Trial Outcomes & Findings for Evaluation of the Effectiveness of ST266 Ophthalmic Drops Compared to Placebo to Treat Allergic Conjunctivitis (NCT NCT02978183)
NCT ID: NCT02978183
Last Updated: 2023-04-10
Results Overview
Ocular itching evaluated by the subject. Ocular itching was evaluated on a 0-4 scale (with half unit increments allowed). Lower scores indicated less itching.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
70 participants
Primary outcome timeframe
Day 7 and 8
Results posted on
2023-04-10
Participant Flow
Participant milestones
| Measure |
Group 1
1X ST266 dosed 4 times a day for 8 days
ST266: One (1) drop of 1X ST266 ophthalmic eye drops will be administered to each eye 4 times a day for 8 days.
|
Group 2
Placebo dosed 4 times a day for 8 days
Saline (0.9% NaCl): One (1) drop of saline ophthalmic eye drops will be administered to each eye 4 times a day for 8 days.
|
|---|---|---|
|
Overall Study
STARTED
|
34
|
36
|
|
Overall Study
COMPLETED
|
34
|
36
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of the Effectiveness of ST266 Ophthalmic Drops Compared to Placebo to Treat Allergic Conjunctivitis
Baseline characteristics by cohort
| Measure |
Group 1
n=34 Participants
1X ST266 dosed 4 times a day for 8 days
ST266: One (1) drop of 1X ST266 ophthalmic eye drops will be administered to each eye 4 times a day for 8 days.
|
Group 2
n=36 Participants
Placebo dosed 4 times a day for 8 days
Saline (0.9% NaCl): One (1) drop of saline ophthalmic eye drops will be administered to each eye 4 times a day for 8 days.
|
Total
n=70 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
43.5 years
STANDARD_DEVIATION 13.44 • n=5 Participants
|
47 years
STANDARD_DEVIATION 13.98 • n=7 Participants
|
45.3 years
STANDARD_DEVIATION 13.74 • n=5 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
30 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
25 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Iris Color
Black
|
0 eyes
n=5 Participants
|
0 eyes
n=7 Participants
|
0 eyes
n=5 Participants
|
|
Iris Color
Blue
|
10 eyes
n=5 Participants
|
20 eyes
n=7 Participants
|
30 eyes
n=5 Participants
|
|
Iris Color
Brown
|
42 eyes
n=5 Participants
|
44 eyes
n=7 Participants
|
86 eyes
n=5 Participants
|
|
Iris Color
Hazel
|
8 eyes
n=5 Participants
|
2 eyes
n=7 Participants
|
10 eyes
n=5 Participants
|
|
Iris Color
Green
|
8 eyes
n=5 Participants
|
6 eyes
n=7 Participants
|
14 eyes
n=5 Participants
|
|
Iris Color
Other
|
0 eyes
n=5 Participants
|
0 eyes
n=7 Participants
|
0 eyes
n=5 Participants
|
|
Allergen Disposition
Dust Mite
|
18 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Allergen Disposition
Dog Dander
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Allergen Disposition
Cockroach
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Allergen Disposition
Cat Dander
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 7 and 8Population: Pre-Conjunctival Allergen Challenge not evaluated in subject 1-011 on visit 5B
Ocular itching evaluated by the subject. Ocular itching was evaluated on a 0-4 scale (with half unit increments allowed). Lower scores indicated less itching.
Outcome measures
| Measure |
Group 1
n=34 Participants
1X ST266 dosed 4 times a day for 8 days
ST266: One (1) drop of 1X ST266 ophthalmic eye drops will be administered to each eye 4 times a day for 8 days.
|
Group 2
n=36 Participants
Placebo dosed 4 times a day for 8 days
Saline (0.9% NaCl): One (1) drop of saline ophthalmic eye drops will be administered to each eye 4 times a day for 8 days.
|
|---|---|---|
|
Ocular Itching
Day 7, Pre-Conjunctival Allergen Challenge
|
0.508 score on a scale
Standard Deviation 0.8373
|
0.139 score on a scale
Standard Deviation 0.3131
|
|
Ocular Itching
Day 7, 5 Minutes Post Conjunctival Allergen Challenge
|
2.485 score on a scale
Standard Deviation 0.9533
|
2.535 score on a scale
Standard Deviation 1.1070
|
|
Ocular Itching
Day 7, 7 Minutes Post Conjunctival Allergen Challenge
|
2.559 score on a scale
Standard Deviation 0.9887
|
2.576 score on a scale
Standard Deviation 1.1113
|
|
Ocular Itching
Day 7, 10 Minutes Post Conjunctival Allergen Challenge
|
2.434 score on a scale
Standard Deviation 0.9320
|
2.458 score on a scale
Standard Deviation 1.1124
|
|
Ocular Itching
Day 7, 15 Minutes Post Conjunctival Allergen Challenge
|
2.154 score on a scale
Standard Deviation 0.9415
|
2.181 score on a scale
Standard Deviation 1.1520
|
|
Ocular Itching
Day 7, 20 Minutes Post Conjunctival Allergen Challenge
|
1.838 score on a scale
Standard Deviation 0.9960
|
1.910 score on a scale
Standard Deviation 1.1482
|
|
Ocular Itching
Day 7, 25 Minutes Post Conjunctival Allergen Challenge
|
1.529 score on a scale
Standard Deviation 0.9103
|
1.722 score on a scale
Standard Deviation 1.1707
|
|
Ocular Itching
Day 7, 30 Minutes Post Conjunctival Allergen Challenge
|
1.346 score on a scale
Standard Deviation 0.9435
|
1.583 score on a scale
Standard Deviation 1.1164
|
|
Ocular Itching
Day 8, pre-Conjunctival Allergen Challenge
|
0.449 score on a scale
Standard Deviation 0.7405
|
0.167 score on a scale
Standard Deviation 0.3827
|
|
Ocular Itching
Day 8, 5 Minutes Post Conjunctival Allergen Challenge
|
2.816 score on a scale
Standard Deviation 0.8968
|
2.618 score on a scale
Standard Deviation 0.9847
|
|
Ocular Itching
Day 8, 7 Minutes Post Conjunctival Allergen Challenge
|
2.787 score on a scale
Standard Deviation 0.9316
|
2.625 score on a scale
Standard Deviation 0.9865
|
|
Ocular Itching
Day 8, 10 Minutes Post Conjunctival Allergen Challenge
|
2.588 score on a scale
Standard Deviation 0.9903
|
2.604 score on a scale
Standard Deviation 1.0357
|
|
Ocular Itching
Day 8, 15 Minutes Post Conjunctival Allergen Challenge
|
2.309 score on a scale
Standard Deviation 0.9654
|
2.299 score on a scale
Standard Deviation 1.0804
|
|
Ocular Itching
Day 8, 20 Minutes Post Conjunctival Allergen Challenge
|
2.081 score on a scale
Standard Deviation 0.9389
|
1.986 score on a scale
Standard Deviation 1.1354
|
|
Ocular Itching
Day 8, 25 Minutes Post Conjunctival Allergen Challenge
|
1.765 score on a scale
Standard Deviation 0.9573
|
1.819 score on a scale
Standard Deviation 1.1158
|
|
Ocular Itching
Day 8, 30 Minutes Post Conjunctival Allergen Challenge
|
1.493 score on a scale
Standard Deviation 0.9262
|
1.590 score on a scale
Standard Deviation 1.1167
|
PRIMARY outcome
Timeframe: Day 7 and 8Conjunctival redness evaluated by the investigator. Conjunctival redness was evaluated on a 0-4 scale (with half unit increments allowed). Lower scores indicated less redness.
