Allergic Conjunctivitis
Conditions
Brief summary
The purpose of this study is to evaluate the efficacy of AC-150 compared to vehicle and its components in the prevention of the signs and symptoms of allergic conjunctivitis in Enviro-CAC™ Model.
Interventions
DRUGAC-150 Combo
1 drop in each eye for up to 14 days
DRUGAC-150A 0.1%
1 drop in each eye once per day for up to 14 days
DRUGAC-150B 0.005%
1 drop in each eye once per day for up to 14 days
DRUGVehicle
1 drop in each eye once per day for up to 14 days
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 study enrollment or during the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ocular Itching at Onset of Action (15 Minutes Post-dose) | 3, 5, 7 minutes post-CAC | A treatment efficacy CAC was performed 15 minutes after drop instillation. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed. |
| Ocular Itching at Duration of Action (16 Hours Post-dose) | 3, 5, 7 minutes post-CAC | A treatment efficacy CAC was performed 16 hours after drop instillation. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed. |
| Ocular Itching at 8 Hours Post-dose at Visit 4A | 3, 5, 7 minutes post-CAC | A treatment efficacy CAC was performed 8 hours after drop instillation. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed. |
| Conjunctival Redness at Onset of Action (15 Minutes Post-dose) | 7, 15, 20 minutes post-CAC | A treatment efficacy CAC was performed 15 minutes after drop instillation. Conjunctival Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of conjunctival redness score over both eyes was analyzed. |
| Conjunctival Redness at Duration of Action (16 Hours Post-dose) | 7, 15, 20 minutes post-CAC | A treatment efficacy CAC was performed 16 hours after drop instillation. Conjunctival Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of conjunctival redness score over both eyes was analyzed. |
| Conjunctival Redness at 8 Hours Post-dose at Visit 4A | 7, 15, 20 minutes post-CAC | A treatment efficacy CAC was performed 8 hours after drop instillation. Conjunctival Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of conjunctival redness score over both eyes was analyzed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Episcleral Redness at 8 Hours Post-dose at Visit 4A | 7, 15, 20 minutes post-CAC | A treatment efficacy CAC was performed 8 hours after drop instillation. Episcleral Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of episcleral redness score over both eyes was analyzed. |
| Total Redness at Onset of Action (15 Minutes Post-dose) | 7, 15, 20 minutes post-CAC | A treatment efficacy CAC was performed 15 minutes after drop instillation. Total redness was defined as the sum of the conjunctival, ciliary and episcleral redness scores, and was, thus, on a 0-12 scale, making the threshold for clinical significance a treatment difference of 3.0 units. Higher scores represent greater severity. |
| Total Redness at Duration of Action (16 Hours Post-dose) | 7, 15, 20 minutes post-CAC | A treatment efficacy CAC was performed 16 hours after drop instillation. Total redness was defined as the sum of the conjunctival, ciliary and episcleral redness scores, and was, thus, on a 0-12 scale, making the threshold for clinical significance a treatment difference of 3.0 units. Higher scores represent greater severity. |
| Total Redness at 8 Hours Post-Dose at Visit 4A | 7, 15, 20 minutes post-CAC | A treatment efficacy CAC was performed 8 hours after drop instillation. Total redness was defined as the sum of the conjunctival, ciliary and episcleral redness scores, and was, thus, on a 0-12 scale, making the threshold for clinical significance a treatment difference of 3.0 units. Higher scores represent greater severity. |
| Lid Swelling at Onset of Action (15 Minutes Post-dose) | 7, 15, 20 minutes post-CAC | A treatment efficacy CAC was performed 15 minutes after drop instillation. Lid swelling was assessed by the patient on a 0-3 scale (0=none to 3=severe). Average of lid swelling score over both eyes was analyzed. |
| 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. |
| Ear or Palate Pruritus at Onset of Action (15 Minutes Post-dose) | 7, 15, 20 minutes post-CAC | A treatment efficacy CAC was performed 15 minutes after drop instillation. Ear or Palate Pruritus was assessed by the patient on a single 0-4 scale (0=none to 4=severe). Ear or Palate Pruritus score for each time point was analyzed. |
| Ear or Palate Pruritus at Duration of Action (16 Hours Post-dose) | 7, 15, 20 minutes post-CAC | A treatment efficacy CAC was performed 15 minutes after drop instillation. Ear or Palate Pruritus was assessed by the patient on a single 0-4 scale (0=none to 4=severe). Ear or Palate Pruritus score for each time point was analyzed. |
| Ear or Palate Pruritus at 8 Hours Post-dose at Visit 4A | 7, 15, 20 minutes post-CAC | A treatment efficacy CAC was performed 15 minutes after drop instillation. Ear or Palate Pruritus was assessed by the patient on a single 0-4 scale (0=none to 4=severe). Ear or Palate Pruritus score for each time point was analyzed. |
| Tolerability of Study Medication at Visit 2B | upon instillation, 1 minute and 2 minutes post instillation | Subjects were asked to rate the comfort of the drop in each eye upon instillation, at 1 minute, and at 2 minutes after instillation of study medication. The assessment used a 10-point scale with 0 as very comfortable and 10 as very uncomfortable. Higher scores represent a worse outcome. |
| Tolerability of Study Medication at Visit 3 | upon instillation, 1 minute and 2 minutes post instillation | Subjects were asked to rate the comfort of the drop in each eye upon instillation, at 1 minute, and at 2 minutes after instillation of study medication. The assessment used a 10-point scale with 0 as very comfortable and 10 as very uncomfortable. Higher scores represent a worse outcome. |
| Lid Swelling Duration of Action (16 Hours Post-dose) | 7, 15, 20 minutes post-CAC | A treatment efficacy CAC was performed 16 hours after drop instillation. Lid swelling was assessed by the patient on a 0-3 scale (0=none to 3=severe). Average of lid swelling score over both eyes was analyzed. |
| Ciliary Redness at Duration of Action (16 Hours Post-dose) | 7, 15, 20 minutes post-CAC | A treatment efficacy CAC was performed 16 hours after drop instillation. Ciliary Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ciliary redness score over both eyes was analyzed. |
| Ciliary Redness at 8 Hours Post-dose at Visit 4A | 7, 15, 20 minutes post-CAC | A treatment efficacy CAC was performed 8 hours after drop instillation. Ciliary Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ciliary redness score over both eyes was analyzed. |
| Lid Swelling at 8 Hours Post-dose at Visit 4A | 7, 15, 20 minutes post-CAC | A treatment efficacy CAC was performed 8 hours after drop instillation. Lid swelling was assessed by the patient on a 0-3 scale (0=none to 3=severe). Average of lid swelling score over both eyes was analyzed. |
| Episcleral Redness at Onset of Action (15 Minutes Post-dose) | 7, 15, 20 minutes post-CAC | A treatment efficacy CAC was performed 15 minutes after drop instillation. Episcleral Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of episcleral redness score over both eyes was analyzed. |
| Episcleral Redness at Duration of Action (16 Hours Post-dose) | 7, 15, 20 minutes post-CAC | A treatment efficacy CAC was performed 16 hours after drop instillation. Episcleral Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of Episcleral redness score over both eyes was analyzed. |
Countries
United States
Participant flow
Recruitment details
Subjects were recruited from two sites in the US.
