Trial Outcomes & Findings for Efficacy of AC-150 for the Treatment of Allergic Conjunctivitis in the Enviro-CAC™ Model (NCT NCT01134328)
NCT ID: NCT01134328
Last Updated: 2017-09-14
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
83 participants
Primary outcome timeframe
3, 5, 7 minutes post-CAC
Results posted on
2017-09-14
Participant Flow
Subjects were recruited from two sites in the US.
There were 83 subjects enrolled, 12 subjects discontinued, and 71 subjects completed the study. Participant flow and baseline characteristics are presented for the 83 subjects that met all inclusion criteria and none of the exclusion criteria and were randomized to receive AC-150 Combo, AC-150A 0.1%, AC-150B 0.005% or Vehicle
Participant milestones
| Measure |
AC-150 Combo
AC-150 Combo: 1 drop in each eye for up to 14 days
|
AC-150A 0.1%
AC-150A 0.1%: 1 drop in each eye once per day for up to 14 days
|
AC-150B 0.005%
AC-150B 0.005%: 1 drop in each eye once per day for up to 14 days
|
Vehicle
Vehicle: 1 drop in each eye once per day for up to 14 days
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
21
|
21
|
20
|
21
|
|
Overall Study
COMPLETED
|
19
|
18
|
17
|
17
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
3
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy of AC-150 for the Treatment of Allergic Conjunctivitis in the Enviro-CAC™ Model
Baseline characteristics by cohort
| Measure |
AC-150 Combo
n=21 Participants
AC-150 Combo: 1 drop in each eye for up to 14 days
|
AC-150A 0.1%
n=21 Participants
AC-150A 0.1%: 1 drop in each eye once per day for up to 14 days
|
AC-150B 0.005%
n=20 Participants
AC-150B 0.005%: 1 drop in each eye once per day for up to 14 days
|
Vehicle
n=21 Participants
Vehicle: 1 drop in each eye once per day for up to 14 days
|
Total
n=83 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
37.7 years
STANDARD_DEVIATION 12.56 • n=5 Participants
|
35.1 years
STANDARD_DEVIATION 14.32 • n=7 Participants
|
40.2 years
STANDARD_DEVIATION 12.23 • n=5 Participants
|
38.3 years
STANDARD_DEVIATION 16.16 • n=4 Participants
|
37.8 years
STANDARD_DEVIATION 13.78 • n=21 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
42 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
41 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
17 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
68 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
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
35 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
39 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
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
21 participants
n=5 Participants
|
21 participants
n=7 Participants
|
20 participants
n=5 Participants
|
21 participants
n=4 Participants
|
83 participants
n=21 Participants
|
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-150 Combo
n=20 Participants
AC-150 Combo: 1 drop in each eye for up to 14 days
|
AC-150A 0.1%
n=20 Participants
AC-150A 0.1%: 1 drop in each eye once per day for up to 14 days
|
AC-150B 0.005%
n=19 Participants
AC-150B 0.005%: 1 drop in each eye once per day for up to 14 days
|
Vehicle
n=19 Participants
Vehicle: 1 drop in each eye once per day for up to 14 days
|
|---|---|---|---|---|
|
Ocular Itching at Onset of Action (15 Minutes Post-dose)
3 minutes post-CAC
|
1.33 units on a scale
Standard Deviation 0.974
|
0.99 units on a scale
Standard Deviation 0.752
|
2.11 units on a scale
Standard Deviation 1.173
|
2.90 units on a scale
Standard Deviation 0.967
|
|
Ocular Itching at Onset of Action (15 Minutes Post-dose)
5 minutes post-CAC
|
1.44 units on a scale
Standard Deviation 1.076
|
1.33 units on a scale
Standard Deviation 0.590
|
2.25 units on a scale
Standard Deviation 1.057
|
3.11 units on a scale
Standard Deviation 0.944
|
|
Ocular Itching at Onset of Action (15 Minutes Post-dose)
7 minutes post-CAC
|
1.31 units on a scale
Standard Deviation 1.033
|
1.59 units on a scale
Standard Deviation 0.894
|
2.03 units on a scale
Standard Deviation 1.131
|
2.97 units on a scale
Standard Deviation 1.018
|
PRIMARY outcome
Timeframe: 3, 5, 7 minutes post-CACPopulation: Intent to Treat (ITT) Population with Last Observation Carried Forward (LOCF)
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-150 Combo
n=20 Participants
AC-150 Combo: 1 drop in each eye for up to 14 days
|
AC-150A 0.1%
n=19 Participants
AC-150A 0.1%: 1 drop in each eye once per day for up to 14 days
|
AC-150B 0.005%
n=18 Participants
AC-150B 0.005%: 1 drop in each eye once per day for up to 14 days
|
Vehicle
n=18 Participants
Vehicle: 1 drop in each eye once per day for up to 14 days
|
|---|---|---|---|---|
|
Ocular Itching at Duration of Action (16 Hours Post-dose)
3 minutes post-CAC
|
1.75 units on a scale
Standard Deviation 1.112
|
1.92 units on a scale
Standard Deviation 1.131
|
1.88 units on a scale
Standard Deviation 1.082
|
3.04 units on a scale
Standard Deviation 0.693
|
|
Ocular Itching at Duration of Action (16 Hours Post-dose)
5 minutes post-CAC
|
1.95 units on a scale
Standard Deviation 1.160
|
2.24 units on a scale
Standard Deviation 0.991
|
2.21 units on a scale
Standard Deviation 1.132
|
3.18 units on a scale
Standard Deviation 0.706
|
|
Ocular Itching at Duration of Action (16 Hours Post-dose)
7 minutes post-CAC
|
1.98 units on a scale
Standard Deviation 1.067
|
2.12 units on a scale
Standard Deviation 1.156
|
2.11 units on a scale
Standard Deviation 1.231
|
3.18 units on a scale
Standard Deviation 0.727
|
PRIMARY outcome
Timeframe: 3, 5, 7 minutes post-CACPopulation: Intent to Treat (ITT) Population with Last Observation Carried Forward (LOCF)
A treatment efficacy CAC was performed 8 hours after drop instillation. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed.