Outcome measures
| Measure |
Group 1
n=34 Participants
1X ST266 dosed 4 times a day for 8 days
ST266: One (1) drop of 1X ST266 ophthalmic eye drops will be administered to each eye 4 times a day for 8 days.
|
Group 2
n=36 Participants
Placebo dosed 4 times a day for 8 days
Saline (0.9% NaCl): One (1) drop of saline ophthalmic eye drops will be administered to each eye 4 times a day for 8 days.
|
|---|---|---|
|
Conjunctival Redness
Day 7, Pre-Conjunctival Allergen Challenge
|
1.103 score on a scale
Standard Deviation 0.7541
|
1.028 score on a scale
Standard Deviation 0.5818
|
|
Conjunctival Redness
Day 7, 10 Minutes Post Conjunctival Allergen Challenge
|
2.125 score on a scale
Standard Deviation 0.8817
|
1.958 score on a scale
Standard Deviation 0.8814
|
|
Conjunctival Redness
Day 7, 15 Minutes Post Conjunctival Allergen Challenge
|
1.897 score on a scale
Standard Deviation 0.9714
|
1.882 score on a scale
Standard Deviation 0.9073
|
|
Conjunctival Redness
Day 7, 20 Minutes Post Conjunctival Allergen Challenge
|
1.926 score on a scale
Standard Deviation 1.0308
|
1.771 score on a scale
Standard Deviation 0.8481
|
|
Conjunctival Redness
Day 7, 25 Minutes Post Conjunctival Allergen Challenge
|
1.875 score on a scale
Standard Deviation 1.0005
|
1.743 score on a scale
Standard Deviation 0.8377
|
|
Conjunctival Redness
Day 7, 30 Minutes Post Conjunctival Allergen Challenge
|
1.816 score on a scale
Standard Deviation 1.0323
|
1.681 score on a scale
Standard Deviation 0.8775
|
|
Conjunctival Redness
Day 8, Pre-Conjunctival Allergen Challenge
|
0.912 score on a scale
Standard Deviation 0.6682
|
0.819 score on a scale
Standard Deviation 0.4766
|
|
Conjunctival Redness
Day 8, 10 Minutes Post Conjunctival Allergen Challenge
|
1.963 score on a scale
Standard Deviation 0.7909
|
1.917 score on a scale
Standard Deviation 0.7319
|
|
Conjunctival Redness
Day 8, 15 Minutes Post Conjunctival Allergen Challenge
|
1.963 score on a scale
Standard Deviation 0.8075
|
2.111 score on a scale
Standard Deviation 0.7870
|
|
Conjunctival Redness
Day 8, 20 Minutes Post Conjunctival Allergen Challenge
|
1.882 score on a scale
Standard Deviation 0.8101
|
1.951 score on a scale
Standard Deviation 0.8036
|
|
Conjunctival Redness
Day 8, 25 Minutes Post Conjunctival Allergen Challenge
|
1.735 score on a scale
Standard Deviation 0.8549
|
1.785 score on a scale
Standard Deviation 0.8241
|
|
Conjunctival Redness
Day 8, 30 Minutes Post Conjunctival Allergen Challenge
|
1.596 score on a scale
Standard Deviation 0.8791
|
1.625 score on a scale
Standard Deviation 0.7476
|
SECONDARY outcome
Timeframe: Day 7 and 8Ciliary redness evaluated by the investigator. Ciliary redness was evaluated on a 0-4 scale (with half unit increments allowed). A lower score was indicative of less redness.
Outcome measures
| Measure |
Group 1
n=34 Participants
1X ST266 dosed 4 times a day for 8 days
ST266: One (1) drop of 1X ST266 ophthalmic eye drops will be administered to each eye 4 times a day for 8 days.
|
Group 2
n=36 Participants
Placebo dosed 4 times a day for 8 days
Saline (0.9% NaCl): One (1) drop of saline ophthalmic eye drops will be administered to each eye 4 times a day for 8 days.