Pre-assignment details
There were 83 subjects enrolled, 12 subjects discontinued, and 71 subjects completed the study. Participant flow and baseline characteristics are presented for the 83 subjects that met all inclusion criteria and none of the exclusion criteria and were randomized to receive AC-150 Combo, AC-150A 0.1%, AC-150B 0.005% or Vehicle
Participants by arm
| Arm | Count |
|---|---|
| AC-150 Combo AC-150 Combo: 1 drop in each eye for up to 14 days | 21 |
| AC-150A 0.1% AC-150A 0.1%: 1 drop in each eye once per day for up to 14 days | 21 |
| AC-150B 0.005% AC-150B 0.005%: 1 drop in each eye once per day for up to 14 days | 20 |
| Vehicle Vehicle: 1 drop in each eye once per day for up to 14 days | 21 |
| Total | 83 |
Baseline characteristics
| Characteristic | AC-150 Combo | Total | Vehicle | AC-150B 0.005% | AC-150A 0.1% |
|---|---|---|---|---|---|
| Age, Continuous | 37.7 years STANDARD_DEVIATION 12.56 | 37.8 years STANDARD_DEVIATION 13.78 | 38.3 years STANDARD_DEVIATION 16.16 | 40.2 years STANDARD_DEVIATION 12.23 | 35.1 years STANDARD_DEVIATION 14.32 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 15 Participants | 3 Participants | 3 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 17 Participants | 68 Participants | 18 Participants | 17 Participants | 16 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 | 1 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 9 Participants | 35 Participants | 10 Participants | 7 Participants | 9 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 2 Participants | 1 Participants | 0 Participants | 0 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 | 1 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 5 Participants | 0 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) White | 10 Participants | 39 Participants | 10 Participants | 10 Participants | 9 Participants |
| Region of Enrollment United States | 21 participants | 83 participants | 21 participants | 20 participants | 21 participants |
| Sex: Female, Male Female | 13 Participants | 42 Participants | 10 Participants | 9 Participants | 10 Participants |
| Sex: Female, Male Male | 8 Participants | 41 Participants | 11 Participants | 11 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 | 0 / 21 | 0 / 21 | 0 / 20 | 0 / 21 |
| serious Total, serious adverse events | 0 / 21 | 0 / 21 | 0 / 20 | 0 / 21 |
Outcome results
Primary
Conjunctival Redness at 8 Hours Post-dose at Visit 4A
A treatment efficacy CAC was performed 8 hours after drop instillation. Conjunctival Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of conjunctival redness score over both eyes was analyzed.
Time frame: 7, 15, 20 minutes post-CAC
Population: Intent to Treat (ITT) Population with Last Observation Carried Forward (LOCF)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AC-150 Combo | Conjunctival Redness at 8 Hours Post-dose at Visit 4A | 7 minutes post-CAC | 1.39 units on a scale | Standard Deviation 0.61 |
| AC-150 Combo | Conjunctival Redness at 8 Hours Post-dose at Visit 4A | 20 minutes post-CAC | 1.44 units on a scale | Standard Deviation 0.617 |
| AC-150 Combo | Conjunctival Redness at 8 Hours Post-dose at Visit 4A | 15 minutes post-CAC | 1.39 units on a scale | Standard Deviation 0.626 |
| AC-150A 0.1% | Conjunctival Redness at 8 Hours Post-dose at Visit 4A | 7 minutes post-CAC | 1.66 units on a scale | Standard Deviation 0.56 |
| AC-150A 0.1% | Conjunctival Redness at 8 Hours Post-dose at Visit 4A | 20 minutes post-CAC | 1.70 units on a scale | Standard Deviation 0.581 |
| AC-150A 0.1% | Conjunctival Redness at 8 Hours Post-dose at Visit 4A | 15 minutes post-CAC | 1.70 units on a scale | Standard Deviation 0.518 |
| AC-150B 0.005% | Conjunctival Redness at 8 Hours Post-dose at Visit 4A | 15 minutes post-CAC | 1.85 units on a scale | Standard Deviation 0.557 |
| AC-150B 0.005% | Conjunctival Redness at 8 Hours Post-dose at Visit 4A | 7 minutes post-CAC | 1.81 units on a scale | Standard Deviation 0.442 |
| AC-150B 0.005% | Conjunctival Redness at 8 Hours Post-dose at Visit 4A | 20 minutes post-CAC | 1.81 units on a scale | Standard Deviation 0.546 |
| Vehicle | Conjunctival Redness at 8 Hours Post-dose at Visit 4A | 7 minutes post-CAC | 1.96 units on a scale | Standard Deviation 0.346 |
| Vehicle | Conjunctival Redness at 8 Hours Post-dose at Visit 4A | 20 minutes post-CAC | 2.14 units on a scale | Standard Deviation 0.395 |
| Vehicle | Conjunctival Redness at 8 Hours Post-dose at Visit 4A | 15 minutes post-CAC | 2.14 units on a scale | Standard Deviation 0.366 |
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) Population with Last Observation Carried Forward (LOCF)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AC-150 Combo | Conjunctival Redness at Duration of Action (16 Hours Post-dose) | 7 minutes post-CAC | 1.56 units on a scale | Standard Deviation 0.451 |
| AC-150 Combo | Conjunctival Redness at Duration of Action (16 Hours Post-dose) | 20 minutes post-CAC | 1.66 units on a scale | Standard Deviation 0.424 |
| AC-150 Combo | Conjunctival Redness at Duration of Action (16 Hours Post-dose) | 15 minutes post-CAC | 1.68 units on a scale | Standard Deviation 0.507 |
| AC-150A 0.1% | Conjunctival Redness at Duration of Action (16 Hours Post-dose) | 7 minutes post-CAC | 1.78 units on a scale | Standard Deviation 0.478 |
| AC-150A 0.1% | Conjunctival Redness at Duration of Action (16 Hours Post-dose) | 20 minutes post-CAC | 1.88 units on a scale | Standard Deviation 0.567 |
| AC-150A 0.1% | Conjunctival Redness at Duration of Action (16 Hours Post-dose) | 15 minutes post-CAC | 1.84 units on a scale | Standard Deviation 0.41 |
| AC-150B 0.005% | Conjunctival Redness at Duration of Action (16 Hours Post-dose) | 15 minutes post-CAC | 1.97 units on a scale | Standard Deviation 0.484 |
| AC-150B 0.005% | Conjunctival Redness at Duration of Action (16 Hours Post-dose) | 7 minutes post-CAC | 1.83 units on a scale | Standard Deviation 0.485 |
| AC-150B 0.005% | Conjunctival Redness at Duration of Action (16 Hours Post-dose) | 20 minutes post-CAC | 1.81 units on a scale | Standard Deviation 0.511 |
| Vehicle | Conjunctival Redness at Duration of Action (16 Hours Post-dose) | 7 minutes post-CAC | 2.01 units on a scale | Standard Deviation 0.348 |
| Vehicle | Conjunctival Redness at Duration of Action (16 Hours Post-dose) | 20 minutes post-CAC | 2.04 units on a scale | Standard Deviation 0.386 |
| Vehicle | Conjunctival Redness at Duration of Action (16 Hours Post-dose) | 15 minutes post-CAC | 2.15 units on a scale | Standard Deviation 0.322 |
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) Population with Last Observation Carried Forward (LOCF)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AC-150 Combo | Conjunctival Redness at Onset of Action (15 Minutes Post-dose) | 7 minutes post-CAC | 1.70 units on a scale | Standard Deviation 0.677 |
| AC-150 Combo | Conjunctival Redness at Onset of Action (15 Minutes Post-dose) | 20 minutes post-CAC | 2.04 units on a scale | Standard Deviation 0.745 |
| AC-150 Combo | Conjunctival Redness at Onset of Action (15 Minutes Post-dose) | 15 minutes post-CAC | 2.04 units on a scale | Standard Deviation 0.704 |
| AC-150A 0.1% | Conjunctival Redness at Onset of Action (15 Minutes Post-dose) | 7 minutes post-CAC | 1.97 units on a scale | Standard Deviation 0.812 |
| AC-150A 0.1% | Conjunctival Redness at Onset of Action (15 Minutes Post-dose) | 20 minutes post-CAC | 2.37 units on a scale | Standard Deviation 0.98 |
| AC-150A 0.1% | Conjunctival Redness at Onset of Action (15 Minutes Post-dose) | 15 minutes post-CAC | 2.25 units on a scale | Standard Deviation 0.997 |
| AC-150B 0.005% | Conjunctival Redness at Onset of Action (15 Minutes Post-dose) | 15 minutes post-CAC | 2.44 units on a scale | Standard Deviation 0.77 |
| AC-150B 0.005% | Conjunctival Redness at Onset of Action (15 Minutes Post-dose) | 7 minutes post-CAC | 2.18 units on a scale | Standard Deviation 0.835 |
| AC-150B 0.005% | Conjunctival Redness at Onset of Action (15 Minutes Post-dose) | 20 minutes post-CAC | 2.51 units on a scale | Standard Deviation 0.838 |
| Vehicle | Conjunctival Redness at Onset of Action (15 Minutes Post-dose) | 7 minutes post-CAC | 2.49 units on a scale | Standard Deviation 0.639 |
| Vehicle | Conjunctival Redness at Onset of Action (15 Minutes Post-dose) | 20 minutes post-CAC | 2.58 units on a scale | Standard Deviation 0.733 |
| Vehicle | Conjunctival Redness at Onset of Action (15 Minutes Post-dose) | 15 minutes post-CAC | 2.58 units on a scale | Standard Deviation 0.733 |
Primary
Ocular Itching at 8 Hours Post-dose at Visit 4A
A treatment efficacy CAC was performed 8 hours after drop instillation. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed.
