Allergic Conjunctivitis
Conditions
Brief summary
The purpose of this study is to evaluate the onset and duration of action of AC-170 0.24% compared to vehicle in the prevention of the signs and symptoms of allergic conjunctivitis in the conjunctival allergen challenge (CAC) model.
Interventions
DRUGAC-170 0.24%
1 drop in each eye at 2 separate times during a 14 day period
DRUGAC-170 0%
1 drop in each eye at 2 separate times during a 14 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 medication during the period indicated prior to the enrollment or during the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ocular Itching at Duration of Action (16 Hours + 1 Hour Post-dose) | 3, 5, 7 minutes post-CAC | A treatment efficacy Conjunctival Allergen Challenge (CAC) was performed 16 hours + 1 hour 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 + 1 Hour Post-dose) | 7, 15, 20 minutes post-CAC | A treatment efficacy CAC was performed 16 hours + 1 hour 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 + 1 Hour Post-dose) | 7, 15, 20 minutes post-CAC | A treatment efficacy CAC was performed 16 hours + 1 hour 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 + 1 Hour Post-dose) | 7, 15, 20 minutes post-CAC | A treatment efficacy CAC was performed 16 hours + 1 hour 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 + 1 Hour Post-dose) | 7, 15, 20 minutes post-CAC | A treatment efficacy CAC was performed 16 hours + 1 hour 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 +1 Hour Post-dose) | 7, 15, 20 minutes post-CAC | A treatment efficacy CAC was performed 16 hours + 1 hour 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 + 1 Hour Post-dose) | 7, 15, 20 minutes post-CAC | A treatment efficacy CAC was performed 16 hours + 1 hour 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 Pruritis 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 Pruritis at Duration of Action (16 Hours + 1 Hour Post-dose) | 7, 15, 20 minutes post-CAC | A treatment efficacy CAC was performed 16 hours + 1 hour 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 Pruritis at Onset of Action (15 Minutes Post-dose) | 7, 15, 20 minutes post-CAC | A treatment efficacy CAC was performed 15 minutes after drop instillation. Ear or Palate Pruritus was assessed by the patient on a single 0-4 scale (0=none to 4=severe). Ear or Palate Pruritus score for each time point was analyzed. |
| Nasal Congestion at Duration of Action (16 Hours + 1 Hour Post-dose) | 7, 15, 20 minutes post-CAC | A treatment efficacy CAC was performed 16 hours + 1 hour 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. |
| Number of Participants With At Least One of the Nasal Symptoms Present (Rhinorrhea + Nasal Pruritus + Ear or Palate Pruritus + Nasal Congestion) at Duration of Action (16 Hours + 1 Hour Post-dose) | 7, 15, 20 minutes post-CAC | A treatment efficacy CAC was performed 16 hours + 1 hour after drop instillation. For Nasal Composite Score the Total Composite Score ranges from 0 to 16, higher scores represent greater severity. Patients needed to have at least one of the nasal symptoms present (Rhinorrhea + Nasal Pruritus + Ear or Palate Pruritus + Nasal Congestion) each symptom was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Composite score for each time point was analyzed. |
| Number of Participants With At Least One of the Nasal Symptoms Present (Rhinorrhea + Nasal Pruritus + Ear or Palate Pruritus + 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. For Nasal Composite Score the Total Composite Score ranges from 0 to 16, higher scores represent greater severity. Patients needed to have at least one of the nasal symptoms present (Rhinorrhea + Nasal Pruritus + Ear or Palate Pruritus + Nasal Congestion) each symptom was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Composite score for each time point was analyzed. |
| Tolerability of Study Medication at Visit 3A | upon instillation, 1 minute and 2 minutes post instillation | Tolerability was assessed upon instillation of study medication, at 1 minute and 2 minutes post study medication instillation. Drop comfort was assessed using a 0-to 10 scale where 0=very comfortable and 10=very uncomfortable. |
| Nasal Pruritis at Duration of Action (16 Hours + 1 Hour Post-dose) | 7, 15, 20 minutes post-CAC | A treatment efficacy CAC was performed 16 hours + 1 hour 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 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 + 1 Hour Post-dose) | 7, 15, 20 minutes post-CAC | A treatment efficacy CAC was performed 16 hours + 1 hour 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 three sites in the US.
Pre-assignment details
There were 91 subjects enrolled, 2 subjects discontinued, and 89 subjects completed the study. Participant flow and baseline characteristics are presented for the 91 subjects that met all inclusion criteria and none of the exclusion criteria and were randomized to receive AC-170 0.24% or AC-170 0%.