|
|---|---|---|
|
Ciliary Redness
Day 7, Pre-Conjunctival Allergen Challenge
|
0.912 score on a scale
Standard Deviation 0.6243
|
0.750 score on a scale
Standard Deviation 0.5445
|
|
Ciliary Redness
Day 7, 10 Minutes Post Conjunctival Allergen Challenge
|
1.838 score on a scale
Standard Deviation 0.8368
|
1.799 score on a scale
Standard Deviation 0.8341
|
|
Ciliary Redness
Day 7, 15 Minutes Post Conjunctival Allergen Challenge
|
1.691 score on a scale
Standard Deviation 0.9925
|
1.729 score on a scale
Standard Deviation 0.8353
|
|
Ciliary Redness
Day 7, 20 Minutes Post Conjunctival Allergen Challenge
|
1.713 score on a scale
Standard Deviation 0.9417
|
1.625 score on a scale
Standard Deviation 0.8420
|
|
Ciliary Redness
Day 7, 25 Minutes Post Conjunctival Allergen Challenge
|
1.654 score on a scale
Standard Deviation 0.9150
|
1.583 score on a scale
Standard Deviation 0.7488
|
|
Ciliary Redness
Day 7, 30 Minutes Post Conjunctival Allergen Challenge
|
1.603 score on a scale
Standard Deviation 0.9869
|
1.493 score on a scale
Standard Deviation 0.8608
|
|
Ciliary Redness
Day 8, pre-Conjunctival Allergen Challenge
|
0.581 score on a scale
Standard Deviation 0.6053
|
0.521 score on a scale
Standard Deviation 0.4487
|
|
Ciliary Redness
Day 8, 10 Minutes Post Conjunctival Allergen Challenge
|
1.691 score on a scale
Standard Deviation 0.8189
|
1.743 score on a scale
Standard Deviation 0.7058
|
|
Ciliary Redness
Day 8, 15 Minutes Post Conjunctival Allergen Challenge
|
1.699 score on a scale
Standard Deviation 0.7804
|
1.931 score on a scale
Standard Deviation 0.7310
|
|
Ciliary Redness
Day 8, 20 Minutes Post Conjunctival Allergen Challenge
|
1.625 score on a scale
Standard Deviation 0.8556
|
1.792 score on a scale
Standard Deviation 0.7688
|
|
Ciliary Redness
Day 8, 25 Minutes Post Conjunctival Allergen Challenge
|
1.463 score on a scale
Standard Deviation 0.9027
|
1.569 score on a scale
Standard Deviation 0.7806
|
|
Ciliary Redness
Day 8, 30 Minutes Post Conjunctival Allergen Challenge
|
1.346 score on a scale
Standard Deviation 0.8528
|
1.458 score on a scale
Standard Deviation 0.8007
|
SECONDARY outcome
Timeframe: Day 7 and 8Episcleral redness evaluated by the investigator. Episcleral redness was evaluated on a 0-4 scale (with half unit increments allowed). A lower score was indicative of less redness.
Outcome measures
| Measure |
Group 1
n=34 Participants
1X ST266 dosed 4 times a day for 8 days
ST266: One (1) drop of 1X ST266 ophthalmic eye drops will be administered to each eye 4 times a day for 8 days.
|
Group 2
n=36 Participants
Placebo dosed 4 times a day for 8 days
Saline (0.9% NaCl): One (1) drop of saline ophthalmic eye drops will be administered to each eye 4 times a day for 8 days.
|
|---|---|---|
|
Episcleral Redness
Day 7, Pre-Conjunctival Allergen Challenge
|
1.029 score on a scale
Standard Deviation 0.6622
|
0.910 score on a scale
Standard Deviation 0.5579
|
|
Episcleral Redness
Day 7, 10 Minutes Post Conjunctival Allergen Challenge
|
1.868 score on a scale
Standard Deviation 0.8217
|
1.819 score on a scale
Standard Deviation 0.8401
|
|
Episcleral Redness
Day 7, 15 Minutes Post Conjunctival Allergen Challenge
|
1.757 score on a scale
Standard Deviation 0.9283
|
1.778 score on a scale
Standard Deviation 0.8468
|
|
Episcleral Redness
Day 7, 20 Minutes Post Conjunctival Allergen Challenge
|
1.787 score on a scale
Standard Deviation 0.9656
|
1.701 score on a scale
Standard Deviation 0.8036
|
|
Episcleral Redness
Day 7, 25 Minutes Post Conjunctival Allergen Challenge
|
1.721 score on a scale
Standard Deviation 0.9939
|
1.618 score on a scale
Standard Deviation 0.7500
|
|
Episcleral Redness
Day 7, 30 Minutes Post Conjunctival Allergen Challenge
|
1.669 score on a scale
Standard Deviation 1.0275
|
1.583 score on a scale
Standard Deviation 0.8345
|
|
Episcleral Redness
Day 8, pre-Conjunctival Allergen Challenge
|
0.507 score on a scale
Standard Deviation 0.5822
|
0.424 score on a scale
Standard Deviation 0.4544
|
|
Episcleral Redness
Day 8, 10 Minutes Post Conjunctival Allergen Challenge
|
1.735 score on a scale
Standard Deviation 0.8210
|
1.708 score on a scale
Standard Deviation 0.6827
|
|
Episcleral Redness
Day 8, 15 Minutes Post Conjunctival Allergen Challenge
|
1.706 score on a scale
Standard Deviation 0.8404
|
1.896 score on a scale
Standard Deviation 0.7055
|
|
Episcleral Redness
Day 8, 20 Minutes Post Conjunctival Allergen Challenge
|
1.647 score on a scale
Standard Deviation 0.8144
|
1.701 score on a scale
Standard Deviation 0.7508
|
|
Episcleral Redness
Day 8, 25 Minutes Post Conjunctival Allergen Challenge
|
1.412 score on a scale
Standard Deviation 0.8680
|
1.583 score on a scale
Standard Deviation 0.7488
|
|
Episcleral Redness
Day 8, 30 Minutes Post Conjunctival Allergen Challenge
|
1.353 score on a scale
Standard Deviation 0.8575
|
1.347 score on a scale
Standard Deviation 0.7495
|
SECONDARY outcome
Timeframe: Day 7 and 8Chemosis evaluated by the investigator. Chemosis was evaluated on a 0-4 scale (with half unit increments allowed). A lower score was indicative of less chemosis.