Outcome measures
| Measure |
AC-150 Combo
n=20 Participants
AC-150 Combo: 1 drop in each eye for up to 14 days
|
AC-150A 0.1%
n=19 Participants
AC-150A 0.1%: 1 drop in each eye once per day for up to 14 days
|
AC-150B 0.005%
n=18 Participants
AC-150B 0.005%: 1 drop in each eye once per day for up to 14 days
|
Vehicle
n=18 Participants
Vehicle: 1 drop in each eye once per day for up to 14 days
|
|---|---|---|---|---|
|
Ocular Itching at 8 Hours Post-dose at Visit 4A
3 minutes post-CAC
|
1.43 units on a scale
Standard Deviation 1.007
|
1.53 units on a scale
Standard Deviation 0.916
|
2.01 units on a scale
Standard Deviation 0.872
|
2.99 units on a scale
Standard Deviation 0.627
|
|
Ocular Itching at 8 Hours Post-dose at Visit 4A
5 minutes post-CAC
|
1.56 units on a scale
Standard Deviation 1.022
|
1.83 units on a scale
Standard Deviation 0.954
|
2.17 units on a scale
Standard Deviation 0.899
|
2.90 units on a scale
Standard Deviation 0.703
|
|
Ocular Itching at 8 Hours Post-dose at Visit 4A
7 minutes post-CAC
|
1.64 units on a scale
Standard Deviation 1.071
|
1.86 units on a scale
Standard Deviation 0.925
|
2.03 units on a scale
Standard Deviation 0.935
|
2.79 units on a scale
Standard Deviation 0.792
|
PRIMARY outcome
Timeframe: 7, 15, 20 minutes post-CACPopulation: Intent to Treat (ITT) Population with Last Observation Carried Forward (LOCF)
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-150 Combo
n=20 Participants
AC-150 Combo: 1 drop in each eye for up to 14 days
|
AC-150A 0.1%
n=19 Participants
AC-150A 0.1%: 1 drop in each eye once per day for up to 14 days
|
AC-150B 0.005%
n=18 Participants
AC-150B 0.005%: 1 drop in each eye once per day for up to 14 days
|
Vehicle
n=18 Participants
Vehicle: 1 drop in each eye once per day for up to 14 days
|
|---|---|---|---|---|
|
Conjunctival Redness at Onset of Action (15 Minutes Post-dose)
7 minutes post-CAC
|
1.70 units on a scale
Standard Deviation 0.677
|
1.97 units on a scale
Standard Deviation 0.812
|
2.18 units on a scale
Standard Deviation 0.835
|
2.49 units on a scale
Standard Deviation 0.639
|
|
Conjunctival Redness at Onset of Action (15 Minutes Post-dose)
15 minutes post-CAC
|
2.04 units on a scale
Standard Deviation 0.704
|
2.25 units on a scale
Standard Deviation 0.997
|
2.44 units on a scale
Standard Deviation 0.770
|
2.58 units on a scale
Standard Deviation 0.733
|
|
Conjunctival Redness at Onset of Action (15 Minutes Post-dose)
20 minutes post-CAC
|
2.04 units on a scale
Standard Deviation 0.745
|
2.37 units on a scale
Standard Deviation 0.980
|
2.51 units on a scale
Standard Deviation 0.838
|
2.58 units on a scale
Standard Deviation 0.733
|
PRIMARY outcome
Timeframe: 7, 15, 20 minutes post-CACPopulation: Intent to Treat (ITT) Population with Last Observation Carried Forward (LOCF)
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-150 Combo
n=20 Participants
AC-150 Combo: 1 drop in each eye for up to 14 days
|
AC-150A 0.1%
n=19 Participants
AC-150A 0.1%: 1 drop in each eye once per day for up to 14 days
|
AC-150B 0.005%
n=18 Participants
AC-150B 0.005%: 1 drop in each eye once per day for up to 14 days
|
Vehicle
n=18 Participants
Vehicle: 1 drop in each eye once per day for up to 14 days
|
|---|---|---|---|---|
|
Conjunctival Redness at Duration of Action (16 Hours Post-dose)
7 minutes post-CAC
|
1.56 units on a scale
Standard Deviation 0.451
|
1.78 units on a scale
Standard Deviation 0.478
|
1.83 units on a scale
Standard Deviation 0.485
|
2.01 units on a scale
Standard Deviation 0.348
|
|
Conjunctival Redness at Duration of Action (16 Hours Post-dose)
15 minutes post-CAC
|
1.68 units on a scale
Standard Deviation 0.507
|
1.84 units on a scale
Standard Deviation 0.410
|
1.97 units on a scale
Standard Deviation 0.484
|
2.15 units on a scale
Standard Deviation 0.322
|
|
Conjunctival Redness at Duration of Action (16 Hours Post-dose)
20 minutes post-CAC
|
1.66 units on a scale
Standard Deviation 0.424
|
1.88 units on a scale
Standard Deviation 0.567
|
1.81 units on a scale
Standard Deviation 0.511
|
2.04 units on a scale
Standard Deviation 0.386
|
PRIMARY outcome
Timeframe: 7, 15, 20 minutes post-CACPopulation: Intent to Treat (ITT) Population with Last Observation Carried Forward (LOCF)
A treatment efficacy CAC was performed 8 hours after drop instillation. Conjunctival Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of conjunctival redness score over both eyes was analyzed.
