Trial Outcomes & Findings for The Purpose of This Study is to Evaluate the Pharmacokinetic Properties of Intravitreal Ocriplasmin Prior to Planned Primary Pars Plana Vitrectomy (PPV) (NCT NCT01159665)
NCT ID: NCT01159665
Last Updated: 2014-12-17
Results Overview
Vitreous samples were obtained at the beginning of vitrectomy in subjects at various times relative to ocriplasmin injection (post-injection), for the determination of ocriplasmin activity (Group 1 \[5-30 minutes\]; Group 2 \[31-60 minutes\]; Group 3 \[2-4 hours\]; Group 4 \[24 hours ±2 hours\]; Group 5 \[7 days ±1 day\]. Subjects in Group 6 (control) did not receive the ocriplasmin injection.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
38 participants
Primary outcome timeframe
5-30 minutes, 31-60 minutes, 2-4 hours, 1 day, or 7 days after ocriplasmin injection
Results posted on
2014-12-17
Participant Flow
The first subject was enroled on 15 Jul 2010 and the last patient completed the study opn 30 Nov 2010.
38 subjects were enrolled into the study. However, the vitreous samples for 2 subjects were excluded from the analysis: * The vitreous sample for Subject 101106 was contaminated during vitrectomy. * Subject 101202 (Group 2) had a previous vitrectomy and retinal detachment in the study eye (exclusion criteria violation).
Participant milestones
| Measure |
PPV 5-30 Minutes After Injection
Primary Pars Plana Vitrectomy 5 to 30 minutes after 125ug of ocriplasmin intravitreal injection
|
PPV 31-60 Minutes After Injection
Primary Pars Plana Vitrectomy 31 to 60 minutes after 125ug of ocriplasmin intravitreal injection
|
PPV 2-4 Hours After Injection
Primary Pars Plana Vitrectomy 2 to 4 hours after 125ug of ocriplasmin intravitreal injection
|
PPV 24 Hours (+2 Hours) After Injection
Primary Pars Plana Vitrectomy 24 hours (+2 hours)after 125ug of ocriplasmin intravitreal injection
|
PPV 7 Days (+1 Day) After Injection
Primary Pars Plana Vitrectomy 7 days (+1 day)after 125ug of ocriplasmin intravitreal injection
|
PPV Without Injection
Control Arm, no ocriplasmin intravitreal injection
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
9
|
9
|
8
|
4
|
4
|
4
|
|
Overall Study
COMPLETED
|
9
|
8
|
8
|
4
|
4
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
PPV 5-30 Minutes After Injection
Primary Pars Plana Vitrectomy 5 to 30 minutes after 125ug of ocriplasmin intravitreal injection
|
PPV 31-60 Minutes After Injection
Primary Pars Plana Vitrectomy 31 to 60 minutes after 125ug of ocriplasmin intravitreal injection
|
PPV 2-4 Hours After Injection
Primary Pars Plana Vitrectomy 2 to 4 hours after 125ug of ocriplasmin intravitreal injection
|
PPV 24 Hours (+2 Hours) After Injection
Primary Pars Plana Vitrectomy 24 hours (+2 hours)after 125ug of ocriplasmin intravitreal injection
|
PPV 7 Days (+1 Day) After Injection
Primary Pars Plana Vitrectomy 7 days (+1 day)after 125ug of ocriplasmin intravitreal injection
|
PPV Without Injection
Control Arm, no ocriplasmin intravitreal injection
|
|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
The Purpose of This Study is to Evaluate the Pharmacokinetic Properties of Intravitreal Ocriplasmin Prior to Planned Primary Pars Plana Vitrectomy (PPV)
Baseline characteristics by cohort
| Measure |
PPV 5-30 Minutes After Injection
n=9 Participants
Primary Pars Plana Vitrectomy 5 to 30 minutes after 125ug of ocriplasmin intravitreal injection
|
PPV 31-60 Minutes After Injection
n=9 Participants