Time frame: 3, 5, 7 minutes post-CAC
Population: Intent to Treat (ITT) Population with Last Observation Carried Forward (LOCF)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AC-150 Combo | Ocular Itching at 8 Hours Post-dose at Visit 4A | 3 minutes post-CAC | 1.43 units on a scale | Standard Deviation 1.007 |
| AC-150 Combo | Ocular Itching at 8 Hours Post-dose at Visit 4A | 5 minutes post-CAC | 1.56 units on a scale | Standard Deviation 1.022 |
| AC-150 Combo | Ocular Itching at 8 Hours Post-dose at Visit 4A | 7 minutes post-CAC | 1.64 units on a scale | Standard Deviation 1.071 |
| AC-150A 0.1% | Ocular Itching at 8 Hours Post-dose at Visit 4A | 5 minutes post-CAC | 1.83 units on a scale | Standard Deviation 0.954 |
| AC-150A 0.1% | Ocular Itching at 8 Hours Post-dose at Visit 4A | 3 minutes post-CAC | 1.53 units on a scale | Standard Deviation 0.916 |
| AC-150A 0.1% | Ocular Itching at 8 Hours Post-dose at Visit 4A | 7 minutes post-CAC | 1.86 units on a scale | Standard Deviation 0.925 |
| AC-150B 0.005% | Ocular Itching at 8 Hours Post-dose at Visit 4A | 5 minutes post-CAC | 2.17 units on a scale | Standard Deviation 0.899 |
| AC-150B 0.005% | Ocular Itching at 8 Hours Post-dose at Visit 4A | 3 minutes post-CAC | 2.01 units on a scale | Standard Deviation 0.872 |
| AC-150B 0.005% | Ocular Itching at 8 Hours Post-dose at Visit 4A | 7 minutes post-CAC | 2.03 units on a scale | Standard Deviation 0.935 |
| Vehicle | Ocular Itching at 8 Hours Post-dose at Visit 4A | 3 minutes post-CAC | 2.99 units on a scale | Standard Deviation 0.627 |
| Vehicle | Ocular Itching at 8 Hours Post-dose at Visit 4A | 5 minutes post-CAC | 2.90 units on a scale | Standard Deviation 0.703 |
| Vehicle | Ocular Itching at 8 Hours Post-dose at Visit 4A | 7 minutes post-CAC | 2.79 units on a scale | Standard Deviation 0.792 |
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) Population with Last Observation Carried Forward (LOCF)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AC-150 Combo | Ocular Itching at Duration of Action (16 Hours Post-dose) | 3 minutes post-CAC | 1.75 units on a scale | Standard Deviation 1.112 |
| AC-150 Combo | Ocular Itching at Duration of Action (16 Hours Post-dose) | 7 minutes post-CAC | 1.98 units on a scale | Standard Deviation 1.067 |
| AC-150 Combo | Ocular Itching at Duration of Action (16 Hours Post-dose) | 5 minutes post-CAC | 1.95 units on a scale | Standard Deviation 1.16 |
| AC-150A 0.1% | Ocular Itching at Duration of Action (16 Hours Post-dose) | 3 minutes post-CAC | 1.92 units on a scale | Standard Deviation 1.131 |
| AC-150A 0.1% | Ocular Itching at Duration of Action (16 Hours Post-dose) | 7 minutes post-CAC | 2.12 units on a scale | Standard Deviation 1.156 |
| AC-150A 0.1% | Ocular Itching at Duration of Action (16 Hours Post-dose) | 5 minutes post-CAC | 2.24 units on a scale | Standard Deviation 0.991 |
| AC-150B 0.005% | Ocular Itching at Duration of Action (16 Hours Post-dose) | 5 minutes post-CAC | 2.21 units on a scale | Standard Deviation 1.132 |
| AC-150B 0.005% | Ocular Itching at Duration of Action (16 Hours Post-dose) | 3 minutes post-CAC | 1.88 units on a scale | Standard Deviation 1.082 |
| AC-150B 0.005% | Ocular Itching at Duration of Action (16 Hours Post-dose) | 7 minutes post-CAC | 2.11 units on a scale | Standard Deviation 1.231 |
| Vehicle | Ocular Itching at Duration of Action (16 Hours Post-dose) | 3 minutes post-CAC | 3.04 units on a scale | Standard Deviation 0.693 |
| Vehicle | Ocular Itching at Duration of Action (16 Hours Post-dose) | 7 minutes post-CAC | 3.18 units on a scale | Standard Deviation 0.727 |
| Vehicle | Ocular Itching at Duration of Action (16 Hours Post-dose) | 5 minutes post-CAC | 3.18 units on a scale | Standard Deviation 0.706 |
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-150 Combo | Ocular Itching at Onset of Action (15 Minutes Post-dose) | 7 minutes post-CAC | 1.31 units on a scale | Standard Deviation 1.033 |
| AC-150 Combo | Ocular Itching at Onset of Action (15 Minutes Post-dose) | 5 minutes post-CAC | 1.44 units on a scale | Standard Deviation 1.076 |
| AC-150 Combo | Ocular Itching at Onset of Action (15 Minutes Post-dose) | 3 minutes post-CAC | 1.33 units on a scale | Standard Deviation 0.974 |
| AC-150A 0.1% | Ocular Itching at Onset of Action (15 Minutes Post-dose) | 5 minutes post-CAC | 1.33 units on a scale | Standard Deviation 0.59 |
| AC-150A 0.1% | Ocular Itching at Onset of Action (15 Minutes Post-dose) | 3 minutes post-CAC | 0.99 units on a scale | Standard Deviation 0.752 |
| AC-150A 0.1% | Ocular Itching at Onset of Action (15 Minutes Post-dose) | 7 minutes post-CAC | 1.59 units on a scale | Standard Deviation 0.894 |
| AC-150B 0.005% | Ocular Itching at Onset of Action (15 Minutes Post-dose) | 3 minutes post-CAC | 2.11 units on a scale | Standard Deviation 1.173 |
| AC-150B 0.005% | Ocular Itching at Onset of Action (15 Minutes Post-dose) | 5 minutes post-CAC | 2.25 units on a scale | Standard Deviation 1.057 |
| AC-150B 0.005% | Ocular Itching at Onset of Action (15 Minutes Post-dose) | 7 minutes post-CAC | 2.03 units on a scale | Standard Deviation 1.131 |
| Vehicle | Ocular Itching at Onset of Action (15 Minutes Post-dose) | 5 minutes post-CAC | 3.11 units on a scale | Standard Deviation 0.944 |
| Vehicle | Ocular Itching at Onset of Action (15 Minutes Post-dose) | 7 minutes post-CAC | 2.97 units on a scale | Standard Deviation 1.018 |
| Vehicle | Ocular Itching at Onset of Action (15 Minutes Post-dose) | 3 minutes post-CAC | 2.90 units on a scale | Standard Deviation 0.967 |
Secondary
Ciliary Redness at 8 Hours Post-dose at Visit 4A
A treatment efficacy CAC was performed 8 hours after drop instillation. Ciliary Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ciliary redness score over both eyes was analyzed.
