Trial Outcomes & Findings for Efficacy of AC-170 for the Treatment of Allergic Conjunctivitis in the Conjunctival Allergen Challenge (CAC) Model (NCT NCT01332188)
NCT ID: NCT01332188
Last Updated: 2017-08-30
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
101 participants
Primary outcome timeframe
3, 5, 7 minutes post-CAC
Results posted on
2017-08-30
Participant Flow
Subjects were recruited from one site in the US.
101 subjects were enrolled, 7 subjects discontinued, and 94 subjects completed the study. The 101 subjects that met all inclusion criteria and none of the exclusion criteria were randomized to receive AC-170 0.05%, AC-170 0.1%, AC-170 0.24% or AC-170 0%. Note: All solutions were "early formulations" and not the final to-be-marketed formulation.
Participant milestones
| Measure |
AC-170 0.05%
AC-170 0.05%: 1 drop in each eye at 3 separate times during a 21 day period
|
AC-170 0.1%
AC-170 0.1%: 1 drop in each eye at 3 separate times during a 21 day period
|
AC-170 0.24%
AC-170 0.24%: 1 drop in each eye at 3 separate times during a 21 day period
|
AC-170 0%
AC-170 0%: 1 drop in each eye at 3 separate times during a 21 day period
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
25
|
26
|
25
|
25
|
|
Overall Study
COMPLETED
|
23
|
25
|
21
|
25
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
4
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy of AC-170 for the Treatment of Allergic Conjunctivitis in the Conjunctival Allergen Challenge (CAC) Model
Baseline characteristics by cohort
| Measure |
AC-170 0.05%
n=25 Participants
AC-170 0.05%: 1 drop in each eye at 3 separate times during a 21 day period
|
AC-170 0.1%
n=26 Participants
AC-170 0.1%: 1 drop in each eye at 3 separate times during a 21 day period
|
AC-170 0.24%
n=25 Participants
AC-170 0.24%: 1 drop in each eye at 3 separate times during a 21 day period
|
AC-170 0%
n=25 Participants
AC-170 0%: 1 drop in each eye at 3 separate times during a 21 day period
|
Total
n=101 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
45.5 years
STANDARD_DEVIATION 13.58 • n=5 Participants
|
43.1 years
STANDARD_DEVIATION 13.5 • n=7 Participants
|
38.9 years
STANDARD_DEVIATION 12.53 • n=5 Participants
|
38.1 years
STANDARD_DEVIATION 14.12 • n=4 Participants
|
41.4 years
STANDARD_DEVIATION 13.59 • n=21 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
56 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
45 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
22 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
85 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
24 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
96 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=5 Participants
|
26 participants
n=7 Participants
|
25 participants
n=5 Participants
|
25 participants
n=4 Participants
|
101 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 3, 5, 7 minutes post-CACPopulation: Intent to Treat (ITT)
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.
Outcome measures
| Measure |
AC-170 0.05%
n=25 Participants
AC-170 0.05%: 1 drop in each eye at 3 separate times during a 21 day period
|
AC-170 0.1%
n=25 Participants
AC-170 0.1%: 1 drop in each eye at 3 separate times during a 21 day period
|
AC-170 0.24%
n=25 Participants
AC-170 0.24%: 1 drop in each eye at 3 separate times during a 21 day period
|
AC-170 0%
n=25 Participants
AC-170 0%: 1 drop in each eye at 3 separate times during a 21 day period
|
|---|---|---|---|---|
|
Ocular Itching at Duration of Action (16 Hours Post-dose)
3 minutes post-CAC
|
1.91 units on a scale
Standard Deviation 0.924
|
2.00 units on a scale
Standard Deviation 0.771
|
1.65 units on a scale
Standard Deviation 0.963
|
2.48 units on a scale
Standard Deviation 0.540
|
|
Ocular Itching at Duration of Action (16 Hours Post-dose)
5 minutes post-CAC
|
2.01 units on a scale
Standard Deviation 1.019
|
2.04 units on a scale
Standard Deviation 0.889
|
1.74 units on a scale
Standard Deviation 0.843
|
2.55 units on a scale
Standard Deviation 0.550
|
|
Ocular Itching at Duration of Action (16 Hours Post-dose)
7 minutes post-CAC
|
1.86 units on a scale
Standard Deviation 0.907
|
1.87 units on a scale
Standard Deviation 0.913
|
1.75 units on a scale
Standard Deviation 0.910
|
2.27 units on a scale
Standard Deviation 0.777
|
PRIMARY outcome
Timeframe: 3, 5, 7 minutes post-CACPopulation: Intent to Treat (ITT)
A treatment efficacy CAC was performed 24 hours after drop instillation. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed.
Outcome measures
| Measure |
AC-170 0.05%
n=25 Participants
AC-170 0.05%: 1 drop in each eye at 3 separate times during a 21 day period
|
AC-170 0.1%
n=26 Participants
AC-170 0.1%: 1 drop in each eye at 3 separate times during a 21 day period
|
AC-170 0.24%
n=25 Participants
AC-170 0.24%: 1 drop in each eye at 3 separate times during a 21 day period
|
AC-170 0%
n=25 Participants
AC-170 0%: 1 drop in each eye at 3 separate times during a 21 day period
|
|---|---|---|---|---|
|
Ocular Itching at Duration of Action (24 Hours Post-dose)
3 minutes post-CAC
|
1.99 units on a scale
Standard Deviation 0.849
|
1.78 units on a scale
Standard Deviation 0.873
|
1.90 units on a scale
Standard Deviation 0.804
|
2.24 units on a scale
Standard Deviation 0.575
|
|
Ocular Itching at Duration of Action (24 Hours Post-dose)
5 minutes post-CAC
|
2.00 units on a scale
Standard Deviation 0.711
|
1.92 units on a scale
Standard Deviation 0.883
|
2.17 units on a scale
Standard Deviation 0.819
|
2.24 units on a scale
Standard Deviation 0.686
|
|
Ocular Itching at Duration of Action (24 Hours Post-dose)
7 minutes post-CAC
|
1.77 units on a scale
Standard Deviation 0.774
|
1.78 units on a scale
Standard Deviation 0.988
|
1.97 units on a scale
Standard Deviation 0.833
|
2.08 units on a scale
Standard Deviation 0.702
|
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 0.05%
n=25 Participants
AC-170 0.05%: 1 drop in each eye at 3 separate times during a 21 day period
|
AC-170 0.1%
n=26 Participants
AC-170 0.1%: 1 drop in each eye at 3 separate times during a 21 day period
|
AC-170 0.24%
n=25 Participants
AC-170 0.24%: 1 drop in each eye at 3 separate times during a 21 day period
|
AC-170 0%
n=25 Participants
AC-170 0%: 1 drop in each eye at 3 separate times during a 21 day period
|
|---|---|---|---|---|
|
Ocular Itching at Onset of Action (15 Minutes Post-dose)
3 minutes post-CAC
|
1.05 units on a scale
Standard Deviation 0.804
|
0.84 units on a scale
Standard Deviation 0.800
|
0.91 units on a scale
Standard Deviation 0.810
|
1.94 units on a scale
Standard Deviation 0.870
|
|
Ocular Itching at Onset of Action (15 Minutes Post-dose)
5 minutes post-CAC
|
1.19 units on a scale
Standard Deviation 0.778
|
1.09 units on a scale
Standard Deviation 0.941
|
1.07 units on a scale
Standard Deviation 0.840
|
2.09 units on a scale
Standard Deviation 0.850
|
|
Ocular Itching at Onset of Action (15 Minutes Post-dose)
7 minutes post-CAC
|
1.01 units on a scale
Standard Deviation 0.789
|
1.07 units on a scale
Standard Deviation 0.929
|
0.97 units on a scale
Standard Deviation 0.843
|
1.94 units on a scale
Standard Deviation 0.893
|
PRIMARY outcome
Timeframe: 7, 15, 20 minutes post-CACPopulation: Intent to Treat (ITT)
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.
Outcome measures
| Measure |
AC-170 0.05%
n=25 Participants
AC-170 0.05%: 1 drop in each eye at 3 separate times during a 21 day period
|
AC-170 0.1%
n=25 Participants
AC-170 0.1%: 1 drop in each eye at 3 separate times during a 21 day period
|
AC-170 0.24%
n=25 Participants
AC-170 0.24%: 1 drop in each eye at 3 separate times during a 21 day period
|
AC-170 0%
n=25 Participants
AC-170 0%: 1 drop in each eye at 3 separate times during a 21 day period
|
|---|---|---|---|---|
|
Conjunctival Redness at Duration of Action (16 Hours Post-dose)
7 minutes post-CAC
|
1.62 units on a scale
Standard Deviation 0.634
|
1.59 units on a scale
Standard Deviation 0.624
|
1.45 units on a scale
Standard Deviation 0.489
|
1.79 units on a scale
Standard Deviation 0.359
|
|
Conjunctival Redness at Duration of Action (16 Hours Post-dose)
15 minutes post-CAC
|
1.68 units on a scale
Standard Deviation 0.606
|
1.65 units on a scale
Standard Deviation 0.711
|
1.61 units on a scale
Standard Deviation 0.545
|
1.91 units on a scale
Standard Deviation 0.426
|
|
Conjunctival Redness at Duration of Action (16 Hours Post-dose)
20 minutes post-CAC
|
1.63 units on a scale
Standard Deviation 0.696
|
1.58 units on a scale
Standard Deviation 0.721
|
1.56 units on a scale
Standard Deviation 0.634
|
1.88 units on a scale
Standard Deviation 0.403
|
PRIMARY outcome
Timeframe: 7, 15, 20 minutes post-CACPopulation: Intent to Treat (ITT)
A treatment efficacy CAC was performed 24 hours after drop instillation. Conjunctival Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of conjunctival redness score over both eyes was analyzed.