Participants by arm
| Arm | Count |
|---|---|
| AC-170 0.24% AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period | 46 |
| AC-170 0% AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period | 45 |
| Total | 91 |
Baseline characteristics
| Characteristic | AC-170 0.24% | Total | AC-170 0% |
|---|---|---|---|
| Age, Continuous | 36.6 years STANDARD_DEVIATION 14.95 | 37.4 years STANDARD_DEVIATION 14.47 | 38.1 years STANDARD_DEVIATION 14.08 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 12 Participants | 25 Participants | 13 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 34 Participants | 66 Participants | 32 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 7 Participants | 14 Participants | 7 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants | 14 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 30 Participants | 63 Participants | 33 Participants |
| Region of Enrollment United States | 46 participants | 91 participants | 45 participants |
| Sex: Female, Male Female | 24 Participants | 52 Participants | 28 Participants |
| Sex: Female, Male Male | 22 Participants | 39 Participants | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 46 | 5 / 45 |
| serious Total, serious adverse events | 0 / 46 | 0 / 45 |
Outcome results
Primary
Conjunctival Redness at Duration of Action (16 Hours + 1 Hour Post-dose)
A treatment efficacy CAC was performed 16 hours + 1 hour 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 0.24% | Conjunctival Redness at Duration of Action (16 Hours + 1 Hour Post-dose) | 7 minutes post-CAC | 1.72 units on a scale | Standard Deviation 0.771 |
| AC-170 0.24% | Conjunctival Redness at Duration of Action (16 Hours + 1 Hour Post-dose) | 15 minutes post-CAC | 1.96 units on a scale | Standard Deviation 0.777 |
| AC-170 0.24% | Conjunctival Redness at Duration of Action (16 Hours + 1 Hour Post-dose) | 20 minutes post-CAC | 1.92 units on a scale | Standard Deviation 0.78 |
| AC-170 0% | Conjunctival Redness at Duration of Action (16 Hours + 1 Hour Post-dose) | 7 minutes post-CAC | 1.94 units on a scale | Standard Deviation 0.796 |
| AC-170 0% | Conjunctival Redness at Duration of Action (16 Hours + 1 Hour Post-dose) | 15 minutes post-CAC | 2.02 units on a scale | Standard Deviation 0.788 |
| AC-170 0% | Conjunctival Redness at Duration of Action (16 Hours + 1 Hour Post-dose) | 20 minutes post-CAC | 1.98 units on a scale | Standard Deviation 0.759 |
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 0.24% | Conjunctival Redness at Onset of Action (15 Minutes Post-dose) | 7 minutes post-CAC | 2.02 units on a scale | Standard Deviation 0.728 |
| AC-170 0.24% | Conjunctival Redness at Onset of Action (15 Minutes Post-dose) | 15 minutes post-CAC | 2.23 units on a scale | Standard Deviation 0.667 |
| AC-170 0.24% | Conjunctival Redness at Onset of Action (15 Minutes Post-dose) | 20 minutes post-CAC | 2.28 units on a scale | Standard Deviation 0.644 |
| AC-170 0% | Conjunctival Redness at Onset of Action (15 Minutes Post-dose) | 7 minutes post-CAC | 2.05 units on a scale | Standard Deviation 0.714 |
| AC-170 0% | Conjunctival Redness at Onset of Action (15 Minutes Post-dose) | 15 minutes post-CAC | 2.13 units on a scale | Standard Deviation 0.736 |
| AC-170 0% | Conjunctival Redness at Onset of Action (15 Minutes Post-dose) | 20 minutes post-CAC | 2.18 units on a scale | Standard Deviation 0.762 |
Primary
Ocular Itching at Duration of Action (16 Hours + 1 Hour Post-dose)
A treatment efficacy Conjunctival Allergen Challenge (CAC) was performed 16 hours + 1 hour 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 0.24% | Ocular Itching at Duration of Action (16 Hours + 1 Hour Post-dose) | 3 minutes post-CAC | 1.71 units on a scale | Standard Deviation 0.886 |
| AC-170 0.24% | Ocular Itching at Duration of Action (16 Hours + 1 Hour Post-dose) | 5 minutes post-CAC | 1.88 units on a scale | Standard Deviation 0.91 |
| AC-170 0.24% | Ocular Itching at Duration of Action (16 Hours + 1 Hour Post-dose) | 7 minutes post-CAC | 1.76 units on a scale | Standard Deviation 0.944 |
| AC-170 0% | Ocular Itching at Duration of Action (16 Hours + 1 Hour Post-dose) | 3 minutes post-CAC | 2.34 units on a scale | Standard Deviation 0.72 |
| AC-170 0% | Ocular Itching at Duration of Action (16 Hours + 1 Hour Post-dose) | 5 minutes post-CAC | 2.50 units on a scale | Standard Deviation 0.644 |