Primary Pars Plana Vitrectomy 31 to 60 minutes after 125ug of ocriplasmin intravitreal injection
|
PPV 2-4 Hours After Injection
n=8 Participants
Primary Pars Plana Vitrectomy 2 to 4 hours after 125ug of ocriplasmin intravitreal injection
|
PPV 24 Hours (+2 Hours) After Injection
n=4 Participants
Primary Pars Plana Vitrectomy 24 hours (+2 hours)after 125ug of ocriplasmin intravitreal injection
|
PPV 7 Days (+1 Day) After Injection
n=4 Participants
Primary Pars Plana Vitrectomy 7 days (+1 day)after 125ug of ocriplasmin intravitreal injection
|
PPV Without Injection
n=4 Participants
Control Arm, no ocriplasmin intravitreal injection
|
Total
n=38 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
71.3 years
STANDARD_DEVIATION 8.56 • n=5 Participants
|
65.6 years
STANDARD_DEVIATION 13.50 • n=7 Participants
|
63.8 years
STANDARD_DEVIATION 9.38 • n=5 Participants
|
62.5 years
STANDARD_DEVIATION 8.66 • n=4 Participants
|
59.3 years
STANDARD_DEVIATION 11.87 • n=21 Participants
|
69.8 years
STANDARD_DEVIATION 7.80 • n=10 Participants
|
66.0 years
STANDARD_DEVIATION 10.5 • n=115 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
26 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
12 Participants
n=115 Participants
|
PRIMARY outcome
Timeframe: 5-30 minutes, 31-60 minutes, 2-4 hours, 1 day, or 7 days after ocriplasmin injectionPopulation: Safety Set. Values for the PPV 7 days (+1 day) after injection and for PPV without injection treatment groups were all \< Lower Limit of Quantification (LLOQ)
Vitreous samples were obtained at the beginning of vitrectomy in subjects at various times relative to ocriplasmin injection (post-injection), for the determination of ocriplasmin activity (Group 1 \[5-30 minutes\]; Group 2 \[31-60 minutes\]; Group 3 \[2-4 hours\]; Group 4 \[24 hours ±2 hours\]; Group 5 \[7 days ±1 day\]. Subjects in Group 6 (control) did not receive the ocriplasmin injection.
Outcome measures
| Measure |
PPV 5-30 Minutes After Injection
n=8 Participants
Primary Pars Plana Vitrectomy 5 to 30 minutes after 125ug of ocriplasmin intravitreal injection
|
PPV 31-60 Minutes After Injection
n=8 Participants
Primary Pars Plana Vitrectomy 31 to 60 minutes after 125ug of ocriplasmin intravitreal injection
|
PPV 2-4 Hours After Injection
n=8 Participants
Primary Pars Plana Vitrectomy 2 to 4 hours after 125ug of ocriplasmin intravitreal injection
|
PPV 24 Hours (+2 Hours) After Injection
n=4 Participants
Primary Pars Plana Vitrectomy 24 hours (+2 hours)after 125ug of ocriplasmin intravitreal injection
|
PPV 7 Days (+1 Day) After Injection
n=4 Participants
Primary Pars Plana Vitrectomy 7 days (+1 day)after 125ug of ocriplasmin intravitreal injection
|
PPV Without Injection
n=4 Participants
Control Arm, no ocriplasmin intravitreal injection
|
|---|---|---|---|---|---|---|
|
Ocriplasmin Activity Levels in Vitreous Samples Obtained at the Beginning of Vitrectomy.
|
11597.711 ng/mL
Standard Deviation 7637.4103
|
8108.726 ng/mL
Standard Deviation 5181.8506
|
2610.563 ng/mL
Standard Deviation 1608.2660
|
496.473 ng/mL
Standard Deviation 288.2498
|
272.370 ng/mL
Standard Deviation 0.00
|
272.370 ng/mL
Standard Deviation 0.00
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From first start of vitrectomy cutter till the end of core vitrectomy phasePopulation: Safety Set
PPV was performed in all subjects. The time necessary to remove the vitreous from the eye, measured from first start of vitrectomy cutter till end of core vitrectomy phase, was calculated.
