Trial Outcomes & Findings for Evaluation of Brimonidine Tartrate/Ketotifen Fumarate Combination in Adults With Seasonal Allergic Conjunctivitis (NCT NCT05591755)
NCT ID: NCT05591755
Last Updated: 2025-07-01
Results Overview
Ocular redness evaluated by the Investigator using slit lamp at 10(±1), 30(±1), 60(±5), 360(±5), 420(±5), and 480(±5) minutes post-instillation of assigned IP at Visit 2 (0-4 scale, allowing half unit increments), with 4 being the worse outcome.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
229 participants
Primary outcome timeframe
Assessed up to 480 minutes post-instillation of assigned IP
Results posted on
2025-07-01
Participant Flow
Each subject was randomized to receive one of the four treatments one time in both eyes
Participant milestones
| Measure |
Brimonidine Tartrate 0.025%/ Ketotifen Fumarate 0.035% Ophthalmic Solution
Brimonidine Tartrate 0.025%/ Ketotifen Fumarate 0.035% Ophthalmic Solution
|
Ketotifen Fumarate Ophthalmic Solution 0.035%
Ketotifen fumarate ophthalmic solution 0.035%
|
Brimonidine Tartrate Ophthalmic Solution 0.025%
Brimonidine tartrate ophthalmic solution 0.025%
|
Vehicle Ophthalmic Solution
Experimental: Vehicle ophthalmic solution
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
58
|
57
|
58
|
56
|
|
Overall Study
COMPLETED
|
57
|
56
|
56
|
56
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
2
|
0
|
Reasons for withdrawal
| Measure |
Brimonidine Tartrate 0.025%/ Ketotifen Fumarate 0.035% Ophthalmic Solution
Brimonidine Tartrate 0.025%/ Ketotifen Fumarate 0.035% Ophthalmic Solution
|
Ketotifen Fumarate Ophthalmic Solution 0.035%
Ketotifen fumarate ophthalmic solution 0.035%
|
Brimonidine Tartrate Ophthalmic Solution 0.025%
Brimonidine tartrate ophthalmic solution 0.025%
|
Vehicle Ophthalmic Solution
Experimental: Vehicle ophthalmic solution
|
|---|---|---|---|---|
|
Overall Study
Screen Failure
|
1
|
0
|
0
|
0
|
|
Overall Study
Protocol Violation
|
0
|
0
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Evaluation of Brimonidine Tartrate/Ketotifen Fumarate Combination in Adults With Seasonal Allergic Conjunctivitis
Baseline characteristics by cohort
| Measure |
Brimonidine Tartrate 0.025%/ Ketotifen Fumarate 0.035% Ophthalmic Solution (n = 56)
n=57 Participants
Brimonidine Tartrate 0.025%/ Ketotifen Fumarate 0.035% Ophthalmic Solution: Brimonidine Tartrate 0.025%/ Ketotifen Fumarate 0.035% Ophthalmic Solution
|
Ketotifen Fumarate Ophthalmic Solution 0.035% (n = 56)
n=56 Participants
Ketotifen fumarate ophthalmic solution 0.035% (n = 56): Ketotifen fumarate ophthalmic solution 0.035% (n = 56)
|
Brimonidine Tartrate Ophthalmic Solution 0.025% (n = 56)
n=58 Participants
Brimonidine tartrate ophthalmic solution 0.025% (n = 56): Brimonidine tartrate ophthalmic solution 0.025% (n = 56)
|
Vehicle Ophthalmic Solution (n = 56)
n=56 Participants
Experimental: Vehicle ophthalmic solution (n = 56): Experimental: Vehicle ophthalmic solution (n = 56)
|
Total
n=227 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
35.5 years
STANDARD_DEVIATION 15.06 • n=5 Participants
|
35.0 years
STANDARD_DEVIATION 12.28 • n=7 Participants
|
37.1 years
STANDARD_DEVIATION 16.05 • n=5 Participants
|
37.1 years
STANDARD_DEVIATION 16.61 • n=4 Participants
|
36.2 years
STANDARD_DEVIATION 15.03 • n=21 Participants
|
|
Age, Customized
Less than 65 years
|
52 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
50 Participants
n=4 Participants
|
212 Participants
n=21 Participants
|
|
Age, Customized
Greater or equal to 65 years
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
39 Participants
n=4 Participants
|
150 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
77 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
12 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
55 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
45 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
41 Participants
n=4 Participants
|
172 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
|
12 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
44 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
7 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
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
35 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
36 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
137 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
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)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
57 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
56 Participants
n=4 Participants
|
227 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Assessed up to 480 minutes post-instillation of assigned IPOcular itching score evaluated by the subject at 10(±1), 30(±1), 60(±5), 360(±5), 420(±5), and 480(±5) minutes post-instillation of assigned IP at Visit 2 (0-4 scale, allowing half unit increments), with 4 is the worse outcome.
