% | Tearing at Duration of Action (24 Hours Post-dose) | 7 minutes post-CAC | 1.0 units on a scale | Standard Deviation 0.78 |
| AC-170 0.05% | Tearing at Duration of Action (24 Hours Post-dose) | 20 minutes post-CAC | 1.0 units on a scale | Standard Deviation 0.77 |
| AC-170 0.05% | Tearing at Duration of Action (24 Hours Post-dose) | 15 minutes post-CAC | 1.1 units on a scale | Standard Deviation 0.79 |
| AC-170 0.1% | Tearing at Duration of Action (24 Hours Post-dose) | 7 minutes post-CAC | 0.7 units on a scale | Standard Deviation 0.61 |
| AC-170 0.1% | Tearing at Duration of Action (24 Hours Post-dose) | 20 minutes post-CAC | 0.5 units on a scale | Standard Deviation 0.53 |
| AC-170 0.1% | Tearing at Duration of Action (24 Hours Post-dose) | 15 minutes post-CAC | 0.6 units on a scale | Standard Deviation 0.54 |
| AC-170 0.24% | Tearing at Duration of Action (24 Hours Post-dose) | 15 minutes post-CAC | 0.7 units on a scale | Standard Deviation 0.66 |
| AC-170 0.24% | Tearing at Duration of Action (24 Hours Post-dose) | 7 minutes post-CAC | 0.6 units on a scale | Standard Deviation 0.75 |
| AC-170 0.24% | Tearing at Duration of Action (24 Hours Post-dose) | 20 minutes post-CAC | 0.7 units on a scale | Standard Deviation 0.72 |
| AC-170 0% | Tearing at Duration of Action (24 Hours Post-dose) | 7 minutes post-CAC | 0.8 units on a scale | Standard Deviation 0.71 |
| AC-170 0% | Tearing at Duration of Action (24 Hours Post-dose) | 20 minutes post-CAC | 0.7 units on a scale | Standard Deviation 0.84 |
| AC-170 0% | Tearing at Duration of Action (24 Hours Post-dose) | 15 minutes post-CAC | 0.8 units on a scale | Standard Deviation 0.82 |
Secondary
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.
Time frame: 7, 15, 20 minutes post-CAC
Population: Intent to Treat (ITT)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AC-170 0.05% | Tearing at Onset of Action (15 Minutes Post-dose) | 7 minutes post-CAC | 0.7 units on a scale | Standard Deviation 0.74 |
| AC-170 0.05% | Tearing at Onset of Action (15 Minutes Post-dose) | 20 minutes post-CAC | 0.5 units on a scale | Standard Deviation 0.6 |
| AC-170 0.05% | Tearing at Onset of Action (15 Minutes Post-dose) | 15 minutes post-CAC | 0.5 units on a scale | Standard Deviation 0.66 |
| AC-170 0.1% | Tearing at Onset of Action (15 Minutes Post-dose) | 7 minutes post-CAC | 0.5 units on a scale | Standard Deviation 0.49 |
| AC-170 0.1% | Tearing at Onset of Action (15 Minutes Post-dose) | 20 minutes post-CAC | 0.4 units on a scale | Standard Deviation 0.47 |
| AC-170 0.1% | Tearing at Onset of Action (15 Minutes Post-dose) | 15 minutes post-CAC | 0.5 units on a scale | Standard Deviation 0.5 |
| AC-170 0.24% | Tearing at Onset of Action (15 Minutes Post-dose) | 15 minutes post-CAC | 0.4 units on a scale | Standard Deviation 0.5 |
| AC-170 0.24% | Tearing at Onset of Action (15 Minutes Post-dose) | 7 minutes post-CAC | 0.3 units on a scale | Standard Deviation 0.56 |
| AC-170 0.24% | Tearing at Onset of Action (15 Minutes Post-dose) | 20 minutes post-CAC | 0.2 units on a scale | Standard Deviation 0.33 |
| AC-170 0% | Tearing at Onset of Action (15 Minutes Post-dose) | 7 minutes post-CAC | 0.6 units on a scale | Standard Deviation 0.64 |
| AC-170 0% | Tearing at Onset of Action (15 Minutes Post-dose) | 20 minutes post-CAC | 0.6 units on a scale | Standard Deviation 0.9 |
| AC-170 0% | Tearing at Onset of Action (15 Minutes Post-dose) | 15 minutes post-CAC | 0.6 units on a scale | Standard Deviation 0.64 |
Secondary
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..
Time frame: upon instillation, 1 minute and 2 minutes post instillation
Population: Intent to Treat (ITT)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AC-170 0.05% | Tolerability of Study Medication at Visit 3A | Upon instillation | 0.5 units on a scale | Standard Deviation 0.95 |
| AC-170 0.05% | Tolerability of Study Medication at Visit 3A | 2 minutes post-instillation | 0.8 units on a scale | Standard Deviation 1.1 |
| AC-170 0.05% | Tolerability of Study Medication at Visit 3A | 1 minute post-instillation | 0.7 units on a scale | Standard Deviation 1.13 |
| AC-170 0.1% | Tolerability of Study Medication at Visit 3A | Upon instillation | 0.7 units on a scale | Standard Deviation 1.04 |
| AC-170 0.1% | Tolerability of Study Medication at Visit 3A | 2 minutes post-instillation | 1.0 units on a scale | Standard Deviation 1.18 |
| AC-170 0.1% | Tolerability of Study Medication at Visit 3A | 1 minute post-instillation | 0.9 units on a scale | Standard Deviation 1.13 |
| AC-170 0.24% | Tolerability of Study Medication at Visit 3A | 1 minute post-instillation | 2.0 units on a scale | Standard Deviation 2.25 |
| AC-170 0.24% | Tolerability of Study Medication at Visit 3A | Upon instillation | 1.3 units on a scale | Standard Deviation 1.93 |
| AC-170 0.24% | Tolerability of Study Medication at Visit 3A | 2 minutes post-instillation | 1.7 units on a scale | Standard Deviation 2.27 |
| AC-170 0% | Tolerability of Study Medication at Visit 3A | Upon instillation | 0.6 units on a scale | Standard Deviation 1.03 |
| AC-170 0% | Tolerability of Study Medication at Visit 3A | 2 minutes post-instillation | 0.6 units on a scale | Standard Deviation 0.79 |
| AC-170 0% | Tolerability of Study Medication at Visit 3A | 1 minute post-instillation | 0.9 units on a scale | Standard Deviation 1.18 |