Outcome measures
| Measure |
PPV 5-30 Minutes After Injection
n=9 Participants
Primary Pars Plana Vitrectomy 5 to 30 minutes after 125ug of ocriplasmin intravitreal injection
|
PPV 31-60 Minutes After Injection
n=6 Participants
Primary Pars Plana Vitrectomy 31 to 60 minutes after 125ug of ocriplasmin intravitreal injection
|
PPV 2-4 Hours After Injection
n=7 Participants
Primary Pars Plana Vitrectomy 2 to 4 hours after 125ug of ocriplasmin intravitreal injection
|
PPV 24 Hours (+2 Hours) After Injection
n=2 Participants
Primary Pars Plana Vitrectomy 24 hours (+2 hours)after 125ug of ocriplasmin intravitreal injection
|
PPV 7 Days (+1 Day) After Injection
n=2 Participants
Primary Pars Plana Vitrectomy 7 days (+1 day)after 125ug of ocriplasmin intravitreal injection
|
PPV Without Injection
n=4 Participants
Control Arm, no ocriplasmin intravitreal injection
|
|---|---|---|---|---|---|---|
|
Time Necessary to Remove the Vitreous From the Eye
|
4.2 Minutes
Standard Deviation 3.07
|
3.7 Minutes
Standard Deviation 2.88
|
5.1 Minutes
Standard Deviation 1.86
|
4.5 Minutes
Standard Deviation 2.12
|
4.0 Minutes
Standard Deviation 1.41
|
4.8 Minutes
Standard Deviation 2.06
|
Adverse Events
PPV 5-30 Minutes After Injection
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
PPV 31-60 Minutes After Injection
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
PPV 2-4 Hours After Injection
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
PPV 24 Hours (+2 Hours) After Injection
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
PPV 7 Days (+1 Day) After Injection
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
PPV Without Injection
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PPV 5-30 Minutes After Injection
n=9 participants at risk
Primary Pars Plana Vitrectomy 5 to 30 minutes after 125ug of ocriplasmin intravitreal injection
|
PPV 31-60 Minutes After Injection
n=9 participants at risk
Primary Pars Plana Vitrectomy 31 to 60 minutes after 125ug of ocriplasmin intravitreal injection
|
PPV 2-4 Hours After Injection
n=8 participants at risk
Primary Pars Plana Vitrectomy 2 to 4 hours after 125ug of ocriplasmin intravitreal injection
|
PPV 24 Hours (+2 Hours) After Injection
n=4 participants at risk
Primary Pars Plana Vitrectomy 24 hours (+2 hours)after 125ug of ocriplasmin intravitreal injection
|
PPV 7 Days (+1 Day) After Injection
n=4 participants at risk
Primary Pars Plana Vitrectomy 7 days (+1 day)after 125ug of ocriplasmin intravitreal injection
|
PPV Without Injection
n=4 participants at risk
Control Arm, no ocriplasmin intravitreal injection
|
|---|---|---|---|---|---|---|
|
Eye disorders
Choroidal Hemorrhage
|
0.00%
0/9 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
0.00%
0/9 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
0.00%
0/8 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
0.00%
0/4 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
0.00%
0/4 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
25.0%
1/4 • Number of events 1 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
|
Eye disorders
Hypaema
|
0.00%
0/9 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
0.00%
0/9 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
0.00%
0/8 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
0.00%
0/4 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
0.00%
0/4 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
25.0%
1/4 • Number of events 1 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
|
Eye disorders
Vitreous Hemorrhage
|
0.00%
0/9 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
0.00%
0/9 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
0.00%
0/8 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
0.00%
0/4 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
0.00%
0/4 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
25.0%
1/4 • Number of events 1 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/9 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
0.00%
0/9 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
0.00%
0/8 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
0.00%
0/4 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
0.00%
0/4 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
25.0%
1/4 • Number of events 1 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Paraneoplastic syndrome
|
0.00%
0/9 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
0.00%
0/9 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
0.00%
0/8 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
0.00%
0/4 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
25.0%
1/4 • Number of events 1 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
0.00%
0/4 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
11.1%
1/9 • Number of events 1 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
0.00%
0/9 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
0.00%
0/8 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
0.00%
0/4 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
0.00%
0/4 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
0.00%
0/4 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
Other adverse events
| Measure |
PPV 5-30 Minutes After Injection
n=9 participants at risk
Primary Pars Plana Vitrectomy 5 to 30 minutes after 125ug of ocriplasmin intravitreal injection
|
PPV 31-60 Minutes After Injection
n=9 participants at risk
Primary Pars Plana Vitrectomy 31 to 60 minutes after 125ug of ocriplasmin intravitreal injection
|
PPV 2-4 Hours After Injection
n=8 participants at risk
Primary Pars Plana Vitrectomy 2 to 4 hours after 125ug of ocriplasmin intravitreal injection
|