| AC-170 0% | Ocular Itching at Duration of Action (16 Hours + 1 Hour Post-dose) | 7 minutes post-CAC | 2.22 units on a scale | Standard Deviation 0.875 |
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 0.24% | Ocular Itching at Onset of Action (15 Minutes Post-dose) | 3 minutes post-CAC | 0.71 units on a scale | Standard Deviation 0.638 |
| AC-170 0.24% | Ocular Itching at Onset of Action (15 Minutes Post-dose) | 5 minutes post-CAC | 1.01 units on a scale | Standard Deviation 0.691 |
| AC-170 0.24% | Ocular Itching at Onset of Action (15 Minutes Post-dose) | 7 minutes post-CAC | 1.00 units on a scale | Standard Deviation 0.783 |
| AC-170 0% | Ocular Itching at Onset of Action (15 Minutes Post-dose) | 3 minutes post-CAC | 2.18 units on a scale | Standard Deviation 0.979 |
| AC-170 0% | Ocular Itching at Onset of Action (15 Minutes Post-dose) | 5 minutes post-CAC | 2.31 units on a scale | Standard Deviation 0.98 |
| AC-170 0% | Ocular Itching at Onset of Action (15 Minutes Post-dose) | 7 minutes post-CAC | 2.10 units on a scale | Standard Deviation 0.998 |
Secondary
Chemosis at Duration of Action (16 Hours + 1 Hour Post-dose)
A treatment efficacy CAC was performed 16 hours + 1 hour 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) with observed data only.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AC-170 0.24% | Chemosis at Duration of Action (16 Hours + 1 Hour Post-dose) | 7 minutes post-CAC | 0.49 units on a scale | Standard Deviation 0.461 |
| AC-170 0.24% | Chemosis at Duration of Action (16 Hours + 1 Hour Post-dose) | 15 minutes post-CAC | 0.71 units on a scale | Standard Deviation 0.605 |
| AC-170 0.24% | Chemosis at Duration of Action (16 Hours + 1 Hour Post-dose) | 20 minutes post-CAC | 0.76 units on a scale | Standard Deviation 0.605 |
| AC-170 0% | Chemosis at Duration of Action (16 Hours + 1 Hour Post-dose) | 7 minutes post-CAC | 0.70 units on a scale | Standard Deviation 0.55 |
| AC-170 0% | Chemosis at Duration of Action (16 Hours + 1 Hour Post-dose) | 15 minutes post-CAC | 1.01 units on a scale | Standard Deviation 0.693 |
| AC-170 0% | Chemosis at Duration of Action (16 Hours + 1 Hour Post-dose) | 20 minutes post-CAC | 1.05 units on a scale | Standard Deviation 0.802 |
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) with observed data only.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AC-170 0.24% | Chemosis at Onset of Action (15 Minutes Post-dose) | 15 minutes post-CAC | 1.12 units on a scale | Standard Deviation 0.685 |
| AC-170 0.24% | Chemosis at Onset of Action (15 Minutes Post-dose) | 7 minutes post-CAC | 0.74 units on a scale | Standard Deviation 0.501 |
| AC-170 0.24% | Chemosis at Onset of Action (15 Minutes Post-dose) | 20 minutes post-CAC | 1.22 units on a scale | Standard Deviation 0.736 |
| AC-170 0% | Chemosis at Onset of Action (15 Minutes Post-dose) | 7 minutes post-CAC | 0.97 units on a scale | Standard Deviation 0.702 |
| AC-170 0% | Chemosis at Onset of Action (15 Minutes Post-dose) | 20 minutes post-CAC | 1.53 units on a scale | Standard Deviation 0.95 |
| AC-170 0% | Chemosis at Onset of Action (15 Minutes Post-dose) | 15 minutes post-CAC | 1.42 units on a scale | Standard Deviation 0.895 |
Secondary
Ciliary Redness at Duration of Action (16 Hours + 1 Hour Post-dose)
A treatment efficacy CAC was performed 16 hours + 1 hour 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) with observed data only.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AC-170 0.24% | Ciliary Redness at Duration of Action (16 Hours + 1 Hour Post-dose) | 7 minutes post-CAC | 1.54 units on a scale | Standard Deviation 0.786 |
| AC-170 0.24% | Ciliary Redness at Duration of Action (16 Hours + 1 Hour Post-dose) | 15 minutes post-CAC | 1.77 units on a scale | Standard Deviation 0.825 |
| AC-170 0.24% | Ciliary Redness at Duration of Action (16 Hours + 1 Hour Post-dose) | 20 minutes post-CAC | 1.72 units on a scale | Standard Deviation 0.821 |
| AC-170 0% | Ciliary Redness at Duration of Action (16 Hours + 1 Hour Post-dose) | 7 minutes post-CAC | 1.82 units on a scale | Standard Deviation 0.832 |
| AC-170 0% | Ciliary Redness at Duration of Action (16 Hours + 1 Hour Post-dose) | 15 minutes post-CAC | 1.96 units on a scale | Standard Deviation 0.756 |