Outcome measures
| Measure |
AC-170 0.05%
n=25 Participants
AC-170 0.05%: 1 drop in each eye at 3 separate times during a 21 day period
|
AC-170 0.1%
n=26 Participants
AC-170 0.1%: 1 drop in each eye at 3 separate times during a 21 day period
|
AC-170 0.24%
n=25 Participants
AC-170 0.24%: 1 drop in each eye at 3 separate times during a 21 day period
|
AC-170 0%
n=25 Participants
AC-170 0%: 1 drop in each eye at 3 separate times during a 21 day period
|
|---|---|---|---|---|
|
Conjunctival Redness at Duration of Action (24 Hours Post-dose)
7 minutes post-CAC
|
1.43 units on a scale
Standard Deviation 0.635
|
1.38 units on a scale
Standard Deviation 0.668
|
1.71 units on a scale
Standard Deviation 0.628
|
1.70 units on a scale
Standard Deviation 0.505
|
|
Conjunctival Redness at Duration of Action (24 Hours Post-dose)
15 minutes post-CAC
|
1.63 units on a scale
Standard Deviation 0.617
|
1.59 units on a scale
Standard Deviation 0.663
|
1.85 units on a scale
Standard Deviation 0.608
|
1.90 units on a scale
Standard Deviation 0.489
|
|
Conjunctival Redness at Duration of Action (24 Hours Post-dose)
20 minutes post-CAC
|
1.61 units on a scale
Standard Deviation 0.617
|
1.54 units on a scale
Standard Deviation 0.677
|
1.79 units on a scale
Standard Deviation 0.713
|
1.76 units on a scale
Standard Deviation 0.575
|
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 0.05%
n=25 Participants
AC-170 0.05%: 1 drop in each eye at 3 separate times during a 21 day period
|
AC-170 0.1%
n=26 Participants
AC-170 0.1%: 1 drop in each eye at 3 separate times during a 21 day period
|
AC-170 0.24%
n=25 Participants
AC-170 0.24%: 1 drop in each eye at 3 separate times during a 21 day period
|
AC-170 0%
n=25 Participants
AC-170 0%: 1 drop in each eye at 3 separate times during a 21 day period
|
|---|---|---|---|---|
|
Conjunctival Redness at Onset of Action (15 Minutes Post-dose)
7 minutes post-CAC
|
1.44 units on a scale
Standard Deviation 0.663
|
1.45 units on a scale
Standard Deviation 0.812
|
1.66 units on a scale
Standard Deviation 0.718
|
1.88 units on a scale
Standard Deviation 0.541
|
|
Conjunctival Redness at Onset of Action (15 Minutes Post-dose)
15 minutes post-CAC
|
1.81 units on a scale
Standard Deviation 0.670
|
1.67 units on a scale
Standard Deviation 0.821
|
1.83 units on a scale
Standard Deviation 0.680
|
1.96 units on a scale
Standard Deviation 0.589
|
|
Conjunctival Redness at Onset of Action (15 Minutes Post-dose)
20 minutes post-CAC
|
1.83 units on a scale
Standard Deviation 0.648
|
1.67 units on a scale
Standard Deviation 0.868
|
1.79 units on a scale
Standard Deviation 0.717
|
1.97 units on a scale
Standard Deviation 0.622
|
SECONDARY outcome
Timeframe: 7, 15, 20 minutes post-CACPopulation: Intent to Treat (ITT)
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.
Outcome measures
| Measure |
AC-170 0.05%
n=25 Participants
AC-170 0.05%: 1 drop in each eye at 3 separate times during a 21 day period
|
AC-170 0.1%
n=25 Participants
AC-170 0.1%: 1 drop in each eye at 3 separate times during a 21 day period
|
AC-170 0.24%
n=25 Participants
AC-170 0.24%: 1 drop in each eye at 3 separate times during a 21 day period
|
AC-170 0%
n=25 Participants
AC-170 0%: 1 drop in each eye at 3 separate times during a 21 day period
|
|---|---|---|---|---|
|
Ciliary Redness at Duration of Action (16 Hours Post-dose)
7 minutes post-CAC
|
1.47 units on a scale
Standard Deviation 0.708
|
1.53 units on a scale
Standard Deviation 0.758
|
1.34 units on a scale
Standard Deviation 0.684
|
1.81 units on a scale
Standard Deviation 0.527
|
|
Ciliary Redness at Duration of Action (16 Hours Post-dose)
15 minutes post-CAC
|
1.60 units on a scale
Standard Deviation 0.707
|
1.65 units on a scale
Standard Deviation 0.842
|
1.52 units on a scale
Standard Deviation 0.732
|
1.99 units on a scale
Standard Deviation 0.523
|
|
Ciliary Redness at Duration of Action (16 Hours Post-dose)
20 minutes post-CAC
|
1.60 units on a scale
Standard Deviation 0.703
|
1.65 units on a scale
Standard Deviation 0.878
|
1.53 units on a scale
Standard Deviation 0.788
|
1.95 units on a scale
Standard Deviation 0.573
|
SECONDARY outcome
Timeframe: 7, 15, 20 minutes post-CACPopulation: Intent to Treat (ITT)
A treatment efficacy CAC was performed 24 hours after drop instillation. Ciliary Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ciliary redness score over both eyes was analyzed.
Outcome measures
| Measure |
AC-170 0.05%
n=25 Participants
AC-170 0.05%: 1 drop in each eye at 3 separate times during a 21 day period
|
AC-170 0.1%
n=26 Participants
AC-170 0.1%: 1 drop in each eye at 3 separate times during a 21 day period
|
AC-170 0.24%
n=25 Participants
AC-170 0.24%: 1 drop in each eye at 3 separate times during a 21 day period
|
AC-170 0%
n=25 Participants
AC-170 0%: 1 drop in each eye at 3 separate times during a 21 day period
|
|---|---|---|---|---|
|
Ciliary Redness at Duration of Action (24 Hours Post-dose)
7 minutes post-CAC
|
1.36 units on a scale
Standard Deviation 0.730
|
1.22 units on a scale
Standard Deviation 0.686
|
1.50 units on a scale
Standard Deviation 0.633
|
1.55 units on a scale
Standard Deviation 0.582
|
|
Ciliary Redness at Duration of Action (24 Hours Post-dose)
15 minutes post-CAC
|
1.49 units on a scale
Standard Deviation 0.596
|
1.47 units on a scale
Standard Deviation 0.723
|
1.74 units on a scale
Standard Deviation 0.716
|
1.77 units on a scale
Standard Deviation 0.544
|
|
Ciliary Redness at Duration of Action (24 Hours Post-dose)
20 minutes post-CAC
|
1.50 units on a scale
Standard Deviation 0.617
|
1.47 units on a scale
Standard Deviation 0.701
|
1.65 units on a scale
Standard Deviation 0.736
|
1.65 units on a scale
Standard Deviation 0.599
|
SECONDARY outcome
Timeframe: 7, 15, 20 minutes post-CACPopulation: Intent to Treat (ITT). Number of analyzed subjects differ due to subject discontinuation during the study.
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 0.05%
n=23 Participants
AC-170 0.05%: 1 drop in each eye at 3 separate times during a 21 day period
|
AC-170 0.1%
n=25 Participants
AC-170 0.1%: 1 drop in each eye at 3 separate times during a 21 day period
|
AC-170 0.24%
n=21 Participants
AC-170 0.24%: 1 drop in each eye at 3 separate times during a 21 day period
|
AC-170 0%
n=24 Participants
AC-170 0%: 1 drop in each eye at 3 separate times during a 21 day period
|
|---|---|---|---|---|
|
Ciliary Redness at Onset of Action (15 Minutes Post-dose)
7 minutes post-CAC
|
1.24 units on a scale
Standard Deviation 0.689
|
1.24 units on a scale
Standard Deviation 0.867
|
1.27 units on a scale
Standard Deviation 0.858
|
1.67 units on a scale
Standard Deviation 0.628
|
|
Ciliary Redness at Onset of Action (15 Minutes Post-dose)
15 minutes post-CAC
|
1.59 units on a scale
Standard Deviation 0.749
|
1.51 units on a scale
Standard Deviation 0.861
|
1.64 units on a scale
Standard Deviation 0.669
|
1.77 units on a scale
Standard Deviation 0.661
|
|
Ciliary Redness at Onset of Action (15 Minutes Post-dose)
20 minutes post-CAC
|
1.65 units on a scale
Standard Deviation 0.647
|
1.52 units on a scale
Standard Deviation 0.952
|
1.73 units on a scale
Standard Deviation 0.622
|
1.79 units on a scale
Standard Deviation 0.644
|
SECONDARY outcome
Timeframe: 7, 15, 20 minutes post-CACPopulation: Intent to Treat (ITT)
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.