Outcome measures
| Measure |
AC-150 Combo
n=20 Participants
AC-150 Combo: 1 drop in each eye for up to 14 days
|
AC-150A 0.1%
n=19 Participants
AC-150A 0.1%: 1 drop in each eye once per day for up to 14 days
|
AC-150B 0.005%
n=18 Participants
AC-150B 0.005%: 1 drop in each eye once per day for up to 14 days
|
Vehicle
n=18 Participants
Vehicle: 1 drop in each eye once per day for up to 14 days
|
|---|---|---|---|---|
|
Conjunctival Redness at 8 Hours Post-dose at Visit 4A
20 minutes post-CAC
|
1.44 units on a scale
Standard Deviation 0.617
|
1.70 units on a scale
Standard Deviation 0.581
|
1.81 units on a scale
Standard Deviation 0.546
|
2.14 units on a scale
Standard Deviation 0.395
|
|
Conjunctival Redness at 8 Hours Post-dose at Visit 4A
7 minutes post-CAC
|
1.39 units on a scale
Standard Deviation 0.610
|
1.66 units on a scale
Standard Deviation 0.560
|
1.81 units on a scale
Standard Deviation 0.442
|
1.96 units on a scale
Standard Deviation 0.346
|
|
Conjunctival Redness at 8 Hours Post-dose at Visit 4A
15 minutes post-CAC
|
1.39 units on a scale
Standard Deviation 0.626
|
1.70 units on a scale
Standard Deviation 0.518
|
1.85 units on a scale
Standard Deviation 0.557
|
2.14 units on a scale
Standard Deviation 0.366
|
SECONDARY outcome
Timeframe: 7, 15, 20 minutes post-CACPopulation: Per protocol population
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-150 Combo
n=18 Participants
AC-150 Combo: 1 drop in each eye for up to 14 days
|
AC-150A 0.1%
n=17 Participants
AC-150A 0.1%: 1 drop in each eye once per day for up to 14 days
|
AC-150B 0.005%
n=17 Participants
AC-150B 0.005%: 1 drop in each eye once per day for up to 14 days
|
Vehicle
n=17 Participants
Vehicle: 1 drop in each eye once per day for up to 14 days
|
|---|---|---|---|---|
|
Ciliary Redness at Onset of Action (15 Minutes Post-dose)
20 minutes post-CAC
|
1.94 units on a scale
Standard Deviation 1.100
|
2.29 units on a scale
Standard Deviation 0.953
|
2.51 units on a scale
Standard Deviation 0.946
|
2.56 units on a scale
Standard Deviation 0.788
|
|
Ciliary Redness at Onset of Action (15 Minutes Post-dose)
7 minutes post-CAC
|
1.44 units on a scale
Standard Deviation 0.898
|
1.84 units on a scale
Standard Deviation 0.852
|
2.35 units on a scale
Standard Deviation 0.834
|
2.37 units on a scale
Standard Deviation 0.857
|
|
Ciliary Redness at Onset of Action (15 Minutes Post-dose)
15 minutes post-CAC
|
1.89 units on a scale
Standard Deviation 0.956
|
2.25 units on a scale
Standard Deviation 0.940
|
2.47 units on a scale
Standard Deviation 0.865
|
2.54 units on a scale
Standard Deviation 0.880
|
SECONDARY outcome
Timeframe: 7, 15, 20 minutes post-CACPopulation: Per protocol population
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-150 Combo
n=18 Participants
AC-150 Combo: 1 drop in each eye for up to 14 days
|
AC-150A 0.1%
n=17 Participants
AC-150A 0.1%: 1 drop in each eye once per day for up to 14 days
|
AC-150B 0.005%
n=17 Participants
AC-150B 0.005%: 1 drop in each eye once per day for up to 14 days
|
Vehicle
n=17 Participants
Vehicle: 1 drop in each eye once per day for up to 14 days
|
|---|---|---|---|---|
|
Ciliary Redness at Duration of Action (16 Hours Post-dose)
7 minutes post-CAC
|
1.38 units on a scale
Standard Deviation 0.577
|
1.81 units on a scale
Standard Deviation 0.616
|
1.71 units on a scale
Standard Deviation 0.626
|
2.03 units on a scale
Standard Deviation 0.499
|
|
Ciliary Redness at Duration of Action (16 Hours Post-dose)
15 minutes post-CAC
|
1.51 units on a scale
Standard Deviation 0.578
|
1.90 units on a scale
Standard Deviation 0.600
|
1.84 units on a scale
Standard Deviation 0.712
|
2.10 units on a scale
Standard Deviation 0.434
|
|
Ciliary Redness at Duration of Action (16 Hours Post-dose)
20 minutes post-CAC
|
1.53 units on a scale
Standard Deviation 0.629
|
1.91 units on a scale
Standard Deviation 0.637
|
1.72 units on a scale
Standard Deviation 0.667
|
2.04 units on a scale
Standard Deviation 0.461
|
SECONDARY outcome
Timeframe: 7, 15, 20 minutes post-CACPopulation: Per protocol population
A treatment efficacy CAC was performed 8 hours after drop instillation. Ciliary Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ciliary redness score over both eyes was analyzed.