| AC-170 0% | Ciliary Redness at Duration of Action (16 Hours + 1 Hour Post-dose) | 20 minutes post-CAC | 1.93 units on a scale | Standard Deviation 0.771 |
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) with observed data only.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AC-170 0.24% | Ciliary Redness at Onset of Action (15 Minutes Post-dose) | 15 minutes post-CAC | 1.85 units on a scale | Standard Deviation 0.789 |
| AC-170 0.24% | Ciliary Redness at Onset of Action (15 Minutes Post-dose) | 7 minutes post-CAC | 1.64 units on a scale | Standard Deviation 0.81 |
| AC-170 0.24% | Ciliary Redness at Onset of Action (15 Minutes Post-dose) | 20 minutes post-CAC | 1.95 units on a scale | Standard Deviation 0.806 |
| AC-170 0% | Ciliary Redness at Onset of Action (15 Minutes Post-dose) | 15 minutes post-CAC | 1.99 units on a scale | Standard Deviation 0.769 |
| AC-170 0% | Ciliary Redness at Onset of Action (15 Minutes Post-dose) | 7 minutes post-CAC | 1.90 units on a scale | Standard Deviation 0.645 |
| AC-170 0% | Ciliary Redness at Onset of Action (15 Minutes Post-dose) | 20 minutes post-CAC | 2.06 units on a scale | Standard Deviation 0.767 |
Secondary
Ear or Palate Pruritis at Duration of Action (16 Hours + 1 Hour Post-dose)
A treatment efficacy CAC was performed 16 hours + 1 hour 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) with observed data only.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AC-170 0.24% | Ear or Palate Pruritis at Duration of Action (16 Hours + 1 Hour Post-dose) | 7 minutes post-CAC | 0.4 units on a scale | Standard Deviation 0.69 |
| AC-170 0.24% | Ear or Palate Pruritis at Duration of Action (16 Hours + 1 Hour Post-dose) | 15 minutes post-CAC | 1.0 units on a scale | Standard Deviation 1.13 |
| AC-170 0.24% | Ear or Palate Pruritis at Duration of Action (16 Hours + 1 Hour Post-dose) | 20 minutes post-CAC | 1.2 units on a scale | Standard Deviation 1.16 |
| AC-170 0% | Ear or Palate Pruritis at Duration of Action (16 Hours + 1 Hour Post-dose) | 7 minutes post-CAC | 1.0 units on a scale | Standard Deviation 1.24 |
| AC-170 0% | Ear or Palate Pruritis at Duration of Action (16 Hours + 1 Hour Post-dose) | 15 minutes post-CAC | 1.3 units on a scale | Standard Deviation 1.41 |
| AC-170 0% | Ear or Palate Pruritis at Duration of Action (16 Hours + 1 Hour Post-dose) | 20 minutes post-CAC | 1.5 units on a scale | Standard Deviation 1.42 |
Secondary
Ear or Palate Pruritis 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) with observed data only.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AC-170 0.24% | Ear or Palate Pruritis at Onset of Action (15 Minutes Post-dose) | 7 minutes post-CAC | 0.3 units on a scale | Standard Deviation 0.51 |
| AC-170 0.24% | Ear or Palate Pruritis at Onset of Action (15 Minutes Post-dose) | 15 minutes post-CAC | 0.5 units on a scale | Standard Deviation 0.66 |
| AC-170 0.24% | Ear or Palate Pruritis at Onset of Action (15 Minutes Post-dose) | 20 minutes post-CAC | 0.6 units on a scale | Standard Deviation 0.69 |
| AC-170 0% | Ear or Palate Pruritis at Onset of Action (15 Minutes Post-dose) | 20 minutes post-CAC | 1.0 units on a scale | Standard Deviation 1.2 |
| AC-170 0% | Ear or Palate Pruritis at Onset of Action (15 Minutes Post-dose) | 7 minutes post-CAC | 1.0 units on a scale | Standard Deviation 1.24 |
| AC-170 0% | Ear or Palate Pruritis at Onset of Action (15 Minutes Post-dose) | 15 minutes post-CAC | 1.1 units on a scale | Standard Deviation 1.27 |
Secondary
Episcleral Redness at Duration of Action (16 Hours + 1 Hour Post-dose)
A treatment efficacy CAC was performed 16 hours + 1 hour 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) with observed data only.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AC-170 0.24% | Episcleral Redness at Duration of Action (16 Hours + 1 Hour Post-dose) | 7 minutes post-CAC | 1.72 units on a scale | Standard Deviation 0.719 |
| AC-170 0.24% | Episcleral Redness at Duration of Action (16 Hours + 1 Hour Post-dose) | 15 minutes post-CAC | 1.94 units on a scale | Standard Deviation 0.781 |
| AC-170 0.24% | Episcleral Redness at Duration of Action (16 Hours + 1 Hour Post-dose) | 20 minutes post-CAC | 1.89 units on a scale | Standard Deviation 0.768 |