Outcome measures
| Measure |
AC-170 0.05%
n=25 Participants
AC-170 0.05%: 1 drop in each eye at 3 separate times during a 21 day period
|
AC-170 0.1%
n=25 Participants
AC-170 0.1%: 1 drop in each eye at 3 separate times during a 21 day period
|
AC-170 0.24%
n=25 Participants
AC-170 0.24%: 1 drop in each eye at 3 separate times during a 21 day period
|
AC-170 0%
n=25 Participants
AC-170 0%: 1 drop in each eye at 3 separate times during a 21 day period
|
|---|---|---|---|---|
|
Episcleral Redness at Duration of Action (16 Hours Post-dose)
7 minutes post-CAC
|
1.68 units on a scale
Standard Deviation 0.602
|
1.74 units on a scale
Standard Deviation 0.690
|
1.57 units on a scale
Standard Deviation 0.497
|
1.90 units on a scale
Standard Deviation 0.439
|
|
Episcleral Redness at Duration of Action (16 Hours Post-dose)
15 minutes post-CAC
|
1.81 units on a scale
Standard Deviation 0.639
|
1.77 units on a scale
Standard Deviation 0.757
|
1.69 units on a scale
Standard Deviation 0.605
|
2.02 units on a scale
Standard Deviation 0.484
|
|
Episcleral Redness at Duration of Action (16 Hours Post-dose)
20 minutes post-CAC
|
1.80 units on a scale
Standard Deviation 0.629
|
1.73 units on a scale
Standard Deviation 0.797
|
1.69 units on a scale
Standard Deviation 0.647
|
1.97 units on a scale
Standard Deviation 0.458
|
SECONDARY outcome
Timeframe: 7, 15, 20 minutes post-CACPopulation: Intent to Treat (ITT)
A treatment efficacy CAC was performed 24 hours after drop instillation. Episcleral Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of episcleral redness score over both eyes was analyzed.
Outcome measures
| Measure |
AC-170 0.05%
n=23 Participants
AC-170 0.05%: 1 drop in each eye at 3 separate times during a 21 day period
|
AC-170 0.1%
n=25 Participants
AC-170 0.1%: 1 drop in each eye at 3 separate times during a 21 day period
|
AC-170 0.24%
n=25 Participants
AC-170 0.24%: 1 drop in each eye at 3 separate times during a 21 day period
|
AC-170 0%
n=25 Participants
AC-170 0%: 1 drop in each eye at 3 separate times during a 21 day period
|
|---|---|---|---|---|
|
Episcleral Redness at Duration of Action (24 Hours Post-dose)
7 minutes post-CAC
|
1.53 units on a scale
Standard Deviation 0.590
|
1.37 units on a scale
Standard Deviation 0.681
|
1.73 units on a scale
Standard Deviation 0.616
|
1.80 units on a scale
Standard Deviation 0.505
|
|
Episcleral Redness at Duration of Action (24 Hours Post-dose)
15 minutes post-CAC
|
1.72 units on a scale
Standard Deviation 0.585
|
1.63 units on a scale
Standard Deviation 0.700
|
1.90 units on a scale
Standard Deviation 0.657
|
2.00 units on a scale
Standard Deviation 0.505
|
|
Episcleral Redness at Duration of Action (24 Hours Post-dose)
20 minutes post-CAC
|
1.70 units on a scale
Standard Deviation 0.579
|
1.60 units on a scale
Standard Deviation 0.688
|
1.87 units on a scale
Standard Deviation 0.696
|
1.85 units on a scale
Standard Deviation 0.530
|
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 0.05%
n=23 Participants
AC-170 0.05%: 1 drop in each eye at 3 separate times during a 21 day period
|
AC-170 0.1%
n=25 Participants
AC-170 0.1%: 1 drop in each eye at 3 separate times during a 21 day period
|
AC-170 0.24%
n=21 Participants
AC-170 0.24%: 1 drop in each eye at 3 separate times during a 21 day period
|
AC-170 0%
n=25 Participants
AC-170 0%: 1 drop in each eye at 3 separate times during a 21 day period
|
|---|---|---|---|---|
|
Episcleral Redness at Onset of Action (15 Minutes Post-dose)
7 minutes post-CAC
|
1.52 units on a scale
Standard Deviation 0.644
|
1.49 units on a scale
Standard Deviation 0.782
|
1.64 units on a scale
Standard Deviation 0.744
|
1.93 units on a scale
Standard Deviation 0.508
|
|
Episcleral Redness at Onset of Action (15 Minutes Post-dose)
15 minutes post-CAC
|
1.86 units on a scale
Standard Deviation 0.652
|
1.73 units on a scale
Standard Deviation 0.803
|
1.98 units on a scale
Standard Deviation 0.698
|
2.01 units on a scale
Standard Deviation 0.575
|
|
Episcleral Redness at Onset of Action (15 Minutes Post-dose)
20 minutes post-CAC
|
1.91 units on a scale
Standard Deviation 0.577
|
1.72 units on a scale
Standard Deviation 0.861
|
1.88 units on a scale
Standard Deviation 0.644
|
2.04 units on a scale
Standard Deviation 0.598
|
SECONDARY outcome
Timeframe: 7, 15, 20 minutes post-CACPopulation: Intent to Treat (ITT)
A treatment efficacy CAC was performed 16 hours after drop instillation. Chemosis was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of chemosis score over both eyes was analyzed.
Outcome measures
| Measure |
AC-170 0.05%
n=25 Participants
AC-170 0.05%: 1 drop in each eye at 3 separate times during a 21 day period
|
AC-170 0.1%
n=25 Participants
AC-170 0.1%: 1 drop in each eye at 3 separate times during a 21 day period
|
AC-170 0.24%
n=25 Participants
AC-170 0.24%: 1 drop in each eye at 3 separate times during a 21 day period
|
AC-170 0%
n=25 Participants
AC-170 0%: 1 drop in each eye at 3 separate times during a 21 day period
|
|---|---|---|---|---|
|
Chemosis at Duration of Action (16 Hours Post-dose)
20 minutes post-CAC
|
0.92 units on a scale
Standard Deviation 0.644
|
0.72 units on a scale
Standard Deviation 0.583
|
0.71 units on a scale
Standard Deviation 0.460
|
1.00 units on a scale
Standard Deviation 0.650
|
|
Chemosis at Duration of Action (16 Hours Post-dose)
7 minutes post-CAC
|
0.71 units on a scale
Standard Deviation 0.553
|
0.58 units on a scale
Standard Deviation 0.406
|
0.53 units on a scale
Standard Deviation 0.292
|
0.72 units on a scale
Standard Deviation 0.532
|
|
Chemosis at Duration of Action (16 Hours Post-dose)
15 minutes post-CAC
|
0.93 units on a scale
Standard Deviation 0.557
|
0.70 units on a scale
Standard Deviation 0.545
|
0.60 units on a scale
Standard Deviation 0.354
|
0.99 units on a scale
Standard Deviation 0.575
|
SECONDARY outcome
Timeframe: 7, 15, 20 minutes post-CACPopulation: Intent to Treat (ITT)
A treatment efficacy CAC was performed 24 hours after drop instillation. Chemosis was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of chemosis score over both eyes was analyzed.
Outcome measures
| Measure |
AC-170 0.05%
n=23 Participants
AC-170 0.05%: 1 drop in each eye at 3 separate times during a 21 day period
|
AC-170 0.1%
n=25 Participants
AC-170 0.1%: 1 drop in each eye at 3 separate times during a 21 day period
|
AC-170 0.24%
n=25 Participants
AC-170 0.24%: 1 drop in each eye at 3 separate times during a 21 day period
|
AC-170 0%
n=25 Participants
AC-170 0%: 1 drop in each eye at 3 separate times during a 21 day period
|
|---|---|---|---|---|
|
Chemosis at Duration of Action (24 Hours Post-dose)
7 minutes post-CAC
|
0.68 units on a scale
Standard Deviation 0.478
|
0.52 units on a scale
Standard Deviation 0.279
|
0.55 units on a scale
Standard Deviation 0.298
|
0.68 units on a scale
Standard Deviation 0.399
|
|
Chemosis at Duration of Action (24 Hours Post-dose)
15 minutes post-CAC
|
0.87 units on a scale
Standard Deviation 0.612
|
0.64 units on a scale
Standard Deviation 0.396
|
0.77 units on a scale
Standard Deviation 0.433
|
0.81 units on a scale
Standard Deviation 0.532
|
|
Chemosis at Duration of Action (24 Hours Post-dose)
20 minutes post-CAC
|
0.90 units on a scale
Standard Deviation 0.647
|
0.71 units on a scale
Standard Deviation 0.419
|
0.84 units on a scale
Standard Deviation 0.572
|
0.90 units on a scale
Standard Deviation 0.568
|
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 0.05%
n=25 Participants
AC-170 0.05%: 1 drop in each eye at 3 separate times during a 21 day period
|
AC-170 0.1%
n=26 Participants
AC-170 0.1%: 1 drop in each eye at 3 separate times during a 21 day period
|
AC-170 0.24%
n=25 Participants
AC-170 0.24%: 1 drop in each eye at 3 separate times during a 21 day period
|
AC-170 0%
n=25 Participants
AC-170 0%: 1 drop in each eye at 3 separate times during a 21 day period
|
|---|---|---|---|---|
|
Chemosis at Onset of Action (15 Minutes Post-dose)
7 minutes post-CAC
|
0.49 units on a scale
Standard Deviation 0.232
|
0.43 units on a scale
Standard Deviation 0.293
|
0.54 units on a scale
Standard Deviation 0.277
|
0.74 units on a scale
Standard Deviation 0.427
|
|
Chemosis at Onset of Action (15 Minutes Post-dose)
15 minutes post-CAC
|
0.74 units on a scale
Standard Deviation 0.423
|
0.52 units on a scale
Standard Deviation 0.314
|
0.79 units on a scale
Standard Deviation 0.456
|
0.80 units on a scale
Standard Deviation 0.554
|
|
Chemosis at Onset of Action (15 Minutes Post-dose)
20 minutes post-CAC
|
0.71 units on a scale
Standard Deviation 0.403
|
0.53 units on a scale
Standard Deviation 0.363
|
0.76 units on a scale
Standard Deviation 0.399
|
0.88 units on a scale
Standard Deviation 0.555
|
SECONDARY outcome
Timeframe: 7, 15, 20 minutes post-CACPopulation: Intent to Treat (ITT)
A treatment efficacy CAC was performed 16 hours after drop instillation. Eyelid swelling was assessed by the patient on a 0-3 scale (0=none to 3=severe). Average of eyelid swelling score over both eyes was analyzed.
