Trial Outcomes & Findings for Study to Evaluate the Safety, Tolerability, and Efficacy of OTX-CSI in Subjects With Dry Eye Disease. (NCT NCT04362670)
NCT ID: NCT04362670
Last Updated: 2023-11-14
Results Overview
Number of Subjects With At Least One (1) Treatment Emergent Adverse Event
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
153 participants
Primary outcome timeframe
From Screening to Study Exit, approximately 156 days.
Results posted on
2023-11-14
Participant Flow
Participant milestones
| Measure |
OTX-CSI Cohort 1 F2A
This arm was open label and all 5 subjects received F2A OTX-CSI 0.36 mg Cyclosporine Ophthalmic Insert (expected approximate persistence 3-4 months)
|
OTX-CSI Cohort 2 F1
Subjects in this arm received OTX-CSI 0.36 mg Cyclosporine Ophthalmic Insert (expected approximate persistence 2-3 months)
|
OTX-CSI Cohort 2 F2A
Subjects in this arm received OTX-CSI 0.36 mg Cyclosporine Ophthalmic Insert (expected approximate persistence 3-4 months)
|
OTX-CSI Cohort 2 F2B
Subjects in this arm received Hydrogel Vehicle Insert (expected approximate persistence 3-4 months)
|
OTX-CSI Cohort 2 F3
Subjects in this arm received Hydrogel Vehicle Insert (expected approximate persistence 1 week)
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
5
|
42
|
41
|
43
|
22
|
|
Overall Study
COMPLETED
|
5
|
39
|
39
|
42
|
22
|
|
Overall Study
NOT COMPLETED
|
0
|
3
|
2
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cohort 1 and the Modified Intent-to-Treat (mITT) population (defined as all subjects who received the insert in the study eye).
Baseline characteristics by cohort
| Measure |
OTX-CSI Cohort 1 F2A
n=5 Participants
This arm was open label and all 5 subjects received F2A OTX-CSI 0.36 mg Cyclosporine Ophthalmic Insert (expected approximate persistence 3-4 months)
|
OTX-CSI Cohort 2 F1
n=42 Participants
Subjects in this arm received OTX-CSI 0.36 mg Cyclosporine Ophthalmic Insert (expected approximate persistence 2-3 months)
|
OTX-CSI Cohort 2 F2A
n=41 Participants
Subjects in this arm received OTX-CSI 0.36 mg Cyclosporine Ophthalmic Insert (expected approximate persistence 3-4 months)
|
OTX-CSI Cohort 2 F2B
n=43 Participants
Subjects in this arm received Hydrogel Vehicle Insert (expected approximate persistence 3-4 months)
|
OTX-CSI Cohort 2 F3
n=22 Participants
Subjects in this arm received Hydrogel Vehicle Insert (expected approximate persistence 1 week)
|
Total
n=153 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants • Cohort 1 and the Modified Intent-to-Treat (mITT) population (defined as all subjects who received the insert in the study eye).
|
0 Participants
n=42 Participants • Cohort 1 and the Modified Intent-to-Treat (mITT) population (defined as all subjects who received the insert in the study eye).
|
0 Participants
n=40 Participants • Cohort 1 and the Modified Intent-to-Treat (mITT) population (defined as all subjects who received the insert in the study eye).
|
0 Participants
n=43 Participants • Cohort 1 and the Modified Intent-to-Treat (mITT) population (defined as all subjects who received the insert in the study eye).
|
0 Participants
n=22 Participants • Cohort 1 and the Modified Intent-to-Treat (mITT) population (defined as all subjects who received the insert in the study eye).
|
0 Participants
n=152 Participants • Cohort 1 and the Modified Intent-to-Treat (mITT) population (defined as all subjects who received the insert in the study eye).
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants • Cohort 1 and the Modified Intent-to-Treat (mITT) population (defined as all subjects who received the insert in the study eye).
|
16 Participants
n=42 Participants • Cohort 1 and the Modified Intent-to-Treat (mITT) population (defined as all subjects who received the insert in the study eye).
|
13 Participants
n=40 Participants • Cohort 1 and the Modified Intent-to-Treat (mITT) population (defined as all subjects who received the insert in the study eye).
|
19 Participants
n=43 Participants • Cohort 1 and the Modified Intent-to-Treat (mITT) population (defined as all subjects who received the insert in the study eye).
|
8 Participants
n=22 Participants • Cohort 1 and the Modified Intent-to-Treat (mITT) population (defined as all subjects who received the insert in the study eye).
|
57 Participants
n=152 Participants • Cohort 1 and the Modified Intent-to-Treat (mITT) population (defined as all subjects who received the insert in the study eye).
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants • Cohort 1 and the Modified Intent-to-Treat (mITT) population (defined as all subjects who received the insert in the study eye).
|
26 Participants
n=42 Participants • Cohort 1 and the Modified Intent-to-Treat (mITT) population (defined as all subjects who received the insert in the study eye).
|
27 Participants
n=40 Participants • Cohort 1 and the Modified Intent-to-Treat (mITT) population (defined as all subjects who received the insert in the study eye).
|
24 Participants
n=43 Participants • Cohort 1 and the Modified Intent-to-Treat (mITT) population (defined as all subjects who received the insert in the study eye).
|
14 Participants
n=22 Participants • Cohort 1 and the Modified Intent-to-Treat (mITT) population (defined as all subjects who received the insert in the study eye).
|
95 Participants
n=152 Participants • Cohort 1 and the Modified Intent-to-Treat (mITT) population (defined as all subjects who received the insert in the study eye).
|
|
Age, Continuous
|
73.0 years
STANDARD_DEVIATION 8.1 • n=5 Participants
|
67.9 years
STANDARD_DEVIATION 10.2 • n=42 Participants
|
68.0 years
STANDARD_DEVIATION 11.5 • n=41 Participants
|
65.5 years
STANDARD_DEVIATION 10.4 • n=43 Participants
|
65.2 years
STANDARD_DEVIATION 9.7 • n=22 Participants
|
67.0 years
STANDARD_DEVIATION 10.5 • n=153 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants • Cohort 1 and the Modified Intent-to-Treat (mITT) population (defined as all subjects who received the insert in the study eye).
|
29 Participants
n=42 Participants • Cohort 1 and the Modified Intent-to-Treat (mITT) population (defined as all subjects who received the insert in the study eye).
|
25 Participants
n=40 Participants • Cohort 1 and the Modified Intent-to-Treat (mITT) population (defined as all subjects who received the insert in the study eye).
|
39 Participants
n=43 Participants • Cohort 1 and the Modified Intent-to-Treat (mITT) population (defined as all subjects who received the insert in the study eye).
|
17 Participants
n=22 Participants • Cohort 1 and the Modified Intent-to-Treat (mITT) population (defined as all subjects who received the insert in the study eye).
|
115 Participants
n=152 Participants • Cohort 1 and the Modified Intent-to-Treat (mITT) population (defined as all subjects who received the insert in the study eye).
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants • Cohort 1 and the Modified Intent-to-Treat (mITT) population (defined as all subjects who received the insert in the study eye).
|
13 Participants
n=42 Participants • Cohort 1 and the Modified Intent-to-Treat (mITT) population (defined as all subjects who received the insert in the study eye).
|
15 Participants
n=40 Participants • Cohort 1 and the Modified Intent-to-Treat (mITT) population (defined as all subjects who received the insert in the study eye).
|
4 Participants
n=43 Participants • Cohort 1 and the Modified Intent-to-Treat (mITT) population (defined as all subjects who received the insert in the study eye).
|
5 Participants
n=22 Participants • Cohort 1 and the Modified Intent-to-Treat (mITT) population (defined as all subjects who received the insert in the study eye).
|
37 Participants
n=152 Participants • Cohort 1 and the Modified Intent-to-Treat (mITT) population (defined as all subjects who received the insert in the study eye).