| AC-170 0% | Episcleral Redness at Duration of Action (16 Hours + 1 Hour Post-dose) | 7 minutes post-CAC | 1.94 units on a scale | Standard Deviation 0.798 |
| AC-170 0% | Episcleral Redness at Duration of Action (16 Hours + 1 Hour Post-dose) | 15 minutes post-CAC | 2.07 units on a scale | Standard Deviation 0.775 |
| AC-170 0% | Episcleral Redness at Duration of Action (16 Hours + 1 Hour Post-dose) | 20 minutes post-CAC | 2.03 units on a scale | Standard Deviation 0.764 |
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) with observed data only.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AC-170 0.24% | Episcleral Redness at Onset of Action (15 Minutes Post-dose) | 7 minutes post-CAC | 1.88 units on a scale | Standard Deviation 0.804 |
| AC-170 0.24% | Episcleral Redness at Onset of Action (15 Minutes Post-dose) | 15 minutes post-CAC | 2.10 units on a scale | Standard Deviation 0.791 |
| AC-170 0.24% | Episcleral Redness at Onset of Action (15 Minutes Post-dose) | 20 minutes post-CAC | 2.20 units on a scale | Standard Deviation 0.758 |
| AC-170 0% | Episcleral Redness at Onset of Action (15 Minutes Post-dose) | 20 minutes post-CAC | 2.16 units on a scale | Standard Deviation 0.778 |
| AC-170 0% | Episcleral Redness at Onset of Action (15 Minutes Post-dose) | 7 minutes post-CAC | 1.96 units on a scale | Standard Deviation 0.725 |
| AC-170 0% | Episcleral Redness at Onset of Action (15 Minutes Post-dose) | 15 minutes post-CAC | 2.10 units on a scale | Standard Deviation 0.793 |
Secondary
Eyelid Swelling at Duration of Action (16 Hours + 1 Hour Post-dose)
A treatment efficacy CAC was performed 16 hours + 1 hour 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) with observed data only.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AC-170 0.24% | Eyelid Swelling at Duration of Action (16 Hours + 1 Hour Post-dose) | 7 minutes post-CAC | 0.7 units on a scale | Standard Deviation 0.73 |
| AC-170 0.24% | Eyelid Swelling at Duration of Action (16 Hours + 1 Hour Post-dose) | 15 minutes post-CAC | 1.0 units on a scale | Standard Deviation 0.89 |
| AC-170 0.24% | Eyelid Swelling at Duration of Action (16 Hours + 1 Hour Post-dose) | 20 minutes post-CAC | 1.0 units on a scale | Standard Deviation 0.97 |
| AC-170 0% | Eyelid Swelling at Duration of Action (16 Hours + 1 Hour Post-dose) | 7 minutes post-CAC | 1.1 units on a scale | Standard Deviation 0.67 |
| AC-170 0% | Eyelid Swelling at Duration of Action (16 Hours + 1 Hour Post-dose) | 15 minutes post-CAC | 1.3 units on a scale | Standard Deviation 0.88 |
| AC-170 0% | Eyelid Swelling at Duration of Action (16 Hours + 1 Hour Post-dose) | 20 minutes post-CAC | 1.2 units on a scale | Standard Deviation 0.95 |
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) with observed data only.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AC-170 0.24% | Eyelid Swelling at Onset of Action (15 Minutes Post-dose) | 7 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 | 0.8 units on a scale | Standard Deviation 0.74 |
| AC-170 0.24% | Eyelid Swelling at Onset of Action (15 Minutes Post-dose) | 20 minutes post-CAC | 0.8 units on a scale | Standard Deviation 0.79 |
| AC-170 0% | Eyelid Swelling at Onset of Action (15 Minutes Post-dose) | 7 minutes post-CAC | 0.9 units on a scale | Standard Deviation 0.75 |
| AC-170 0% | Eyelid Swelling at Onset of Action (15 Minutes Post-dose) | 15 minutes post-CAC | 1.1 units on a scale | Standard Deviation 0.76 |
| AC-170 0% | Eyelid Swelling at Onset of Action (15 Minutes Post-dose) | 20 minutes post-CAC | 1.1 units on a scale | Standard Deviation 0.89 |
Secondary
Nasal Congestion at Duration of Action (16 Hours + 1 Hour Post-dose)
A treatment efficacy CAC was performed 16 hours + 1 hour 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) with observed data only.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AC-170 0.24% | Nasal Congestion at Duration of Action (16 Hours + 1 Hour Post-dose) | 7 minutes post-CAC | 0.9 units on a scale | Standard Deviation 0.94 |
| AC-170 0.24% | Nasal Congestion at Duration of Action (16 Hours + 1 Hour Post-dose) | 15 minutes post-CAC | 1.1 units on a scale | Standard Deviation 1.04 |
| AC-170 0.24% | Nasal Congestion at Duration of Action (16 Hours + 1 Hour Post-dose) | 20 minutes post-CAC | 1.2 units on a scale | Standard Deviation 1.15 |