Outcome measures
| Measure |
Brimonidine Tartrate 0.025%/ Ketotifen Fumarate 0.035% Ophthalmic Solution
n=57 Participants
Brimonidine Tartrate 0.025%/ Ketotifen Fumarate 0.035% Ophthalmic Solution
|
Ketotifen Fumarate Ophthalmic Solution 0.035%
n=56 Participants
Ketotifen fumarate ophthalmic solution 0.035%
|
Brimonidine Tartrate Ophthalmic Solution 0.025%
n=58 Participants
Brimonidine tartrate ophthalmic solution 0.025%
|
Vehicle Ophthalmic Solution
n=56 Participants
Experimental: Vehicle ophthalmic solution
|
|---|---|---|---|---|
|
Ocular Itching Symptom Score
Visit 2, Before Qualification ABC
|
0.175 score on a scale
Standard Deviation 0.6031
|
0.085 score on a scale
Standard Deviation 0.3136
|
0.267 score on a scale
Standard Deviation 0.7549
|
0.098 score on a scale
Standard Deviation 0.3493
|
|
Ocular Itching Symptom Score
Visit 2, 90 Minutes during Qualification ABC (Baseline)
|
2.728 score on a scale
Standard Deviation 0.5830
|
2.719 score on a scale
Standard Deviation 0.5310
|
2.659 score on a scale
Standard Deviation 0.4581
|
2.647 score on a scale
Standard Deviation 0.5174
|
|
Ocular Itching Symptom Score
Visit 2, 10 min Post-Instillation
|
1.807 score on a scale
Standard Deviation 1.0501
|
1.808 score on a scale
Standard Deviation 0.8712
|
1.991 score on a scale
Standard Deviation 1.0163
|
2.022 score on a scale
Standard Deviation 0.8302
|
|
Ocular Itching Symptom Score
Visit 2, 30 min Post-Instillation
|
1.443 score on a scale
Standard Deviation 0.8914
|
1.335 score on a scale
Standard Deviation 0.8275
|
1.513 score on a scale
Standard Deviation 1.0621
|
1.790 score on a scale
Standard Deviation 0.8979
|
|
Ocular Itching Symptom Score
Visit 2, 60 min Post-Instillation
|
1.110 score on a scale
Standard Deviation 0.8737
|
1.205 score on a scale
Standard Deviation 0.9171
|
1.220 score on a scale
Standard Deviation 0.9425
|
1.438 score on a scale
Standard Deviation 0.7720
|
|
Ocular Itching Symptom Score
Visit 2, 360 min Post-Instillation
|
0.811 score on a scale
Standard Deviation 0.8599
|
0.723 score on a scale
Standard Deviation 0.7365
|
1.125 score on a scale
Standard Deviation 0.9485
|
1.089 score on a scale
Standard Deviation 1.0252
|
|
Ocular Itching Symptom Score
Visit 2, 420 min Post-Instillation
|
0.851 score on a scale
Standard Deviation 0.8568
|
0.656 score on a scale
Standard Deviation 0.7348
|
1.078 score on a scale
Standard Deviation 0.9461
|
0.978 score on a scale
Standard Deviation 0.8624
|
|
Ocular Itching Symptom Score
Visit 2, 480 min Post-Instillation
|
0.961 score on a scale
Standard Deviation 1.0020
|
0.777 score on a scale
Standard Deviation 0.8786
|
1.009 score on a scale
Standard Deviation 0.9188
|
1.063 score on a scale
Standard Deviation 0.9011
|
PRIMARY outcome
Timeframe: Assessed up to 480 minutes post-instillation of assigned IPOcular redness evaluated by the Investigator using slit lamp at 10(±1), 30(±1), 60(±5), 360(±5), 420(±5), and 480(±5) minutes post-instillation of assigned IP at Visit 2 (0-4 scale, allowing half unit increments), with 4 being the worse outcome.
