Trial Outcomes & Findings for A Single-Center,Evaluation of the Onset and Duration of Action of AC-170 0.24% Compared to Vehicle (NCT NCT01685242)
NCT ID: NCT01685242
Last Updated: 2017-10-10
Results Overview
A treatment efficacy CAC was performed 8 hours + 30 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.
COMPLETED
PHASE3
100 participants
3, 5, 7 minutes post-CAC
2017-10-10
Participant Flow
Subjects were recruited from one site in the US.
There were 100 subjects enrolled, 4 subjects discontinued, and 96 subjects completed the study. Participant flow and baseline characteristics are presented for the 100 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%.
Participant milestones
| Measure |
AC-170 0.24%
AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period
|
AC-170 0%
AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
50
|
|
Overall Study
COMPLETED
|
49
|
47
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Single-Center,Evaluation of the Onset and Duration of Action of AC-170 0.24% Compared to Vehicle
Baseline characteristics by cohort
| Measure |
AC-170 0.24%
n=50 Participants
AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period
|
AC-170 0%
n=50 Participants
AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
39.5 years
STANDARD_DEVIATION 17.32 • n=5 Participants
|
38.1 years
STANDARD_DEVIATION 14.56 • n=7 Participants
|
38.8 years
STANDARD_DEVIATION 15.93 • n=5 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
39 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
85 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
44 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
90 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
50 participants
n=5 Participants
|
50 participants
n=7 Participants
|
100 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3, 5, 7 minutes post-CACPopulation: Intent to Treat (ITT)
A treatment efficacy CAC was performed 8 hours + 30 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.
Outcome measures
| Measure |
AC-170 0.24%
n=50 Participants
AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period
|
AC-170 0%
n=50 Participants
AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
|
|---|---|---|
|
Ocular Itching at Duration of Action (8 Hours + 30 Minutes Post-dose)
3 minutes post-CAC
|
1.76 units on a scale
Standard Deviation 0.940
|
2.69 units on a scale
Standard Deviation 0.663
|
|
Ocular Itching at Duration of Action (8 Hours + 30 Minutes Post-dose)
5 minutes post-CAC
|
1.85 units on a scale
Standard Deviation 0.938
|
2.74 units on a scale
Standard Deviation 0.824
|
|
Ocular Itching at Duration of Action (8 Hours + 30 Minutes Post-dose)
7 minutes post-CAC
|
1.54 units on a scale
Standard Deviation 0.971
|
2.53 units on a scale
Standard Deviation 1.058
|
PRIMARY outcome
Timeframe: 3, 5, 7 minutes post-CACPopulation: Intent to Treat (ITT)
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.
Outcome measures
| Measure |
AC-170 0.24%
n=50 Participants
AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period
|
AC-170 0%
n=50 Participants
AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
|
|---|---|---|
|
Ocular Itching at Onset of Action (15 Minutes Post-dose)
3 minutes post-CAC
|
1.00 units on a scale
Standard Deviation 0.911
|
2.38 units on a scale
Standard Deviation 0.722
|
|
Ocular Itching at Onset of Action (15 Minutes Post-dose)
5 minutes post-CAC
|
1.18 units on a scale
Standard Deviation 0.931
|
2.43 units on a scale
Standard Deviation 0.687
|
|
Ocular Itching at Onset of Action (15 Minutes Post-dose)
7 minutes post-CAC
|
1.11 units on a scale
Standard Deviation 0.863
|
2.11 units on a scale
Standard Deviation 0.872
|
PRIMARY outcome
Timeframe: 7, 15, 20 minutes post-CACPopulation: Intent to Treat (ITT)
A treatment efficacy CAC was performed 8 hours + 30 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.