Outcome measures
| Measure |
AC-170 0.05%
n=25 Participants
AC-170 0.05%: 1 drop in each eye at 3 separate times during a 21 day period
|
AC-170 0.1%
n=25 Participants
AC-170 0.1%: 1 drop in each eye at 3 separate times during a 21 day period
|
AC-170 0.24%
n=25 Participants
AC-170 0.24%: 1 drop in each eye at 3 separate times during a 21 day period
|
AC-170 0%
n=25 Participants
AC-170 0%: 1 drop in each eye at 3 separate times during a 21 day period
|
|---|---|---|---|---|
|
Eyelid Swelling at Duration of Action (16 Hours Post-dose)
7 minutes post-CAC
|
0.6 units on a scale
Standard Deviation 0.75
|
0.8 units on a scale
Standard Deviation 0.66
|
0.8 units on a scale
Standard Deviation 0.66
|
0.9 units on a scale
Standard Deviation 0.71
|
|
Eyelid Swelling at Duration of Action (16 Hours Post-dose)
15 minutes post-CAC
|
0.7 units on a scale
Standard Deviation 0.79
|
0.9 units on a scale
Standard Deviation 0.75
|
0.8 units on a scale
Standard Deviation 0.54
|
1.1 units on a scale
Standard Deviation 0.86
|
|
Eyelid Swelling at Duration of Action (16 Hours Post-dose)
20 minutes post-CAC
|
0.6 units on a scale
Standard Deviation 0.76
|
0.8 units on a scale
Standard Deviation 0.73
|
0.7 units on a scale
Standard Deviation 0.56
|
1.0 units on a scale
Standard Deviation 0.85
|
SECONDARY outcome
Timeframe: 7, 15, 20 minutes post-CACPopulation: Intent to Treat (ITT)
A treatment efficacy CAC was performed 24 hours after drop instillation. Eyelid swelling was assessed by the patient on a 0-3 scale (0=none to 3=severe). Average of eyelid swelling score over both eyes was analyzed.
Outcome measures
| Measure |
AC-170 0.05%
n=23 Participants
AC-170 0.05%: 1 drop in each eye at 3 separate times during a 21 day period
|
AC-170 0.1%
n=25 Participants
AC-170 0.1%: 1 drop in each eye at 3 separate times during a 21 day period
|
AC-170 0.24%
n=25 Participants
AC-170 0.24%: 1 drop in each eye at 3 separate times during a 21 day period
|
AC-170 0%
n=25 Participants
AC-170 0%: 1 drop in each eye at 3 separate times during a 21 day period
|
|---|---|---|---|---|
|
Eyelid Swelling at Duration of Action (24 Hours Post-dose)
7 minutes post-CAC
|
0.7 units on a scale
Standard Deviation 0.60
|
0.7 units on a scale
Standard Deviation 0.54
|
0.9 units on a scale
Standard Deviation 0.68
|
0.7 units on a scale
Standard Deviation 0.74
|
|
Eyelid Swelling at Duration of Action (24 Hours Post-dose)
15 minutes post-CAC
|
0.8 units on a scale
Standard Deviation 0.70
|
0.8 units on a scale
Standard Deviation 0.73
|
0.9 units on a scale
Standard Deviation 0.82
|
0.9 units on a scale
Standard Deviation 0.82
|
|
Eyelid Swelling at Duration of Action (24 Hours Post-dose)
20 minutes post-CAC
|
0.8 units on a scale
Standard Deviation 0.69
|
0.8 units on a scale
Standard Deviation 0.76
|
0.9 units on a scale
Standard Deviation 0.72
|
0.9 units on a scale
Standard Deviation 0.85
|
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 0.05%
n=23 Participants
AC-170 0.05%: 1 drop in each eye at 3 separate times during a 21 day period
|
AC-170 0.1%
n=25 Participants
AC-170 0.1%: 1 drop in each eye at 3 separate times during a 21 day period
|
AC-170 0.24%
n=21 Participants
AC-170 0.24%: 1 drop in each eye at 3 separate times during a 21 day period
|
AC-170 0%
n=25 Participants
AC-170 0%: 1 drop in each eye at 3 separate times during a 21 day period
|
|---|---|---|---|---|
|
Eyelid Swelling at Onset of Action (15 Minutes Post-dose)
7 minutes post-CAC
|
0.4 units on a scale
Standard Deviation 0.56
|
0.5 units on a scale
Standard Deviation 0.70
|
0.5 units on a scale
Standard Deviation 0.49
|
0.7 units on a scale
Standard Deviation 0.81
|
|
Eyelid Swelling at Onset of Action (15 Minutes Post-dose)
15 minutes post-CAC
|
0.5 units on a scale
Standard Deviation 0.68
|
0.6 units on a scale
Standard Deviation 0.65
|
0.6 units on a scale
Standard Deviation 0.65
|
0.8 units on a scale
Standard Deviation 0.89
|
|
Eyelid Swelling at Onset of Action (15 Minutes Post-dose)
20 minutes post-CAC
|
0.5 units on a scale
Standard Deviation 0.71
|
0.6 units on a scale
Standard Deviation 0.58
|
0.5 units on a scale
Standard Deviation 0.49
|
0.7 units on a scale
Standard Deviation 0.84
|
SECONDARY outcome
Timeframe: 7, 15, 20 minutes post-CACPopulation: Intent to Treat (ITT)
A treatment efficacy CAC was performed 16 hours after drop instillation. Tearing was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of tearing score over both eyes was analyzed.
Outcome measures
| Measure |
AC-170 0.05%
n=25 Participants
AC-170 0.05%: 1 drop in each eye at 3 separate times during a 21 day period
|
AC-170 0.1%
n=25 Participants
AC-170 0.1%: 1 drop in each eye at 3 separate times during a 21 day period
|
AC-170 0.24%
n=25 Participants
AC-170 0.24%: 1 drop in each eye at 3 separate times during a 21 day period
|
AC-170 0%
n=25 Participants
AC-170 0%: 1 drop in each eye at 3 separate times during a 21 day period
|
|---|---|---|---|---|
|
Tearing at Duration of Action (16 Hours Post-dose)
7 minutes post-CAC
|
1.0 units on a scale
Standard Deviation 1.07
|
0.8 units on a scale
Standard Deviation 0.72
|
0.6 units on a scale
Standard Deviation 0.51
|
0.6 units on a scale
Standard Deviation 0.67
|
|
Tearing at Duration of Action (16 Hours Post-dose)
15 minutes post-CAC
|
0.8 units on a scale
Standard Deviation 0.89
|
0.5 units on a scale
Standard Deviation 0.64
|
0.7 units on a scale
Standard Deviation 0.65
|
0.9 units on a scale
Standard Deviation 0.82
|
|
Tearing at Duration of Action (16 Hours Post-dose)
20 minutes post-CAC
|
0.7 units on a scale
Standard Deviation 0.85
|
0.4 units on a scale
Standard Deviation 0.63
|
0.7 units on a scale
Standard Deviation 0.62
|
0.9 units on a scale
Standard Deviation 0.97
|
SECONDARY outcome
Timeframe: 7, 15, 20 minutes post-CACPopulation: Intent to Treat (ITT)
A treatment efficacy CAC was performed 24 hours after drop instillation. Tearing was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of tearing score over both eyes was analyzed.