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants • Cohort 1 and the Modified Intent-to-Treat (mITT) population (defined as all subjects who received the insert in the study eye).
|
0 Participants
n=42 Participants • Cohort 1 and the Modified Intent-to-Treat (mITT) population (defined as all subjects who received the insert in the study eye).
|
0 Participants
n=40 Participants • Cohort 1 and the Modified Intent-to-Treat (mITT) population (defined as all subjects who received the insert in the study eye).
|
0 Participants
n=43 Participants • Cohort 1 and the Modified Intent-to-Treat (mITT) population (defined as all subjects who received the insert in the study eye).
|
0 Participants
n=22 Participants • Cohort 1 and the Modified Intent-to-Treat (mITT) population (defined as all subjects who received the insert in the study eye).
|
0 Participants
n=152 Participants • Cohort 1 and the Modified Intent-to-Treat (mITT) population (defined as all subjects who received the insert in the study eye).
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants • Cohort 1 and the Modified Intent-to-Treat (mITT) population (defined as all subjects who received the insert in the study eye).
|
0 Participants
n=42 Participants • Cohort 1 and the Modified Intent-to-Treat (mITT) population (defined as all subjects who received the insert in the study eye).
|
0 Participants
n=40 Participants • Cohort 1 and the Modified Intent-to-Treat (mITT) population (defined as all subjects who received the insert in the study eye).
|
1 Participants
n=43 Participants • Cohort 1 and the Modified Intent-to-Treat (mITT) population (defined as all subjects who received the insert in the study eye).
|
1 Participants
n=22 Participants • Cohort 1 and the Modified Intent-to-Treat (mITT) population (defined as all subjects who received the insert in the study eye).
|
2 Participants
n=152 Participants • Cohort 1 and the Modified Intent-to-Treat (mITT) population (defined as all subjects who received the insert in the study eye).
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants • Cohort 1 and the Modified Intent-to-Treat (mITT) population (defined as all subjects who received the insert in the study eye).
|
0 Participants
n=42 Participants • Cohort 1 and the Modified Intent-to-Treat (mITT) population (defined as all subjects who received the insert in the study eye).
|
0 Participants
n=40 Participants • Cohort 1 and the Modified Intent-to-Treat (mITT) population (defined as all subjects who received the insert in the study eye).
|
0 Participants
n=43 Participants • Cohort 1 and the Modified Intent-to-Treat (mITT) population (defined as all subjects who received the insert in the study eye).
|
0 Participants
n=22 Participants • Cohort 1 and the Modified Intent-to-Treat (mITT) population (defined as all subjects who received the insert in the study eye).
|
0 Participants
n=152 Participants • Cohort 1 and the Modified Intent-to-Treat (mITT) population (defined as all subjects who received the insert in the study eye).
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants • Cohort 1 and the Modified Intent-to-Treat (mITT) population (defined as all subjects who received the insert in the study eye).
|
6 Participants
n=42 Participants • Cohort 1 and the Modified Intent-to-Treat (mITT) population (defined as all subjects who received the insert in the study eye).
|
7 Participants
n=40 Participants • Cohort 1 and the Modified Intent-to-Treat (mITT) population (defined as all subjects who received the insert in the study eye).
|
8 Participants
n=43 Participants • Cohort 1 and the Modified Intent-to-Treat (mITT) population (defined as all subjects who received the insert in the study eye).
|
2 Participants
n=22 Participants • Cohort 1 and the Modified Intent-to-Treat (mITT) population (defined as all subjects who received the insert in the study eye).
|
23 Participants
n=152 Participants • Cohort 1 and the Modified Intent-to-Treat (mITT) population (defined as all subjects who received the insert in the study eye).
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants • Cohort 1 and the Modified Intent-to-Treat (mITT) population (defined as all subjects who received the insert in the study eye).
|
36 Participants
n=42 Participants • Cohort 1 and the Modified Intent-to-Treat (mITT) population (defined as all subjects who received the insert in the study eye).
|
33 Participants
n=40 Participants • Cohort 1 and the Modified Intent-to-Treat (mITT) population (defined as all subjects who received the insert in the study eye).
|
34 Participants
n=43 Participants • Cohort 1 and the Modified Intent-to-Treat (mITT) population (defined as all subjects who received the insert in the study eye).
|
18 Participants
n=22 Participants • Cohort 1 and the Modified Intent-to-Treat (mITT) population (defined as all subjects who received the insert in the study eye).
|
126 Participants
n=152 Participants • Cohort 1 and the Modified Intent-to-Treat (mITT) population (defined as all subjects who received the insert in the study eye).
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants • Cohort 1 and the Modified Intent-to-Treat (mITT) population (defined as all subjects who received the insert in the study eye).
|
0 Participants
n=42 Participants • Cohort 1 and the Modified Intent-to-Treat (mITT) population (defined as all subjects who received the insert in the study eye).
|
0 Participants
n=40 Participants • Cohort 1 and the Modified Intent-to-Treat (mITT) population (defined as all subjects who received the insert in the study eye).
|
0 Participants
n=43 Participants • Cohort 1 and the Modified Intent-to-Treat (mITT) population (defined as all subjects who received the insert in the study eye).
|
0 Participants
n=22 Participants • Cohort 1 and the Modified Intent-to-Treat (mITT) population (defined as all subjects who received the insert in the study eye).
|
0 Participants
n=152 Participants • Cohort 1 and the Modified Intent-to-Treat (mITT) population (defined as all subjects who received the insert in the study eye).
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants • Cohort 1 and the Modified Intent-to-Treat (mITT) population (defined as all subjects who received the insert in the study eye).
|
0 Participants
n=42 Participants • Cohort 1 and the Modified Intent-to-Treat (mITT) population (defined as all subjects who received the insert in the study eye).
|
0 Participants
n=40 Participants • Cohort 1 and the Modified Intent-to-Treat (mITT) population (defined as all subjects who received the insert in the study eye).
|
0 Participants
n=43 Participants • Cohort 1 and the Modified Intent-to-Treat (mITT) population (defined as all subjects who received the insert in the study eye).
|
1 Participants
n=22 Participants • Cohort 1 and the Modified Intent-to-Treat (mITT) population (defined as all subjects who received the insert in the study eye).
|
1 Participants
n=152 Participants • Cohort 1 and the Modified Intent-to-Treat (mITT) population (defined as all subjects who received the insert in the study eye).
|
|
Region of Enrollment
North America
|
5 participants
n=5 Participants • Cohort 1 and the Modified Intent-to-Treat (mITT) population (defined as all subjects who received the insert in the study eye).
|
42 participants
n=42 Participants • Cohort 1 and the Modified Intent-to-Treat (mITT) population (defined as all subjects who received the insert in the study eye).
|
40 participants
n=40 Participants • Cohort 1 and the Modified Intent-to-Treat (mITT) population (defined as all subjects who received the insert in the study eye).
|
43 participants
n=43 Participants • Cohort 1 and the Modified Intent-to-Treat (mITT) population (defined as all subjects who received the insert in the study eye).
|
22 participants
n=22 Participants • Cohort 1 and the Modified Intent-to-Treat (mITT) population (defined as all subjects who received the insert in the study eye).