Outcome measures
| Measure |
Brimonidine Tartrate 0.025%/ Ketotifen Fumarate 0.035% Ophthalmic Solution
n=55 Participants
Brimonidine Tartrate 0.025%/ Ketotifen Fumarate 0.035% Ophthalmic Solution
|
Ketotifen Fumarate Ophthalmic Solution 0.035%
n=55 Participants
Ketotifen fumarate ophthalmic solution 0.035%
|
Brimonidine Tartrate Ophthalmic Solution 0.025%
n=58 Participants
Brimonidine tartrate ophthalmic solution 0.025%
|
Vehicle Ophthalmic Solution
n=56 Participants
Experimental: Vehicle ophthalmic solution
|
|---|---|---|---|---|
|
Ocular Redness Measured by Ocular Itching Scale
Visit 2, Before Qualification ABC
|
1.218 score on a scale
Standard Deviation 0.5815
|
1.327 score on a scale
Standard Deviation 0.5771
|
1.384 score on a scale
Standard Deviation 0.5815
|
1.268 score on a scale
Standard Deviation 0.6464
|
|
Ocular Redness Measured by Ocular Itching Scale
Visit 2, 90 Minutes during Qualification ABC (Baseline)
|
2.469 score on a scale
Standard Deviation 0.5430
|
2.500 score on a scale
Standard Deviation 0.5045
|
2.642 score on a scale
Standard Deviation 0.5832
|
2.478 score on a scale
Standard Deviation 0.4984
|
|
Ocular Redness Measured by Ocular Itching Scale
Visit 2, 10 min Post-Instillation
|
1.127 score on a scale
Standard Deviation 0.8253
|
2.116 score on a scale
Standard Deviation 0.6178
|
1.293 score on a scale
Standard Deviation 0.8194
|
2.268 score on a scale
Standard Deviation 0.6195
|
|
Ocular Redness Measured by Ocular Itching Scale
Visit 2, 30 min Post-Instillation
|
0.934 score on a scale
Standard Deviation 0.7388
|
1.911 score on a scale
Standard Deviation 0.6421
|
1.103 score on a scale
Standard Deviation 0.7609
|
2.165 score on a scale
Standard Deviation 0.7011
|
|
Ocular Redness Measured by Ocular Itching Scale
Visit 2, 60 min Post-Instillation
|
0.904 score on a scale
Standard Deviation 0.6924
|
1.795 score on a scale
Standard Deviation 0.7184
|
1.026 score on a scale
Standard Deviation 0.7517
|
2.098 score on a scale
Standard Deviation 0.6787
|
|
Ocular Redness Measured by Ocular Itching Scale
Visit 2, 360 min Post-Instillation
|
1.316 score on a scale
Standard Deviation 0.8245
|
1.723 score on a scale
Standard Deviation 0.7608
|
1.405 score on a scale
Standard Deviation 0.6896
|
1.955 score on a scale
Standard Deviation 0.6416
|
|
Ocular Redness Measured by Ocular Itching Scale
Visit 2, 420 min Post-Instillation
|
1.456 score on a scale
Standard Deviation 0.7936
|
1.759 score on a scale
Standard Deviation 0.7847
|
1.582 score on a scale
Standard Deviation 0.6873
|
1.933 score on a scale
Standard Deviation 0.6440
|
|
Ocular Redness Measured by Ocular Itching Scale
Visit 2, 480 min Post-Instillation
|
1.553 score on a scale
Standard Deviation 0.8125
|
1.929 score on a scale
Standard Deviation 0.8471
|
1.832 score on a scale
Standard Deviation 0.7757
|
2.063 score on a scale
Standard Deviation 0.7043
|
SECONDARY outcome
Timeframe: up to 480 minutes post-instillation of assigned IPTearing evaluated by the subject at 10(±1), 30(±1), 60(±5), 360(±5), 420(±5), and 480(±5) minutes post-instillation of assigned IP at Visit 2 (0-4 scale, NOT allowing half unit increments), with 4 being the worse outcome.