Outcome measures
| Measure |
AC-170 0.05%
n=23 Participants
AC-170 0.05%: 1 drop in each eye at 3 separate times during a 21 day period
|
AC-170 0.1%
n=25 Participants
AC-170 0.1%: 1 drop in each eye at 3 separate times during a 21 day period
|
AC-170 0.24%
n=25 Participants
AC-170 0.24%: 1 drop in each eye at 3 separate times during a 21 day period
|
AC-170 0%
n=25 Participants
AC-170 0%: 1 drop in each eye at 3 separate times during a 21 day period
|
|---|---|---|---|---|
|
Tearing at Duration of Action (24 Hours Post-dose)
7 minutes post-CAC
|
1.0 units on a scale
Standard Deviation 0.78
|
0.7 units on a scale
Standard Deviation 0.61
|
0.6 units on a scale
Standard Deviation 0.75
|
0.8 units on a scale
Standard Deviation 0.71
|
|
Tearing at Duration of Action (24 Hours Post-dose)
15 minutes post-CAC
|
1.1 units on a scale
Standard Deviation 0.79
|
0.6 units on a scale
Standard Deviation 0.54
|
0.7 units on a scale
Standard Deviation 0.66
|
0.8 units on a scale
Standard Deviation 0.82
|
|
Tearing at Duration of Action (24 Hours Post-dose)
20 minutes post-CAC
|
1.0 units on a scale
Standard Deviation 0.77
|
0.5 units on a scale
Standard Deviation 0.53
|
0.7 units on a scale
Standard Deviation 0.72
|
0.7 units on a scale
Standard Deviation 0.84
|
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 0.05%
n=23 Participants
AC-170 0.05%: 1 drop in each eye at 3 separate times during a 21 day period
|
AC-170 0.1%
n=25 Participants
AC-170 0.1%: 1 drop in each eye at 3 separate times during a 21 day period
|
AC-170 0.24%
n=21 Participants
AC-170 0.24%: 1 drop in each eye at 3 separate times during a 21 day period
|
AC-170 0%
n=25 Participants
AC-170 0%: 1 drop in each eye at 3 separate times during a 21 day period
|
|---|---|---|---|---|
|
Tearing at Onset of Action (15 Minutes Post-dose)
7 minutes post-CAC
|
0.7 units on a scale
Standard Deviation 0.74
|
0.5 units on a scale
Standard Deviation 0.49
|
0.3 units on a scale
Standard Deviation 0.56
|
0.6 units on a scale
Standard Deviation 0.64
|
|
Tearing at Onset of Action (15 Minutes Post-dose)
15 minutes post-CAC
|
0.5 units on a scale
Standard Deviation 0.66
|
0.5 units on a scale
Standard Deviation 0.50
|
0.4 units on a scale
Standard Deviation 0.50
|
0.6 units on a scale
Standard Deviation 0.64
|
|
Tearing at Onset of Action (15 Minutes Post-dose)
20 minutes post-CAC
|
0.5 units on a scale
Standard Deviation 0.60
|
0.4 units on a scale
Standard Deviation 0.47
|
0.2 units on a scale
Standard Deviation 0.33
|
0.6 units on a scale
Standard Deviation 0.90
|
SECONDARY outcome
Timeframe: 7, 15, 20 minutes post-CACPopulation: Intent to Treat (ITT)
A treatment efficacy CAC was performed 16 hours after drop instillation. Rhinorrhea was assessed by the patient on a 0-4 scale (0=none to 4=severe). Rhinorrhea score for each time point was analyzed.
Outcome measures
| Measure |
AC-170 0.05%
n=25 Participants
AC-170 0.05%: 1 drop in each eye at 3 separate times during a 21 day period
|
AC-170 0.1%
n=25 Participants
AC-170 0.1%: 1 drop in each eye at 3 separate times during a 21 day period
|
AC-170 0.24%
n=25 Participants
AC-170 0.24%: 1 drop in each eye at 3 separate times during a 21 day period
|
AC-170 0%
n=25 Participants
AC-170 0%: 1 drop in each eye at 3 separate times during a 21 day period
|
|---|---|---|---|---|
|
Rhinorrhea at Duration of Action (16 Hours Post-dose)
7 minutes post-CAC
|
1.1 units on a scale
Standard Deviation 1.26
|
0.4 units on a scale
Standard Deviation 0.49
|
0.7 units on a scale
Standard Deviation 0.99
|
0.7 units on a scale
Standard Deviation 0.80
|
|
Rhinorrhea at Duration of Action (16 Hours Post-dose)
15 minutes post-CAC
|
1.2 units on a scale
Standard Deviation 1.01
|
0.6 units on a scale
Standard Deviation 0.77
|
1.1 units on a scale
Standard Deviation 1.04
|
1.0 units on a scale
Standard Deviation 1.12
|
|
Rhinorrhea at Duration of Action (16 Hours Post-dose)
20 minutes post-CAC
|
1.3 units on a scale
Standard Deviation 1.14
|
0.7 units on a scale
Standard Deviation 0.80
|
1.1 units on a scale
Standard Deviation 1.05
|
1.1 units on a scale
Standard Deviation 1.24
|
SECONDARY outcome
Timeframe: 7, 15, 20 minutes post-CACPopulation: Intent to Treat (ITT)
A treatment efficacy CAC was performed 24 hours after drop instillation. Rhinorrhea was assessed by the patient on a 0-4 scale (0=none to 4=severe). Rhinorrhea score for each time point was analyzed.
Outcome measures
| Measure |
AC-170 0.05%
n=23 Participants
AC-170 0.05%: 1 drop in each eye at 3 separate times during a 21 day period
|
AC-170 0.1%
n=25 Participants
AC-170 0.1%: 1 drop in each eye at 3 separate times during a 21 day period
|
AC-170 0.24%
n=25 Participants
AC-170 0.24%: 1 drop in each eye at 3 separate times during a 21 day period
|
AC-170 0%
n=25 Participants
AC-170 0%: 1 drop in each eye at 3 separate times during a 21 day period
|
|---|---|---|---|---|
|
Rhinorrhea at Duration of Action (24 Hours Post-dose)
7 minutes post-CAC
|
1.1 units on a scale
Standard Deviation 1.28
|
0.6 units on a scale
Standard Deviation 0.65
|
0.8 units on a scale
Standard Deviation 0.90
|
0.7 units on a scale
Standard Deviation 0.69
|
|
Rhinorrhea at Duration of Action (24 Hours Post-dose)
15 minutes post-CAC
|
1.1 units on a scale
Standard Deviation 1.29
|
0.7 units on a scale
Standard Deviation 0.69
|
1.2 units on a scale
Standard Deviation 0.91
|
1.0 units on a scale
Standard Deviation 0.84
|
|
Rhinorrhea at Duration of Action (24 Hours Post-dose)
20 minutes post-CAC
|
1.2 units on a scale
Standard Deviation 1.28
|
0.6 units on a scale
Standard Deviation 0.70
|
1.0 units on a scale
Standard Deviation 0.71
|
0.8 units on a scale
Standard Deviation 0.90
|
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 0.05%
n=23 Participants
AC-170 0.05%: 1 drop in each eye at 3 separate times during a 21 day period
|
AC-170 0.1%
n=25 Participants
AC-170 0.1%: 1 drop in each eye at 3 separate times during a 21 day period
|
AC-170 0.24%
n=21 Participants
AC-170 0.24%: 1 drop in each eye at 3 separate times during a 21 day period
|
AC-170 0%
n=25 Participants
AC-170 0%: 1 drop in each eye at 3 separate times during a 21 day period
|
|---|---|---|---|---|
|
Rhinorrhea at Onset of Action (15 Minutes Post-dose)
7 minutes post-CAC
|
0.6 units on a scale
Standard Deviation 1.20
|
0.2 units on a scale
Standard Deviation 0.41
|
0.3 units on a scale
Standard Deviation 0.58
|
0.6 units on a scale
Standard Deviation 0.82
|
|
Rhinorrhea at Onset of Action (15 Minutes Post-dose)
15 minutes post-CAC
|
0.9 units on a scale
Standard Deviation 1.25
|
0.4 units on a scale
Standard Deviation 0.65
|
0.5 units on a scale
Standard Deviation 0.75
|
0.8 units on a scale
Standard Deviation 0.87
|
|
Rhinorrhea at Onset of Action (15 Minutes Post-dose)
20 minutes post-CAC
|
0.8 units on a scale
Standard Deviation 1.23
|
0.4 units on a scale
Standard Deviation 0.71
|
0.5 units on a scale
Standard Deviation 0.68
|
0.6 units on a scale
Standard Deviation 0.70
|
SECONDARY outcome
Timeframe: 7, 15, 20 minutes post-CACPopulation: Intent to Treat (ITT)
A treatment efficacy CAC was performed 16 hours after drop instillation. Nasal Pruritus was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Pruritus score for each time point was analyzed.
Outcome measures
| Measure |
AC-170 0.05%
n=25 Participants
AC-170 0.05%: 1 drop in each eye at 3 separate times during a 21 day period
|
AC-170 0.1%
n=25 Participants
AC-170 0.1%: 1 drop in each eye at 3 separate times during a 21 day period
|
AC-170 0.24%
n=25 Participants
AC-170 0.24%: 1 drop in each eye at 3 separate times during a 21 day period
|
AC-170 0%
n=25 Participants
AC-170 0%: 1 drop in each eye at 3 separate times during a 21 day period
|
|---|---|---|---|---|
|
Nasal Pruritus at Duration of Action (16 Hours Post-dose)
7 minutes post-CAC
|
0.6 units on a scale
Standard Deviation 0.91
|
0.2 units on a scale
Standard Deviation 0.37
|
0.5 units on a scale
Standard Deviation 0.65
|
0.4 units on a scale
Standard Deviation 0.71
|
|
Nasal Pruritus at Duration of Action (16 Hours Post-dose)
15 minutes post-CAC
|
0.6 units on a scale
Standard Deviation 0.91
|
0.4 units on a scale
Standard Deviation 0.65
|
0.7 units on a scale
Standard Deviation 0.80
|
0.8 units on a scale
Standard Deviation 1.01
|
|
Nasal Pruritus at Duration of Action (16 Hours Post-dose)
20 minutes post-CAC
|
0.7 units on a scale
Standard Deviation 0.99
|
0.6 units on a scale
Standard Deviation 0.91
|
0.6 units on a scale
Standard Deviation 0.65
|
0.8 units on a scale
Standard Deviation 1.13
|
SECONDARY outcome
Timeframe: 7, 15, 20 minutes post-CACPopulation: Intent to Treat (ITT)
A treatment efficacy CAC was performed 24 hours after drop instillation. Nasal Pruritus was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Pruritus score for each time point was analyzed.