|
152 participants
n=152 Participants • Cohort 1 and the Modified Intent-to-Treat (mITT) population (defined as all subjects who received the insert in the study eye).
|
PRIMARY outcome
Timeframe: From Screening to Study Exit, approximately 156 days.Number of Subjects With At Least One (1) Treatment Emergent Adverse Event
Outcome measures
| Measure |
OTX-CSI Cohort 1 F2A
n=5 Participants
This arm was open label and all 5 subjects received F2A OTX-CSI 0.36 mg Cyclosporine Ophthalmic Insert (expected approximate persistence 3-4 months)
|
OTX-CSI Cohort 2 F1
n=42 Participants
Subjects in this arm received OTX-CSI 0.36 mg Cyclosporine Ophthalmic Insert (expected approximate persistence 2-3 months)
|
OTX-CSI Cohort 2 F2A
n=41 Participants
Subjects in this arm received OTX-CSI 0.36 mg Cyclosporine Ophthalmic Insert (expected approximate persistence 3-4 months)
|
OTX-CSI Cohort 2 F2B
n=43 Participants
Subjects in this arm received Hydrogel Vehicle Insert (expected approximate persistence 3-4 months)
|
OTX-CSI Cohort 2 F3
n=22 Participants
Subjects in this arm received Hydrogel Vehicle Insert (expected approximate persistence 1 week)
|
|---|---|---|---|---|---|
|
Number of Subjects With At Least One (1) Treatment Emergent Adverse Event
|
0 count of participants
|
16 count of participants
|
15 count of participants
|
5 count of participants
|
1 count of participants
|
PRIMARY outcome
Timeframe: Change from Baseline at Week 12Population: Cohort 1 was not included in this analysis, as Cohort 1 was evaluated for Safety only.
A Schirmer test strip measures the amount of tear production and provides a unit of measure in millimeters (mm).
Outcome measures
| Measure |
OTX-CSI Cohort 1 F2A
This arm was open label and all 5 subjects received F2A OTX-CSI 0.36 mg Cyclosporine Ophthalmic Insert (expected approximate persistence 3-4 months)
|
OTX-CSI Cohort 2 F1
n=42 Participants
Subjects in this arm received OTX-CSI 0.36 mg Cyclosporine Ophthalmic Insert (expected approximate persistence 2-3 months)
|
OTX-CSI Cohort 2 F2A
n=40 Participants
Subjects in this arm received OTX-CSI 0.36 mg Cyclosporine Ophthalmic Insert (expected approximate persistence 3-4 months)
|
OTX-CSI Cohort 2 F2B
n=43 Participants
Subjects in this arm received Hydrogel Vehicle Insert (expected approximate persistence 3-4 months)
|
OTX-CSI Cohort 2 F3
n=22 Participants
Subjects in this arm received Hydrogel Vehicle Insert (expected approximate persistence 1 week)
|
|---|---|---|---|---|---|
|
Schirmer Test Score, CFB at Week 12
|
—
|
1.98 millimeters
Interval 0.04 to 3.92
|
1.91 millimeters
Interval -0.01 to 3.82
|
2.24 millimeters
Interval 0.38 to 4.1
|
3.08 millimeters
Interval 0.51 to 5.65
|
Adverse Events
OTX-CSI Cohort 1 F2A
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
OTX-CSI Cohort 2 F1
Serious events: 1 serious events
Other events: 15 other events
Deaths: 0 deaths
OTX-CSI Cohort 2 F2A
Serious events: 2 serious events
Other events: 14 other events
Deaths: 0 deaths
OTX-CSI Cohort 2 F2B
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
OTX-CSI Cohort 2 F3
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
OTX-CSI Cohort 1 F2A
n=5 participants at risk
This arm was open label and all 5 subjects received F2A OTX-CSI 0.36 mg Cyclosporine Ophthalmic Insert (expected approximate persistence 3-4 months)
|
OTX-CSI Cohort 2 F1
n=42 participants at risk
Subjects in this arm received OTX-CSI 0.36 mg Cyclosporine Ophthalmic Insert (expected approximate persistence 2-3 months)
|
OTX-CSI Cohort 2 F2A
n=41 participants at risk
Subjects in this arm received OTX-CSI 0.36 mg Cyclosporine Ophthalmic Insert (expected approximate persistence 3-4 months)
|
OTX-CSI Cohort 2 F2B
n=43 participants at risk
Subjects in this arm received Hydrogel Vehicle Insert (expected approximate persistence 3-4 months)
|
OTX-CSI Cohort 2 F3
n=22 participants at risk
Subjects in this arm received Hydrogel Vehicle Insert (expected approximate persistence 1 week)
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Hiatus Hernia
|
0.00%
0/5 • approximately 156 days
"OTX-CSI Cohort 2F1","OTX-CSI Cohort 2 F2A", and"OTX-CSI Cohort 2 F2B" Arms had 16, 15, and 5 participants, respectively, who experienced at least 1 Treatment Emergent Adverse Event (TEAE).Of these 16, 15, and 5 participants, some experienced more than 1 TEAE. Since some subjects reported more than 1 TEAE, the count of participants in Section 1 (subjects that reported at least 1 TEAE) may not match the sum of Affected subjects in the "SAE" and the "Other (Not Including Serious) AE" sections
|
2.4%
1/42 • approximately 156 days
"OTX-CSI Cohort 2F1","OTX-CSI Cohort 2 F2A", and"OTX-CSI Cohort 2 F2B" Arms had 16, 15, and 5 participants, respectively, who experienced at least 1 Treatment Emergent Adverse Event (TEAE).Of these 16, 15, and 5 participants, some experienced more than 1 TEAE. Since some subjects reported more than 1 TEAE, the count of participants in Section 1 (subjects that reported at least 1 TEAE) may not match the sum of Affected subjects in the "SAE" and the "Other (Not Including Serious) AE" sections
|
0.00%
0/41 • approximately 156 days
"OTX-CSI Cohort 2F1","OTX-CSI Cohort 2 F2A", and"OTX-CSI Cohort 2 F2B" Arms had 16, 15, and 5 participants, respectively, who experienced at least 1 Treatment Emergent Adverse Event (TEAE).Of these 16, 15, and 5 participants, some experienced more than 1 TEAE. Since some subjects reported more than 1 TEAE, the count of participants in Section 1 (subjects that reported at least 1 TEAE) may not match the sum of Affected subjects in the "SAE" and the "Other (Not Including Serious) AE" sections
|
0.00%
0/43 • approximately 156 days
"OTX-CSI Cohort 2F1","OTX-CSI Cohort 2 F2A", and"OTX-CSI Cohort 2 F2B" Arms had 16, 15, and 5 participants, respectively, who experienced at least 1 Treatment Emergent Adverse Event (TEAE).Of these 16, 15, and 5 participants, some experienced more than 1 TEAE. Since some subjects reported more than 1 TEAE, the count of participants in Section 1 (subjects that reported at least 1 TEAE) may not match the sum of Affected subjects in the "SAE" and the "Other (Not Including Serious) AE" sections
|
0.00%
0/22 • approximately 156 days
"OTX-CSI Cohort 2F1","OTX-CSI Cohort 2 F2A", and"OTX-CSI Cohort 2 F2B" Arms had 16, 15, and 5 participants, respectively, who experienced at least 1 Treatment Emergent Adverse Event (TEAE).Of these 16, 15, and 5 participants, some experienced more than 1 TEAE. Since some subjects reported more than 1 TEAE, the count of participants in Section 1 (subjects that reported at least 1 TEAE) may not match the sum of Affected subjects in the "SAE" and the "Other (Not Including Serious) AE" sections
|
|