Outcome measures
| Measure |
AC-170 0.24%
n=50 Participants
AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period
|
AC-170 0%
n=50 Participants
AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
|
|---|---|---|
|
Conjunctival Redness at Duration of Action (8 Hours + 30 Minutes Post-dose)
7 minutes post-CAC
|
1.97 units on a scale
Standard Deviation 0.664
|
2.27 units on a scale
Standard Deviation 0.492
|
|
Conjunctival Redness at Duration of Action (8 Hours + 30 Minutes Post-dose)
15 minutes post-CAC
|
2.30 units on a scale
Standard Deviation 0.635
|
2.34 units on a scale
Standard Deviation 0.486
|
|
Conjunctival Redness at Duration of Action (8 Hours + 30 Minutes Post-dose)
20 minutes post-CAC
|
2.30 units on a scale
Standard Deviation 0.663
|
2.32 units on a scale
Standard Deviation 0.555
|
PRIMARY outcome
Timeframe: 7, 15, 20 minutes post-CACPopulation: Intent to Treat (ITT)
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.
Outcome measures
| Measure |
AC-170 0.24%
n=50 Participants
AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period
|
AC-170 0%
n=50 Participants
AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
|
|---|---|---|
|
Conjunctival Redness at Onset of Action (15 Minutes Post-dose)
20 minutes post-CAC
|
1.95 units on a scale
Standard Deviation 0.484
|
2.09 units on a scale
Standard Deviation 0.458
|
|
Conjunctival Redness at Onset of Action (15 Minutes Post-dose)
7 minutes post-CAC
|
1.66 units on a scale
Standard Deviation 0.429
|
1.98 units on a scale
Standard Deviation 0.434
|
|
Conjunctival Redness at Onset of Action (15 Minutes Post-dose)
15 minutes post-CAC
|
1.93 units on a scale
Standard Deviation 0.388
|
2.09 units on a scale
Standard Deviation 0.434
|
SECONDARY outcome
Timeframe: 7, 15, 20 minutes post-CACPopulation: Intent to Treat (ITT)
A treatment efficacy CAC was performed 8 hours + 30 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.
Outcome measures
| Measure |
AC-170 0.24%
n=50 Participants
AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period
|
AC-170 0%
n=50 Participants
AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
|
|---|---|---|
|
Ciliary Redness at Duration of Action (8 Hours + 30 Minutes)
15 minutes post-CAC
|
2.18 units on a scale
Standard Deviation 0.686
|
2.33 units on a scale
Standard Deviation 0.501
|
|
Ciliary Redness at Duration of Action (8 Hours + 30 Minutes)
20 minutes post-CAC
|
2.21 units on a scale
Standard Deviation 0.680
|
2.30 units on a scale
Standard Deviation 0.531
|
|
Ciliary Redness at Duration of Action (8 Hours + 30 Minutes)
7 minutes post-CAC
|
1.84 units on a scale
Standard Deviation 0.647
|
2.19 units on a scale
Standard Deviation 0.533
|
SECONDARY outcome
Timeframe: 7, 15, 20 minutes post-CACPopulation: Intent to Treat (ITT)
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.
Outcome measures
| Measure |
AC-170 0.24%
n=50 Participants
AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period
|
AC-170 0%
n=50 Participants
AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
|
|---|---|---|
|
Ciliary Redness at Onset of Action (15 Minutes Post-dose)
15 minutes post-CAC
|
1.86 units on a scale
Standard Deviation 0.505
|
2.06 units on a scale
Standard Deviation 0.419
|
|
Ciliary Redness at Onset of Action (15 Minutes Post-dose)
20 minutes post-CAC
|
1.90 units on a scale
Standard Deviation 0.500
|
2.05 units on a scale
Standard Deviation 0.430
|
|
Ciliary Redness at Onset of Action (15 Minutes Post-dose)
7 minutes post-CAC
|
1.57 units on a scale
Standard Deviation 0.481
|
1.98 units on a scale
Standard Deviation 0.425
|
SECONDARY outcome
Timeframe: 7, 15, 20 minutes post-CACPopulation: Intent to Treat (ITT)
A treatment efficacy CAC was performed 8 hours + 30 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.