Time frame: 7, 15, 20 minutes post-CAC
Population: Per protocol population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AC-150 Combo | Ciliary Redness at 8 Hours Post-dose at Visit 4A | 7 minutes post-CAC | 1.04 units on a scale | Standard Deviation 0.759 |
| AC-150 Combo | Ciliary Redness at 8 Hours Post-dose at Visit 4A | 20 minutes post-CAC | 1.15 units on a scale | Standard Deviation 0.713 |
| AC-150 Combo | Ciliary Redness at 8 Hours Post-dose at Visit 4A | 15 minutes post-CAC | 1.08 units on a scale | Standard Deviation 0.702 |
| AC-150A 0.1% | Ciliary Redness at 8 Hours Post-dose at Visit 4A | 7 minutes post-CAC | 1.65 units on a scale | Standard Deviation 0.673 |
| AC-150A 0.1% | Ciliary Redness at 8 Hours Post-dose at Visit 4A | 20 minutes post-CAC | 1.63 units on a scale | Standard Deviation 0.65 |
| AC-150A 0.1% | Ciliary Redness at 8 Hours Post-dose at Visit 4A | 15 minutes post-CAC | 1.69 units on a scale | Standard Deviation 0.693 |
| AC-150B 0.005% | Ciliary Redness at 8 Hours Post-dose at Visit 4A | 15 minutes post-CAC | 1.74 units on a scale | Standard Deviation 0.603 |
| AC-150B 0.005% | Ciliary Redness at 8 Hours Post-dose at Visit 4A | 7 minutes post-CAC | 1.68 units on a scale | Standard Deviation 0.557 |
| AC-150B 0.005% | Ciliary Redness at 8 Hours Post-dose at Visit 4A | 20 minutes post-CAC | 1.68 units on a scale | Standard Deviation 0.717 |
| Vehicle | Ciliary Redness at 8 Hours Post-dose at Visit 4A | 7 minutes post-CAC | 2.01 units on a scale | Standard Deviation 0.437 |
| Vehicle | Ciliary Redness at 8 Hours Post-dose at Visit 4A | 20 minutes post-CAC | 2.10 units on a scale | Standard Deviation 0.566 |
| Vehicle | Ciliary Redness at 8 Hours Post-dose at Visit 4A | 15 minutes post-CAC | 2.18 units on a scale | Standard Deviation 0.393 |
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: Per protocol population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AC-150 Combo | Ciliary Redness at Duration of Action (16 Hours Post-dose) | 7 minutes post-CAC | 1.38 units on a scale | Standard Deviation 0.577 |
| AC-150 Combo | Ciliary Redness at Duration of Action (16 Hours Post-dose) | 20 minutes post-CAC | 1.53 units on a scale | Standard Deviation 0.629 |
| AC-150 Combo | Ciliary Redness at Duration of Action (16 Hours Post-dose) | 15 minutes post-CAC | 1.51 units on a scale | Standard Deviation 0.578 |
| AC-150A 0.1% | Ciliary Redness at Duration of Action (16 Hours Post-dose) | 7 minutes post-CAC | 1.81 units on a scale | Standard Deviation 0.616 |
| AC-150A 0.1% | Ciliary Redness at Duration of Action (16 Hours Post-dose) | 20 minutes post-CAC | 1.91 units on a scale | Standard Deviation 0.637 |
| AC-150A 0.1% | Ciliary Redness at Duration of Action (16 Hours Post-dose) | 15 minutes post-CAC | 1.90 units on a scale | Standard Deviation 0.6 |
| AC-150B 0.005% | Ciliary Redness at Duration of Action (16 Hours Post-dose) | 15 minutes post-CAC | 1.84 units on a scale | Standard Deviation 0.712 |
| AC-150B 0.005% | Ciliary Redness at Duration of Action (16 Hours Post-dose) | 7 minutes post-CAC | 1.71 units on a scale | Standard Deviation 0.626 |
| AC-150B 0.005% | Ciliary Redness at Duration of Action (16 Hours Post-dose) | 20 minutes post-CAC | 1.72 units on a scale | Standard Deviation 0.667 |
| Vehicle | Ciliary Redness at Duration of Action (16 Hours Post-dose) | 7 minutes post-CAC | 2.03 units on a scale | Standard Deviation 0.499 |
| Vehicle | Ciliary Redness at Duration of Action (16 Hours Post-dose) | 20 minutes post-CAC | 2.04 units on a scale | Standard Deviation 0.461 |
| Vehicle | Ciliary Redness at Duration of Action (16 Hours Post-dose) | 15 minutes post-CAC | 2.10 units on a scale | Standard Deviation 0.434 |
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: Per protocol population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AC-150 Combo | Ciliary Redness at Onset of Action (15 Minutes Post-dose) | 7 minutes post-CAC | 1.44 units on a scale | Standard Deviation 0.898 |
| AC-150 Combo | Ciliary Redness at Onset of Action (15 Minutes Post-dose) | 20 minutes post-CAC | 1.94 units on a scale | Standard Deviation 1.1 |
| AC-150 Combo | Ciliary Redness at Onset of Action (15 Minutes Post-dose) | 15 minutes post-CAC | 1.89 units on a scale | Standard Deviation 0.956 |
| AC-150A 0.1% | Ciliary Redness at Onset of Action (15 Minutes Post-dose) | 7 minutes post-CAC | 1.84 units on a scale | Standard Deviation 0.852 |
| AC-150A 0.1% | Ciliary Redness at Onset of Action (15 Minutes Post-dose) | 20 minutes post-CAC | 2.29 units on a scale | Standard Deviation 0.953 |
| AC-150A 0.1% | Ciliary Redness at Onset of Action (15 Minutes Post-dose) | 15 minutes post-CAC | 2.25 units on a scale | Standard Deviation 0.94 |
| AC-150B 0.005% | Ciliary Redness at Onset of Action (15 Minutes Post-dose) | 15 minutes post-CAC | 2.47 units on a scale | Standard Deviation 0.865 |
| AC-150B 0.005% | Ciliary Redness at Onset of Action (15 Minutes Post-dose) | 7 minutes post-CAC | 2.35 units on a scale | Standard Deviation 0.834 |
| AC-150B 0.005% | Ciliary Redness at Onset of Action (15 Minutes Post-dose) | 20 minutes post-CAC | 2.51 units on a scale | Standard Deviation 0.946 |
| Vehicle | Ciliary Redness at Onset of Action (15 Minutes Post-dose) | 7 minutes post-CAC | 2.37 units on a scale | Standard Deviation 0.857 |
| Vehicle | Ciliary Redness at Onset of Action (15 Minutes Post-dose) | 20 minutes post-CAC | 2.56 units on a scale | Standard Deviation 0.788 |
| Vehicle | Ciliary Redness at Onset of Action (15 Minutes Post-dose) | 15 minutes post-CAC | 2.54 units on a scale | Standard Deviation 0.88 |
Secondary
Ear or Palate Pruritus at 8 Hours Post-dose at Visit 4A
A treatment efficacy CAC was performed 15 minutes after drop instillation. Ear or Palate Pruritus was assessed by the patient on a single 0-4 scale (0=none to 4=severe). Ear or Palate Pruritus score for each time point was analyzed.
Time frame: 7, 15, 20 minutes post-CAC
Population: Per protocol population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AC-150 Combo | Ear or Palate Pruritus at 8 Hours Post-dose at Visit 4A | 7 minutes post-CAC | 0.3 units on a scale | Standard Deviation 0.69 |
| AC-150 Combo | Ear or Palate Pruritus at 8 Hours Post-dose at Visit 4A | 20 minutes post-CAC | 0.5 units on a scale | Standard Deviation 0.86 |
| AC-150 Combo | Ear or Palate Pruritus at 8 Hours Post-dose at Visit 4A | 15 minutes post-CAC | 0.4 units on a scale | Standard Deviation 0.78 |
| AC-150A 0.1% | Ear or Palate Pruritus at 8 Hours Post-dose at Visit 4A | 7 minutes post-CAC | 0.7 units on a scale | Standard Deviation 0.85 |
| AC-150A 0.1% | Ear or Palate Pruritus at 8 Hours Post-dose at Visit 4A | 20 minutes post-CAC | 1.2 units on a scale | Standard Deviation 1.01 |
| AC-150A 0.1% | Ear or Palate Pruritus at 8 Hours Post-dose at Visit 4A | 15 minutes post-CAC | 1.1 units on a scale | Standard Deviation 1.05 |
| AC-150B 0.005% | Ear or Palate Pruritus at 8 Hours Post-dose at Visit 4A | 15 minutes post-CAC | 0.8 units on a scale | Standard Deviation 1.24 |
| AC-150B 0.005% | Ear or Palate Pruritus at 8 Hours Post-dose at Visit 4A | 7 minutes post-CAC | 0.6 units on a scale | Standard Deviation 1.06 |
| AC-150B 0.005% | Ear or Palate Pruritus at 8 Hours Post-dose at Visit 4A | 20 minutes post-CAC | 0.8 units on a scale | Standard Deviation 1.2 |
| Vehicle | Ear or Palate Pruritus at 8 Hours Post-dose at Visit 4A | 7 minutes post-CAC | 1.2 units on a scale | Standard Deviation 1.24 |
| Vehicle | Ear or Palate Pruritus at 8 Hours Post-dose at Visit 4A | 20 minutes post-CAC | 1.3 units on a scale | Standard Deviation 1.16 |
| Vehicle | Ear or Palate Pruritus at 8 Hours Post-dose at Visit 4A | 15 minutes post-CAC | 1.2 units on a scale | Standard Deviation 1.15 |
Secondary
Ear or Palate Pruritus at Duration of Action (16 Hours Post-dose)
A treatment efficacy CAC was performed 15 minutes after drop instillation. Ear or Palate Pruritus was assessed by the patient on a single 0-4 scale (0=none to 4=severe). Ear or Palate Pruritus score for each time point was analyzed.