Infections and infestations
COVID-19 Pneumonia
|
0.00%
0/5 • approximately 156 days
"OTX-CSI Cohort 2F1","OTX-CSI Cohort 2 F2A", and"OTX-CSI Cohort 2 F2B" Arms had 16, 15, and 5 participants, respectively, who experienced at least 1 Treatment Emergent Adverse Event (TEAE).Of these 16, 15, and 5 participants, some experienced more than 1 TEAE. Since some subjects reported more than 1 TEAE, the count of participants in Section 1 (subjects that reported at least 1 TEAE) may not match the sum of Affected subjects in the "SAE" and the "Other (Not Including Serious) AE" sections
|
0.00%
0/42 • approximately 156 days
"OTX-CSI Cohort 2F1","OTX-CSI Cohort 2 F2A", and"OTX-CSI Cohort 2 F2B" Arms had 16, 15, and 5 participants, respectively, who experienced at least 1 Treatment Emergent Adverse Event (TEAE).Of these 16, 15, and 5 participants, some experienced more than 1 TEAE. Since some subjects reported more than 1 TEAE, the count of participants in Section 1 (subjects that reported at least 1 TEAE) may not match the sum of Affected subjects in the "SAE" and the "Other (Not Including Serious) AE" sections
|
2.4%
1/41 • approximately 156 days
"OTX-CSI Cohort 2F1","OTX-CSI Cohort 2 F2A", and"OTX-CSI Cohort 2 F2B" Arms had 16, 15, and 5 participants, respectively, who experienced at least 1 Treatment Emergent Adverse Event (TEAE).Of these 16, 15, and 5 participants, some experienced more than 1 TEAE. Since some subjects reported more than 1 TEAE, the count of participants in Section 1 (subjects that reported at least 1 TEAE) may not match the sum of Affected subjects in the "SAE" and the "Other (Not Including Serious) AE" sections
|
0.00%
0/43 • approximately 156 days
"OTX-CSI Cohort 2F1","OTX-CSI Cohort 2 F2A", and"OTX-CSI Cohort 2 F2B" Arms had 16, 15, and 5 participants, respectively, who experienced at least 1 Treatment Emergent Adverse Event (TEAE).Of these 16, 15, and 5 participants, some experienced more than 1 TEAE. Since some subjects reported more than 1 TEAE, the count of participants in Section 1 (subjects that reported at least 1 TEAE) may not match the sum of Affected subjects in the "SAE" and the "Other (Not Including Serious) AE" sections
|
0.00%
0/22 • approximately 156 days
"OTX-CSI Cohort 2F1","OTX-CSI Cohort 2 F2A", and"OTX-CSI Cohort 2 F2B" Arms had 16, 15, and 5 participants, respectively, who experienced at least 1 Treatment Emergent Adverse Event (TEAE).Of these 16, 15, and 5 participants, some experienced more than 1 TEAE. Since some subjects reported more than 1 TEAE, the count of participants in Section 1 (subjects that reported at least 1 TEAE) may not match the sum of Affected subjects in the "SAE" and the "Other (Not Including Serious) AE" sections
|
|
Injury, poisoning and procedural complications
Hip Fracture
|
0.00%
0/5 • approximately 156 days
"OTX-CSI Cohort 2F1","OTX-CSI Cohort 2 F2A", and"OTX-CSI Cohort 2 F2B" Arms had 16, 15, and 5 participants, respectively, who experienced at least 1 Treatment Emergent Adverse Event (TEAE).Of these 16, 15, and 5 participants, some experienced more than 1 TEAE. Since some subjects reported more than 1 TEAE, the count of participants in Section 1 (subjects that reported at least 1 TEAE) may not match the sum of Affected subjects in the "SAE" and the "Other (Not Including Serious) AE" sections
|
0.00%
0/42 • approximately 156 days
"OTX-CSI Cohort 2F1","OTX-CSI Cohort 2 F2A", and"OTX-CSI Cohort 2 F2B" Arms had 16, 15, and 5 participants, respectively, who experienced at least 1 Treatment Emergent Adverse Event (TEAE).Of these 16, 15, and 5 participants, some experienced more than 1 TEAE. Since some subjects reported more than 1 TEAE, the count of participants in Section 1 (subjects that reported at least 1 TEAE) may not match the sum of Affected subjects in the "SAE" and the "Other (Not Including Serious) AE" sections
|
2.4%
1/41 • approximately 156 days
"OTX-CSI Cohort 2F1","OTX-CSI Cohort 2 F2A", and"OTX-CSI Cohort 2 F2B" Arms had 16, 15, and 5 participants, respectively, who experienced at least 1 Treatment Emergent Adverse Event (TEAE).Of these 16, 15, and 5 participants, some experienced more than 1 TEAE. Since some subjects reported more than 1 TEAE, the count of participants in Section 1 (subjects that reported at least 1 TEAE) may not match the sum of Affected subjects in the "SAE" and the "Other (Not Including Serious) AE" sections
|
0.00%
0/43 • approximately 156 days
"OTX-CSI Cohort 2F1","OTX-CSI Cohort 2 F2A", and"OTX-CSI Cohort 2 F2B" Arms had 16, 15, and 5 participants, respectively, who experienced at least 1 Treatment Emergent Adverse Event (TEAE).Of these 16, 15, and 5 participants, some experienced more than 1 TEAE. Since some subjects reported more than 1 TEAE, the count of participants in Section 1 (subjects that reported at least 1 TEAE) may not match the sum of Affected subjects in the "SAE" and the "Other (Not Including Serious) AE" sections
|
0.00%
0/22 • approximately 156 days
"OTX-CSI Cohort 2F1","OTX-CSI Cohort 2 F2A", and"OTX-CSI Cohort 2 F2B" Arms had 16, 15, and 5 participants, respectively, who experienced at least 1 Treatment Emergent Adverse Event (TEAE).Of these 16, 15, and 5 participants, some experienced more than 1 TEAE. Since some subjects reported more than 1 TEAE, the count of participants in Section 1 (subjects that reported at least 1 TEAE) may not match the sum of Affected subjects in the "SAE" and the "Other (Not Including Serious) AE" sections
|
Other adverse events
| Measure |
OTX-CSI Cohort 1 F2A
n=5 participants at risk
This arm was open label and all 5 subjects received F2A OTX-CSI 0.36 mg Cyclosporine Ophthalmic Insert (expected approximate persistence 3-4 months)
|
OTX-CSI Cohort 2 F1
n=42 participants at risk
Subjects in this arm received OTX-CSI 0.36 mg Cyclosporine Ophthalmic Insert (expected approximate persistence 2-3 months)
|
OTX-CSI Cohort 2 F2A
n=41 participants at risk
Subjects in this arm received OTX-CSI 0.36 mg Cyclosporine Ophthalmic Insert (expected approximate persistence 3-4 months)
|
OTX-CSI Cohort 2 F2B
n=43 participants at risk
Subjects in this arm received Hydrogel Vehicle Insert (expected approximate persistence 3-4 months)
|
OTX-CSI Cohort 2 F3
n=22 participants at risk
Subjects in this arm received Hydrogel Vehicle Insert (expected approximate persistence 1 week)
|
|---|---|---|---|---|---|
|
Eye disorders
Eye Disorders
|
0.00%
0/5 • approximately 156 days
"OTX-CSI Cohort 2F1","OTX-CSI Cohort 2 F2A", and"OTX-CSI Cohort 2 F2B" Arms had 16, 15, and 5 participants, respectively, who experienced at least 1 Treatment Emergent Adverse Event (TEAE).Of these 16, 15, and 5 participants, some experienced more than 1 TEAE. Since some subjects reported more than 1 TEAE, the count of participants in Section 1 (subjects that reported at least 1 TEAE) may not match the sum of Affected subjects in the "SAE" and the "Other (Not Including Serious) AE" sections