| AC-170 0% | Nasal Congestion at Duration of Action (16 Hours + 1 Hour Post-dose) | 7 minutes post-CAC | 1.3 units on a scale | Standard Deviation 1.05 |
| AC-170 0% | Nasal Congestion at Duration of Action (16 Hours + 1 Hour Post-dose) | 15 minutes post-CAC | 1.5 units on a scale | Standard Deviation 1.16 |
| AC-170 0% | Nasal Congestion at Duration of Action (16 Hours + 1 Hour Post-dose) | 20 minutes post-CAC | 1.4 units on a scale | Standard Deviation 1.14 |
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) with observed data only.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AC-170 0.24% | Nasal Congestion at Onset of Action (15 Minutes Post-dose) | 7 minutes post-CAC | 0.3 units on a scale | Standard Deviation 0.6 |
| AC-170 0.24% | Nasal Congestion at Onset of Action (15 Minutes Post-dose) | 15 minutes post-CAC | 0.7 units on a scale | Standard Deviation 0.86 |
| AC-170 0.24% | Nasal Congestion at Onset of Action (15 Minutes Post-dose) | 20 minutes post-CAC | 0.8 units on a scale | Standard Deviation 1.1 |
| AC-170 0% | Nasal Congestion at Onset of Action (15 Minutes Post-dose) | 7 minutes post-CAC | 1.0 units on a scale | Standard Deviation 0.89 |
| AC-170 0% | Nasal Congestion at Onset of Action (15 Minutes Post-dose) | 15 minutes post-CAC | 1.2 units on a scale | Standard Deviation 1.01 |
| AC-170 0% | Nasal Congestion at Onset of Action (15 Minutes Post-dose) | 20 minutes post-CAC | 1.2 units on a scale | Standard Deviation 1.05 |
Secondary
Nasal Pruritis at Duration of Action (16 Hours + 1 Hour Post-dose)
A treatment efficacy CAC was performed 16 hours + 1 hour 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) with observed data only.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AC-170 0.24% | Nasal Pruritis at Duration of Action (16 Hours + 1 Hour Post-dose) | 7 minutes post-CAC | 0.4 units on a scale | Standard Deviation 0.72 |
| AC-170 0.24% | Nasal Pruritis at Duration of Action (16 Hours + 1 Hour Post-dose) | 15 minutes post-CAC | 0.8 units on a scale | Standard Deviation 1.03 |
| AC-170 0.24% | Nasal Pruritis at Duration of Action (16 Hours + 1 Hour Post-dose) | 20 minutes post-CAC | 0.8 units on a scale | Standard Deviation 0.95 |
| AC-170 0% | Nasal Pruritis at Duration of Action (16 Hours + 1 Hour Post-dose) | 7 minutes post-CAC | 1.0 units on a scale | Standard Deviation 1.14 |
| AC-170 0% | Nasal Pruritis at Duration of Action (16 Hours + 1 Hour Post-dose) | 15 minutes post-CAC | 1.0 units on a scale | Standard Deviation 1.14 |
| AC-170 0% | Nasal Pruritis at Duration of Action (16 Hours + 1 Hour Post-dose) | 20 minutes post-CAC | 1.1 units on a scale | Standard Deviation 1.2 |
Secondary
Nasal Pruritis 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) with observed data only.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AC-170 0.24% | Nasal Pruritis at Onset of Action (15 Minutes Post-dose) | 7 minutes post-CAC | 0.3 units on a scale | Standard Deviation 0.53 |
| AC-170 0.24% | Nasal Pruritis at Onset of Action (15 Minutes Post-dose) | 15 minutes post-CAC | 0.3 units on a scale | Standard Deviation 0.59 |
| AC-170 0.24% | Nasal Pruritis at Onset of Action (15 Minutes Post-dose) | 20 minutes post-CAC | 0.5 units on a scale | Standard Deviation 0.73 |
| AC-170 0% | Nasal Pruritis at Onset of Action (15 Minutes Post-dose) | 7 minutes post-CAC | 0.7 units on a scale | Standard Deviation 0.92 |
| AC-170 0% | Nasal Pruritis at Onset of Action (15 Minutes Post-dose) | 15 minutes post-CAC | 0.8 units on a scale | Standard Deviation 0.97 |
| AC-170 0% | Nasal Pruritis at Onset of Action (15 Minutes Post-dose) | 20 minutes post-CAC | 0.7 units on a scale | Standard Deviation 0.85 |
Secondary
Number of Participants With At Least One of the Nasal Symptoms Present (Rhinorrhea + Nasal Pruritus + Ear or Palate Pruritus + Nasal Congestion) at Duration of Action (16 Hours + 1 Hour Post-dose)
A treatment efficacy CAC was performed 16 hours + 1 hour after drop instillation. For Nasal Composite Score the Total Composite Score ranges from 0 to 16, higher scores represent greater severity. Patients needed to have at least one of the nasal symptoms present (Rhinorrhea + Nasal Pruritus + Ear or Palate Pruritus + Nasal Congestion) each symptom was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Composite score for each time point was analyzed.