Outcome measures
| Measure |
AC-170 0.24%
n=50 Participants
AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period
|
AC-170 0%
n=50 Participants
AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
|
|---|---|---|
|
Episcleral Redness at Duration of Action (8 Hours + 30 Minutes Post-dose)
15 minutes post-CAC
|
2.28 units on a scale
Standard Deviation 0.596
|
2.35 units on a scale
Standard Deviation 0.434
|
|
Episcleral Redness at Duration of Action (8 Hours + 30 Minutes Post-dose)
20 minutes post-CAC
|
2.30 units on a scale
Standard Deviation 0.627
|
2.35 units on a scale
Standard Deviation 0.525
|
|
Episcleral Redness at Duration of Action (8 Hours + 30 Minutes Post-dose)
7 minutes post-CAC
|
1.97 units on a scale
Standard Deviation 0.645
|
2.31 units on a scale
Standard Deviation 0.453
|
SECONDARY outcome
Timeframe: 7, 15, 20 minutes post-CACPopulation: Intent to Treat (ITT)
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.
Outcome measures
| Measure |
AC-170 0.24%
n=50 Participants
AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period
|
AC-170 0%
n=50 Participants
AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
|
|---|---|---|
|
Episcleral Redness at Onset of Action (15 Minutes Post-dose)
7 minutes post-CAC
|
1.77 units on a scale
Standard Deviation 0.460
|
2.03 units on a scale
Standard Deviation 0.461
|
|
Episcleral Redness at Onset of Action (15 Minutes Post-dose)
15 minutes post-CAC
|
2.03 units on a scale
Standard Deviation 0.461
|
2.13 units on a scale
Standard Deviation 0.448
|
|
Episcleral Redness at Onset of Action (15 Minutes Post-dose)
20 minutes post-CAC
|
2.02 units on a scale
Standard Deviation 0.488
|
2.11 units on a scale
Standard Deviation 0.477
|
SECONDARY outcome
Timeframe: 7, 15, 20 minutes post-CACPopulation: Intent to Treat (ITT)
A treatment efficacy CAC was performed 8 hours + 30 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.
Outcome measures
| Measure |
AC-170 0.24%
n=50 Participants
AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period
|
AC-170 0%
n=50 Participants
AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
|
|---|---|---|
|
Chemosis at Duration of Action (8 Hours + 30 Minutes Post-dose)
7 minutes post-CAC
|
0.89 units on a scale
Standard Deviation 0.557
|
1.24 units on a scale
Standard Deviation 0.635
|
|
Chemosis at Duration of Action (8 Hours + 30 Minutes Post-dose)
15 minutes post-CAC
|
1.29 units on a scale
Standard Deviation 0.656
|
1.44 units on a scale
Standard Deviation 0.747
|
|
Chemosis at Duration of Action (8 Hours + 30 Minutes Post-dose)
20 minutes post-CAC
|
1.32 units on a scale
Standard Deviation 0.718
|
1.51 units on a scale
Standard Deviation 0.803
|
SECONDARY outcome
Timeframe: 7, 15, 20 minutes post-CACPopulation: Intent to Treat (ITT)
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.
Outcome measures
| Measure |
AC-170 0.24%
n=50 Participants
AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period
|
AC-170 0%
n=50 Participants
AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
|
|---|---|---|
|
Chemosis at Onset of Action (15 Minutes)
7 minutes post-CAC
|
0.63 units on a scale
Standard Deviation 0.379
|
1.03 units on a scale
Standard Deviation 0.398
|
|
Chemosis at Onset of Action (15 Minutes)
15 minutes post-CAC
|
0.99 units on a scale
Standard Deviation 0.403
|
1.28 units on a scale
Standard Deviation 0.611
|
|
Chemosis at Onset of Action (15 Minutes)
20 minutes post-CAC
|
1.14 units on a scale
Standard Deviation 0.525
|
1.43 units on a scale
Standard Deviation 0.705
|
SECONDARY outcome
Timeframe: 7, 15, 20 minutes post-CACPopulation: Intent to Treat (ITT)
A treatment efficacy CAC was performed 8 hours + 30 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.