|
31.0%
13/42 • approximately 156 days
"OTX-CSI Cohort 2F1","OTX-CSI Cohort 2 F2A", and"OTX-CSI Cohort 2 F2B" Arms had 16, 15, and 5 participants, respectively, who experienced at least 1 Treatment Emergent Adverse Event (TEAE).Of these 16, 15, and 5 participants, some experienced more than 1 TEAE. Since some subjects reported more than 1 TEAE, the count of participants in Section 1 (subjects that reported at least 1 TEAE) may not match the sum of Affected subjects in the "SAE" and the "Other (Not Including Serious) AE" sections
|
26.8%
11/41 • approximately 156 days
"OTX-CSI Cohort 2F1","OTX-CSI Cohort 2 F2A", and"OTX-CSI Cohort 2 F2B" Arms had 16, 15, and 5 participants, respectively, who experienced at least 1 Treatment Emergent Adverse Event (TEAE).Of these 16, 15, and 5 participants, some experienced more than 1 TEAE. Since some subjects reported more than 1 TEAE, the count of participants in Section 1 (subjects that reported at least 1 TEAE) may not match the sum of Affected subjects in the "SAE" and the "Other (Not Including Serious) AE" sections
|
7.0%
3/43 • approximately 156 days
"OTX-CSI Cohort 2F1","OTX-CSI Cohort 2 F2A", and"OTX-CSI Cohort 2 F2B" Arms had 16, 15, and 5 participants, respectively, who experienced at least 1 Treatment Emergent Adverse Event (TEAE).Of these 16, 15, and 5 participants, some experienced more than 1 TEAE. Since some subjects reported more than 1 TEAE, the count of participants in Section 1 (subjects that reported at least 1 TEAE) may not match the sum of Affected subjects in the "SAE" and the "Other (Not Including Serious) AE" sections
|
4.5%
1/22 • approximately 156 days
"OTX-CSI Cohort 2F1","OTX-CSI Cohort 2 F2A", and"OTX-CSI Cohort 2 F2B" Arms had 16, 15, and 5 participants, respectively, who experienced at least 1 Treatment Emergent Adverse Event (TEAE).Of these 16, 15, and 5 participants, some experienced more than 1 TEAE. Since some subjects reported more than 1 TEAE, the count of participants in Section 1 (subjects that reported at least 1 TEAE) may not match the sum of Affected subjects in the "SAE" and the "Other (Not Including Serious) AE" sections
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/5 • approximately 156 days
"OTX-CSI Cohort 2F1","OTX-CSI Cohort 2 F2A", and"OTX-CSI Cohort 2 F2B" Arms had 16, 15, and 5 participants, respectively, who experienced at least 1 Treatment Emergent Adverse Event (TEAE).Of these 16, 15, and 5 participants, some experienced more than 1 TEAE. Since some subjects reported more than 1 TEAE, the count of participants in Section 1 (subjects that reported at least 1 TEAE) may not match the sum of Affected subjects in the "SAE" and the "Other (Not Including Serious) AE" sections
|
2.4%
1/42 • approximately 156 days
"OTX-CSI Cohort 2F1","OTX-CSI Cohort 2 F2A", and"OTX-CSI Cohort 2 F2B" Arms had 16, 15, and 5 participants, respectively, who experienced at least 1 Treatment Emergent Adverse Event (TEAE).Of these 16, 15, and 5 participants, some experienced more than 1 TEAE. Since some subjects reported more than 1 TEAE, the count of participants in Section 1 (subjects that reported at least 1 TEAE) may not match the sum of Affected subjects in the "SAE" and the "Other (Not Including Serious) AE" sections
|
0.00%
0/41 • approximately 156 days
"OTX-CSI Cohort 2F1","OTX-CSI Cohort 2 F2A", and"OTX-CSI Cohort 2 F2B" Arms had 16, 15, and 5 participants, respectively, who experienced at least 1 Treatment Emergent Adverse Event (TEAE).Of these 16, 15, and 5 participants, some experienced more than 1 TEAE. Since some subjects reported more than 1 TEAE, the count of participants in Section 1 (subjects that reported at least 1 TEAE) may not match the sum of Affected subjects in the "SAE" and the "Other (Not Including Serious) AE" sections
|
0.00%
0/43 • approximately 156 days
"OTX-CSI Cohort 2F1","OTX-CSI Cohort 2 F2A", and"OTX-CSI Cohort 2 F2B" Arms had 16, 15, and 5 participants, respectively, who experienced at least 1 Treatment Emergent Adverse Event (TEAE).Of these 16, 15, and 5 participants, some experienced more than 1 TEAE. Since some subjects reported more than 1 TEAE, the count of participants in Section 1 (subjects that reported at least 1 TEAE) may not match the sum of Affected subjects in the "SAE" and the "Other (Not Including Serious) AE" sections
|
0.00%
0/22 • approximately 156 days
"OTX-CSI Cohort 2F1","OTX-CSI Cohort 2 F2A", and"OTX-CSI Cohort 2 F2B" Arms had 16, 15, and 5 participants, respectively, who experienced at least 1 Treatment Emergent Adverse Event (TEAE).Of these 16, 15, and 5 participants, some experienced more than 1 TEAE. Since some subjects reported more than 1 TEAE, the count of participants in Section 1 (subjects that reported at least 1 TEAE) may not match the sum of Affected subjects in the "SAE" and the "Other (Not Including Serious) AE" sections
|
|
Nervous system disorders
Headache
|
0.00%
0/5 • approximately 156 days
"OTX-CSI Cohort 2F1","OTX-CSI Cohort 2 F2A", and"OTX-CSI Cohort 2 F2B" Arms had 16, 15, and 5 participants, respectively, who experienced at least 1 Treatment Emergent Adverse Event (TEAE).Of these 16, 15, and 5 participants, some experienced more than 1 TEAE. Since some subjects reported more than 1 TEAE, the count of participants in Section 1 (subjects that reported at least 1 TEAE) may not match the sum of Affected subjects in the "SAE" and the "Other (Not Including Serious) AE" sections
|
2.4%
1/42 • approximately 156 days
"OTX-CSI Cohort 2F1","OTX-CSI Cohort 2 F2A", and"OTX-CSI Cohort 2 F2B" Arms had 16, 15, and 5 participants, respectively, who experienced at least 1 Treatment Emergent Adverse Event (TEAE).Of these 16, 15, and 5 participants, some experienced more than 1 TEAE. Since some subjects reported more than 1 TEAE, the count of participants in Section 1 (subjects that reported at least 1 TEAE) may not match the sum of Affected subjects in the "SAE" and the "Other (Not Including Serious) AE" sections
|
0.00%
0/41 • approximately 156 days
"OTX-CSI Cohort 2F1","OTX-CSI Cohort 2 F2A", and"OTX-CSI Cohort 2 F2B" Arms had 16, 15, and 5 participants, respectively, who experienced at least 1 Treatment Emergent Adverse Event (TEAE).Of these 16, 15, and 5 participants, some experienced more than 1 TEAE. Since some subjects reported more than 1 TEAE, the count of participants in Section 1 (subjects that reported at least 1 TEAE) may not match the sum of Affected subjects in the "SAE" and the "Other (Not Including Serious) AE" sections
|
0.00%