Outcome measures
| Measure |
AC-150 Combo
n=18 Participants
AC-150 Combo: 1 drop in each eye for up to 14 days
|
AC-150A 0.1%
n=17 Participants
AC-150A 0.1%: 1 drop in each eye once per day for up to 14 days
|
AC-150B 0.005%
n=17 Participants
AC-150B 0.005%: 1 drop in each eye once per day for up to 14 days
|
Vehicle
n=17 Participants
Vehicle: 1 drop in each eye once per day for up to 14 days
|
|---|---|---|---|---|
|
Ciliary Redness at 8 Hours Post-dose at Visit 4A
7 minutes post-CAC
|
1.04 units on a scale
Standard Deviation 0.759
|
1.65 units on a scale
Standard Deviation 0.673
|
1.68 units on a scale
Standard Deviation 0.557
|
2.01 units on a scale
Standard Deviation 0.437
|
|
Ciliary Redness at 8 Hours Post-dose at Visit 4A
15 minutes post-CAC
|
1.08 units on a scale
Standard Deviation 0.702
|
1.69 units on a scale
Standard Deviation 0.693
|
1.74 units on a scale
Standard Deviation 0.603
|
2.18 units on a scale
Standard Deviation 0.393
|
|
Ciliary Redness at 8 Hours Post-dose at Visit 4A
20 minutes post-CAC
|
1.15 units on a scale
Standard Deviation 0.713
|
1.63 units on a scale
Standard Deviation 0.650
|
1.68 units on a scale
Standard Deviation 0.717
|
2.10 units on a scale
Standard Deviation 0.566
|
SECONDARY outcome
Timeframe: 7, 15, 20 minutes post-CACPopulation: Per protocol population
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-150 Combo
n=18 Participants
AC-150 Combo: 1 drop in each eye for up to 14 days
|
AC-150A 0.1%
n=17 Participants
AC-150A 0.1%: 1 drop in each eye once per day for up to 14 days
|
AC-150B 0.005%
n=17 Participants
AC-150B 0.005%: 1 drop in each eye once per day for up to 14 days
|
Vehicle
n=17 Participants
Vehicle: 1 drop in each eye once per day for up to 14 days
|
|---|---|---|---|---|
|
Episcleral Redness at Onset of Action (15 Minutes Post-dose)
7 minutes post-CAC
|
1.63 units on a scale
Standard Deviation 0.749
|
2.03 units on a scale
Standard Deviation 0.888
|
2.35 units on a scale
Standard Deviation 0.755
|
2.50 units on a scale
Standard Deviation 0.667
|
|
Episcleral Redness at Onset of Action (15 Minutes Post-dose)
15 minutes post-CAC
|
1.90 units on a scale
Standard Deviation 0.642
|
2.40 units on a scale
Standard Deviation 0.960
|
2.51 units on a scale
Standard Deviation 0.763
|
2.71 units on a scale
Standard Deviation 0.675
|
|
Episcleral Redness at Onset of Action (15 Minutes Post-dose)
20 minutes post-CAC
|
1.94 units on a scale
Standard Deviation 0.816
|
2.53 units on a scale
Standard Deviation 0.951
|
2.56 units on a scale
Standard Deviation 0.855
|
2.71 units on a scale
Standard Deviation 0.692
|
SECONDARY outcome
Timeframe: 7, 15, 20 minutes post-CACPopulation: Per protocol population
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-150 Combo
n=18 Participants
AC-150 Combo: 1 drop in each eye for up to 14 days
|
AC-150A 0.1%
n=17 Participants
AC-150A 0.1%: 1 drop in each eye once per day for up to 14 days
|
AC-150B 0.005%
n=17 Participants
AC-150B 0.005%: 1 drop in each eye once per day for up to 14 days
|
Vehicle
n=17 Participants
Vehicle: 1 drop in each eye once per day for up to 14 days
|
|---|---|---|---|---|
|
Episcleral Redness at Duration of Action (16 Hours Post-dose)
7 minutes post-CAC
|
1.72 units on a scale
Standard Deviation 0.575
|
2.12 units on a scale
Standard Deviation 0.638
|
2.15 units on a scale
Standard Deviation 0.538
|
2.37 units on a scale
Standard Deviation 0.516
|
|
Episcleral Redness at Duration of Action (16 Hours Post-dose)
15 minutes post-CAC
|
1.79 units on a scale
Standard Deviation 0.564
|
2.24 units on a scale
Standard Deviation 0.583
|
2.21 units on a scale
Standard Deviation 0.663
|
2.53 units on a scale
Standard Deviation 0.514
|
|
Episcleral Redness at Duration of Action (16 Hours Post-dose)
20 minutes post-CAC
|
1.78 units on a scale
Standard Deviation 0.528
|
2.22 units on a scale
Standard Deviation 0.522
|
2.16 units on a scale
Standard Deviation 0.606
|
2.47 units on a scale
Standard Deviation 0.558
|
SECONDARY outcome
Timeframe: 7, 15, 20 minutes post-CACPopulation: Per protocol population
A treatment efficacy CAC was performed 8 hours after drop instillation. Episcleral Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of episcleral redness score over both eyes was analyzed.