Outcome measures
| Measure |
Brimonidine Tartrate 0.025%/ Ketotifen Fumarate 0.035% Ophthalmic Solution
n=57 Participants
Brimonidine Tartrate 0.025%/ Ketotifen Fumarate 0.035% Ophthalmic Solution
|
Ketotifen Fumarate Ophthalmic Solution 0.035%
n=56 Participants
Ketotifen fumarate ophthalmic solution 0.035%
|
Brimonidine Tartrate Ophthalmic Solution 0.025%
n=58 Participants
Brimonidine tartrate ophthalmic solution 0.025%
|
Vehicle Ophthalmic Solution
n=56 Participants
Experimental: Vehicle ophthalmic solution
|
|---|---|---|---|---|
|
Tearing Measured by Watery Eyes Scale
Visit 2, 60 min Post-Instillation
|
0.66 score on a scale
Standard Deviation 0.757
|
0.65 score on a scale
Standard Deviation 0.909
|
0.73 score on a scale
Standard Deviation 0.865
|
0.76 score on a scale
Standard Deviation 0.879
|
|
Tearing Measured by Watery Eyes Scale
Visit 2, 360 min Post-Instillation change from baseline
|
-0.92 score on a scale
Standard Deviation 1.113
|
-0.82 score on a scale
Standard Deviation 0.811
|
-0.77 score on a scale
Standard Deviation 1.035
|
-0.45 score on a scale
Standard Deviation 1.030
|
|
Tearing Measured by Watery Eyes Scale
Visit 2, 420 min Post-Instillation
|
0.50 score on a scale
Standard Deviation 0.726
|
0.34 score on a scale
Standard Deviation 0.581
|
0.68 score on a scale
Standard Deviation 0.945
|
0.46 score on a scale
Standard Deviation 0.582
|
|
Tearing Measured by Watery Eyes Scale
Visit 2, 420 min Post-Instillation change from baseline
|
-0.84 score on a scale
Standard Deviation 1.123
|
-0.89 score on a scale
Standard Deviation 0.857
|
-0.72 score on a scale
Standard Deviation 1.085
|
-0.64 score on a scale
Standard Deviation 1.065
|
|
Tearing Measured by Watery Eyes Scale
Visit 2, 480 min Post-Instillation
|
0.54 score on a scale
Standard Deviation 0.761
|
0.27 score on a scale
Standard Deviation 0.539
|
0.56 score on a scale
Standard Deviation 0.720
|
0.46 score on a scale
Standard Deviation 0.785
|
|
Tearing Measured by Watery Eyes Scale
Visit 2, 480 min Post-Instillation change from baseline
|
-0.81 score on a scale
Standard Deviation 1.097
|
-0.96 score on a scale
Standard Deviation 0.830
|
-0.84 score on a scale
Standard Deviation 1.056
|
-0.63 score on a scale
Standard Deviation 1.102
|
|
Tearing Measured by Watery Eyes Scale
Visit 2, 60 min Post-Instillation change from baseline
|
-0.68 score on a scale
Standard Deviation 0.989
|
-0.58 score on a scale
Standard Deviation 1.048
|
-0.67 score on a scale
Standard Deviation 1.024
|
-0.34 score on a scale
Standard Deviation 0.944
|
|
Tearing Measured by Watery Eyes Scale
Visit 2, 360 min Post-Instillation
|
0.42 score on a scale
Standard Deviation 0.667
|
0.41 score on a scale
Standard Deviation 0.668
|
0.64 score on a scale
Standard Deviation 0.883
|
0.65 score on a scale
Standard Deviation 0.744
|
|
Tearing Measured by Watery Eyes Scale
Visit 2, Before Qualification ABC
|
0.12 score on a scale
Standard Deviation 0.503
|
0.04 score on a scale
Standard Deviation 0.197
|
0.22 score on a scale
Standard Deviation 0.773
|
0.13 score on a scale
Standard Deviation 0.429
|
|
Tearing Measured by Watery Eyes Scale
Visit 2, 90 Minutes during Qualification ABC (Baseline)
|
1.34 score on a scale
Standard Deviation 1.192
|
1.23 score on a scale