Time frame: 7, 15, 20 minutes post-CAC
Population: Per protocol population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AC-150 Combo | Ear or Palate Pruritus at Duration of Action (16 Hours Post-dose) | 7 minutes post-CAC | 0.4 units on a scale | Standard Deviation 0.85 |
| AC-150 Combo | Ear or Palate Pruritus at Duration of Action (16 Hours Post-dose) | 20 minutes post-CAC | 0.7 units on a scale | Standard Deviation 1.08 |
| AC-150 Combo | Ear or Palate Pruritus at Duration of Action (16 Hours Post-dose) | 15 minutes post-CAC | 0.7 units on a scale | Standard Deviation 1.13 |
| AC-150A 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 0.62 |
| AC-150A 0.1% | Ear or Palate Pruritus at Duration of Action (16 Hours Post-dose) | 20 minutes post-CAC | 1.2 units on a scale | Standard Deviation 1.03 |
| AC-150A 0.1% | Ear or Palate Pruritus at Duration of Action (16 Hours Post-dose) | 15 minutes post-CAC | 1.3 units on a scale | Standard Deviation 0.99 |
| AC-150B 0.005% | Ear or Palate Pruritus at Duration of Action (16 Hours Post-dose) | 15 minutes post-CAC | 0.6 units on a scale | Standard Deviation 1.11 |
| AC-150B 0.005% | 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-150B 0.005% | Ear or Palate Pruritus at Duration of Action (16 Hours Post-dose) | 20 minutes post-CAC | 0.9 units on a scale | Standard Deviation 1.43 |
| Vehicle | Ear or Palate Pruritus at Duration of Action (16 Hours Post-dose) | 7 minutes post-CAC | 1.5 units on a scale | Standard Deviation 1.33 |
| Vehicle | Ear or Palate Pruritus at Duration of Action (16 Hours Post-dose) | 20 minutes post-CAC | 1.5 units on a scale | Standard Deviation 1.23 |
| Vehicle | Ear or Palate Pruritus at Duration of Action (16 Hours Post-dose) | 15 minutes post-CAC | 1.5 units on a scale | Standard Deviation 1.37 |
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: Per protocol population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AC-150 Combo | Ear or Palate Pruritus at Onset of Action (15 Minutes Post-dose) | 7 minutes post-CAC | 0.4 units on a scale | Standard Deviation 0.78 |
| AC-150 Combo | Ear or Palate Pruritus at Onset of Action (15 Minutes Post-dose) | 20 minutes post-CAC | 0.6 units on a scale | Standard Deviation 1.04 |
| AC-150 Combo | Ear or Palate Pruritus at Onset of Action (15 Minutes Post-dose) | 15 minutes post-CAC | 0.4 units on a scale | Standard Deviation 0.85 |
| AC-150A 0.1% | Ear or Palate Pruritus at Onset of Action (15 Minutes Post-dose) | 7 minutes post-CAC | 0.3 units on a scale | Standard Deviation 0.59 |
| AC-150A 0.1% | Ear or Palate Pruritus at Onset of Action (15 Minutes Post-dose) | 20 minutes post-CAC | 0.8 units on a scale | Standard Deviation 0.9 |
| AC-150A 0.1% | Ear or Palate Pruritus at Onset of Action (15 Minutes Post-dose) | 15 minutes post-CAC | 0.6 units on a scale | Standard Deviation 0.93 |
| AC-150B 0.005% | Ear or Palate Pruritus at Onset of Action (15 Minutes Post-dose) | 15 minutes post-CAC | 0.7 units on a scale | Standard Deviation 1.1 |
| AC-150B 0.005% | Ear or Palate Pruritus at Onset of Action (15 Minutes Post-dose) | 7 minutes post-CAC | 0.5 units on a scale | Standard Deviation 0.94 |
| AC-150B 0.005% | Ear or Palate Pruritus at Onset of Action (15 Minutes Post-dose) | 20 minutes post-CAC | 1.0 units on a scale | Standard Deviation 1.27 |
| Vehicle | Ear or Palate Pruritus at Onset of Action (15 Minutes Post-dose) | 7 minutes post-CAC | 1.2 units on a scale | Standard Deviation 1.39 |
| Vehicle | Ear or Palate Pruritus at Onset of Action (15 Minutes Post-dose) | 20 minutes post-CAC | 1.5 units on a scale | Standard Deviation 1.42 |
| Vehicle | Ear or Palate Pruritus at Onset of Action (15 Minutes Post-dose) | 15 minutes post-CAC | 1.4 units on a scale | Standard Deviation 1.33 |
Secondary
Episcleral Redness at 8 Hours Post-dose at Visit 4A
A treatment efficacy CAC was performed 8 hours after drop instillation. Episcleral Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of episcleral redness score over both eyes was analyzed.