Outcome measures
| Measure |
AC-170 0.05%
n=23 Participants
AC-170 0.05%: 1 drop in each eye at 3 separate times during a 21 day period
|
AC-170 0.1%
n=25 Participants
AC-170 0.1%: 1 drop in each eye at 3 separate times during a 21 day period
|
AC-170 0.24%
n=25 Participants
AC-170 0.24%: 1 drop in each eye at 3 separate times during a 21 day period
|
AC-170 0%
n=25 Participants
AC-170 0%: 1 drop in each eye at 3 separate times during a 21 day period
|
|---|---|---|---|---|
|
Nasal Pruritus at Duration of Action (24 Hours Post-dose)
7 minutes post-CAC
|
0.7 units on a scale
Standard Deviation 0.93
|
0.4 units on a scale
Standard Deviation 0.64
|
0.4 units on a scale
Standard Deviation 0.58
|
0.4 units on a scale
Standard Deviation 0.82
|
|
Nasal Pruritus at Duration of Action (24 Hours Post-dose)
15 minutes post-CAC
|
0.7 units on a scale
Standard Deviation 1.03
|
0.4 units on a scale
Standard Deviation 0.58
|
0.8 units on a scale
Standard Deviation 0.93
|
0.6 units on a scale
Standard Deviation 0.99
|
|
Nasal Pruritus at Duration of Action (24 Hours Post-dose)
20 minutes post-CAC
|
0.5 units on a scale
Standard Deviation 0.90
|
0.5 units on a scale
Standard Deviation 0.65
|
0.6 units on a scale
Standard Deviation 0.82
|
0.7 units on a scale
Standard Deviation 0.85
|
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 0.05%
n=23 Participants
AC-170 0.05%: 1 drop in each eye at 3 separate times during a 21 day period
|
AC-170 0.1%
n=25 Participants
AC-170 0.1%: 1 drop in each eye at 3 separate times during a 21 day period
|
AC-170 0.24%
n=21 Participants
AC-170 0.24%: 1 drop in each eye at 3 separate times during a 21 day period
|
AC-170 0%
n=25 Participants
AC-170 0%: 1 drop in each eye at 3 separate times during a 21 day period
|
|---|---|---|---|---|
|
Nasal Pruritus at Onset of Action (15 Minutes Post-dose)
7 minutes post-CAC
|
0.4 units on a scale
Standard Deviation 0.99
|
0.2 units on a scale
Standard Deviation 0.37
|
0.3 units on a scale
Standard Deviation 0.56
|
0.4 units on a scale
Standard Deviation 0.65
|
|
Nasal Pruritus at Onset of Action (15 Minutes Post-dose)
15 minutes post-CAC
|
0.4 units on a scale
Standard Deviation 0.84
|
0.3 units on a scale
Standard Deviation 0.56
|
0.2 units on a scale
Standard Deviation 0.44
|
0.4 units on a scale
Standard Deviation 0.58
|
|
Nasal Pruritus at Onset of Action (15 Minutes Post-dose)
20 minutes post-CAC
|
0.4 units on a scale
Standard Deviation 0.95
|
0.4 units on a scale
Standard Deviation 0.64
|
0.3 units on a scale
Standard Deviation 0.66
|
0.4 units on a scale
Standard Deviation 0.65
|
SECONDARY outcome
Timeframe: 7, 15, 20 minutes post-CACPopulation: Intent to Treat (ITT)
A treatment efficacy CAC was performed 16 hours after drop instillation. Ear or Palate Pruritus was assessed by the patient on a single 0-4 scale (0=none to 4=severe). Ear or Palate Pruritus score for each time point was analyzed.
Outcome measures
| Measure |
AC-170 0.05%
n=25 Participants
AC-170 0.05%: 1 drop in each eye at 3 separate times during a 21 day period
|
AC-170 0.1%
n=25 Participants
AC-170 0.1%: 1 drop in each eye at 3 separate times during a 21 day period
|
AC-170 0.24%
n=25 Participants
AC-170 0.24%: 1 drop in each eye at 3 separate times during a 21 day period
|
AC-170 0%
n=25 Participants
AC-170 0%: 1 drop in each eye at 3 separate times during a 21 day period
|
|---|---|---|---|---|
|
Ear or Palate Pruritus at Duration of Action (16 Hours Post-dose)
20 minutes post-CAC
|
0.8 units on a scale
Standard Deviation 1.11
|
0.9 units on a scale
Standard Deviation 0.91
|
0.8 units on a scale
Standard Deviation 0.93
|
1.2 units on a scale
Standard Deviation 1.31
|
|
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
|
0.4 units on a scale
Standard Deviation 0.57
|
0.3 units on a scale
Standard Deviation 0.74
|
0.5 units on a scale
Standard Deviation 0.87
|
|
Ear or Palate Pruritus at Duration of Action (16 Hours Post-dose)
15 minutes post-CAC
|
0.9 units on a scale
Standard Deviation 1.09
|
0.8 units on a scale
Standard Deviation 0.90
|
0.5 units on a scale
Standard Deviation 0.77
|
1.0 units on a scale
Standard Deviation 1.10
|
SECONDARY outcome
Timeframe: 7, 15, 20 minutes post-CACPopulation: Intent to Treat (ITT)
A treatment efficacy CAC was performed 24 hours after drop instillation. Ear or Palate Pruritus was assessed by the patient on a single 0-4 scale (0=none to 4=severe). Ear or Palate Pruritus score for each time point was analyzed.
Outcome measures
| Measure |
AC-170 0.05%
n=23 Participants
AC-170 0.05%: 1 drop in each eye at 3 separate times during a 21 day period
|
AC-170 0.1%
n=25 Participants
AC-170 0.1%: 1 drop in each eye at 3 separate times during a 21 day period
|
AC-170 0.24%
n=25 Participants
AC-170 0.24%: 1 drop in each eye at 3 separate times during a 21 day period
|
AC-170 0%
n=25 Participants
AC-170 0%: 1 drop in each eye at 3 separate times during a 21 day period
|
|---|---|---|---|---|
|
Ear or Palate Pruritus at Duration of Action (24 Hours Post-dose)
7 minutes post-CAC
|
0.6 units on a scale
Standard Deviation 0.89
|
0.3 units on a scale
Standard Deviation 0.46
|
0.4 units on a scale
Standard Deviation 0.76
|
0.5 units on a scale
Standard Deviation 0.96
|
|
Ear or Palate Pruritus at Duration of Action (24 Hours Post-dose)
15 minutes post-CAC
|
0.7 units on a scale
Standard Deviation 0.96
|
0.6 units on a scale
Standard Deviation 0.65
|
0.7 units on a scale
Standard Deviation 0.98
|
0.8 units on a scale
Standard Deviation 1.19
|
|
Ear or Palate Pruritus at Duration of Action (24 Hours Post-dose)
20 minutes post-CAC
|
0.8 units on a scale
Standard Deviation 1.11
|
0.7 units on a scale
Standard Deviation 0.74
|
0.7 units on a scale
Standard Deviation 0.90
|
0.7 units on a scale
Standard Deviation 1.07
|
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 0.05%
n=23 Participants
AC-170 0.05%: 1 drop in each eye at 3 separate times during a 21 day period
|
AC-170 0.1%
n=25 Participants
AC-170 0.1%: 1 drop in each eye at 3 separate times during a 21 day period
|
AC-170 0.24%
n=21 Participants
AC-170 0.24%: 1 drop in each eye at 3 separate times during a 21 day period
|
AC-170 0%
n=25 Participants
AC-170 0%: 1 drop in each eye at 3 separate times during a 21 day period
|
|---|---|---|---|---|
|
Ear or Palate Pruritus at Onset of Action (15 Minutes Post-dose)
7 minutes post-CAC
|
0.6 units on a scale
Standard Deviation 0.99
|
0.2 units on a scale
Standard Deviation 0.52
|
0.3 units on a scale
Standard Deviation 0.56
|
0.4 units on a scale
Standard Deviation 0.76
|
|
Ear or Palate Pruritus at Onset of Action (15 Minutes Post-dose)
15 minutes post-CAC
|
08 units on a scale
Standard Deviation 0.95
|
0.4 units on a scale
Standard Deviation 0.76
|
0.3 units on a scale
Standard Deviation 0.58
|
0.7 units on a scale
Standard Deviation 1.07
|
|
Ear or Palate Pruritus at Onset of Action (15 Minutes Post-dose)
20 minutes post-CAC
|
0.7 units on a scale
Standard Deviation 1.01
|
0.5 units on a scale
Standard Deviation 0.77
|
0.3 units on a scale
Standard Deviation 0.58
|
0.7 units on a scale
Standard Deviation 1.07
|
SECONDARY outcome
Timeframe: 7, 15, 20 minutes post-CACPopulation: Intent to Treat (ITT)
A treatment efficacy CAC was performed 16 hours after drop instillation. Nasal Congestion was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Congestion score for each time point was analyzed.