Outcome measures
| Measure |
AC-150 Combo
n=18 Participants
AC-150 Combo: 1 drop in each eye for up to 14 days
|
AC-150A 0.1%
n=17 Participants
AC-150A 0.1%: 1 drop in each eye once per day for up to 14 days
|
AC-150B 0.005%
n=17 Participants
AC-150B 0.005%: 1 drop in each eye once per day for up to 14 days
|
Vehicle
n=17 Participants
Vehicle: 1 drop in each eye once per day for up to 14 days
|
|---|---|---|---|---|
|
Episcleral Redness at 8 Hours Post-dose at Visit 4A
7 minutes post-CAC
|
1.49 units on a scale
Standard Deviation 0.672
|
1.88 units on a scale
Standard Deviation 0.644
|
2.04 units on a scale
Standard Deviation 0.453
|
2.34 units on a scale
Standard Deviation 0.436
|
|
Episcleral Redness at 8 Hours Post-dose at Visit 4A
15 minutes post-CAC
|
1.50 units on a scale
Standard Deviation 0.712
|
2.04 units on a scale
Standard Deviation 0.607
|
2.07 units on a scale
Standard Deviation 0.598
|
2.41 units on a scale
Standard Deviation 0.484
|
|
Episcleral Redness at 8 Hours Post-dose at Visit 4A
20 minutes post-CAC
|
1.57 units on a scale
Standard Deviation 0.674
|
1.94 units on a scale
Standard Deviation 0.705
|
2.07 units on a scale
Standard Deviation 0.630
|
2.40 units on a scale
Standard Deviation 0.516
|
SECONDARY outcome
Timeframe: 7, 15, 20 minutes post-CACPopulation: Per protocol population
A treatment efficacy CAC was performed 15 minutes after drop instillation. Total redness was defined as the sum of the conjunctival, ciliary and episcleral redness scores, and was, thus, on a 0-12 scale, making the threshold for clinical significance a treatment difference of 3.0 units. Higher scores represent greater severity.
Outcome measures
| Measure |
AC-150 Combo
n=18 Participants
AC-150 Combo: 1 drop in each eye for up to 14 days
|
AC-150A 0.1%
n=17 Participants
AC-150A 0.1%: 1 drop in each eye once per day for up to 14 days
|
AC-150B 0.005%
n=17 Participants
AC-150B 0.005%: 1 drop in each eye once per day for up to 14 days
|
Vehicle
n=17 Participants
Vehicle: 1 drop in each eye once per day for up to 14 days
|
|---|---|---|---|---|
|
Total Redness at Onset of Action (15 Minutes Post-dose)
7 minutes post-CAC
|
4.72 units on a scale
Standard Deviation 2.252
|
5.96 units on a scale
Standard Deviation 2.450
|
6.99 units on a scale
Standard Deviation 2.230
|
7.37 units on a scale
Standard Deviation 2.123
|
|
Total Redness at Onset of Action (15 Minutes Post-dose)
15 minutes post-CAC
|
5.76 units on a scale
Standard Deviation 2.225
|
7.03 units on a scale
Standard Deviation 2.802
|
7.49 units on a scale
Standard Deviation 2.312
|
7.87 units on a scale
Standard Deviation 2.208
|
|
Total Redness at Onset of Action (15 Minutes Post-dose)
20 minutes post-CAC
|
5.86 units on a scale
Standard Deviation 2.579
|
7.32 units on a scale
Standard Deviation 2.778
|
7.60 units on a scale
Standard Deviation 2.631
|
7.88 units on a scale
Standard Deviation 2.171
|
SECONDARY outcome
Timeframe: 7, 15, 20 minutes post-CACPopulation: Per protocol population
A treatment efficacy CAC was performed 16 hours after drop instillation. Total redness was defined as the sum of the conjunctival, ciliary and episcleral redness scores, and was, thus, on a 0-12 scale, making the threshold for clinical significance a treatment difference of 3.0 units. Higher scores represent greater severity.
Outcome measures
| Measure |
AC-150 Combo
n=18 Participants
AC-150 Combo: 1 drop in each eye for up to 14 days
|
AC-150A 0.1%
n=17 Participants
AC-150A 0.1%: 1 drop in each eye once per day for up to 14 days
|
AC-150B 0.005%
n=17 Participants
AC-150B 0.005%: 1 drop in each eye once per day for up to 14 days
|
Vehicle
n=17 Participants
Vehicle: 1 drop in each eye once per day for up to 14 days
|
|---|---|---|---|---|
|
Total Redness at Duration of Action (16 Hours Post-dose)
7 minutes post-CAC
|
4.60 units on a scale
Standard Deviation 1.451
|
5.75 units on a scale
Standard Deviation 1.658
|
5.66 units on a scale
Standard Deviation 1.591
|
6.40 units on a scale
Standard Deviation 1.263
|
|
Total Redness at Duration of Action (16 Hours Post-dose)
15 minutes post-CAC
|
4.92 units on a scale
Standard Deviation 1.483
|
6.03 units on a scale
Standard Deviation 1.489
|
5.88 units on a scale
Standard Deviation 1.898
|
6.78 units on a scale
Standard Deviation 1.202
|
|
Total Redness at Duration of Action (16 Hours Post-dose)
20 minutes post-CAC
|
4.90 units on a scale
Standard Deviation 1.402
|
6.10 units on a scale
Standard Deviation 1.606
|
5.68 units on a scale
Standard Deviation 1.736
|
6.54 units on a scale
Standard Deviation 1.312
|
SECONDARY outcome
Timeframe: 7, 15, 20 minutes post-CACPopulation: Per protocol population
A treatment efficacy CAC was performed 8 hours after drop instillation. Total redness was defined as the sum of the conjunctival, ciliary and episcleral redness scores, and was, thus, on a 0-12 scale, making the threshold for clinical significance a treatment difference of 3.0 units. Higher scores represent greater severity.