Outcome measures
| Measure |
AC-170 0.24%
n=50 Participants
AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period
|
AC-170 0%
n=50 Participants
AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
|
|---|---|---|
|
Eyelid Swelling at Duration of Action (8 Hours + 30 Minutes Post-dose)
7 minutes post-CAC
|
0.6 units on a scale
Standard Deviation 0.68
|
1.1 units on a scale
Standard Deviation 0.79
|
|
Eyelid Swelling at Duration of Action (8 Hours + 30 Minutes Post-dose)
15 minutes post-CAC
|
0.8 units on a scale
Standard Deviation 0.86
|
1.2 units on a scale
Standard Deviation 0.87
|
|
Eyelid Swelling at Duration of Action (8 Hours + 30 Minutes Post-dose)
20 minutes post-CAC
|
0.8 units on a scale
Standard Deviation 0.80
|
1.1 units on a scale
Standard Deviation 0.86
|
SECONDARY outcome
Timeframe: 7, 15, 20 minutes post-CACPopulation: Intent to Treat (ITT)
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.
Outcome measures
| Measure |
AC-170 0.24%
n=50 Participants
AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period
|
AC-170 0%
n=50 Participants
AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
|
|---|---|---|
|
Eyelid Swelling at Onset of Action (15 Minutes Post-dose)
7 minutes post-CAC
|
0.6 units on a scale
Standard Deviation 0.67
|
1.0 units on a scale
Standard Deviation 0.72
|
|
Eyelid Swelling at Onset of Action (15 Minutes Post-dose)
15 minutes post-CAC
|
0.8 units on a scale
Standard Deviation 0.74
|
1.0 units on a scale
Standard Deviation 0.80
|
|
Eyelid Swelling at Onset of Action (15 Minutes Post-dose)
20 minutes post-CAC
|
0.8 units on a scale
Standard Deviation 0.77
|
1.0 units on a scale
Standard Deviation 0.89
|
SECONDARY outcome
Timeframe: 7, 15, 20 minutes post-CACPopulation: Intent to Treat (ITT)
A treatment efficacy CAC was performed 8 hours + 30 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.
Outcome measures
| Measure |
AC-170 0.24%
n=50 Participants
AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period
|
AC-170 0%
n=50 Participants
AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
|
|---|---|---|
|
Tearing at Duration of Action (8 Hours + 30 Minutes Post-dose)
20 minutes post-CAC
|
1.0 units on a scale
Standard Deviation 0.92
|
0.9 units on a scale
Standard Deviation 0.73
|
|
Tearing at Duration of Action (8 Hours + 30 Minutes Post-dose)
7 minutes post-CAC
|
0.8 units on a scale
Standard Deviation 0.72
|
1.0 units on a scale
Standard Deviation 0.87
|
|
Tearing at Duration of Action (8 Hours + 30 Minutes Post-dose)
15 minutes post-CAC
|
0.9 units on a scale
Standard Deviation 0.92
|
1.0 units on a scale
Standard Deviation 0.81
|
SECONDARY outcome
Timeframe: 7, 15, 20 minutes post-CACPopulation: Intent to Treat (ITT)
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.
Outcome measures
| Measure |
AC-170 0.24%
n=50 Participants
AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period
|
AC-170 0%
n=50 Participants
AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
|
|---|---|---|
|
Tearing at Onset of Action (15 Minutes Post-dose)
7 minutes post-CAC
|
0.6 units on a scale
Standard Deviation 0.67
|
1.0 units on a scale
Standard Deviation 0.68
|
|
Tearing at Onset of Action (15 Minutes Post-dose)
15 minutes post-CAC
|
0.8 units on a scale
Standard Deviation 0.85
|
0.9 units on a scale
Standard Deviation 0.68
|
|
Tearing at Onset of Action (15 Minutes Post-dose)
20 minutes post-CAC
|
0.7 units on a scale
Standard Deviation 0.84
|
0.8 units on a scale
Standard Deviation 0.67
|
SECONDARY outcome
Timeframe: 7, 15, 20 minutes post-CACPopulation: Intent to Treat (ITT)
A treatment efficacy CAC was performed 8 hours + 30 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.