Standard Deviation 0.977
|
1.41 score on a scale
Standard Deviation 1.219
|
1.10 score on a scale
Standard Deviation 0.997
|
|
Tearing Measured by Watery Eyes Scale
Visit 2, 10 min Post-Instillation
|
1.21 score on a scale
Standard Deviation 1.056
|
1.10 score on a scale
Standard Deviation 0.988
|
1.16 score on a scale
Standard Deviation 1.056
|
1.14 score on a scale
Standard Deviation 0.971
|
|
Tearing Measured by Watery Eyes Scale
Visit 2, 10 min Post-Instillation change from baseline
|
-0.13 score on a scale
Standard Deviation 0.961
|
-0.13 score on a scale
Standard Deviation 0.839
|
-0.25 score on a scale
Standard Deviation 0.768
|
0.04 score on a scale
Standard Deviation 0.945
|
|
Tearing Measured by Watery Eyes Scale
Visit 2, 30 min Post-Instillation
|
0.77 score on a scale
Standard Deviation 0.835
|
0.79 score on a scale
Standard Deviation 0.883
|
0.94 score on a scale
Standard Deviation 0.937
|
0.98 score on a scale
Standard Deviation 0.958
|
|
Tearing Measured by Watery Eyes Scale
Visit 2, 30 min Post-Instillation change from baseline
|
-0.57 score on a scale
Standard Deviation 1.006
|
-0.44 score on a scale
Standard Deviation 0.826
|
-0.47 score on a scale
Standard Deviation 0.991
|
-0.12 score on a scale
Standard Deviation 0.853
|
SECONDARY outcome
Timeframe: up to 480 minutes post-instillation of assigned IPLid swelling evaluated by the subject at 10(±1), 30(±1), 60(±5), 360(±5), 420(±5), and 480(±5) minutes post-instillation of assigned IP at Visit 2 (0-3 scale, NOT allowing half unit increments), with 3 being the worst outcome
Outcome measures
| Measure |
Brimonidine Tartrate 0.025%/ Ketotifen Fumarate 0.035% Ophthalmic Solution
n=57 Participants
Brimonidine Tartrate 0.025%/ Ketotifen Fumarate 0.035% Ophthalmic Solution
|
Ketotifen Fumarate Ophthalmic Solution 0.035%
n=56 Participants
Ketotifen fumarate ophthalmic solution 0.035%
|
Brimonidine Tartrate Ophthalmic Solution 0.025%
n=58 Participants
Brimonidine tartrate ophthalmic solution 0.025%
|
Vehicle Ophthalmic Solution
n=56 Participants
Experimental: Vehicle ophthalmic solution
|
|---|---|---|---|---|
|
Lid Swelling Measured by Eyelid Swelling Scale
Visit 2, Before Qualification ABC
|
0.09 score on a scale
Standard Deviation 0.434
|
0.00 score on a scale
Standard Deviation 0.000
|
0.11 score on a scale
Standard Deviation 0.409
|
0.04 score on a scale
Standard Deviation 0.187
|
|
Lid Swelling Measured by Eyelid Swelling Scale
Visit 2, 90 Minutes during Qualification ABC (Baseline)
|
1.04 score on a scale
Standard Deviation 0.972
|
0.70 score on a scale
Standard Deviation 0.883
|
1.05 score on a scale
Standard Deviation 0.921
|
0.92 score on a scale
Standard Deviation 0.873
|
|
Lid Swelling Measured by Eyelid Swelling Scale
Visit 2, 10 min Post-Instillation
|
0.85 score on a scale
Standard Deviation 0.973
|
0.77 score on a scale
Standard Deviation 0.874
|
1.03 score on a scale
Standard Deviation 0.957
|
0.98 score on a scale
Standard Deviation 0.904
|
|
Lid Swelling Measured by Eyelid Swelling Scale
Visit 2, 10 min Post-Instillation change from baseline
|
-0.18 score on a scale
Standard Deviation 0.748
|
0.07 score on a scale
Standard Deviation 0.606
|
-0.03 score on a scale
Standard Deviation 0.652
|
0.06 score on a scale
Standard Deviation 0.714