Time frame: 7, 15, 20 minutes post-CAC
Population: Intent to Treat (ITT) with observed data only.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AC-170 0.24% | Number of Participants With At Least One of the Nasal Symptoms Present (Rhinorrhea + Nasal Pruritus + Ear or Palate Pruritus + Nasal Congestion) at Duration of Action (16 Hours + 1 Hour Post-dose) | 7 minutes post-CAC | 68.9 %participants with at least 1 nasal symp |
| AC-170 0.24% | Number of Participants With At Least One of the Nasal Symptoms Present (Rhinorrhea + Nasal Pruritus + Ear or Palate Pruritus + Nasal Congestion) at Duration of Action (16 Hours + 1 Hour Post-dose) | 15 minutes post-CAC | 80.0 %participants with at least 1 nasal symp |
| AC-170 0.24% | Number of Participants With At Least One of the Nasal Symptoms Present (Rhinorrhea + Nasal Pruritus + Ear or Palate Pruritus + Nasal Congestion) at Duration of Action (16 Hours + 1 Hour Post-dose) | 20 minutes post-CAC | 86.7 %participants with at least 1 nasal symp |
| AC-170 0% | Number of Participants With At Least One of the Nasal Symptoms Present (Rhinorrhea + Nasal Pruritus + Ear or Palate Pruritus + Nasal Congestion) at Duration of Action (16 Hours + 1 Hour Post-dose) | 7 minutes post-CAC | 84.4 %participants with at least 1 nasal symp |
| AC-170 0% | Number of Participants With At Least One of the Nasal Symptoms Present (Rhinorrhea + Nasal Pruritus + Ear or Palate Pruritus + Nasal Congestion) at Duration of Action (16 Hours + 1 Hour Post-dose) | 15 minutes post-CAC | 88.9 %participants with at least 1 nasal symp |
| AC-170 0% | Number of Participants With At Least One of the Nasal Symptoms Present (Rhinorrhea + Nasal Pruritus + Ear or Palate Pruritus + Nasal Congestion) at Duration of Action (16 Hours + 1 Hour Post-dose) | 20 minutes post-CAC | 93.3 %participants with at least 1 nasal symp |
Secondary
Number of Participants With At Least One of the Nasal Symptoms Present (Rhinorrhea + Nasal Pruritus + Ear or Palate Pruritus + Nasal Congestion) at Onset of Action (15 Minutes Post-dose)
A treatment efficacy CAC was performed 15 minutes after drop instillation. For Nasal Composite Score the Total Composite Score ranges from 0 to 16, higher scores represent greater severity. Patients needed to have at least one of the nasal symptoms present (Rhinorrhea + Nasal Pruritus + Ear or Palate Pruritus + Nasal Congestion) each symptom was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Composite score for each time point was analyzed.
Time frame: 7, 15, 20 minutes post-CAC
Population: Intent to Treat (ITT) with observed data only.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AC-170 0.24% | Number of Participants With At Least One of the Nasal Symptoms Present (Rhinorrhea + Nasal Pruritus + Ear or Palate Pruritus + Nasal Congestion) at Onset of Action (15 Minutes Post-dose) | 7 minutes post-CAC | 50 %participants with at least 1 nasal symp |
| AC-170 0.24% | Number of Participants With At Least One of the Nasal Symptoms Present (Rhinorrhea + Nasal Pruritus + Ear or Palate Pruritus + Nasal Congestion) at Onset of Action (15 Minutes Post-dose) | 15 minutes post-CAC | 65.9 %participants with at least 1 nasal symp |
| AC-170 0.24% | Number of Participants With At Least One of the Nasal Symptoms Present (Rhinorrhea + Nasal Pruritus + Ear or Palate Pruritus + Nasal Congestion) at Onset of Action (15 Minutes Post-dose) | 20 minutes post-CAC | 70.5 %participants with at least 1 nasal symp |
| AC-170 0% | Number of Participants With At Least One of the Nasal Symptoms Present (Rhinorrhea + Nasal Pruritus + Ear or Palate Pruritus + Nasal Congestion) at Onset of Action (15 Minutes Post-dose) | 7 minutes post-CAC | 82.2 %participants with at least 1 nasal symp |
| AC-170 0% | Number of Participants With At Least One of the Nasal Symptoms Present (Rhinorrhea + Nasal Pruritus + Ear or Palate Pruritus + Nasal Congestion) at Onset of Action (15 Minutes Post-dose) | 15 minutes post-CAC | 86.7 %participants with at least 1 nasal symp |
| AC-170 0% | Number of Participants With At Least One of the Nasal Symptoms Present (Rhinorrhea + Nasal Pruritus + Ear or Palate Pruritus + Nasal Congestion) at Onset of Action (15 Minutes Post-dose) | 20 minutes post-CAC | 84.4 %participants with at least 1 nasal symp |
Secondary
Rhinorrhea at Duration of Action (16 Hours +1 Hour Post-dose)
A treatment efficacy CAC was performed 16 hours + 1 hour 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) with observed data only.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AC-170 0.24% | Rhinorrhea at Duration of Action (16 Hours +1 Hour Post-dose) | 7 minutes post-CAC | 0.7 units on a scale | Standard Deviation 0.89 |
| AC-170 0.24% | Rhinorrhea at Duration of Action (16 Hours +1 Hour Post-dose) | 15 minutes post-CAC | 1.0 units on a scale | Standard Deviation 1.03 |