Outcome measures
| Measure |
AC-170 0.24%
n=50 Participants
AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period
|
AC-170 0%
n=50 Participants
AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
|
|---|---|---|
|
Rhinorrhea at Duration of Action (8 Hours + 30 Minutes Post-dose)
7 minutes post-CAC
|
0.5 units on a scale
Standard Deviation 0.68
|
1.3 units on a scale
Standard Deviation 1.03
|
|
Rhinorrhea at Duration of Action (8 Hours + 30 Minutes Post-dose)
15 minutes post-CAC
|
0.8 units on a scale
Standard Deviation 0.98
|
1.6 units on a scale
Standard Deviation 0.95
|
|
Rhinorrhea at Duration of Action (8 Hours + 30 Minutes Post-dose)
20 minutes post-CAC
|
0.7 units on a scale
Standard Deviation 0.95
|
1.5 units on a scale
Standard Deviation 1.02
|
SECONDARY outcome
Timeframe: 7, 15, 20 minutes post-CACPopulation: Intent to Treat (ITT)
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.
Outcome measures
| Measure |
AC-170 0.24%
n=50 Participants
AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period
|
AC-170 0%
n=50 Participants
AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
|
|---|---|---|
|
Rhinorrhea at Onset of Action (15 Minutes Post-dose)
7 minutes post-CAC
|
0.5 units on a scale
Standard Deviation 0.77
|
1.1 units on a scale
Standard Deviation 0.86
|
|
Rhinorrhea at Onset of Action (15 Minutes Post-dose)
15 minutes post-CAC
|
0.9 units on a scale
Standard Deviation 0.94
|
1.3 units on a scale
Standard Deviation 0.99
|
|
Rhinorrhea at Onset of Action (15 Minutes Post-dose)
20 minutes post-CAC
|
0.8 units on a scale
Standard Deviation 1.01
|
1.2 units on a scale
Standard Deviation 0.87
|
SECONDARY outcome
Timeframe: 7, 15, 20 minutes post-CACPopulation: Intent to Treat (ITT)
A treatment efficacy CAC was performed 8 hours + 30 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.
Outcome measures
| Measure |
AC-170 0.24%
n=50 Participants
AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period
|
AC-170 0%
n=50 Participants
AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
|
|---|---|---|
|
Nasal Pruritus at Duration of Action (8 Hours + 30 Minutes Post-dose)
7 minutes post-CAC
|
0.3 units on a scale
Standard Deviation 0.58
|
0.8 units on a scale
Standard Deviation 0.87
|
|
Nasal Pruritus at Duration of Action (8 Hours + 30 Minutes Post-dose)
15 minutes post-CAC
|
0.5 units on a scale
Standard Deviation 0.82
|
1.0 units on a scale
Standard Deviation 1.00
|
|
Nasal Pruritus at Duration of Action (8 Hours + 30 Minutes Post-dose)
20 minutes post-CAC
|
0.5 units on a scale
Standard Deviation 0.79
|
0.9 units on a scale
Standard Deviation 0.93
|
SECONDARY outcome
Timeframe: 7, 15, 20 minutes post-CACPopulation: Intent to Treat (ITT)
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.
Outcome measures
| Measure |
AC-170 0.24%
n=50 Participants
AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period
|
AC-170 0%
n=50 Participants
AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
|
|---|---|---|
|
Nasal Pruritus at Onset of Action (15 Minutes Post-dose)
7 minutes post-CAC
|
0.4 units on a scale
Standard Deviation 0.76
|
0.6 units on a scale
Standard Deviation 0.79
|
|
Nasal Pruritus at Onset of Action (15 Minutes Post-dose)
15 minutes post-CAC
|
0.6 units on a scale
Standard Deviation 0.97
|
0.8 units on a scale
Standard Deviation 0.91
|
|
Nasal Pruritus at Onset of Action (15 Minutes Post-dose)
20 minutes post-CAC
|
0.6 units on a scale
Standard Deviation 0.79
|
0.7 units on a scale
Standard Deviation 0.77
|
SECONDARY outcome
Timeframe: 7, 15, 20 minutes post-CACPopulation: Intent to Treat (ITT)
A treatment efficacy CAC was performed 8 hours + 30 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.