Outcome measures
| Measure |
Group 1
n=34 Participants
1X ST266 dosed 4 times a day for 8 days
ST266: One (1) drop of 1X ST266 ophthalmic eye drops will be administered to each eye 4 times a day for 8 days.
|
Group 2
n=36 Participants
Placebo dosed 4 times a day for 8 days
Saline (0.9% NaCl): One (1) drop of saline ophthalmic eye drops will be administered to each eye 4 times a day for 8 days.
|
|---|---|---|
|
Chemosis
Day 7, Pre-Conjunctival Allergen Challenge
|
0.390 score on a scale
Standard Deviation 0.3703
|
0.465 score on a scale
Standard Deviation 0.3787
|
|
Chemosis
Day 7, 10 Minutes Post Conjunctival Allergen Challenge
|
0.765 score on a scale
Standard Deviation 0.4306
|
0.840 score on a scale
Standard Deviation 0.4711
|
|
Chemosis
Day 7, 15 Minutes Post Conjunctival Allergen Challenge
|
0.669 score on a scale
Standard Deviation 0.5391
|
0.708 score on a scale
Standard Deviation 0.4762
|
|
Chemosis
Day 7, 20 Minutes Post Conjunctival Allergen Challenge
|
0.691 score on a scale
Standard Deviation 0.5709
|
0.778 score on a scale
Standard Deviation 0.4259
|
|
Chemosis
Day 7, 25 Minutes Post Conjunctival Allergen Challenge
|
0.691 score on a scale
Standard Deviation 0.6001
|
0.785 score on a scale
Standard Deviation 0.5146
|
|
Chemosis
Day 7, 30 Minutes Post Conjunctival Allergen Challenge
|
0.676 score on a scale
Standard Deviation 0.6047
|
0.757 score on a scale
Standard Deviation 0.4075
|
|
Chemosis
Day 8, pre-Conjunctival Allergen Challenge
|
0.081 score on a scale
Standard Deviation 0.2280
|
0.104 score on a scale
Standard Deviation 0.1925
|
|
Chemosis
Day 8, 10 Minutes Post Conjunctival Allergen Challenge
|
0.574 score on a scale
Standard Deviation 0.6262
|
0.674 score on a scale
Standard Deviation 0.4994
|
|
Chemosis
Day 8, 15 Minutes Post Conjunctival Allergen Challenge
|
0.632 score on a scale
Standard Deviation 0.7288
|
0.764 score on a scale
Standard Deviation 0.4265
|
|
Chemosis
Day 8, 20 Minutes Post Conjunctival Allergen Challenge
|
0.684 score on a scale
Standard Deviation 0.7792
|
0.708 score on a scale
Standard Deviation 0.4571
|
|
Chemosis
Day 8, 25 Minutes Post Conjunctival Allergen Challenge
|
0.566 score on a scale
Standard Deviation 0.7444
|
0.590 score on a scale
Standard Deviation 0.5674
|
|
Chemosis
Day 8, 30 Minutes Post Conjunctival Allergen Challenge
|
0.551 score on a scale
Standard Deviation 0.8137
|
0.493 score on a scale
Standard Deviation 0.6196
|
SECONDARY outcome
Timeframe: Day 7 and 8Eyelid swelling evaluated by the subject. Eyelid swelling was evaluated on a 0-4 scale in which 0.5 unit increments were not allowed. A lower score was indicative of less swelling.
Outcome measures
| Measure |
Group 1
n=34 Participants
1X ST266 dosed 4 times a day for 8 days
ST266: One (1) drop of 1X ST266 ophthalmic eye drops will be administered to each eye 4 times a day for 8 days.
|
Group 2
n=36 Participants
Placebo dosed 4 times a day for 8 days
Saline (0.9% NaCl): One (1) drop of saline ophthalmic eye drops will be administered to each eye 4 times a day for 8 days.
|
|---|---|---|
|
Eyelid Swelling
Day 7, 25 Minutes Post Conjunctival Allergen Challenge
|
0.96 score on a scale
Standard Deviation 0.711
|
1.22 score on a scale
Standard Deviation 0.857
|
|
Eyelid Swelling
Day 7, 30 Minutes Post Conjunctival Allergen Challenge
|
0.79 score on a scale
Standard Deviation 0.780
|
0.97 score on a scale
Standard Deviation 0.836
|
|
Eyelid Swelling
Day 7, Pre-Conjunctival Allergen Challenge
|
0.45 score on a scale
Standard Deviation 0.711
|
0.22 score on a scale
Standard Deviation 0.404
|
|
Eyelid Swelling
Day 7, 10 Minutes Post Conjunctival Allergen Challenge
|
1.22 score on a scale
Standard Deviation 0.889
|
1.39 score on a scale
Standard Deviation 0.871
|
|
Eyelid Swelling
Day 7, 15 Minutes Post Conjunctival Allergen Challenge
|
1.25 score on a scale
Standard Deviation 0.915
|
1.33 score on a scale
Standard Deviation 0.837
|
|
Eyelid Swelling
Day 7, 20 Minutes Post Conjunctival Allergen Challenge
|
1.06 score on a scale
Standard Deviation 0.776
|
1.25 score on a scale
Standard Deviation 0.841
|
|
Eyelid Swelling
Day 8, pre-Conjunctival Allergen Challenge
|
0.41 score on a scale
Standard Deviation 0.621
|
0.26 score on a scale
Standard Deviation 0.500
|
|
Eyelid Swelling
Day 8, 10 Minutes Post Conjunctival Allergen Challenge
|
1.35 score on a scale
Standard Deviation 0.744
|
1.21 score on a scale
Standard Deviation 0.873
|
|
Eyelid Swelling
Day 8, 15 Minutes Post Conjunctival Allergen Challenge
|
1.29 score on a scale
Standard Deviation 0.740
|
1.19 score on a scale
Standard Deviation 0.881
|
|
Eyelid Swelling
Day 8, 20 Minutes Post Conjunctival Allergen Challenge
|
1.12 score on a scale
Standard Deviation 0.817
|
1.11 score on a scale
Standard Deviation 0.887
|
|
Eyelid Swelling
Day 8, 25 Minutes Post Conjunctival Allergen Challenge
|
0.94 score on a scale
Standard Deviation 0.766
|
1.10 score on a scale
Standard Deviation 0.893
|
|
Eyelid Swelling
Day 8, 30 Minutes Post Conjunctival Allergen Challenge
|
0.81 score on a scale
Standard Deviation 0.728
|
0.89 score on a scale
Standard Deviation 0.887
|
SECONDARY outcome
Timeframe: Day 7 and 8Tearing evaluated by the subject. Tearing was evaluated on a 0-4 scale in which 0.5 unit increments were not allowed. A lower score was indicative of less tearing.