Outcome measures
| Measure |
AC-150 Combo
n=18 Participants
AC-150 Combo: 1 drop in each eye for up to 14 days
|
AC-150A 0.1%
n=17 Participants
AC-150A 0.1%: 1 drop in each eye once per day for up to 14 days
|
AC-150B 0.005%
n=17 Participants
AC-150B 0.005%: 1 drop in each eye once per day for up to 14 days
|
Vehicle
n=17 Participants
Vehicle: 1 drop in each eye once per day for up to 14 days
|
|---|---|---|---|---|
|
Total Redness at 8 Hours Post-Dose at Visit 4A
20 minutes post-CAC
|
4.07 units on a scale
Standard Deviation 1.905
|
5.35 units on a scale
Standard Deviation 1.831
|
5.54 units on a scale
Standard Deviation 1.859
|
6.63 units on a scale
Standard Deviation 1.415
|
|
Total Redness at 8 Hours Post-Dose at Visit 4A
7 minutes post-CAC
|
3.83 units on a scale
Standard Deviation 1.955
|
5.25 units on a scale
Standard Deviation 1.803
|
5.50 units on a scale
Standard Deviation 1.389
|
6.29 units on a scale
Standard Deviation 1.108
|
|
Total Redness at 8 Hours Post-Dose at Visit 4A
15 minutes post-CAC
|
3.88 units on a scale
Standard Deviation 1.927
|
5.50 units on a scale
Standard Deviation 1.730
|
5.63 units on a scale
Standard Deviation 1.680
|
6.72 units on a scale
Standard Deviation 1.169
|
SECONDARY outcome
Timeframe: 7, 15, 20 minutes post-CACPopulation: Per protocol population
A treatment efficacy CAC was performed 15 minutes after drop instillation. Lid swelling was assessed by the patient on a 0-3 scale (0=none to 3=severe). Average of lid swelling score over both eyes was analyzed.
Outcome measures
| Measure |
AC-150 Combo
n=18 Participants
AC-150 Combo: 1 drop in each eye for up to 14 days
|
AC-150A 0.1%
n=17 Participants
AC-150A 0.1%: 1 drop in each eye once per day for up to 14 days
|
AC-150B 0.005%
n=17 Participants
AC-150B 0.005%: 1 drop in each eye once per day for up to 14 days
|
Vehicle
n=17 Participants
Vehicle: 1 drop in each eye once per day for up to 14 days
|
|---|---|---|---|---|
|
Lid Swelling at Onset of Action (15 Minutes Post-dose)
7 minutes post-CAC
|
0.2 units on a scale
Standard Deviation 0.43
|
0.5 units on a scale
Standard Deviation 0.50
|
1.2 units on a scale
Standard Deviation 0.88
|
1.4 units on a scale
Standard Deviation 0.63
|
|
Lid Swelling at Onset of Action (15 Minutes Post-dose)
15 minutes post-CAC
|
0.4 units on a scale
Standard Deviation 0.61
|
0.7 units on a scale
Standard Deviation 0.75
|
1.1 units on a scale
Standard Deviation 0.97
|
1.5 units on a scale
Standard Deviation 0.74
|
|
Lid Swelling at Onset of Action (15 Minutes Post-dose)
20 minutes post-CAC
|
0.4 units on a scale
Standard Deviation 0.62
|
0.9 units on a scale
Standard Deviation 0.75
|
1.1 units on a scale
Standard Deviation 0.86
|
1.5 units on a scale
Standard Deviation 0.85
|
SECONDARY outcome
Timeframe: 7, 15, 20 minutes post-CACPopulation: Per protocol population
A treatment efficacy CAC was performed 16 hours after drop instillation. Lid swelling was assessed by the patient on a 0-3 scale (0=none to 3=severe). Average of lid swelling score over both eyes was analyzed.
Outcome measures
| Measure |
AC-150 Combo
n=18 Participants
AC-150 Combo: 1 drop in each eye for up to 14 days
|
AC-150A 0.1%
n=17 Participants
AC-150A 0.1%: 1 drop in each eye once per day for up to 14 days
|
AC-150B 0.005%
n=17 Participants
AC-150B 0.005%: 1 drop in each eye once per day for up to 14 days
|
Vehicle
n=17 Participants
Vehicle: 1 drop in each eye once per day for up to 14 days
|
|---|---|---|---|---|
|
Lid Swelling Duration of Action (16 Hours Post-dose)
7 minutes post-CAC
|
0.6 units on a scale
Standard Deviation 0.51
|
1.2 units on a scale
Standard Deviation 0.95
|
1.1 units on a scale
Standard Deviation 0.86
|
1.5 units on a scale
Standard Deviation 0.66
|
|
Lid Swelling Duration of Action (16 Hours Post-dose)
15 minutes post-CAC
|
0.7 units on a scale
Standard Deviation 0.59
|
1.3 units on a scale
Standard Deviation 1.00
|
1.1 units on a scale
Standard Deviation 0.86
|
1.6 units on a scale
Standard Deviation 0.70
|
|
Lid Swelling Duration of Action (16 Hours Post-dose)
20 minutes post-CAC
|
0.7 units on a scale
Standard Deviation 0.59
|
1.3 units on a scale
Standard Deviation 0.92
|
1.2 units on a scale
Standard Deviation 0.95
|
1.7 units on a scale
Standard Deviation 0.68
|
SECONDARY outcome
Timeframe: 7, 15, 20 minutes post-CACPopulation: Per protocol population
A treatment efficacy CAC was performed 8 hours after drop instillation. Lid swelling was assessed by the patient on a 0-3 scale (0=none to 3=severe). Average of lid swelling score over both eyes was analyzed.