Outcome measures
| Measure |
AC-170 0.24%
n=50 Participants
AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period
|
AC-170 0%
n=50 Participants
AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
|
|---|---|---|
|
Ear or Palate Pruritus at Duration of Action (8 Hours + 30 Minutes Post-dose)
7 minutes post-CAC
|
0.5 units on a scale
Standard Deviation 0.82
|
0.8 units on a scale
Standard Deviation 1.09
|
|
Ear or Palate Pruritus at Duration of Action (8 Hours + 30 Minutes Post-dose)
15 minutes post-CAC
|
0.9 units on a scale
Standard Deviation 1.11
|
1.3 units on a scale
Standard Deviation 1.16
|
|
Ear or Palate Pruritus at Duration of Action (8 Hours + 30 Minutes Post-dose)
20 minutes post-CAC
|
1.0 units on a scale
Standard Deviation 1.09
|
1.3 units on a scale
Standard Deviation 1.25
|
SECONDARY outcome
Timeframe: 7, 15, 20 minutes post-CACPopulation: Intent to Treat (ITT)
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.
Outcome measures
| Measure |
AC-170 0.24%
n=50 Participants
AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period
|
AC-170 0%
n=50 Participants
AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
|
|---|---|---|
|
Ear or Palate Pruritus at Onset of Action (15 Minutes Post-dose)
20 minutes post-CAC
|
0.9 units on a scale
Standard Deviation 1.10
|
1.1 units on a scale
Standard Deviation 1.13
|
|
Ear or Palate Pruritus at Onset of Action (15 Minutes Post-dose)
7 minutes post-CAC
|
0.3 units on a scale
Standard Deviation 0.77
|
0.8 units on a scale
Standard Deviation 1.04
|
|
Ear or Palate Pruritus at Onset of Action (15 Minutes Post-dose)
15 minutes post-CAC
|
0.7 units on a scale
Standard Deviation 0.98
|
1.1 units on a scale
Standard Deviation 1.14
|
SECONDARY outcome
Timeframe: 7, 15, 20 minutes post-CACPopulation: Intent to Treat (ITT)
A treatment efficacy CAC was performed 8 hours + 30 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.
Outcome measures
| Measure |
AC-170 0.24%
n=50 Participants
AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period
|
AC-170 0%
n=50 Participants
AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
|
|---|---|---|
|
Nasal Congestion at Duration of Action (8 Hours + 30 Minutes Post-dose)
7 minutes post-CAC
|
0.7 units on a scale
Standard Deviation 0.85
|
1.2 units on a scale
Standard Deviation 1.02
|
|
Nasal Congestion at Duration of Action (8 Hours + 30 Minutes Post-dose)
15 minutes post-CAC
|
0.9 units on a scale
Standard Deviation 1.03
|
1.6 units on a scale
Standard Deviation 0.99
|
|
Nasal Congestion at Duration of Action (8 Hours + 30 Minutes Post-dose)
20 minutes post-CAC
|
1.0 units on a scale
Standard Deviation 1.06
|
1.5 units on a scale
Standard Deviation 1.03
|
SECONDARY outcome
Timeframe: 7, 15, 20 minutes post-CACPopulation: Intent to Treat (ITT)
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.
Outcome measures
| Measure |
AC-170 0.24%
n=50 Participants
AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period
|
AC-170 0%
n=50 Participants
AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
|
|---|---|---|
|
Nasal Congestion at Onset of Action (15 Minutes Post-dose)
7 minutes post-CAC
|
0.8 units on a scale
Standard Deviation 1.03
|
1.1 units on a scale
Standard Deviation 0.86
|
|
Nasal Congestion at Onset of Action (15 Minutes Post-dose)
15 minutes post-CAC
|
1.1 units on a scale
Standard Deviation 1.16
|
1.3 units on a scale
Standard Deviation 0.90
|
|
Nasal Congestion at Onset of Action (15 Minutes Post-dose)
20 minutes post-CAC
|
1.1 units on a scale
Standard Deviation 1.09
|
1.4 units on a scale
Standard Deviation 0.99
|
SECONDARY outcome
Timeframe: 7, 15, 20 minutes post-CACPopulation: Intent to Treat (ITT)
A treatment efficacy CAC was performed 8 hours + 30 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.