Outcome measures
| Measure |
Group 1
n=34 Participants
1X ST266 dosed 4 times a day for 8 days
ST266: One (1) drop of 1X ST266 ophthalmic eye drops will be administered to each eye 4 times a day for 8 days.
|
Group 2
n=36 Participants
Placebo dosed 4 times a day for 8 days
Saline (0.9% NaCl): One (1) drop of saline ophthalmic eye drops will be administered to each eye 4 times a day for 8 days.
|
|---|---|---|
|
Tearing/Watery Eyes
Day 7, Pre-Conjunctival Allergen Challenge
|
0.38 score on a scale
Standard Deviation 0.707
|
0.21 score on a scale
Standard Deviation 0.437
|
|
Tearing/Watery Eyes
Day 7, 10 Minutes Post Conjunctival Allergen Challenge
|
1.15 score on a scale
Standard Deviation 0.966
|
1.38 score on a scale
Standard Deviation 1.024
|
|
Tearing/Watery Eyes
Day 7, 15 Minutes Post Conjunctival Allergen Challenge
|
0.88 score on a scale
Standard Deviation 1.038
|
1.22 score on a scale
Standard Deviation 1.003
|
|
Tearing/Watery Eyes
Day 7, 20 Minutes Post Conjunctival Allergen Challenge
|
0.72 score on a scale
Standard Deviation 0.898
|
1.07 score on a scale
Standard Deviation 0.965
|
|
Tearing/Watery Eyes
Day 7, 25 Minutes Post Conjunctival Allergen Challenge
|
0.71 score on a scale
Standard Deviation 0.930
|
0.94 score on a scale
Standard Deviation 1.034
|
|
Tearing/Watery Eyes
Day 7, 30 Minutes Post Conjunctival Allergen Challenge
|
0.65 score on a scale
Standard Deviation 0.875
|
0.85 score on a scale
Standard Deviation 0.909
|
|
Tearing/Watery Eyes
Day 8, pre-Conjunctival Allergen Challenge
|
0.37 score on a scale
Standard Deviation 0.810
|
0.28 score on a scale
Standard Deviation 0.553
|
|
Tearing/Watery Eyes
Day 8, 10 Minutes Post Conjunctival Allergen Challenge
|
1.07 score on a scale
Standard Deviation 1.074
|
1.15 score on a scale
Standard Deviation 0.970
|
|
Tearing/Watery Eyes
Day 8, 15 Minutes Post Conjunctival Allergen Challenge
|
1.04 score on a scale
Standard Deviation 1.090
|
1.13 score on a scale
Standard Deviation 0.929
|
|
Tearing/Watery Eyes
Day 8, 20 Minutes Post Conjunctival Allergen Challenge
|
0.87 score on a scale
Standard Deviation 0.864
|
1.01 score on a scale
Standard Deviation 0.906
|
|
Tearing/Watery Eyes
Day 8, 25 Minutes Post Conjunctival Allergen Challenge
|
0.76 score on a scale
Standard Deviation 0.809
|
1.00 score on a scale
Standard Deviation 0.956
|
|
Tearing/Watery Eyes
Day 8, 30 Minutes Post Conjunctival Allergen Challenge
|
0.65 score on a scale
Standard Deviation 0.803
|
0.88 score on a scale
Standard Deviation 0.952
|
SECONDARY outcome
Timeframe: Day 7 and 8Rhinorrhea evaluated by the subject. Rhinorrhea was evaluated on a 0-4 scale in which 0.5 unit increments were not allowed. A lower score was indicative of less severity.
Outcome measures
| Measure |
Group 1
n=34 Participants
1X ST266 dosed 4 times a day for 8 days
ST266: One (1) drop of 1X ST266 ophthalmic eye drops will be administered to each eye 4 times a day for 8 days.
|
Group 2
n=36 Participants
Placebo dosed 4 times a day for 8 days
Saline (0.9% NaCl): One (1) drop of saline ophthalmic eye drops will be administered to each eye 4 times a day for 8 days.
|
|---|---|---|
|
Rhinorrhea
Day 8, pre-Conjunctival Allergen Challenge
|
0.29 score on a scale
Standard Deviation 0.579
|
0.22 score on a scale
Standard Deviation 0.591
|
|
Rhinorrhea
Day 7, Pre-Conjunctival Allergen Challenge
|
0.33 score on a scale
Standard Deviation 0.595
|
0.19 score on a scale
Standard Deviation 0.525
|
|
Rhinorrhea
Day 7, 10 Minutes Post Conjunctival Allergen Challenge
|
1.35 score on a scale
Standard Deviation 1.152
|
1.47 score on a scale
Standard Deviation 1.134
|
|
Rhinorrhea
Day 7, 15 Minutes Post Conjunctival Allergen Challenge
|
1.18 score on a scale
Standard Deviation 0.904
|
1.31 score on a scale
Standard Deviation 1.142
|
|
Rhinorrhea
Day 7, 20 Minutes Post Conjunctival Allergen Challenge
|
0.97 score on a scale
Standard Deviation 0.870
|
0.97 score on a scale
Standard Deviation 1.082
|
|
Rhinorrhea
Day 7, 25 Minutes Post Conjunctival Allergen Challenge
|
0.85 score on a scale
Standard Deviation 0.821
|
0.89 score on a scale
Standard Deviation 1.090
|
|
Rhinorrhea
Day 7, 30 Minutes Post Conjunctival Allergen Challenge
|
0.85 score on a scale
Standard Deviation 0.784
|
0.94 score on a scale
Standard Deviation 1.068
|
|
Rhinorrhea
Day 8, 10 Minutes Post Conjunctival Allergen Challenge
|
1.29 score on a scale
Standard Deviation 0.938
|
1.39 score on a scale
Standard Deviation 1.225
|
|
Rhinorrhea
Day 8, 15 Minutes Post Conjunctival Allergen Challenge
|
1.26 score on a scale
Standard Deviation 0.963
|
1.31 score on a scale
Standard Deviation 1.283
|
|
Rhinorrhea
Day 8, 20 Minutes Post Conjunctival Allergen Challenge
|
1.09 score on a scale
Standard Deviation 0.933
|
1.08 score on a scale
Standard Deviation 1.156
|
|
Rhinorrhea
Day 8, 25 Minutes Post Conjunctival Allergen Challenge
|
1.00 score on a scale
Standard Deviation 0.853
|
0.92 score on a scale
Standard Deviation 1.180
|
|
Rhinorrhea
Day 8, 30 Minutes Post Conjunctival Allergen Challenge
|
0.94 score on a scale
Standard Deviation 0.776
|
0.83 score on a scale
Standard Deviation 1.108
|
SECONDARY outcome
Timeframe: Day 7 and 8Population: Pre-Conjunctival Allergen Challenge not evaluated in subject 1-011 on visit 5B
Nasal Pruritus evaluated by the subject. Nasal pruritus was evaluated on a 0-4 scale in which 0.5 unit increments were not allowed. A lower score was indicative of less severity.