|
|
Lid Swelling Measured by Eyelid Swelling Scale
Visit 2, 30 min Post-Instillation
|
0.75 score on a scale
Standard Deviation 0.851
|
0.75 score on a scale
Standard Deviation 0.905
|
0.72 score on a scale
Standard Deviation 0.750
|
0.90 score on a scale
Standard Deviation 0.881
|
|
Lid Swelling Measured by Eyelid Swelling Scale
Visit 2, 30 min Post-Instillation change from baseline
|
-0.28 score on a scale
Standard Deviation 0.851
|
0.05 score on a scale
Standard Deviation 0.644
|
-0.34 score on a scale
Standard Deviation 0.740
|
-0.02 score on a scale
Standard Deviation 0.798
|
|
Lid Swelling Measured by Eyelid Swelling Scale
Visit 2, 60 min Post-Instillation
|
0.65 score on a scale
Standard Deviation 0.802
|
0.64 score on a scale
Standard Deviation 0.841
|
0.59 score on a scale
Standard Deviation 0.744
|
0.81 score on a scale
Standard Deviation 0.902
|
|
Lid Swelling Measured by Eyelid Swelling Scale
Visit 2, 60 min Post-Instillation change from baseline
|
-0.39 score on a scale
Standard Deviation 0.835
|
-0.05 score on a scale
Standard Deviation 0.644
|
-0.47 score on a scale
Standard Deviation 0.805
|
-0.11 score on a scale
Standard Deviation 0.785
|
|
Lid Swelling Measured by Eyelid Swelling Scale
Visit 2, 360 min Post-Instillation
|
0.48 score on a scale
Standard Deviation 0.762
|
0.43 score on a scale
Standard Deviation 0.817
|
0.61 score on a scale
Standard Deviation 0.864
|
0.67 score on a scale
Standard Deviation 0.886
|
|
Lid Swelling Measured by Eyelid Swelling Scale
Visit 2, 360 min Post-Instillation change from baseline
|
-0.55 score on a scale
Standard Deviation 0.817
|
-0.27 score on a scale
Standard Deviation 0.707
|
-0.44 score on a scale
Standard Deviation 0.869
|
-0.25 score on a scale
Standard Deviation 0.929
|
|
Lid Swelling Measured by Eyelid Swelling Scale
Visit 2, 420 min Post-Instillation
|
0.60 score on a scale
Standard Deviation 0.832
|
0.44 score on a scale
Standard Deviation 0.695
|
0.61 score on a scale
Standard Deviation 0.838
|
0.61 score on a scale
Standard Deviation 0.824
|
|
Lid Swelling Measured by Eyelid Swelling Scale
Visit 2, 420 min Post-Instillation change from baseline
|
-0.44 score on a scale
Standard Deviation 0.921
|
-0.26 score on a scale
Standard Deviation 0.681
|
-0.44 score on a scale
Standard Deviation 0.822
|
-0.31 score on a scale
Standard Deviation 0.877
|
|
Lid Swelling Measured by Eyelid Swelling Scale
Visit 2, 480 min Post-Instillation
|
0.55 score on a scale
Standard Deviation 0.777
|
0.42 score on a scale
Standard Deviation 0.731
|
0.55 score on a scale
Standard Deviation 0.826
|
0.58 score on a scale
Standard Deviation 0.857
|
|
Lid Swelling Measured by Eyelid Swelling Scale
Visit 2, 480 min Post-Instillation change from baseline
|
-0.48 score on a scale
Standard Deviation 0.802
|
-0.28 score on a scale
Standard Deviation 0.750
|
-0.50 score on a scale
Standard Deviation 0.827
|
-0.34 score on a scale
Standard Deviation 0.895
|
SECONDARY outcome
Timeframe: up to 480 minutes post-instillation of assigned IPChemosis evaluated by the Investigator using slit lamp at 10(±1), 30(±1), 60(±5), 360(±5), 420(±5), and 480(±5) minutes post-instillation of assigned IP at Visit 2 (0-4 scale, allowing half unit increments), with 4 being the worse outcome.