0/43 • approximately 156 days
"OTX-CSI Cohort 2F1","OTX-CSI Cohort 2 F2A", and"OTX-CSI Cohort 2 F2B" Arms had 16, 15, and 5 participants, respectively, who experienced at least 1 Treatment Emergent Adverse Event (TEAE).Of these 16, 15, and 5 participants, some experienced more than 1 TEAE. Since some subjects reported more than 1 TEAE, the count of participants in Section 1 (subjects that reported at least 1 TEAE) may not match the sum of Affected subjects in the "SAE" and the "Other (Not Including Serious) AE" sections
|
0.00%
0/22 • approximately 156 days
"OTX-CSI Cohort 2F1","OTX-CSI Cohort 2 F2A", and"OTX-CSI Cohort 2 F2B" Arms had 16, 15, and 5 participants, respectively, who experienced at least 1 Treatment Emergent Adverse Event (TEAE).Of these 16, 15, and 5 participants, some experienced more than 1 TEAE. Since some subjects reported more than 1 TEAE, the count of participants in Section 1 (subjects that reported at least 1 TEAE) may not match the sum of Affected subjects in the "SAE" and the "Other (Not Including Serious) AE" sections
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/5 • approximately 156 days
"OTX-CSI Cohort 2F1","OTX-CSI Cohort 2 F2A", and"OTX-CSI Cohort 2 F2B" Arms had 16, 15, and 5 participants, respectively, who experienced at least 1 Treatment Emergent Adverse Event (TEAE).Of these 16, 15, and 5 participants, some experienced more than 1 TEAE. Since some subjects reported more than 1 TEAE, the count of participants in Section 1 (subjects that reported at least 1 TEAE) may not match the sum of Affected subjects in the "SAE" and the "Other (Not Including Serious) AE" sections
|
0.00%
0/42 • approximately 156 days
"OTX-CSI Cohort 2F1","OTX-CSI Cohort 2 F2A", and"OTX-CSI Cohort 2 F2B" Arms had 16, 15, and 5 participants, respectively, who experienced at least 1 Treatment Emergent Adverse Event (TEAE).Of these 16, 15, and 5 participants, some experienced more than 1 TEAE. Since some subjects reported more than 1 TEAE, the count of participants in Section 1 (subjects that reported at least 1 TEAE) may not match the sum of Affected subjects in the "SAE" and the "Other (Not Including Serious) AE" sections
|
2.4%
1/41 • approximately 156 days
"OTX-CSI Cohort 2F1","OTX-CSI Cohort 2 F2A", and"OTX-CSI Cohort 2 F2B" Arms had 16, 15, and 5 participants, respectively, who experienced at least 1 Treatment Emergent Adverse Event (TEAE).Of these 16, 15, and 5 participants, some experienced more than 1 TEAE. Since some subjects reported more than 1 TEAE, the count of participants in Section 1 (subjects that reported at least 1 TEAE) may not match the sum of Affected subjects in the "SAE" and the "Other (Not Including Serious) AE" sections
|
0.00%
0/43 • approximately 156 days
"OTX-CSI Cohort 2F1","OTX-CSI Cohort 2 F2A", and"OTX-CSI Cohort 2 F2B" Arms had 16, 15, and 5 participants, respectively, who experienced at least 1 Treatment Emergent Adverse Event (TEAE).Of these 16, 15, and 5 participants, some experienced more than 1 TEAE. Since some subjects reported more than 1 TEAE, the count of participants in Section 1 (subjects that reported at least 1 TEAE) may not match the sum of Affected subjects in the "SAE" and the "Other (Not Including Serious) AE" sections
|
0.00%
0/22 • approximately 156 days
"OTX-CSI Cohort 2F1","OTX-CSI Cohort 2 F2A", and"OTX-CSI Cohort 2 F2B" Arms had 16, 15, and 5 participants, respectively, who experienced at least 1 Treatment Emergent Adverse Event (TEAE).Of these 16, 15, and 5 participants, some experienced more than 1 TEAE. Since some subjects reported more than 1 TEAE, the count of participants in Section 1 (subjects that reported at least 1 TEAE) may not match the sum of Affected subjects in the "SAE" and the "Other (Not Including Serious) AE" sections
|
|
Infections and infestations
COVID-19
|
0.00%
0/5 • approximately 156 days
"OTX-CSI Cohort 2F1","OTX-CSI Cohort 2 F2A", and"OTX-CSI Cohort 2 F2B" Arms had 16, 15, and 5 participants, respectively, who experienced at least 1 Treatment Emergent Adverse Event (TEAE).Of these 16, 15, and 5 participants, some experienced more than 1 TEAE. Since some subjects reported more than 1 TEAE, the count of participants in Section 1 (subjects that reported at least 1 TEAE) may not match the sum of Affected subjects in the "SAE" and the "Other (Not Including Serious) AE" sections
|
0.00%
0/42 • approximately 156 days
"OTX-CSI Cohort 2F1","OTX-CSI Cohort 2 F2A", and"OTX-CSI Cohort 2 F2B" Arms had 16, 15, and 5 participants, respectively, who experienced at least 1 Treatment Emergent Adverse Event (TEAE).Of these 16, 15, and 5 participants, some experienced more than 1 TEAE. Since some subjects reported more than 1 TEAE, the count of participants in Section 1 (subjects that reported at least 1 TEAE) may not match the sum of Affected subjects in the "SAE" and the "Other (Not Including Serious) AE" sections
|
4.9%
2/41 • approximately 156 days
"OTX-CSI Cohort 2F1","OTX-CSI Cohort 2 F2A", and"OTX-CSI Cohort 2 F2B" Arms had 16, 15, and 5 participants, respectively, who experienced at least 1 Treatment Emergent Adverse Event (TEAE).Of these 16, 15, and 5 participants, some experienced more than 1 TEAE. Since some subjects reported more than 1 TEAE, the count of participants in Section 1 (subjects that reported at least 1 TEAE) may not match the sum of Affected subjects in the "SAE" and the "Other (Not Including Serious) AE" sections
|
2.3%
1/43 • approximately 156 days
"OTX-CSI Cohort 2F1","OTX-CSI Cohort 2 F2A", and"OTX-CSI Cohort 2 F2B" Arms had 16, 15, and 5 participants, respectively, who experienced at least 1 Treatment Emergent Adverse Event (TEAE).Of these 16, 15, and 5 participants, some experienced more than 1 TEAE. Since some subjects reported more than 1 TEAE, the count of participants in Section 1 (subjects that reported at least 1 TEAE) may not match the sum of Affected subjects in the "SAE" and the "Other (Not Including Serious) AE" sections
|
0.00%
0/22 • approximately 156 days
"OTX-CSI Cohort 2F1","OTX-CSI Cohort 2 F2A", and"OTX-CSI Cohort 2 F2B" Arms had 16, 15, and 5 participants, respectively, who experienced at least 1 Treatment Emergent Adverse Event (TEAE).Of these 16, 15, and 5 participants, some experienced more than 1 TEAE. Since some subjects reported more than 1 TEAE, the count of participants in Section 1 (subjects that reported at least 1 TEAE) may not match the sum of Affected subjects in the "SAE" and the "Other (Not Including Serious) AE" sections
|
|
Infections and infestations
Oral Herpes
|
0.00%
0/5 • approximately 156 days