Outcome measures
| Measure |
Group 1
n=34 Participants
1X ST266 dosed 4 times a day for 8 days
ST266: One (1) drop of 1X ST266 ophthalmic eye drops will be administered to each eye 4 times a day for 8 days.
|
Group 2
n=36 Participants
Placebo dosed 4 times a day for 8 days
Saline (0.9% NaCl): One (1) drop of saline ophthalmic eye drops will be administered to each eye 4 times a day for 8 days.
|
|---|---|---|
|
Nasal Pruritus
Day 7, Pre-Conjunctival Allergen Challenge
|
0.30 score on a scale
Standard Deviation 0.467
|
0.06 score on a scale
Standard Deviation 0.232
|
|
Nasal Pruritus
Day 7, 10 Minutes Post Conjunctival Allergen Challenge
|
1.03 score on a scale
Standard Deviation 1.141
|
1.11 score on a scale
Standard Deviation 1.116
|
|
Nasal Pruritus
Day 7, 15 Minutes Post Conjunctival Allergen Challenge
|
0.91 score on a scale
Standard Deviation 0.965
|
1.03 score on a scale
Standard Deviation 1.082
|
|
Nasal Pruritus
Day 7, 20 Minutes Post Conjunctival Allergen Challenge
|
0.76 score on a scale
Standard Deviation 0.923
|
0.89 score on a scale
Standard Deviation 0.950
|
|
Nasal Pruritus
Day 7, 25 Minutes Post Conjunctival Allergen Challenge
|
0.76 score on a scale
Standard Deviation 0.890
|
0.83 score on a scale
Standard Deviation 0.971
|
|
Nasal Pruritus
Day 7, 30 Minutes Post Conjunctival Allergen Challenge
|
0.65 score on a scale
Standard Deviation 0.774
|
0.75 score on a scale
Standard Deviation 0.967
|
|
Nasal Pruritus
Day 8, pre-Conjunctival Allergen Challenge
|
0.24 score on a scale
Standard Deviation 0.554
|
0.14 score on a scale
Standard Deviation 0.487
|
|
Nasal Pruritus
Day 8, 10 Minutes Post Conjunctival Allergen Challenge
|
1.03 score on a scale
Standard Deviation 1.167
|
0.94 score on a scale
Standard Deviation 1.145
|
|
Nasal Pruritus
Day 8, 15 Minutes Post Conjunctival Allergen Challenge
|
1.03 score on a scale
Standard Deviation 1.087
|
0.83 score on a scale
Standard Deviation 1.082
|
|
Nasal Pruritus
Day 8, 20 Minutes Post Conjunctival Allergen Challenge
|
0.91 score on a scale
Standard Deviation 1.111
|
0.69 score on a scale
Standard Deviation 1.009
|
|
Nasal Pruritus
Day 8, 25 Minutes Post Conjunctival Allergen Challenge
|
0.68 score on a scale
Standard Deviation 0.912
|
0.69 score on a scale
Standard Deviation 1.009
|
|
Nasal Pruritus
Day 8, 30 Minutes Post Conjunctival Allergen Challenge
|
0.59 score on a scale
Standard Deviation 0.821
|
0.64 score on a scale
Standard Deviation 1.018
|
SECONDARY outcome
Timeframe: Day 7 and 8Population: Pre-Conjunctival Allergen Challenge not evaluated in subject 1-011 on visit 5B
Ear or palate pruritus evaluated by the subject. Ear or palate pruritus was evaluated on a 0-4 scale in which 0.5 unit increments were not allowed. A lower score was indicative of less severity.
Outcome measures
| Measure |
Group 1
n=34 Participants
1X ST266 dosed 4 times a day for 8 days
ST266: One (1) drop of 1X ST266 ophthalmic eye drops will be administered to each eye 4 times a day for 8 days.
|
Group 2
n=36 Participants
Placebo dosed 4 times a day for 8 days
Saline (0.9% NaCl): One (1) drop of saline ophthalmic eye drops will be administered to each eye 4 times a day for 8 days.