Outcome measures
| Measure |
AC-170 0.05%
n=25 Participants
AC-170 0.05%: 1 drop in each eye at 3 separate times during a 21 day period
|
AC-170 0.1%
n=25 Participants
AC-170 0.1%: 1 drop in each eye at 3 separate times during a 21 day period
|
AC-170 0.24%
n=25 Participants
AC-170 0.24%: 1 drop in each eye at 3 separate times during a 21 day period
|
AC-170 0%
n=25 Participants
AC-170 0%: 1 drop in each eye at 3 separate times during a 21 day period
|
|---|---|---|---|---|
|
Nasal Congestion at Onset of Action (16 Hours Post-dose)
7 minutes post-CAC
|
1.2 units on a scale
Standard Deviation 0.99
|
0.5 units on a scale
Standard Deviation 0.65
|
0.8 units on a scale
Standard Deviation 1.18
|
0.8 units on a scale
Standard Deviation 0.78
|
|
Nasal Congestion at Onset of Action (16 Hours Post-dose)
15 minutes post-CAC
|
1.4 units on a scale
Standard Deviation 1.04
|
0.6 units on a scale
Standard Deviation 0.76
|
1.0 units on a scale
Standard Deviation 1.19
|
1.2 units on a scale
Standard Deviation 0.85
|
|
Nasal Congestion at Onset of Action (16 Hours Post-dose)
20 minutes post-CAC
|
1.5 units on a scale
Standard Deviation 1.05
|
0.8 units on a scale
Standard Deviation 0.99
|
1.0 units on a scale
Standard Deviation 1.14
|
1.3 units on a scale
Standard Deviation 1.21
|
SECONDARY outcome
Timeframe: 7, 15, 20 minutes post-CACA treatment efficacy CAC was performed 24 hours after drop instillation. Nasal Congestion was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Congestion score for each time point was analyzed.
Outcome measures
| Measure |
AC-170 0.05%
n=23 Participants
AC-170 0.05%: 1 drop in each eye at 3 separate times during a 21 day period
|
AC-170 0.1%
n=25 Participants
AC-170 0.1%: 1 drop in each eye at 3 separate times during a 21 day period
|
AC-170 0.24%
n=25 Participants
AC-170 0.24%: 1 drop in each eye at 3 separate times during a 21 day period
|
AC-170 0%
n=25 Participants
AC-170 0%: 1 drop in each eye at 3 separate times during a 21 day period
|
|---|---|---|---|---|
|
Nasal Congestion at Duration of Action (24 Hours Post-dose)
7 minutes post-CAC
|
0.9 units on a scale
Standard Deviation 0.97
|
0.6 units on a scale
Standard Deviation 0.58
|
0.8 units on a scale
Standard Deviation 0.80
|
0.7 units on a scale
Standard Deviation 0.69
|
|
Nasal Congestion at Duration of Action (24 Hours Post-dose)
15 minutes post-CAC
|
1.2 units on a scale
Standard Deviation 0.98
|
0.6 units on a scale
Standard Deviation 0.58
|
1.2 units on a scale
Standard Deviation 0.94
|
1.1 units on a scale
Standard Deviation 0.83
|
|
Nasal Congestion at Duration of Action (24 Hours Post-dose)
20 minutes post-CAC
|
1.2 units on a scale
Standard Deviation 1.00
|
0.6 units on a scale
Standard Deviation 0.65
|
1.1 units on a scale
Standard Deviation 1.04
|
1.2 units on a scale
Standard Deviation 0.88
|
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 0.05%
n=23 Participants
AC-170 0.05%: 1 drop in each eye at 3 separate times during a 21 day period
|
AC-170 0.1%
n=25 Participants
AC-170 0.1%: 1 drop in each eye at 3 separate times during a 21 day period
|
AC-170 0.24%
n=21 Participants
AC-170 0.24%: 1 drop in each eye at 3 separate times during a 21 day period
|
AC-170 0%
n=25 Participants
AC-170 0%: 1 drop in each eye at 3 separate times during a 21 day period
|
|---|---|---|---|---|
|
Nasal Congestion at Onset of Action (15 Minutes Post-dose)
20 minutes post-CAC
|
1.1 units on a scale
Standard Deviation 1.14
|
0.5 units on a scale
Standard Deviation 0.65
|
0.4 units on a scale
Standard Deviation 0.59
|
1.4 units on a scale
Standard Deviation 0.87
|
|
Nasal Congestion at Onset of Action (15 Minutes Post-dose)
7 minutes post-CAC
|
0.7 units on a scale
Standard Deviation 1.05
|
0.4 units on a scale
Standard Deviation 0.58
|
0.4 units on a scale
Standard Deviation 0.59
|
0.8 units on a scale
Standard Deviation 0.78
|
|
Nasal Congestion at Onset of Action (15 Minutes Post-dose)
15 minutes post-CAC
|
1.1 units on a scale
Standard Deviation 1.08
|
0.5 units on a scale
Standard Deviation 0.65
|
0.4 units on a scale
Standard Deviation 0.59
|
1.4 units on a scale
Standard Deviation 0.86
|
SECONDARY outcome
Timeframe: 7, 15, 20 minutes post-CACPopulation: Intent to Treat (ITT)
A nasal composite score was summed for each patient based on the presence of at least one of the following four nasal symptoms on a 0-4 scale (0=none to 4=severe): rhinorrhea; nasal pruritus; ear or palate pruritus; and nasal congestion. The percentage of subjects with at least one nasal symptom present was calculated for each time point.
Outcome measures
| Measure |
AC-170 0.05%
n=23 Participants
AC-170 0.05%: 1 drop in each eye at 3 separate times during a 21 day period
|
AC-170 0.1%
n=25 Participants
AC-170 0.1%: 1 drop in each eye at 3 separate times during a 21 day period
|
AC-170 0.24%
n=21 Participants
AC-170 0.24%: 1 drop in each eye at 3 separate times during a 21 day period
|
AC-170 0%
n=25 Participants
AC-170 0%: 1 drop in each eye at 3 separate times during a 21 day period
|
|---|---|---|---|---|
|
Nasal Composite Score at Duration of Action (16 Hours Post-dose)
7 minutes post-CAC
|
82.6 percentage of subjects
|
66.7 percentage of subjects
|
52.4 percentage of subjects
|
76.0 percentage of subjects
|
|
Nasal Composite Score at Duration of Action (16 Hours Post-dose)
15 minutes post-CAC
|
82.6 percentage of subjects
|
79.2 percentage of subjects
|
90.5 percentage of subjects
|
84.0 percentage of subjects
|
|
Nasal Composite Score at Duration of Action (16 Hours Post-dose)
20 minutes post-CAC
|
91.3 percentage of subjects
|
83.3 percentage of subjects
|
95.2 percentage of subjects
|
84.0 percentage of subjects
|
SECONDARY outcome
Timeframe: 7, 15, 20 minutes post-CACPopulation: Intent to Treat (ITT)
A nasal composite score was summed for each patient based on the presence of at least one of the following four nasal symptoms on a 0-4 scale (0=none to 4=severe): rhinorrhea; nasal pruritus; ear or palate pruritus; and nasal congestion. The percentage of subjects with at least one nasal symptom present was calculated for each time point.
Outcome measures
| Measure |
AC-170 0.05%
n=23 Participants
AC-170 0.05%: 1 drop in each eye at 3 separate times during a 21 day period
|
AC-170 0.1%
n=25 Participants
AC-170 0.1%: 1 drop in each eye at 3 separate times during a 21 day period
|
AC-170 0.24%
n=21 Participants
AC-170 0.24%: 1 drop in each eye at 3 separate times during a 21 day period
|
AC-170 0%
n=25 Participants
AC-170 0%: 1 drop in each eye at 3 separate times during a 21 day period
|
|---|---|---|---|---|
|
Nasal Composite Score at Duration of Action (24 Hours Post-dose)
7 minutes post-CAC
|
69.6 percentage of subjects
|
76.0 percentage of subjects
|
85.7 percentage of subjects
|
68.0 percentage of subjects
|
|
Nasal Composite Score at Duration of Action (24 Hours Post-dose)
15 minutes post-CAC
|
82.6 percentage of subjects
|
84.0 percentage of subjects
|
90.5 percentage of subjects
|
92.0 percentage of subjects
|
|
Nasal Composite Score at Duration of Action (24 Hours Post-dose)
20 minutes post-CAC
|
82.6 percentage of subjects
|
88.0 percentage of subjects
|
81.0 percentage of subjects
|
92.0 percentage of subjects
|
SECONDARY outcome
Timeframe: 7, 15, 20 minutes post-CACPopulation: Intent to Treat (ITT)
A nasal composite score was summed for each patient based on the presence of at least one of the following four nasal symptoms on a 0-4 scale (0=none to 4=severe): rhinorrhea; nasal pruritus; ear or palate pruritus; and nasal congestion. The percentage of subjects with at least one nasal symptom present was calculated for each time point.