Outcome measures
| Measure |
Brimonidine Tartrate 0.025%/ Ketotifen Fumarate 0.035% Ophthalmic Solution
n=57 Participants
Brimonidine Tartrate 0.025%/ Ketotifen Fumarate 0.035% Ophthalmic Solution
|
Ketotifen Fumarate Ophthalmic Solution 0.035%
n=56 Participants
Ketotifen fumarate ophthalmic solution 0.035%
|
Brimonidine Tartrate Ophthalmic Solution 0.025%
n=58 Participants
Brimonidine tartrate ophthalmic solution 0.025%
|
Vehicle Ophthalmic Solution
n=56 Participants
Experimental: Vehicle ophthalmic solution
|
|---|---|---|---|---|
|
Chemosis Evaluated
Visit 2, Before Qualification ABC
|
0.000 score on a scale
Standard Deviation 0.0000
|
0.000 score on a scale
Standard Deviation 0.0000
|
0.004 score on a scale
Standard Deviation 0.0328
|
0.022 score on a scale
Standard Deviation 0.1372
|
|
Chemosis Evaluated
Visit 2, 90 Minutes during Qualification ABC (Baseline)
|
0.298 score on a scale
Standard Deviation 0.7249
|
0.143 score on a scale
Standard Deviation 0.3626
|
0.134 score on a scale
Standard Deviation 0.3811
|
0.129 score on a scale
Standard Deviation 0.3843
|
|
Chemosis Evaluated
Visit 2, 10 min Post-Instillation
|
0.228 score on a scale
Standard Deviation 0.5830
|
0.121 score on a scale
Standard Deviation 0.3371
|
0.086 score on a scale
Standard Deviation 0.2502
|
0.156 score on a scale
Standard Deviation 0.4537
|
|
Chemosis Evaluated
Visit 2, 10 min Post-Instillation change from baseline
|
-0.070 score on a scale
Standard Deviation 0.3196
|
-0.022 score on a scale
Standard Deviation 0.2490
|
-0.047 score on a scale
Standard Deviation 0.1957
|
0.027 score on a scale
Standard Deviation 0.3804
|
|
Chemosis Evaluated
Visit 2, 30 min Post-Instillation
|
0.158 score on a scale
Standard Deviation 0.5274
|
0.094 score on a scale
Standard Deviation 0.3110
|
0.039 score on a scale
Standard Deviation 0.1609
|
0.134 score on a scale
Standard Deviation 0.4290
|
|
Chemosis Evaluated
Visit 2, 30 min Post-Instillation change from baseline
|
-0.140 score on a scale
Standard Deviation 0.4092
|
-0.049 score on a scale
Standard Deviation 0.2877
|
-0.095 score on a scale
Standard Deviation 0.2683
|
0.004 score on a scale
Standard Deviation 0.5319
|
|
Chemosis Evaluated
Visit 2, 60 min Post-Instillation
|
0.154 score on a scale
Standard Deviation 0.5298
|
0.094 score on a scale
Standard Deviation 0.2883
|
0.052 score on a scale
Standard Deviation 0.1973
|
0.112 score on a scale
Standard Deviation 0.3597
|
|
Chemosis Evaluated
Visit 2, 60 min Post-Instillation change from baseline
|
-0.145 score on a scale
Standard Deviation 0.4405
|
-0.049 score on a scale
Standard Deviation 0.2450
|
-0.082 score on a scale
Standard Deviation 0.2406
|
-0.018 score on a scale
Standard Deviation 0.4764
|
|
Chemosis Evaluated
Visit 2, 360 min Post-Instillation
|
0.114 score on a scale
Standard Deviation 0.3662
|
0.094 score on a scale
Standard Deviation 0.2960
|
0.069 score on a scale
Standard Deviation 0.2556
|
0.089 score on a scale
Standard Deviation 0.2756
|
|
Chemosis Evaluated
Visit 2, 360 min Post-Instillation change from baseline
|
-0.184 score on a scale
Standard Deviation 0.5561
|
-0.049 score on a scale
Standard Deviation 0.3706
|
-0.065 score on a scale
Standard Deviation 0.2321
|
-0.040 score on a scale
Standard Deviation 0.4258
|
|
Chemosis Evaluated
Visit 2, 420 min Post-Instillation
|
0.105 score on a scale
Standard Deviation 0.3502
|
0.067 score on a scale
Standard Deviation 0.2050
|
0.082 score on a scale
Standard Deviation 0.2624
|
0.076 score on a scale
Standard Deviation 0.2608
|
|
Chemosis Evaluated
Visit 2, 420 min Post-Instillation change from baseline
|
-0.193 score on a scale
Standard Deviation 0.5408
|
-0.076 score on a scale
Standard Deviation 0.2564
|
-0.052 score on a scale
Standard Deviation 0.2555
|
-0.054 score on a scale
Standard Deviation 0.4439
|
|
Chemosis Evaluated
Visit 2, 480 min Post-Instillation
|
0.088 score on a scale
Standard Deviation 0.3006
|
0.076 score on a scale
Standard Deviation 0.2232
|
0.091 score on a scale
Standard Deviation 0.2678
|
0.058 score on a scale