Time frame: 7, 15, 20 minutes post-CAC
Population: Per protocol population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AC-150 Combo | Episcleral Redness at 8 Hours Post-dose at Visit 4A | 7 minutes post-CAC | 1.49 units on a scale | Standard Deviation 0.672 |
| AC-150 Combo | Episcleral Redness at 8 Hours Post-dose at Visit 4A | 20 minutes post-CAC | 1.57 units on a scale | Standard Deviation 0.674 |
| AC-150 Combo | Episcleral Redness at 8 Hours Post-dose at Visit 4A | 15 minutes post-CAC | 1.50 units on a scale | Standard Deviation 0.712 |
| AC-150A 0.1% | Episcleral Redness at 8 Hours Post-dose at Visit 4A | 7 minutes post-CAC | 1.88 units on a scale | Standard Deviation 0.644 |
| AC-150A 0.1% | Episcleral Redness at 8 Hours Post-dose at Visit 4A | 20 minutes post-CAC | 1.94 units on a scale | Standard Deviation 0.705 |
| AC-150A 0.1% | Episcleral Redness at 8 Hours Post-dose at Visit 4A | 15 minutes post-CAC | 2.04 units on a scale | Standard Deviation 0.607 |
| AC-150B 0.005% | Episcleral Redness at 8 Hours Post-dose at Visit 4A | 15 minutes post-CAC | 2.07 units on a scale | Standard Deviation 0.598 |
| AC-150B 0.005% | Episcleral Redness at 8 Hours Post-dose at Visit 4A | 7 minutes post-CAC | 2.04 units on a scale | Standard Deviation 0.453 |
| AC-150B 0.005% | Episcleral Redness at 8 Hours Post-dose at Visit 4A | 20 minutes post-CAC | 2.07 units on a scale | Standard Deviation 0.63 |
| Vehicle | Episcleral Redness at 8 Hours Post-dose at Visit 4A | 7 minutes post-CAC | 2.34 units on a scale | Standard Deviation 0.436 |
| Vehicle | Episcleral Redness at 8 Hours Post-dose at Visit 4A | 20 minutes post-CAC | 2.40 units on a scale | Standard Deviation 0.516 |
| Vehicle | Episcleral Redness at 8 Hours Post-dose at Visit 4A | 15 minutes post-CAC | 2.41 units on a scale | Standard Deviation 0.484 |
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: Per protocol population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AC-150 Combo | Episcleral Redness at Duration of Action (16 Hours Post-dose) | 7 minutes post-CAC | 1.72 units on a scale | Standard Deviation 0.575 |
| AC-150 Combo | Episcleral Redness at Duration of Action (16 Hours Post-dose) | 20 minutes post-CAC | 1.78 units on a scale | Standard Deviation 0.528 |
| AC-150 Combo | Episcleral Redness at Duration of Action (16 Hours Post-dose) | 15 minutes post-CAC | 1.79 units on a scale | Standard Deviation 0.564 |
| AC-150A 0.1% | Episcleral Redness at Duration of Action (16 Hours Post-dose) | 7 minutes post-CAC | 2.12 units on a scale | Standard Deviation 0.638 |
| AC-150A 0.1% | Episcleral Redness at Duration of Action (16 Hours Post-dose) | 20 minutes post-CAC | 2.22 units on a scale | Standard Deviation 0.522 |
| AC-150A 0.1% | Episcleral Redness at Duration of Action (16 Hours Post-dose) | 15 minutes post-CAC | 2.24 units on a scale | Standard Deviation 0.583 |
| AC-150B 0.005% | Episcleral Redness at Duration of Action (16 Hours Post-dose) | 15 minutes post-CAC | 2.21 units on a scale | Standard Deviation 0.663 |
| AC-150B 0.005% | Episcleral Redness at Duration of Action (16 Hours Post-dose) | 7 minutes post-CAC | 2.15 units on a scale | Standard Deviation 0.538 |
| AC-150B 0.005% | Episcleral Redness at Duration of Action (16 Hours Post-dose) | 20 minutes post-CAC | 2.16 units on a scale | Standard Deviation 0.606 |
| Vehicle | Episcleral Redness at Duration of Action (16 Hours Post-dose) | 7 minutes post-CAC | 2.37 units on a scale | Standard Deviation 0.516 |
| Vehicle | Episcleral Redness at Duration of Action (16 Hours Post-dose) | 20 minutes post-CAC | 2.47 units on a scale | Standard Deviation 0.558 |
| Vehicle | Episcleral Redness at Duration of Action (16 Hours Post-dose) | 15 minutes post-CAC | 2.53 units on a scale | Standard Deviation 0.514 |
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: Per protocol population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AC-150 Combo | Episcleral Redness at Onset of Action (15 Minutes Post-dose) | 7 minutes post-CAC | 1.63 units on a scale | Standard Deviation 0.749 |
| AC-150 Combo | Episcleral Redness at Onset of Action (15 Minutes Post-dose) | 20 minutes post-CAC | 1.94 units on a scale | Standard Deviation 0.816 |
| AC-150 Combo | Episcleral Redness at Onset of Action (15 Minutes Post-dose) | 15 minutes post-CAC | 1.90 units on a scale | Standard Deviation 0.642 |
| AC-150A 0.1% | Episcleral Redness at Onset of Action (15 Minutes Post-dose) | 7 minutes post-CAC | 2.03 units on a scale | Standard Deviation 0.888 |
| AC-150A 0.1% | Episcleral Redness at Onset of Action (15 Minutes Post-dose) | 20 minutes post-CAC | 2.53 units on a scale | Standard Deviation 0.951 |
| AC-150A 0.1% | Episcleral Redness at Onset of Action (15 Minutes Post-dose) | 15 minutes post-CAC | 2.40 units on a scale | Standard Deviation 0.96 |
| AC-150B 0.005% | Episcleral Redness at Onset of Action (15 Minutes Post-dose) | 15 minutes post-CAC | 2.51 units on a scale | Standard Deviation 0.763 |
| AC-150B 0.005% | Episcleral Redness at Onset of Action (15 Minutes Post-dose) | 7 minutes post-CAC | 2.35 units on a scale | Standard Deviation 0.755 |
| AC-150B 0.005% | Episcleral Redness at Onset of Action (15 Minutes Post-dose) | 20 minutes post-CAC | 2.56 units on a scale | Standard Deviation 0.855 |
| Vehicle | Episcleral Redness at Onset of Action (15 Minutes Post-dose) | 7 minutes post-CAC | 2.50 units on a scale | Standard Deviation 0.667 |
| Vehicle | Episcleral Redness at Onset of Action (15 Minutes Post-dose) | 20 minutes post-CAC | 2.71 units on a scale | Standard Deviation 0.692 |
| Vehicle | Episcleral Redness at Onset of Action (15 Minutes Post-dose) | 15 minutes post-CAC | 2.71 units on a scale | Standard Deviation 0.675 |
Secondary
Lid Swelling at 8 Hours Post-dose at Visit 4A
A treatment efficacy CAC was performed 8 hours after drop instillation. Lid swelling was assessed by the patient on a 0-3 scale (0=none to 3=severe). Average of lid swelling score over both eyes was analyzed.
Time frame: 7, 15, 20 minutes post-CAC
Population: Per protocol population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AC-150 Combo | Lid Swelling at 8 Hours Post-dose at Visit 4A | 20 minutes post-CAC | 0.5 units on a scale | Standard Deviation 0.5 |
| AC-150 Combo | Lid Swelling at 8 Hours Post-dose at Visit 4A | 7 minutes post-CAC | 0.4 units on a scale | Standard Deviation 0.51 |
| AC-150 Combo | Lid Swelling at 8 Hours Post-dose at Visit 4A | 15 minutes post-CAC | 0.5 units on a scale | Standard Deviation 0.5 |
| AC-150A 0.1% | Lid Swelling at 8 Hours Post-dose at Visit 4A | 15 minutes post-CAC | 1.0 units on a scale | Standard Deviation 0.76 |
| AC-150A 0.1% | Lid Swelling at 8 Hours Post-dose at Visit 4A | 7 minutes post-CAC | 0.7 units on a scale | Standard Deviation 0.58 |
| AC-150A 0.1% | Lid Swelling at 8 Hours Post-dose at Visit 4A | 20 minutes post-CAC | 1.0 units on a scale | Standard Deviation 0.88 |
| AC-150B 0.005% | Lid Swelling at 8 Hours Post-dose at Visit 4A | 20 minutes post-CAC | 1.0 units on a scale | Standard Deviation 0.94 |
| AC-150B 0.005% | Lid Swelling at 8 Hours Post-dose at Visit 4A | 7 minutes post-CAC | 1.1 units on a scale | Standard Deviation 1.03 |
| AC-150B 0.005% | Lid Swelling at 8 Hours Post-dose at Visit 4A | 15 minutes post-CAC | 1.1 units on a scale | Standard Deviation 1 |
| Vehicle | Lid Swelling at 8 Hours Post-dose at Visit 4A | 15 minutes post-CAC | 1.6 units on a scale | Standard Deviation 0.7 |
| Vehicle | Lid Swelling at 8 Hours Post-dose at Visit 4A | 7 minutes post-CAC | 1.6 units on a scale | Standard Deviation 0.93 |
| Vehicle | Lid Swelling at 8 Hours Post-dose at Visit 4A | 20 minutes post-CAC | 1.6 units on a scale | Standard Deviation 0.66 |
Secondary
Lid Swelling at Onset of Action (15 Minutes Post-dose)
A treatment efficacy CAC was performed 15 minutes after drop instillation. Lid swelling was assessed by the patient on a 0-3 scale (0=none to 3=severe). Average of lid swelling score over both eyes was analyzed.