|
|---|---|---|
|
Ear or Palate Pruritus
Day 7, Pre-Conjunctival Allergen Challenge
|
0.33 score on a scale
Standard Deviation 0.595
|
0.19 score on a scale
Standard Deviation 0.401
|
|
Ear or Palate Pruritus
Day 7, 10 Minutes Post Conjunctival Allergen Challenge
|
1.26 score on a scale
Standard Deviation 1.355
|
1.22 score on a scale
Standard Deviation 1.245
|
|
Ear or Palate Pruritus
Day 7, 15 Minutes Post Conjunctival Allergen Challenge
|
1.18 score on a scale
Standard Deviation 1.193
|
1.11 score on a scale
Standard Deviation 1.214
|
|
Ear or Palate Pruritus
Day 7, 20 Minutes Post Conjunctival Allergen Challenge
|
1.00 score on a scale
Standard Deviation 1.073
|
1.08 score on a scale
Standard Deviation 1.105
|
|
Ear or Palate Pruritus
Day 7, 25 Minutes Post Conjunctival Allergen Challenge
|
0.91 score on a scale
Standard Deviation 0.965
|
0.94 score on a scale
Standard Deviation 1.094
|
|
Ear or Palate Pruritus
Day 7, 30 Minutes Post Conjunctival Allergen Challenge
|
0.88 score on a scale
Standard Deviation 0.808
|
0.83 score on a scale
Standard Deviation 0.971
|
|
Ear or Palate Pruritus
Day 8, pre-Conjunctival Allergen Challenge
|
0.06 score on a scale
Standard Deviation 0.239
|
0.19 score on a scale
Standard Deviation 0.401
|
|
Ear or Palate Pruritus
Day 8, 10 Minutes Post Conjunctival Allergen Challenge
|
1.18 score on a scale
Standard Deviation 1.336
|
1.33 score on a scale
Standard Deviation 1.352
|
|
Ear or Palate Pruritus
Day 8, 15 Minutes Post Conjunctival Allergen Challenge
|
1.15 score on a scale
Standard Deviation 1.282
|
1.28 score on a scale
Standard Deviation 1.344
|
|
Ear or Palate Pruritus
Day 8, 20 Minutes Post Conjunctival Allergen Challenge
|
1.12 score on a scale
Standard Deviation 1.274
|
1.19 score on a scale
Standard Deviation 1.283
|
|
Ear or Palate Pruritus
Day 8, 25 Minutes Post Conjunctival Allergen Challenge
|
1.00 score on a scale
Standard Deviation 1.181
|
1.08 score on a scale
Standard Deviation 1.204
|
|
Ear or Palate Pruritus
Day 8, 30 Minutes Post Conjunctival Allergen Challenge
|
1.00 score on a scale
Standard Deviation 1.128
|
0.97 score on a scale
Standard Deviation 1.253
|
SECONDARY outcome
Timeframe: Day 7 and 8Population: Pre-Conjunctival Allergen Challenge not evaluated in subject 1-011 on visit 5B
Nasal congestion evaluated by the subject. Nasal congestion was evaluated on a 0-4 scale in which 0.5 unit increments were not allowed. A lower score was indicative of less severity.
Outcome measures
| Measure |
Group 1
n=34 Participants
1X ST266 dosed 4 times a day for 8 days
ST266: One (1) drop of 1X ST266 ophthalmic eye drops will be administered to each eye 4 times a day for 8 days.
|
Group 2
n=36 Participants
Placebo dosed 4 times a day for 8 days
Saline (0.9% NaCl): One (1) drop of saline ophthalmic eye drops will be administered to each eye 4 times a day for 8 days.
|
|---|---|---|
|
Nasal Congestion
Day 7, Pre-Conjunctival Allergen Challenge
|
0.67 score on a scale
Standard Deviation 0.816
|
0.42 score on a scale
Standard Deviation 0.906
|
|
Nasal Congestion
Day 7, 10 Minutes Post Conjunctival Allergen Challenge
|
1.44 score on a scale
Standard Deviation 1.160
|
1.47 score on a scale
Standard Deviation 1.230
|
|
Nasal Congestion
Day 7, 15 Minutes Post Conjunctival Allergen Challenge
|
1.41 score on a scale
Standard Deviation 1.048
|
1.36 score on a scale
Standard Deviation 1.099
|
|
Nasal Congestion
Day 7, 20 Minutes Post Conjunctival Allergen Challenge
|
1.24 score on a scale
Standard Deviation 0.987
|
1.22 score on a scale
Standard Deviation 1.072
|
|
Nasal Congestion
Day 7, 25 Minutes Post Conjunctival Allergen Challenge
|
1.15 score on a scale
Standard Deviation 0.989
|
1.22 score on a scale
Standard Deviation 1.174
|
|
Nasal Congestion
Day 7, 30 Minutes Post Conjunctival Allergen Challenge
|
1.12 score on a scale
Standard Deviation 1.008
|
1.17 score on a scale
Standard Deviation 1.159
|
|
Nasal Congestion
Day 8, pre-Conjunctival Allergen Challenge
|
0.47 score on a scale
Standard Deviation 0.662
|
0.33 score on a scale
Standard Deviation 0.717
|
|
Nasal Congestion
Day 8, 10 Minutes Post Conjunctival Allergen Challenge
|
1.29 score on a scale
Standard Deviation 1.060
|
1.36 score on a scale
Standard Deviation 1.199
|
|
Nasal Congestion
Day 8, 15 Minutes Post Conjunctival Allergen Challenge
|
1.35 score on a scale
Standard Deviation 1.070
|
1.39 score on a scale
Standard Deviation 1.293
|
|
Nasal Congestion
Day 8, 20 Minutes Post Conjunctival Allergen Challenge
|
1.26 score on a scale
Standard Deviation 1.024
|
1.28 score on a scale
Standard Deviation 1.279
|
|
Nasal Congestion
Day 8, 25 Minutes Post Conjunctival Allergen Challenge
|
1.18 score on a scale
Standard Deviation 0.968
|
1.28 score on a scale
Standard Deviation 1.210
|
|
Nasal Congestion
Day 8, 30 Minutes Post Conjunctival Allergen Challenge
|
1.15 score on a scale
Standard Deviation 1.048
|
1.22 score on a scale
Standard Deviation 1.222
|
SECONDARY outcome
Timeframe: Day 7 and 8Population: Pre-Conjunctival Allergen Challenge not evaluated in subject 1-011 on visit 5B
A composite score of presence or absence of at least one nasal symptom evaluated by the subject
Outcome measures
| Measure |
Group 1
n=34 Participants
1X ST266 dosed 4 times a day for 8 days
ST266: One (1) drop of 1X ST266 ophthalmic eye drops will be administered to each eye 4 times a day for 8 days.
|
Group 2
n=36 Participants
Placebo dosed 4 times a day for 8 days
Saline (0.9% NaCl): One (1) drop of saline ophthalmic eye drops will be administered to each eye 4 times a day for 8 days.