Outcome measures
| Measure |
AC-150 Combo
n=18 Participants
AC-150 Combo: 1 drop in each eye for up to 14 days
|
AC-150A 0.1%
n=17 Participants
AC-150A 0.1%: 1 drop in each eye once per day for up to 14 days
|
AC-150B 0.005%
n=17 Participants
AC-150B 0.005%: 1 drop in each eye once per day for up to 14 days
|
Vehicle
n=17 Participants
Vehicle: 1 drop in each eye once per day for up to 14 days
|
|---|---|---|---|---|
|
Lid Swelling at 8 Hours Post-dose at Visit 4A
7 minutes post-CAC
|
0.4 units on a scale
Standard Deviation 0.51
|
0.7 units on a scale
Standard Deviation 0.58
|
1.1 units on a scale
Standard Deviation 1.03
|
1.6 units on a scale
Standard Deviation 0.93
|
|
Lid Swelling at 8 Hours Post-dose at Visit 4A
15 minutes post-CAC
|
0.5 units on a scale
Standard Deviation 0.50
|
1.0 units on a scale
Standard Deviation 0.76
|
1.1 units on a scale
Standard Deviation 1.00
|
1.6 units on a scale
Standard Deviation 0.70
|
|
Lid Swelling at 8 Hours Post-dose at Visit 4A
20 minutes post-CAC
|
0.5 units on a scale
Standard Deviation 0.50
|
1.0 units on a scale
Standard Deviation 0.88
|
1.0 units on a scale
Standard Deviation 0.94
|
1.6 units on a scale
Standard Deviation 0.66
|
SECONDARY outcome
Timeframe: 7, 15, 20 minutes post-CACPopulation: Per protocol population
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-150 Combo
n=18 Participants
AC-150 Combo: 1 drop in each eye for up to 14 days
|
AC-150A 0.1%
n=17 Participants
AC-150A 0.1%: 1 drop in each eye once per day for up to 14 days
|
AC-150B 0.005%
n=17 Participants
AC-150B 0.005%: 1 drop in each eye once per day for up to 14 days
|
Vehicle
n=17 Participants
Vehicle: 1 drop in each eye once per day for up to 14 days
|
|---|---|---|---|---|
|
Ear or Palate Pruritus at Onset of Action (15 Minutes Post-dose)
7 minutes post-CAC
|
0.4 units on a scale
Standard Deviation 0.78
|
0.3 units on a scale
Standard Deviation 0.59
|
0.5 units on a scale
Standard Deviation 0.94
|
1.2 units on a scale
Standard Deviation 1.39
|
|
Ear or Palate Pruritus at Onset of Action (15 Minutes Post-dose)
15 minutes post-CAC
|
0.4 units on a scale
Standard Deviation 0.85
|
0.6 units on a scale
Standard Deviation 0.93
|
0.7 units on a scale
Standard Deviation 1.10
|
1.4 units on a scale
Standard Deviation 1.33
|
|
Ear or Palate Pruritus at Onset of Action (15 Minutes Post-dose)
20 minutes post-CAC
|
0.6 units on a scale
Standard Deviation 1.04
|
0.8 units on a scale
Standard Deviation 0.90
|
1.0 units on a scale
Standard Deviation 1.27
|
1.5 units on a scale
Standard Deviation 1.42
|
SECONDARY outcome
Timeframe: 7, 15, 20 minutes post-CACPopulation: Per protocol population
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-150 Combo
n=18 Participants
AC-150 Combo: 1 drop in each eye for up to 14 days
|
AC-150A 0.1%
n=17 Participants
AC-150A 0.1%: 1 drop in each eye once per day for up to 14 days
|
AC-150B 0.005%
n=17 Participants
AC-150B 0.005%: 1 drop in each eye once per day for up to 14 days
|
Vehicle
n=17 Participants
Vehicle: 1 drop in each eye once per day for up to 14 days
|
|---|---|---|---|---|
|
Ear or Palate Pruritus at Duration of Action (16 Hours Post-dose)
7 minutes post-CAC
|
0.4 units on a scale
Standard Deviation 0.85
|
0.4 units on a scale
Standard Deviation 0.62
|
0.4 units on a scale
Standard Deviation 0.87
|
1.5 units on a scale
Standard Deviation 1.33
|
|
Ear or Palate Pruritus at Duration of Action (16 Hours Post-dose)
15 minutes post-CAC
|
0.7 units on a scale
Standard Deviation 1.13
|
1.3 units on a scale
Standard Deviation 0.99
|
0.6 units on a scale
Standard Deviation 1.11
|
1.5 units on a scale
Standard Deviation 1.37
|
|
Ear or Palate Pruritus at Duration of Action (16 Hours Post-dose)
20 minutes post-CAC
|
0.7 units on a scale
Standard Deviation 1.08
|
1.2 units on a scale
Standard Deviation 1.03
|
0.9 units on a scale
Standard Deviation 1.43
|
1.5 units on a scale
Standard Deviation 1.23
|
SECONDARY outcome
Timeframe: 7, 15, 20 minutes post-CACPopulation: Per protocol population
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-150 Combo
n=18 Participants
AC-150 Combo: 1 drop in each eye for up to 14 days