Time frame: 7, 15, 20 minutes post-CAC
Population: Per protocol population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AC-150 Combo | Lid Swelling at Onset of Action (15 Minutes Post-dose) | 7 minutes post-CAC | 0.2 units on a scale | Standard Deviation 0.43 |
| AC-150 Combo | Lid Swelling at Onset of Action (15 Minutes Post-dose) | 20 minutes post-CAC | 0.4 units on a scale | Standard Deviation 0.62 |
| AC-150 Combo | Lid Swelling at Onset of Action (15 Minutes Post-dose) | 15 minutes post-CAC | 0.4 units on a scale | Standard Deviation 0.61 |
| AC-150A 0.1% | Lid Swelling at Onset of Action (15 Minutes Post-dose) | 7 minutes post-CAC | 0.5 units on a scale | Standard Deviation 0.5 |
| AC-150A 0.1% | Lid Swelling at Onset of Action (15 Minutes Post-dose) | 20 minutes post-CAC | 0.9 units on a scale | Standard Deviation 0.75 |
| AC-150A 0.1% | Lid Swelling at Onset of Action (15 Minutes Post-dose) | 15 minutes post-CAC | 0.7 units on a scale | Standard Deviation 0.75 |
| AC-150B 0.005% | Lid Swelling at Onset of Action (15 Minutes Post-dose) | 15 minutes post-CAC | 1.1 units on a scale | Standard Deviation 0.97 |
| AC-150B 0.005% | Lid Swelling at Onset of Action (15 Minutes Post-dose) | 7 minutes post-CAC | 1.2 units on a scale | Standard Deviation 0.88 |
| AC-150B 0.005% | Lid Swelling at Onset of Action (15 Minutes Post-dose) | 20 minutes post-CAC | 1.1 units on a scale | Standard Deviation 0.86 |
| Vehicle | Lid Swelling at Onset of Action (15 Minutes Post-dose) | 7 minutes post-CAC | 1.4 units on a scale | Standard Deviation 0.63 |
| Vehicle | Lid Swelling at Onset of Action (15 Minutes Post-dose) | 20 minutes post-CAC | 1.5 units on a scale | Standard Deviation 0.85 |
| Vehicle | Lid Swelling at Onset of Action (15 Minutes Post-dose) | 15 minutes post-CAC | 1.5 units on a scale | Standard Deviation 0.74 |
Secondary
Lid Swelling Duration of Action (16 Hours Post-dose)
A treatment efficacy CAC was performed 16 hours after drop instillation. Lid swelling was assessed by the patient on a 0-3 scale (0=none to 3=severe). Average of lid swelling score over both eyes was analyzed.
Time frame: 7, 15, 20 minutes post-CAC
Population: Per protocol population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AC-150 Combo | Lid Swelling Duration of Action (16 Hours Post-dose) | 7 minutes post-CAC | 0.6 units on a scale | Standard Deviation 0.51 |
| AC-150 Combo | Lid Swelling Duration of Action (16 Hours Post-dose) | 20 minutes post-CAC | 0.7 units on a scale | Standard Deviation 0.59 |
| AC-150 Combo | Lid Swelling Duration of Action (16 Hours Post-dose) | 15 minutes post-CAC | 0.7 units on a scale | Standard Deviation 0.59 |
| AC-150A 0.1% | Lid Swelling Duration of Action (16 Hours Post-dose) | 7 minutes post-CAC | 1.2 units on a scale | Standard Deviation 0.95 |
| AC-150A 0.1% | Lid Swelling Duration of Action (16 Hours Post-dose) | 20 minutes post-CAC | 1.3 units on a scale | Standard Deviation 0.92 |
| AC-150A 0.1% | Lid Swelling Duration of Action (16 Hours Post-dose) | 15 minutes post-CAC | 1.3 units on a scale | Standard Deviation 1 |
| AC-150B 0.005% | Lid Swelling Duration of Action (16 Hours Post-dose) | 15 minutes post-CAC | 1.1 units on a scale | Standard Deviation 0.86 |
| AC-150B 0.005% | Lid Swelling Duration of Action (16 Hours Post-dose) | 7 minutes post-CAC | 1.1 units on a scale | Standard Deviation 0.86 |
| AC-150B 0.005% | Lid Swelling Duration of Action (16 Hours Post-dose) | 20 minutes post-CAC | 1.2 units on a scale | Standard Deviation 0.95 |
| Vehicle | Lid Swelling Duration of Action (16 Hours Post-dose) | 7 minutes post-CAC | 1.5 units on a scale | Standard Deviation 0.66 |
| Vehicle | Lid Swelling Duration of Action (16 Hours Post-dose) | 20 minutes post-CAC | 1.7 units on a scale | Standard Deviation 0.68 |
| Vehicle | Lid Swelling Duration of Action (16 Hours Post-dose) | 15 minutes post-CAC | 1.6 units on a scale | Standard Deviation 0.7 |
Secondary
Tolerability of Study Medication at Visit 2B
Subjects were asked to rate the comfort of the drop in each eye upon instillation, at 1 minute, and at 2 minutes after instillation of study medication. The assessment used a 10-point scale with 0 as very comfortable and 10 as very uncomfortable. Higher scores represent a worse outcome.
Time frame: upon instillation, 1 minute and 2 minutes post instillation
Population: Intent to Treat (ITT). Number of analyzed subjects differ due to subject discontinuation during the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AC-150 Combo | Tolerability of Study Medication at Visit 2B | Upon instillation | 2.3 units on a scale | Standard Deviation 1.94 |
| AC-150 Combo | Tolerability of Study Medication at Visit 2B | 2 minutes post-instillation | 1.9 units on a scale | Standard Deviation 1.41 |
| AC-150 Combo | Tolerability of Study Medication at Visit 2B | 1 minute post-instillation | 2.3 units on a scale | Standard Deviation 1.59 |
| AC-150A 0.1% | Tolerability of Study Medication at Visit 2B | Upon instillation | 2.2 units on a scale | Standard Deviation 2.19 |
| AC-150A 0.1% | Tolerability of Study Medication at Visit 2B | 2 minutes post-instillation | 1.4 units on a scale | Standard Deviation 1.82 |
| AC-150A 0.1% | Tolerability of Study Medication at Visit 2B | 1 minute post-instillation | 2.0 units on a scale | Standard Deviation 2.08 |
| AC-150B 0.005% | Tolerability of Study Medication at Visit 2B | 1 minute post-instillation | 0.9 units on a scale | Standard Deviation 1.45 |
| AC-150B 0.005% | Tolerability of Study Medication at Visit 2B | Upon instillation | 1.1 units on a scale | Standard Deviation 1.54 |
| AC-150B 0.005% | Tolerability of Study Medication at Visit 2B | 2 minutes post-instillation | 0.8 units on a scale | Standard Deviation 1.25 |
| Vehicle | Tolerability of Study Medication at Visit 2B | Upon instillation | 2.0 units on a scale | Standard Deviation 1.94 |
| Vehicle | Tolerability of Study Medication at Visit 2B | 2 minutes post-instillation | 1.6 units on a scale | Standard Deviation 1.4 |
| Vehicle | Tolerability of Study Medication at Visit 2B | 1 minute post-instillation | 1.7 units on a scale | Standard Deviation 1.55 |
Secondary
Tolerability of Study Medication at Visit 3
Subjects were asked to rate the comfort of the drop in each eye upon instillation, at 1 minute, and at 2 minutes after instillation of study medication. The assessment used a 10-point scale with 0 as very comfortable and 10 as very uncomfortable. Higher scores represent a worse outcome.
Time frame: upon instillation, 1 minute and 2 minutes post instillation
Population: Intent to Treat (ITT)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AC-150 Combo | Tolerability of Study Medication at Visit 3 | Upon instillation | 2.0 units on a scale | Standard Deviation 1.86 |
| AC-150 Combo | Tolerability of Study Medication at Visit 3 | 2 minutes post-instillation | 1.6 units on a scale | Standard Deviation 1.33 |
| AC-150 Combo | Tolerability of Study Medication at Visit 3 | 1 minute post-instillation | 1.6 units on a scale | Standard Deviation 1.31 |
| AC-150A 0.1% | Tolerability of Study Medication at Visit 3 | Upon instillation | 1.5 units on a scale | Standard Deviation 2.12 |
| AC-150A 0.1% | Tolerability of Study Medication at Visit 3 | 2 minutes post-instillation | 1.3 units on a scale | Standard Deviation 1.25 |
| AC-150A 0.1% | Tolerability of Study Medication at Visit 3 | 1 minute post-instillation | 1.4 units on a scale | Standard Deviation 1.42 |
| AC-150B 0.005% | Tolerability of Study Medication at Visit 3 | 1 minute post-instillation | 0.8 units on a scale | Standard Deviation 1.06 |
| AC-150B 0.005% | Tolerability of Study Medication at Visit 3 | Upon instillation | 0.9 units on a scale | Standard Deviation 1.18 |
| AC-150B 0.005% | Tolerability of Study Medication at Visit 3 | 2 minutes post-instillation | 0.7 units on a scale | Standard Deviation 0.96 |
| Vehicle | Tolerability of Study Medication at Visit 3 | Upon instillation | 1.4 units on a scale | Standard Deviation 1.78 |
| Vehicle | Tolerability of Study Medication at Visit 3 | 2 minutes post-instillation | 0.8 units on a scale | Standard Deviation 1.25 |
| Vehicle | Tolerability of Study Medication at Visit 3 | 1 minute post-instillation | 1.0 units on a scale | Standard Deviation 1.29 |
Secondary
Total Redness at 8 Hours Post-Dose at Visit 4A
A treatment efficacy CAC was performed 8 hours after drop instillation. Total redness was defined as the sum of the conjunctival, ciliary and episcleral redness scores, and was, thus, on a 0-12 scale, making the threshold for clinical significance a treatment difference of 3.0 units. Higher scores represent greater severity.