"OTX-CSI Cohort 2F1","OTX-CSI Cohort 2 F2A", and"OTX-CSI Cohort 2 F2B" Arms had 16, 15, and 5 participants, respectively, who experienced at least 1 Treatment Emergent Adverse Event (TEAE).Of these 16, 15, and 5 participants, some experienced more than 1 TEAE. Since some subjects reported more than 1 TEAE, the count of participants in Section 1 (subjects that reported at least 1 TEAE) may not match the sum of Affected subjects in the "SAE" and the "Other (Not Including Serious) AE" sections
|
0.00%
0/42 • approximately 156 days
"OTX-CSI Cohort 2F1","OTX-CSI Cohort 2 F2A", and"OTX-CSI Cohort 2 F2B" Arms had 16, 15, and 5 participants, respectively, who experienced at least 1 Treatment Emergent Adverse Event (TEAE).Of these 16, 15, and 5 participants, some experienced more than 1 TEAE. Since some subjects reported more than 1 TEAE, the count of participants in Section 1 (subjects that reported at least 1 TEAE) may not match the sum of Affected subjects in the "SAE" and the "Other (Not Including Serious) AE" sections
|
2.4%
1/41 • approximately 156 days
"OTX-CSI Cohort 2F1","OTX-CSI Cohort 2 F2A", and"OTX-CSI Cohort 2 F2B" Arms had 16, 15, and 5 participants, respectively, who experienced at least 1 Treatment Emergent Adverse Event (TEAE).Of these 16, 15, and 5 participants, some experienced more than 1 TEAE. Since some subjects reported more than 1 TEAE, the count of participants in Section 1 (subjects that reported at least 1 TEAE) may not match the sum of Affected subjects in the "SAE" and the "Other (Not Including Serious) AE" sections
|
0.00%
0/43 • approximately 156 days
"OTX-CSI Cohort 2F1","OTX-CSI Cohort 2 F2A", and"OTX-CSI Cohort 2 F2B" Arms had 16, 15, and 5 participants, respectively, who experienced at least 1 Treatment Emergent Adverse Event (TEAE).Of these 16, 15, and 5 participants, some experienced more than 1 TEAE. Since some subjects reported more than 1 TEAE, the count of participants in Section 1 (subjects that reported at least 1 TEAE) may not match the sum of Affected subjects in the "SAE" and the "Other (Not Including Serious) AE" sections
|
0.00%
0/22 • approximately 156 days
"OTX-CSI Cohort 2F1","OTX-CSI Cohort 2 F2A", and"OTX-CSI Cohort 2 F2B" Arms had 16, 15, and 5 participants, respectively, who experienced at least 1 Treatment Emergent Adverse Event (TEAE).Of these 16, 15, and 5 participants, some experienced more than 1 TEAE. Since some subjects reported more than 1 TEAE, the count of participants in Section 1 (subjects that reported at least 1 TEAE) may not match the sum of Affected subjects in the "SAE" and the "Other (Not Including Serious) AE" sections
|
|
Injury, poisoning and procedural complications
Ankle Fracture
|
0.00%
0/5 • approximately 156 days
"OTX-CSI Cohort 2F1","OTX-CSI Cohort 2 F2A", and"OTX-CSI Cohort 2 F2B" Arms had 16, 15, and 5 participants, respectively, who experienced at least 1 Treatment Emergent Adverse Event (TEAE).Of these 16, 15, and 5 participants, some experienced more than 1 TEAE. Since some subjects reported more than 1 TEAE, the count of participants in Section 1 (subjects that reported at least 1 TEAE) may not match the sum of Affected subjects in the "SAE" and the "Other (Not Including Serious) AE" sections
|
0.00%
0/42 • approximately 156 days
"OTX-CSI Cohort 2F1","OTX-CSI Cohort 2 F2A", and"OTX-CSI Cohort 2 F2B" Arms had 16, 15, and 5 participants, respectively, who experienced at least 1 Treatment Emergent Adverse Event (TEAE).Of these 16, 15, and 5 participants, some experienced more than 1 TEAE. Since some subjects reported more than 1 TEAE, the count of participants in Section 1 (subjects that reported at least 1 TEAE) may not match the sum of Affected subjects in the "SAE" and the "Other (Not Including Serious) AE" sections
|
2.4%
1/41 • approximately 156 days
"OTX-CSI Cohort 2F1","OTX-CSI Cohort 2 F2A", and"OTX-CSI Cohort 2 F2B" Arms had 16, 15, and 5 participants, respectively, who experienced at least 1 Treatment Emergent Adverse Event (TEAE).Of these 16, 15, and 5 participants, some experienced more than 1 TEAE. Since some subjects reported more than 1 TEAE, the count of participants in Section 1 (subjects that reported at least 1 TEAE) may not match the sum of Affected subjects in the "SAE" and the "Other (Not Including Serious) AE" sections
|
0.00%
0/43 • approximately 156 days
"OTX-CSI Cohort 2F1","OTX-CSI Cohort 2 F2A", and"OTX-CSI Cohort 2 F2B" Arms had 16, 15, and 5 participants, respectively, who experienced at least 1 Treatment Emergent Adverse Event (TEAE).Of these 16, 15, and 5 participants, some experienced more than 1 TEAE. Since some subjects reported more than 1 TEAE, the count of participants in Section 1 (subjects that reported at least 1 TEAE) may not match the sum of Affected subjects in the "SAE" and the "Other (Not Including Serious) AE" sections
|
0.00%
0/22 • approximately 156 days
"OTX-CSI Cohort 2F1","OTX-CSI Cohort 2 F2A", and"OTX-CSI Cohort 2 F2B" Arms had 16, 15, and 5 participants, respectively, who experienced at least 1 Treatment Emergent Adverse Event (TEAE).Of these 16, 15, and 5 participants, some experienced more than 1 TEAE. Since some subjects reported more than 1 TEAE, the count of participants in Section 1 (subjects that reported at least 1 TEAE) may not match the sum of Affected subjects in the "SAE" and the "Other (Not Including Serious) AE" sections
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/5 • approximately 156 days
"OTX-CSI Cohort 2F1","OTX-CSI Cohort 2 F2A", and"OTX-CSI Cohort 2 F2B" Arms had 16, 15, and 5 participants, respectively, who experienced at least 1 Treatment Emergent Adverse Event (TEAE).Of these 16, 15, and 5 participants, some experienced more than 1 TEAE. Since some subjects reported more than 1 TEAE, the count of participants in Section 1 (subjects that reported at least 1 TEAE) may not match the sum of Affected subjects in the "SAE" and the "Other (Not Including Serious) AE" sections
|
0.00%
0/42 • approximately 156 days
"OTX-CSI Cohort 2F1","OTX-CSI Cohort 2 F2A", and"OTX-CSI Cohort 2 F2B" Arms had 16, 15, and 5 participants, respectively, who experienced at least 1 Treatment Emergent Adverse Event (TEAE).Of these 16, 15, and 5 participants, some experienced more than 1 TEAE. Since some subjects reported more than 1 TEAE, the count of participants in Section 1 (subjects that reported at least 1 TEAE) may not match the sum of Affected subjects in the "SAE" and the "Other (Not Including Serious) AE" sections
|
2.4%
1/41 • approximately 156 days
"OTX-CSI Cohort 2F1","OTX-CSI Cohort 2 F2A", and"OTX-CSI Cohort 2 F2B" Arms had 16, 15, and 5 participants, respectively, who experienced at least 1 Treatment Emergent Adverse Event (TEAE).Of these 16, 15, and 5 participants, some experienced more than 1 TEAE. Since some subjects reported more than 1 TEAE, the count of participants in Section 1 (subjects that reported at least 1 TEAE) may not match the sum of Affected subjects in the "SAE" and the "Other (Not Including Serious) AE" sections