Outcome measures
| Measure |
AC-170 0.05%
n=23 Participants
AC-170 0.05%: 1 drop in each eye at 3 separate times during a 21 day period
|
AC-170 0.1%
n=25 Participants
AC-170 0.1%: 1 drop in each eye at 3 separate times during a 21 day period
|
AC-170 0.24%
n=21 Participants
AC-170 0.24%: 1 drop in each eye at 3 separate times during a 21 day period
|
AC-170 0%
n=25 Participants
AC-170 0%: 1 drop in each eye at 3 separate times during a 21 day period
|
|---|---|---|---|---|
|
Nasal Composite Score at Onset of Action (15 Minutes Post-dose)
7 minutes post-CAC
|
52.2 percentage of subjects
|
56 percentage of subjects
|
47.6 percentage of subjects
|
72 percentage of subjects
|
|
Nasal Composite Score at Onset of Action (15 Minutes Post-dose)
15 minutes post-CAC
|
82.6 percentage of subjects
|
56 percentage of subjects
|
47.6 percentage of subjects
|
84 percentage of subjects
|
|
Nasal Composite Score at Onset of Action (15 Minutes Post-dose)
20 minutes post-CAC
|
73.9 percentage of subjects
|
52 percentage of subjects
|
52.4 percentage of subjects
|
84 percentage of subjects
|
SECONDARY outcome
Timeframe: upon instillation, 1 minute and 2 minutes post instillationPopulation: Intent to Treat (ITT)
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..
Outcome measures
| Measure |
AC-170 0.05%
n=25 Participants
AC-170 0.05%: 1 drop in each eye at 3 separate times during a 21 day period
|
AC-170 0.1%
n=26 Participants
AC-170 0.1%: 1 drop in each eye at 3 separate times during a 21 day period
|
AC-170 0.24%
n=25 Participants
AC-170 0.24%: 1 drop in each eye at 3 separate times during a 21 day period
|
AC-170 0%
n=25 Participants
AC-170 0%: 1 drop in each eye at 3 separate times during a 21 day period
|
|---|---|---|---|---|
|
Tolerability of Study Medication at Visit 3A
1 minute post-instillation
|
0.7 units on a scale
Standard Deviation 1.13
|
0.9 units on a scale
Standard Deviation 1.13
|
2.0 units on a scale
Standard Deviation 2.25
|
0.9 units on a scale
Standard Deviation 1.18
|
|
Tolerability of Study Medication at Visit 3A
2 minutes post-instillation
|
0.8 units on a scale
Standard Deviation 1.10
|
1.0 units on a scale
Standard Deviation 1.18
|
1.7 units on a scale
Standard Deviation 2.27
|
0.6 units on a scale
Standard Deviation 0.79
|
|
Tolerability of Study Medication at Visit 3A
Upon instillation
|
0.5 units on a scale
Standard Deviation 0.95
|
0.7 units on a scale
Standard Deviation 1.04
|
1.3 units on a scale
Standard Deviation 1.93
|
0.6 units on a scale
Standard Deviation 1.03
|
Adverse Events
AC-170 0.05%
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
AC-170 0.1%
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
AC-170 0.24%
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
AC-170 0%
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
AC-170 0.05%
n=25 participants at risk
AC-170 0.05%: 1 drop in each eye at 3 separate times during a 21 day period
|
AC-170 0.1%
n=26 participants at risk
AC-170 0.1%: 1 drop in each eye at 3 separate times during a 21 day period
|
AC-170 0.24%
n=25 participants at risk
AC-170 0.24%: 1 drop in each eye at 3 separate times during a 21 day period
|
AC-170 0%
n=25 participants at risk
AC-170 0%: 1 drop in each eye at 3 separate times during a 21 day period
|
|---|---|---|---|---|
|
Eye disorders
Photophobia
|
0.00%
0/25 • Adverse events were assessed through study completion, approximately two months. 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%
0/26 • Adverse events were assessed through study completion, approximately two months. 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%
1/25 • Number of events 1 • Adverse events were assessed through study completion, approximately two months. 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%
0/25 • Adverse events were assessed through study completion, approximately two months. 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
Visual acuity reducsed
|
8.0%
2/25 • Number of events 2 • Adverse events were assessed through study completion, approximately two months. All subjects who received study medication were evaluable for the safety analysis.
Throughout the visits, staff collected all Adverse Events reported, elicited or observed.
|
3.8%
1/26 • Number of events 1 • Adverse events were assessed through study completion, approximately two months. 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%
0/25 • Adverse events were assessed through study completion, approximately two months. 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%
1/25 • Number of events 1 • Adverse events were assessed through study completion, approximately two months. All subjects who received study medication were evaluable for the safety analysis.
Throughout the visits, staff collected all Adverse Events reported, elicited or observed.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/25 • Adverse events were assessed through study completion, approximately two months. 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%
0/26 • Adverse events were assessed through study completion, approximately two months. 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%
0/25 • Adverse events were assessed through study completion, approximately two months. 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%
1/25 • Number of events 1 • Adverse events were assessed through study completion, approximately two months. All subjects who received study medication were evaluable for the safety analysis.
Throughout the visits, staff collected all Adverse Events reported, elicited or observed.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/25 • Adverse events were assessed through study completion, approximately two months. 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%
0/26 • Adverse events were assessed through study completion, approximately two months. 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%
1/25 • Number of events 1 • Adverse events were assessed through study completion, approximately two months. 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%
0/25 • Adverse events were assessed through study completion, approximately two months. 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
Back pain
|
4.0%
1/25 • Number of events 1 • Adverse events were assessed through study completion, approximately two months. 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%
0/26 • Adverse events were assessed through study completion, approximately two months. 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%
0/25 • Adverse events were assessed through study completion, approximately two months. 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%
0/25 • Adverse events were assessed through study completion, approximately two months. 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
Pain in jaw
|
0.00%
0/25 • Adverse events were assessed through study completion, approximately two months. All subjects who received study medication were evaluable for the safety analysis.
Throughout the visits, staff collected all Adverse Events reported, elicited or observed.
|
3.8%
1/26 • Number of events 1 • Adverse events were assessed through study completion, approximately two months. 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%
0/25 • Adverse events were assessed through study completion, approximately two months. 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%
0/25 • Adverse events were assessed through study completion, approximately two months. All subjects who received study medication were evaluable for the safety analysis.
Throughout the visits, staff collected all Adverse Events reported, elicited or observed.
|
|
Gastrointestinal disorders
Oral pruritus
|
4.0%
1/25 • Number of events 1 • Adverse events were assessed through study completion, approximately two months. 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%
0/26 • Adverse events were assessed through study completion, approximately two months. 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%
0/25 • Adverse events were assessed through study completion, approximately two months. 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%
0/25 • Adverse events were assessed through study completion, approximately two months. All subjects who received study medication were evaluable for the safety analysis.
Throughout the visits, staff collected all Adverse Events reported, elicited or observed.
|
|
Gastrointestinal disorders
Palatal Oedema
|
4.0%
1/25 • Number of events 1 • Adverse events were assessed through study completion, approximately two months. 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%
0/26 • Adverse events were assessed through study completion, approximately two months. 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%
0/25 • Adverse events were assessed through study completion, approximately two months. 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%
0/25 • Adverse events were assessed through study completion, approximately two months. 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
Nasopharyngitis
|
4.0%
1/25 • Number of events 1 • Adverse events were assessed through study completion, approximately two months. 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%
0/26 • Adverse events were assessed through study completion, approximately two months. 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%
0/25 • Adverse events were assessed through study completion, approximately two months. 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%
0/25 • Adverse events were assessed through study completion, approximately two months. All subjects who received study medication were evaluable for the safety analysis.
Throughout the visits, staff collected all Adverse Events reported, elicited or observed.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/25 • Adverse events were assessed through study completion, approximately two months. All subjects who received study medication were evaluable for the safety analysis.
Throughout the visits, staff collected all Adverse Events reported, elicited or observed.
|
3.8%
1/26 • Number of events 1 • Adverse events were assessed through study completion, approximately two months. 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%
0/25 • Adverse events were assessed through study completion, approximately two months. 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%
0/25 • Adverse events were assessed through study completion, approximately two months. All subjects who received study medication were evaluable for the safety analysis.
Throughout the visits, staff collected all Adverse Events reported, elicited or observed.
|
|
Nervous system disorders
Headache
|
0.00%
0/25 • Adverse events were assessed through study completion, approximately two months. 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%
0/26 • Adverse events were assessed through study completion, approximately two months. 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%
1/25 • Number of events 1 • Adverse events were assessed through study completion, approximately two months. 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%
0/25 • Adverse events were assessed through study completion, approximately two months. 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
Epistaxis
|
0.00%
0/25 • Adverse events were assessed through study completion, approximately two months. 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%
0/26 • Adverse events were assessed through study completion, approximately two months. 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%
1/25 • Number of events 1 • Adverse events were assessed through study completion, approximately two months. 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%
0/25 • Adverse events were assessed through study completion, approximately two months. 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.
Phone: 817-529-9315
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place