Time frame: 7, 15, 20 minutes post-CAC
Population: Per protocol population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AC-150 Combo | Total Redness at 8 Hours Post-Dose at Visit 4A | 7 minutes post-CAC | 3.83 units on a scale | Standard Deviation 1.955 |
| AC-150 Combo | Total Redness at 8 Hours Post-Dose at Visit 4A | 20 minutes post-CAC | 4.07 units on a scale | Standard Deviation 1.905 |
| AC-150 Combo | Total Redness at 8 Hours Post-Dose at Visit 4A | 15 minutes post-CAC | 3.88 units on a scale | Standard Deviation 1.927 |
| AC-150A 0.1% | Total Redness at 8 Hours Post-Dose at Visit 4A | 7 minutes post-CAC | 5.25 units on a scale | Standard Deviation 1.803 |
| AC-150A 0.1% | Total Redness at 8 Hours Post-Dose at Visit 4A | 20 minutes post-CAC | 5.35 units on a scale | Standard Deviation 1.831 |
| AC-150A 0.1% | Total Redness at 8 Hours Post-Dose at Visit 4A | 15 minutes post-CAC | 5.50 units on a scale | Standard Deviation 1.73 |
| AC-150B 0.005% | Total Redness at 8 Hours Post-Dose at Visit 4A | 15 minutes post-CAC | 5.63 units on a scale | Standard Deviation 1.68 |
| AC-150B 0.005% | Total Redness at 8 Hours Post-Dose at Visit 4A | 7 minutes post-CAC | 5.50 units on a scale | Standard Deviation 1.389 |
| AC-150B 0.005% | Total Redness at 8 Hours Post-Dose at Visit 4A | 20 minutes post-CAC | 5.54 units on a scale | Standard Deviation 1.859 |
| Vehicle | Total Redness at 8 Hours Post-Dose at Visit 4A | 7 minutes post-CAC | 6.29 units on a scale | Standard Deviation 1.108 |
| Vehicle | Total Redness at 8 Hours Post-Dose at Visit 4A | 20 minutes post-CAC | 6.63 units on a scale | Standard Deviation 1.415 |
| Vehicle | Total Redness at 8 Hours Post-Dose at Visit 4A | 15 minutes post-CAC | 6.72 units on a scale | Standard Deviation 1.169 |
Secondary
Total Redness at Duration of Action (16 Hours Post-dose)
A treatment efficacy CAC was performed 16 hours after drop instillation. Total redness was defined as the sum of the conjunctival, ciliary and episcleral redness scores, and was, thus, on a 0-12 scale, making the threshold for clinical significance a treatment difference of 3.0 units. Higher scores represent greater severity.
Time frame: 7, 15, 20 minutes post-CAC
Population: Per protocol population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AC-150 Combo | Total Redness at Duration of Action (16 Hours Post-dose) | 7 minutes post-CAC | 4.60 units on a scale | Standard Deviation 1.451 |
| AC-150 Combo | Total Redness at Duration of Action (16 Hours Post-dose) | 20 minutes post-CAC | 4.90 units on a scale | Standard Deviation 1.402 |
| AC-150 Combo | Total Redness at Duration of Action (16 Hours Post-dose) | 15 minutes post-CAC | 4.92 units on a scale | Standard Deviation 1.483 |
| AC-150A 0.1% | Total Redness at Duration of Action (16 Hours Post-dose) | 7 minutes post-CAC | 5.75 units on a scale | Standard Deviation 1.658 |
| AC-150A 0.1% | Total Redness at Duration of Action (16 Hours Post-dose) | 20 minutes post-CAC | 6.10 units on a scale | Standard Deviation 1.606 |
| AC-150A 0.1% | Total Redness at Duration of Action (16 Hours Post-dose) | 15 minutes post-CAC | 6.03 units on a scale | Standard Deviation 1.489 |
| AC-150B 0.005% | Total Redness at Duration of Action (16 Hours Post-dose) | 15 minutes post-CAC | 5.88 units on a scale | Standard Deviation 1.898 |
| AC-150B 0.005% | Total Redness at Duration of Action (16 Hours Post-dose) | 7 minutes post-CAC | 5.66 units on a scale | Standard Deviation 1.591 |
| AC-150B 0.005% | Total Redness at Duration of Action (16 Hours Post-dose) | 20 minutes post-CAC | 5.68 units on a scale | Standard Deviation 1.736 |
| Vehicle | Total Redness at Duration of Action (16 Hours Post-dose) | 7 minutes post-CAC | 6.40 units on a scale | Standard Deviation 1.263 |
| Vehicle | Total Redness at Duration of Action (16 Hours Post-dose) | 20 minutes post-CAC | 6.54 units on a scale | Standard Deviation 1.312 |
| Vehicle | Total Redness at Duration of Action (16 Hours Post-dose) | 15 minutes post-CAC | 6.78 units on a scale | Standard Deviation 1.202 |
Secondary
Total Redness at Onset of Action (15 Minutes Post-dose)
A treatment efficacy CAC was performed 15 minutes after drop instillation. Total redness was defined as the sum of the conjunctival, ciliary and episcleral redness scores, and was, thus, on a 0-12 scale, making the threshold for clinical significance a treatment difference of 3.0 units. Higher scores represent greater severity.
Time frame: 7, 15, 20 minutes post-CAC
Population: Per protocol population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AC-150 Combo | Total Redness at Onset of Action (15 Minutes Post-dose) | 7 minutes post-CAC | 4.72 units on a scale | Standard Deviation 2.252 |
| AC-150 Combo | Total Redness at Onset of Action (15 Minutes Post-dose) | 20 minutes post-CAC | 5.86 units on a scale | Standard Deviation 2.579 |
| AC-150 Combo | Total Redness at Onset of Action (15 Minutes Post-dose) | 15 minutes post-CAC | 5.76 units on a scale | Standard Deviation 2.225 |
| AC-150A 0.1% | Total Redness at Onset of Action (15 Minutes Post-dose) | 7 minutes post-CAC | 5.96 units on a scale | Standard Deviation 2.45 |
| AC-150A 0.1% | Total Redness at Onset of Action (15 Minutes Post-dose) | 20 minutes post-CAC | 7.32 units on a scale | Standard Deviation 2.778 |
| AC-150A 0.1% | Total Redness at Onset of Action (15 Minutes Post-dose) | 15 minutes post-CAC | 7.03 units on a scale | Standard Deviation 2.802 |
| AC-150B 0.005% | Total Redness at Onset of Action (15 Minutes Post-dose) | 15 minutes post-CAC | 7.49 units on a scale | Standard Deviation 2.312 |
| AC-150B 0.005% | Total Redness at Onset of Action (15 Minutes Post-dose) | 7 minutes post-CAC | 6.99 units on a scale | Standard Deviation 2.23 |
| AC-150B 0.005% | Total Redness at Onset of Action (15 Minutes Post-dose) | 20 minutes post-CAC | 7.60 units on a scale | Standard Deviation 2.631 |
| Vehicle | Total Redness at Onset of Action (15 Minutes Post-dose) | 7 minutes post-CAC | 7.37 units on a scale | Standard Deviation 2.123 |
| Vehicle | Total Redness at Onset of Action (15 Minutes Post-dose) | 20 minutes post-CAC | 7.88 units on a scale | Standard Deviation 2.171 |
| Vehicle | Total Redness at Onset of Action (15 Minutes Post-dose) | 15 minutes post-CAC | 7.87 units on a scale | Standard Deviation 2.208 |