Standard Deviation 0.2184
|
|
Chemosis Evaluated
Visit 2, 480 min Post-Instillation change from baseline
|
-0.211 score on a scale
Standard Deviation 0.5505
|
-0.067 score on a scale
Standard Deviation 0.2919
|
-0.043 score on a scale
Standard Deviation 0.2815
|
-0.071 score on a scale
Standard Deviation 0.4490
|
Adverse Events
Brimonidine Tartrate 0.025%/ Ketotifen Fumarate 0.035% Ophthalmic Solution
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Ketotifen Fumarate Ophthalmic Solution 0.035%
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Brimonidine Tartrate Ophthalmic Solution 0.025%
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Vehicle Ophthalmic Solution
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Brimonidine Tartrate 0.025%/ Ketotifen Fumarate 0.035% Ophthalmic Solution
n=57 participants at risk
Brimonidine Tartrate 0.025%/ Ketotifen Fumarate 0.035% Ophthalmic Solution
|
Ketotifen Fumarate Ophthalmic Solution 0.035%
n=56 participants at risk
Ketotifen fumarate ophthalmic solution 0.035%
|
Brimonidine Tartrate Ophthalmic Solution 0.025%
n=58 participants at risk
Brimonidine tartrate ophthalmic solution 0.025%
|
Vehicle Ophthalmic Solution
n=56 participants at risk
Experimental: Vehicle ophthalmic solution
|
|---|---|---|---|---|
|
Eye disorders
Visual acuity reduced
|
1.8%
1/57 • Assessed for approximately 8 hours after treatment
Ocular Adverse events were reported at the participant level
|
3.6%
2/56 • Assessed for approximately 8 hours after treatment
Ocular Adverse events were reported at the participant level
|
3.4%
2/58 • Assessed for approximately 8 hours after treatment
Ocular Adverse events were reported at the participant level
|
3.6%
2/56 • Assessed for approximately 8 hours after treatment
Ocular Adverse events were reported at the participant level
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/57 • Assessed for approximately 8 hours after treatment
Ocular Adverse events were reported at the participant level
|
3.6%
2/56 • Assessed for approximately 8 hours after treatment
Ocular Adverse events were reported at the participant level
|
0.00%
0/58 • Assessed for approximately 8 hours after treatment
Ocular Adverse events were reported at the participant level
|
1.8%
1/56 • Assessed for approximately 8 hours after treatment
Ocular Adverse events were reported at the participant level
|
|
Eye disorders
Eyelid exfoliation
|
0.00%
0/57 • Assessed for approximately 8 hours after treatment
Ocular Adverse events were reported at the participant level
|
0.00%
0/56 • Assessed for approximately 8 hours after treatment
Ocular Adverse events were reported at the participant level
|
0.00%
0/58 • Assessed for approximately 8 hours after treatment
Ocular Adverse events were reported at the participant level
|
1.8%
1/56 • Assessed for approximately 8 hours after treatment
Ocular Adverse events were reported at the participant level
|
|
Eye disorders
Erythema of eyelid
|
0.00%
0/57 • Assessed for approximately 8 hours after treatment
Ocular Adverse events were reported at the participant level
|
0.00%
0/56 • Assessed for approximately 8 hours after treatment
Ocular Adverse events were reported at the participant level
|
0.00%
0/58 • Assessed for approximately 8 hours after treatment
Ocular Adverse events were reported at the participant level
|
1.8%
1/56 • Assessed for approximately 8 hours after treatment
Ocular Adverse events were reported at the participant level
|
|
Eye disorders
Conjunctival oedema
|
0.00%
0/57 • Assessed for approximately 8 hours after treatment
Ocular Adverse events were reported at the participant level
|
3.6%
2/56 • Assessed for approximately 8 hours after treatment
Ocular Adverse events were reported at the participant level
|
0.00%
0/58 • Assessed for approximately 8 hours after treatment
Ocular Adverse events were reported at the participant level
|
0.00%
0/56 • Assessed for approximately 8 hours after treatment
Ocular Adverse events were reported at the participant level
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place