|
0.00%
0/43 • approximately 156 days
"OTX-CSI Cohort 2F1","OTX-CSI Cohort 2 F2A", and"OTX-CSI Cohort 2 F2B" Arms had 16, 15, and 5 participants, respectively, who experienced at least 1 Treatment Emergent Adverse Event (TEAE).Of these 16, 15, and 5 participants, some experienced more than 1 TEAE. Since some subjects reported more than 1 TEAE, the count of participants in Section 1 (subjects that reported at least 1 TEAE) may not match the sum of Affected subjects in the "SAE" and the "Other (Not Including Serious) AE" sections
|
0.00%
0/22 • approximately 156 days
"OTX-CSI Cohort 2F1","OTX-CSI Cohort 2 F2A", and"OTX-CSI Cohort 2 F2B" Arms had 16, 15, and 5 participants, respectively, who experienced at least 1 Treatment Emergent Adverse Event (TEAE).Of these 16, 15, and 5 participants, some experienced more than 1 TEAE. Since some subjects reported more than 1 TEAE, the count of participants in Section 1 (subjects that reported at least 1 TEAE) may not match the sum of Affected subjects in the "SAE" and the "Other (Not Including Serious) AE" sections
|
|
Infections and infestations
Candida Infection
|
0.00%
0/5 • approximately 156 days
"OTX-CSI Cohort 2F1","OTX-CSI Cohort 2 F2A", and"OTX-CSI Cohort 2 F2B" Arms had 16, 15, and 5 participants, respectively, who experienced at least 1 Treatment Emergent Adverse Event (TEAE).Of these 16, 15, and 5 participants, some experienced more than 1 TEAE. Since some subjects reported more than 1 TEAE, the count of participants in Section 1 (subjects that reported at least 1 TEAE) may not match the sum of Affected subjects in the "SAE" and the "Other (Not Including Serious) AE" sections
|
0.00%
0/42 • approximately 156 days
"OTX-CSI Cohort 2F1","OTX-CSI Cohort 2 F2A", and"OTX-CSI Cohort 2 F2B" Arms had 16, 15, and 5 participants, respectively, who experienced at least 1 Treatment Emergent Adverse Event (TEAE).Of these 16, 15, and 5 participants, some experienced more than 1 TEAE. Since some subjects reported more than 1 TEAE, the count of participants in Section 1 (subjects that reported at least 1 TEAE) may not match the sum of Affected subjects in the "SAE" and the "Other (Not Including Serious) AE" sections
|
0.00%
0/41 • approximately 156 days
"OTX-CSI Cohort 2F1","OTX-CSI Cohort 2 F2A", and"OTX-CSI Cohort 2 F2B" Arms had 16, 15, and 5 participants, respectively, who experienced at least 1 Treatment Emergent Adverse Event (TEAE).Of these 16, 15, and 5 participants, some experienced more than 1 TEAE. Since some subjects reported more than 1 TEAE, the count of participants in Section 1 (subjects that reported at least 1 TEAE) may not match the sum of Affected subjects in the "SAE" and the "Other (Not Including Serious) AE" sections
|
2.3%
1/43 • approximately 156 days
"OTX-CSI Cohort 2F1","OTX-CSI Cohort 2 F2A", and"OTX-CSI Cohort 2 F2B" Arms had 16, 15, and 5 participants, respectively, who experienced at least 1 Treatment Emergent Adverse Event (TEAE).Of these 16, 15, and 5 participants, some experienced more than 1 TEAE. Since some subjects reported more than 1 TEAE, the count of participants in Section 1 (subjects that reported at least 1 TEAE) may not match the sum of Affected subjects in the "SAE" and the "Other (Not Including Serious) AE" sections
|
0.00%
0/22 • approximately 156 days
"OTX-CSI Cohort 2F1","OTX-CSI Cohort 2 F2A", and"OTX-CSI Cohort 2 F2B" Arms had 16, 15, and 5 participants, respectively, who experienced at least 1 Treatment Emergent Adverse Event (TEAE).Of these 16, 15, and 5 participants, some experienced more than 1 TEAE. Since some subjects reported more than 1 TEAE, the count of participants in Section 1 (subjects that reported at least 1 TEAE) may not match the sum of Affected subjects in the "SAE" and the "Other (Not Including Serious) AE" sections
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/5 • approximately 156 days
"OTX-CSI Cohort 2F1","OTX-CSI Cohort 2 F2A", and"OTX-CSI Cohort 2 F2B" Arms had 16, 15, and 5 participants, respectively, who experienced at least 1 Treatment Emergent Adverse Event (TEAE).Of these 16, 15, and 5 participants, some experienced more than 1 TEAE. Since some subjects reported more than 1 TEAE, the count of participants in Section 1 (subjects that reported at least 1 TEAE) may not match the sum of Affected subjects in the "SAE" and the "Other (Not Including Serious) AE" sections
|
0.00%
0/42 • approximately 156 days
"OTX-CSI Cohort 2F1","OTX-CSI Cohort 2 F2A", and"OTX-CSI Cohort 2 F2B" Arms had 16, 15, and 5 participants, respectively, who experienced at least 1 Treatment Emergent Adverse Event (TEAE).Of these 16, 15, and 5 participants, some experienced more than 1 TEAE. Since some subjects reported more than 1 TEAE, the count of participants in Section 1 (subjects that reported at least 1 TEAE) may not match the sum of Affected subjects in the "SAE" and the "Other (Not Including Serious) AE" sections
|
0.00%
0/41 • approximately 156 days
"OTX-CSI Cohort 2F1","OTX-CSI Cohort 2 F2A", and"OTX-CSI Cohort 2 F2B" Arms had 16, 15, and 5 participants, respectively, who experienced at least 1 Treatment Emergent Adverse Event (TEAE).Of these 16, 15, and 5 participants, some experienced more than 1 TEAE. Since some subjects reported more than 1 TEAE, the count of participants in Section 1 (subjects that reported at least 1 TEAE) may not match the sum of Affected subjects in the "SAE" and the "Other (Not Including Serious) AE" sections
|
2.3%
1/43 • approximately 156 days
"OTX-CSI Cohort 2F1","OTX-CSI Cohort 2 F2A", and"OTX-CSI Cohort 2 F2B" Arms had 16, 15, and 5 participants, respectively, who experienced at least 1 Treatment Emergent Adverse Event (TEAE).Of these 16, 15, and 5 participants, some experienced more than 1 TEAE. Since some subjects reported more than 1 TEAE, the count of participants in Section 1 (subjects that reported at least 1 TEAE) may not match the sum of Affected subjects in the "SAE" and the "Other (Not Including Serious) AE" sections
|
0.00%
0/22 • approximately 156 days
"OTX-CSI Cohort 2F1","OTX-CSI Cohort 2 F2A", and"OTX-CSI Cohort 2 F2B" Arms had 16, 15, and 5 participants, respectively, who experienced at least 1 Treatment Emergent Adverse Event (TEAE).Of these 16, 15, and 5 participants, some experienced more than 1 TEAE. Since some subjects reported more than 1 TEAE, the count of participants in Section 1 (subjects that reported at least 1 TEAE) may not match the sum of Affected subjects in the "SAE" and the "Other (Not Including Serious) AE" sections
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place