|
AC-150A 0.1%
n=17 Participants
AC-150A 0.1%: 1 drop in each eye once per day for up to 14 days
|
AC-150B 0.005%
n=17 Participants
AC-150B 0.005%: 1 drop in each eye once per day for up to 14 days
|
Vehicle
n=17 Participants
Vehicle: 1 drop in each eye once per day for up to 14 days
|
|---|---|---|---|---|
|
Ear or Palate Pruritus at 8 Hours Post-dose at Visit 4A
20 minutes post-CAC
|
0.5 units on a scale
Standard Deviation 0.86
|
1.2 units on a scale
Standard Deviation 1.01
|
0.8 units on a scale
Standard Deviation 1.20
|
1.3 units on a scale
Standard Deviation 1.16
|
|
Ear or Palate Pruritus at 8 Hours Post-dose at Visit 4A
7 minutes post-CAC
|
0.3 units on a scale
Standard Deviation 0.69
|
0.7 units on a scale
Standard Deviation 0.85
|
0.6 units on a scale
Standard Deviation 1.06
|
1.2 units on a scale
Standard Deviation 1.24
|
|
Ear or Palate Pruritus at 8 Hours Post-dose at Visit 4A
15 minutes post-CAC
|
0.4 units on a scale
Standard Deviation 0.78
|
1.1 units on a scale
Standard Deviation 1.05
|
0.8 units on a scale
Standard Deviation 1.24
|
1.2 units on a scale
Standard Deviation 1.15
|
SECONDARY outcome
Timeframe: upon instillation, 1 minute and 2 minutes post instillationPopulation: Intent to Treat (ITT). Number of analyzed subjects differ due to subject discontinuation during the study.
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-150 Combo
n=21 Participants
AC-150 Combo: 1 drop in each eye for up to 14 days
|
AC-150A 0.1%
n=21 Participants
AC-150A 0.1%: 1 drop in each eye once per day for up to 14 days
|
AC-150B 0.005%
n=20 Participants
AC-150B 0.005%: 1 drop in each eye once per day for up to 14 days
|
Vehicle
n=21 Participants
Vehicle: 1 drop in each eye once per day for up to 14 days
|
|---|---|---|---|---|
|
Tolerability of Study Medication at Visit 2B
Upon instillation
|
2.3 units on a scale
Standard Deviation 1.94
|
2.2 units on a scale
Standard Deviation 2.19
|
1.1 units on a scale
Standard Deviation 1.54
|
2.0 units on a scale
Standard Deviation 1.94
|
|
Tolerability of Study Medication at Visit 2B
1 minute post-instillation
|
2.3 units on a scale
Standard Deviation 1.59
|
2.0 units on a scale
Standard Deviation 2.08
|
0.9 units on a scale
Standard Deviation 1.45
|
1.7 units on a scale
Standard Deviation 1.55
|
|
Tolerability of Study Medication at Visit 2B
2 minutes post-instillation
|
1.9 units on a scale
Standard Deviation 1.41
|
1.4 units on a scale
Standard Deviation 1.82
|
0.8 units on a scale
Standard Deviation 1.25
|
1.6 units on a scale
Standard Deviation 1.40
|
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-150 Combo
n=20 Participants
AC-150 Combo: 1 drop in each eye for up to 14 days
|
AC-150A 0.1%
n=19 Participants
AC-150A 0.1%: 1 drop in each eye once per day for up to 14 days
|
AC-150B 0.005%
n=18 Participants
AC-150B 0.005%: 1 drop in each eye once per day for up to 14 days
|
Vehicle
n=18 Participants
Vehicle: 1 drop in each eye once per day for up to 14 days
|
|---|---|---|---|---|
|
Tolerability of Study Medication at Visit 3
Upon instillation
|
2.0 units on a scale
Standard Deviation 1.86
|
1.5 units on a scale
Standard Deviation 2.12
|
0.9 units on a scale
Standard Deviation 1.18
|
1.4 units on a scale
Standard Deviation 1.78
|
|
Tolerability of Study Medication at Visit 3
1 minute post-instillation
|
1.6 units on a scale
Standard Deviation 1.31
|
1.4 units on a scale
Standard Deviation 1.42
|
0.8 units on a scale
Standard Deviation 1.06
|
1.0 units on a scale
Standard Deviation 1.29
|
|
Tolerability of Study Medication at Visit 3
2 minutes post-instillation
|
1.6 units on a scale
Standard Deviation 1.33
|
1.3 units on a scale
Standard Deviation 1.25
|
0.7 units on a scale
Standard Deviation 0.96
|
0.8 units on a scale
Standard Deviation 1.25
|
Adverse Events
AC-150 Combo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
AC-150A 0.1%
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
AC-150B 0.005%
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Vehicle
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
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