| AC-170 0.24% | Rhinorrhea at Duration of Action (16 Hours +1 Hour Post-dose) | 20 minutes post-CAC | 1.1 units on a scale | Standard Deviation 1.1 |
| AC-170 0% | Rhinorrhea at Duration of Action (16 Hours +1 Hour Post-dose) | 7 minutes post-CAC | 1.4 units on a scale | Standard Deviation 1.11 |
| AC-170 0% | Rhinorrhea at Duration of Action (16 Hours +1 Hour Post-dose) | 15 minutes post-CAC | 1.3 units on a scale | Standard Deviation 1.14 |
| AC-170 0% | Rhinorrhea at Duration of Action (16 Hours +1 Hour Post-dose) | 20 minutes post-CAC | 1.4 units on a scale | Standard Deviation 1.22 |
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) with observed data only.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 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 0.73 |
| AC-170 0.24% | Rhinorrhea at Onset of Action (15 Minutes Post-dose) | 20 minutes post-CAC | 0.6 units on a scale | Standard Deviation 0.82 |
| 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 0.64 |
| AC-170 0% | Rhinorrhea at Onset of Action (15 Minutes Post-dose) | 15 minutes post-CAC | 1.0 units on a scale | Standard Deviation 1.04 |
| AC-170 0% | Rhinorrhea at Onset of Action (15 Minutes Post-dose) | 7 minutes post-CAC | 1.1 units on a scale | Standard Deviation 0.97 |
| AC-170 0% | Rhinorrhea at Onset of Action (15 Minutes Post-dose) | 20 minutes post-CAC | 1.0 units on a scale | Standard Deviation 1.04 |
Secondary
Tearing at Duration of Action (16 Hours + 1 Hour Post-dose)
A treatment efficacy CAC was performed 16 hours + 1 hour 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) with observed data only.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AC-170 0.24% | Tearing at Duration of Action (16 Hours + 1 Hour Post-dose) | 7 minutes post-CAC | 0.8 units on a scale | Standard Deviation 0.69 |
| AC-170 0.24% | Tearing at Duration of Action (16 Hours + 1 Hour Post-dose) | 15 minutes post-CAC | 0.9 units on a scale | Standard Deviation 0.89 |
| AC-170 0.24% | Tearing at Duration of Action (16 Hours + 1 Hour Post-dose) | 20 minutes post-CAC | 0.9 units on a scale | Standard Deviation 0.98 |
| AC-170 0% | Tearing at Duration of Action (16 Hours + 1 Hour Post-dose) | 7 minutes post-CAC | 1.1 units on a scale | Standard Deviation 1.08 |
| AC-170 0% | Tearing at Duration of Action (16 Hours + 1 Hour Post-dose) | 15 minutes post-CAC | 1.2 units on a scale | Standard Deviation 1.16 |
| AC-170 0% | Tearing at Duration of Action (16 Hours + 1 Hour Post-dose) | 20 minutes post-CAC | 1.1 units on a scale | Standard Deviation 1.25 |
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) with observed data only.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AC-170 0.24% | Tearing at Onset of Action (15 Minutes Post-dose) | 7 minutes post-CAC | 0.4 units on a scale | Standard Deviation 0.57 |
| AC-170 0.24% | Tearing at Onset of Action (15 Minutes Post-dose) | 15 minutes post-CAC | 0.6 units on a scale | Standard Deviation 0.87 |
| AC-170 0.24% | Tearing at Onset of Action (15 Minutes Post-dose) | 20 minutes post-CAC | 0.7 units on a scale | Standard Deviation 0.88 |
| AC-170 0% | Tearing at Onset of Action (15 Minutes Post-dose) | 7 minutes post-CAC | 1.0 units on a scale | Standard Deviation 0.88 |
| AC-170 0% | Tearing at Onset of Action (15 Minutes Post-dose) | 15 minutes post-CAC | 0.8 units on a scale | Standard Deviation 0.84 |
| AC-170 0% | Tearing at Onset of Action (15 Minutes Post-dose) | 20 minutes post-CAC | 0.8 units on a scale | Standard Deviation 0.97 |
Secondary
Tolerability of Study Medication at Visit 3A
Tolerability was assessed upon instillation of study medication, at 1 minute and 2 minutes post study medication instillation. Drop comfort was assessed using a 0-to 10 scale where 0=very comfortable and 10=very uncomfortable.
Time frame: upon instillation, 1 minute and 2 minutes post instillation
Population: Intent to Treat (ITT)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AC-170 0.24% | Tolerability of Study Medication at Visit 3A | Upon instillation | 1.2 units on a scale | Standard Deviation 1.44 |
| AC-170 0.24% | Tolerability of Study Medication at Visit 3A | 1 minute post-instillation | 2.4 units on a scale | Standard Deviation 2.37 |
| AC-170 0.24% | Tolerability of Study Medication at Visit 3A | 2 minutes post-instillation | 2.1 units on a scale | Standard Deviation 2.29 |
| AC-170 0% | Tolerability of Study Medication at Visit 3A | Upon instillation | 0.9 units on a scale | Standard Deviation 1.27 |
| AC-170 0% | Tolerability of Study Medication at Visit 3A | 1 minute post-instillation | 0.6 units on a scale | Standard Deviation 0.8 |
| AC-170 0% | Tolerability of Study Medication at Visit 3A | 2 minutes post-instillation | 0.6 units on a scale | Standard Deviation 0.78 |