Outcome measures
| Measure |
AC-170 0.24%
n=49 Participants
AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period
|
AC-170 0%
n=50 Participants
AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
|
|---|---|---|
|
Nasal Composite Score at Duration of Action (8 Hours + 30 Minutes Post-dose)
15 minutes post-CAC
|
81.6 %participants with at least 1 nasal symp
|
94 %participants with at least 1 nasal symp
|
|
Nasal Composite Score at Duration of Action (8 Hours + 30 Minutes Post-dose)
7 minutes post-CAC
|
61.2 %participants with at least 1 nasal symp
|
82 %participants with at least 1 nasal symp
|
|
Nasal Composite Score at Duration of Action (8 Hours + 30 Minutes Post-dose)
20 minutes post-CAC
|
83.7 %participants with at least 1 nasal symp
|
94 %participants with at least 1 nasal symp
|
SECONDARY outcome
Timeframe: 7, 15, 20 minutes post-CACPopulation: Intent to Treat (ITT)
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.
Outcome measures
| Measure |
AC-170 0.24%
n=49 Participants
AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period
|
AC-170 0%
n=47 Participants
AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
|
|---|---|---|
|
Nasal Composite Score at Onset of Action (15 Minutes Post-dose)
7 minutes post-CAC
|
65.3 %participants with at least 1 nasal symp
|
83 %participants with at least 1 nasal symp
|
|
Nasal Composite Score at Onset of Action (15 Minutes Post-dose)
15 minutes post-CAC
|
81.6 %participants with at least 1 nasal symp
|
91.5 %participants with at least 1 nasal symp
|
|
Nasal Composite Score at Onset of Action (15 Minutes Post-dose)
20 minutes post-CAC
|
77.6 %participants with at least 1 nasal symp
|
93.6 %participants with at least 1 nasal symp
|
SECONDARY outcome
Timeframe: upon instillation, 1 minute and 2 minutes post instillationPopulation: Intent to Treat (ITT)
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.
Outcome measures
| Measure |
AC-170 0.24%
n=50 Participants
AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period
|
AC-170 0%
n=50 Participants
AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
|
|---|---|---|
|
Tolerability of Study Medication at Visit 3A
Upon instillation
|
1.2 units on a scale
Standard Deviation 1.42
|
1.0 units on a scale
Standard Deviation 1.49
|
|
Tolerability of Study Medication at Visit 3A
1 minute post-instillation
|
1.4 units on a scale
Standard Deviation 1.44
|
1.2 units on a scale
Standard Deviation 1.60
|
|
Tolerability of Study Medication at Visit 3A
2 minutes post-instillation
|
1.3 units on a scale
Standard Deviation 1.44
|
1.0 units on a scale
Standard Deviation 1.50
|
Adverse Events
AC-170 0.24%
AC-170 0%
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
AC-170 0.24%
n=50 participants at risk
AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period
|
AC-170 0%
n=50 participants at risk
AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
|
|---|---|---|
|
Eye disorders
Visual Acuity Reduced
|
0.00%
0/50 • Adverse events were collected through study completion, 6 or 12 weeks depending on the subject subpopulation. All subjects who received study medication were evaluable for the safety analysis.
Throughout the visits, staff collected all Adverse Events reported, elicited or observed.
|
4.0%
2/50 • Number of events 2 • Adverse events were collected through study completion, 6 or 12 weeks depending on the subject subpopulation. All subjects who received study medication were evaluable for the safety analysis.
Throughout the visits, staff collected all Adverse Events reported, elicited or observed.
|
|
Eye disorders
Eye Pain
|
2.0%
1/50 • Number of events 1 • Adverse events were collected through study completion, 6 or 12 weeks depending on the subject subpopulation. All subjects who received study medication were evaluable for the safety analysis.
Throughout the visits, staff collected all Adverse Events reported, elicited or observed.
|
0.00%
0/50 • Adverse events were collected through study completion, 6 or 12 weeks depending on the subject subpopulation. All subjects who received study medication were evaluable for the safety analysis.