|
|---|---|---|
|
Nasal Composite Score
Day 7, Pre-Conjunctival Allergen Challenge · Absent
|
11 Participants
|
23 Participants
|
|
Nasal Composite Score
Day 7, Pre-Conjunctival Allergen Challenge · PResent
|
22 Participants
|
13 Participants
|
|
Nasal Composite Score
Day 7, 10 Minutes Post Conjunctival Allergen Challenge · Absent
|
2 Participants
|
2 Participants
|
|
Nasal Composite Score
Day 7, 10 Minutes Post Conjunctival Allergen Challenge · PResent
|
32 Participants
|
34 Participants
|
|
Nasal Composite Score
Day 7, 15 Minutes Post Conjunctival Allergen Challenge · Absent
|
2 Participants
|
2 Participants
|
|
Nasal Composite Score
Day 7, 15 Minutes Post Conjunctival Allergen Challenge · PResent
|
32 Participants
|
34 Participants
|
|
Nasal Composite Score
Day 7, 20 Minutes Post Conjunctival Allergen Challenge · Absent
|
3 Participants
|
3 Participants
|
|
Nasal Composite Score
Day 7, 20 Minutes Post Conjunctival Allergen Challenge · PResent
|
31 Participants
|
33 Participants
|
|
Nasal Composite Score
Day 7, 25 Minutes Post Conjunctival Allergen Challenge · Absent
|
5 Participants
|
4 Participants
|
|
Nasal Composite Score
Day 7, 25 Minutes Post Conjunctival Allergen Challenge · PResent
|
29 Participants
|
32 Participants
|
|
Nasal Composite Score
Day 7, 30 Minutes Post Conjunctival Allergen Challenge · Absent
|
4 Participants
|
4 Participants
|
|
Nasal Composite Score
Day 7, 30 Minutes Post Conjunctival Allergen Challenge · PResent
|
30 Participants
|
32 Participants
|
|
Nasal Composite Score
Day 8, pre-Conjunctival Allergen Challenge · Absent
|
18 Participants
|
26 Participants
|
|
Nasal Composite Score
Day 8, pre-Conjunctival Allergen Challenge · PResent
|
16 Participants
|
10 Participants
|
|
Nasal Composite Score
Day 8, 10 Minutes Post Conjunctival Allergen Challenge · Absent
|
1 Participants
|
2 Participants
|
|
Nasal Composite Score
Day 8, 10 Minutes Post Conjunctival Allergen Challenge · PResent
|
33 Participants
|
34 Participants
|
|
Nasal Composite Score
Day 8, 15 Minutes Post Conjunctival Allergen Challenge · Absent
|
2 Participants
|
3 Participants
|
|
Nasal Composite Score
Day 8, 15 Minutes Post Conjunctival Allergen Challenge · PResent
|
32 Participants
|
33 Participants
|
|
Nasal Composite Score
Day 8, 20 Minutes Post Conjunctival Allergen Challenge · Absent
|
4 Participants
|
4 Participants
|
|
Nasal Composite Score
Day 8, 20 Minutes Post Conjunctival Allergen Challenge · PResent
|
30 Participants
|
32 Participants
|
|
Nasal Composite Score
Day 8, 25 Minutes Post Conjunctival Allergen Challenge · Absent
|
2 Participants
|
5 Participants
|
|
Nasal Composite Score
Day 8, 25 Minutes Post Conjunctival Allergen Challenge · PResent
|
32 Participants
|
31 Participants
|
|
Nasal Composite Score
Day 8, 30 Minutes Post Conjunctival Allergen Challenge · Absent
|
3 Participants
|
6 Participants
|
|
Nasal Composite Score
Day 8, 30 Minutes Post Conjunctival Allergen Challenge · PResent
|
31 Participants
|
30 Participants
|
Adverse Events
Group 1
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Group 2
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group 1
n=34 participants at risk
1X ST266 dosed 4 times a day for 8 days
ST266: One (1) drop of 1X ST266 ophthalmic eye drops will be administered to each eye 4 times a day for 8 days.
|
Group 2
n=36 participants at risk
Placebo dosed 4 times a day for 8 days
Saline (0.9% NaCl): One (1) drop of saline ophthalmic eye drops will be administered to each eye 4 times a day for 8 days.
|
|---|---|---|
|
Eye disorders
Visual Acuity Reduced
|
2.9%
1/34 • Number of events 1 • Adverse events were assessed for subjects over a period of 8 days during active treatment. If an AE was unresolved at the final study visit Investigators were instructed to follow-up with subjects until the AE resolved or they were lost to follow-up. If the patient is lost to follow-up, the Investigator should make 3 reasonable attempts to contact the patient via telephone, post, or certified mail.
|
0.00%
0/36 • Adverse events were assessed for subjects over a period of 8 days during active treatment. If an AE was unresolved at the final study visit Investigators were instructed to follow-up with subjects until the AE resolved or they were lost to follow-up. If the patient is lost to follow-up, the Investigator should make 3 reasonable attempts to contact the patient via telephone, post, or certified mail.
|
|
Infections and infestations
Infected Bite
|
2.9%
1/34 • Number of events 1 • Adverse events were assessed for subjects over a period of 8 days during active treatment. If an AE was unresolved at the final study visit Investigators were instructed to follow-up with subjects until the AE resolved or they were lost to follow-up. If the patient is lost to follow-up, the Investigator should make 3 reasonable attempts to contact the patient via telephone, post, or certified mail.
|
0.00%
0/36 • Adverse events were assessed for subjects over a period of 8 days during active treatment. If an AE was unresolved at the final study visit Investigators were instructed to follow-up with subjects until the AE resolved or they were lost to follow-up. If the patient is lost to follow-up, the Investigator should make 3 reasonable attempts to contact the patient via telephone, post, or certified mail.
|
|
Nervous system disorders
Headache
|
0.00%
0/34 • Adverse events were assessed for subjects over a period of 8 days during active treatment. If an AE was unresolved at the final study visit Investigators were instructed to follow-up with subjects until the AE resolved or they were lost to follow-up. If the patient is lost to follow-up, the Investigator should make 3 reasonable attempts to contact the patient via telephone, post, or certified mail.
|
8.3%
3/36 • Number of events 3 • Adverse events were assessed for subjects over a period of 8 days during active treatment. If an AE was unresolved at the final study visit Investigators were instructed to follow-up with subjects until the AE resolved or they were lost to follow-up. If the patient is lost to follow-up, the Investigator should make 3 reasonable attempts to contact the patient via telephone, post, or certified mail.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place