Throughout the visits, staff collected all Adverse Events reported, elicited or observed.
|
|
Eye disorders
Punctate Keratitis
|
0.00%
0/50 • Adverse events were collected through study completion, 6 or 12 weeks depending on the subject subpopulation. All subjects who received study medication were evaluable for the safety analysis.
Throughout the visits, staff collected all Adverse Events reported, elicited or observed.
|
2.0%
1/50 • Number of events 1 • Adverse events were collected through study completion, 6 or 12 weeks depending on the subject subpopulation. All subjects who received study medication were evaluable for the safety analysis.
Throughout the visits, staff collected all Adverse Events reported, elicited or observed.
|
|
Infections and infestations
Lower Respiratory Tract Infection
|
0.00%
0/50 • Adverse events were collected through study completion, 6 or 12 weeks depending on the subject subpopulation. All subjects who received study medication were evaluable for the safety analysis.
Throughout the visits, staff collected all Adverse Events reported, elicited or observed.
|
2.0%
1/50 • Number of events 1 • Adverse events were collected through study completion, 6 or 12 weeks depending on the subject subpopulation. All subjects who received study medication were evaluable for the safety analysis.
Throughout the visits, staff collected all Adverse Events reported, elicited or observed.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/50 • Adverse events were collected through study completion, 6 or 12 weeks depending on the subject subpopulation. All subjects who received study medication were evaluable for the safety analysis.
Throughout the visits, staff collected all Adverse Events reported, elicited or observed.
|
2.0%
1/50 • Number of events 1 • Adverse events were collected through study completion, 6 or 12 weeks depending on the subject subpopulation. All subjects who received study medication were evaluable for the safety analysis.
Throughout the visits, staff collected all Adverse Events reported, elicited or observed.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.0%
1/50 • Number of events 1 • Adverse events were collected through study completion, 6 or 12 weeks depending on the subject subpopulation. All subjects who received study medication were evaluable for the safety analysis.
Throughout the visits, staff collected all Adverse Events reported, elicited or observed.
|
0.00%
0/50 • Adverse events were collected through study completion, 6 or 12 weeks depending on the subject subpopulation. All subjects who received study medication were evaluable for the safety analysis.
Throughout the visits, staff collected all Adverse Events reported, elicited or observed.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal Oedema
|
2.0%
1/50 • Number of events 1 • Adverse events were collected through study completion, 6 or 12 weeks depending on the subject subpopulation. All subjects who received study medication were evaluable for the safety analysis.
Throughout the visits, staff collected all Adverse Events reported, elicited or observed.
|
0.00%
0/50 • Adverse events were collected through study completion, 6 or 12 weeks depending on the subject subpopulation. All subjects who received study medication were evaluable for the safety analysis.
Throughout the visits, staff collected all Adverse Events reported, elicited or observed.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.0%
1/50 • Number of events 1 • Adverse events were collected through study completion, 6 or 12 weeks depending on the subject subpopulation. All subjects who received study medication were evaluable for the safety analysis.
Throughout the visits, staff collected all Adverse Events reported, elicited or observed.
|
0.00%
0/50 • Adverse events were collected through study completion, 6 or 12 weeks depending on the subject subpopulation. All subjects who received study medication were evaluable for the safety analysis.
Throughout the visits, staff collected all Adverse Events reported, elicited or observed.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid Arthritis
|
2.0%
1/50 • Number of events 1 • Adverse events were collected through study completion, 6 or 12 weeks depending on the subject subpopulation. All subjects who received study medication were evaluable for the safety analysis.
Throughout the visits, staff collected all Adverse Events reported, elicited or observed.
|
0.00%
0/50 • Adverse events were collected through study completion, 6 or 12 weeks depending on the subject subpopulation. All subjects who received study medication were evaluable for the safety analysis.
Throughout the visits, staff collected all Adverse Events reported, elicited or observed.
|
Additional Information
Michael V.W. Bergamini, PhD - Chief Scientific Officer/Executive Vice President
Nicox Ophthalmics Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place