PPV 24 Hours (+2 Hours) After Injection
n=4 participants at risk
Primary Pars Plana Vitrectomy 24 hours (+2 hours)after 125ug of ocriplasmin intravitreal injection
|
PPV 7 Days (+1 Day) After Injection
n=4 participants at risk
Primary Pars Plana Vitrectomy 7 days (+1 day)after 125ug of ocriplasmin intravitreal injection
|
PPV Without Injection
n=4 participants at risk
Control Arm, no ocriplasmin intravitreal injection
|
|---|---|---|---|---|---|---|
|
Eye disorders
Cataract cortical
|
0.00%
0/9 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
0.00%
0/9 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
0.00%
0/8 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
0.00%
0/4 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
25.0%
1/4 • Number of events 1 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
0.00%
0/4 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/9 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
0.00%
0/9 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
0.00%
0/8 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
0.00%
0/4 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
25.0%
1/4 • Number of events 1 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
0.00%
0/4 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
|
Eye disorders
Corneal erosion
|
0.00%
0/9 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
0.00%
0/9 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
0.00%
0/8 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
0.00%
0/4 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
0.00%
0/4 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
25.0%
1/4 • Number of events 1 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
|
Eye disorders
Photopsia
|
0.00%
0/9 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
0.00%
0/9 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
0.00%
0/8 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
25.0%
1/4 • Number of events 1 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
100.0%
4/4 • Number of events 4 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
0.00%
0/4 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
|
Eye disorders
Visual acuity reduced
|
0.00%
0/9 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
0.00%
0/9 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
0.00%
0/8 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
75.0%
3/4 • Number of events 3 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
100.0%
4/4 • Number of events 4 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
0.00%
0/4 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
|
Eye disorders
Vitreous floaters
|
0.00%
0/9 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
0.00%
0/9 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
0.00%
0/8 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
75.0%
3/4 • Number of events 3 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
100.0%
4/4 • Number of events 4 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
0.00%
0/4 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
|
Eye disorders
Chromatopsia
|
0.00%
0/9 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
0.00%
0/9 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
0.00%
0/8 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
50.0%
2/4 • Number of events 2 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
50.0%
2/4 • Number of events 2 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
0.00%
0/4 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
|
Eye disorders
Eye pain
|
0.00%
0/9 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
0.00%
0/9 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
0.00%
0/8 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
25.0%
1/4 • Number of events 1 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
0.00%
0/4 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
0.00%
0/4 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
|
Eye disorders
Hypotony of eye
|
0.00%
0/9 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
0.00%
0/9 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
0.00%
0/8 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
0.00%
0/4 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
25.0%
1/4 • Number of events 1 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
0.00%
0/4 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
|
Eye disorders
Macular oedema
|
0.00%
0/9 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
11.1%
1/9 • Number of events 1 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
25.0%
2/8 • Number of events 2 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
0.00%
0/4 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
0.00%
0/4 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
0.00%
0/4 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
|
Eye disorders
Metamorphosia
|
0.00%
0/9 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
0.00%
0/9 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
0.00%
0/8 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
0.00%
0/4 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
25.0%
1/4 • Number of events 1 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
0.00%
0/4 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
|
Eye disorders
Photophobia
|
0.00%
0/9 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
0.00%
0/9 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
0.00%
0/8 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
0.00%
0/4 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
25.0%
1/4 • Number of events 1 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
0.00%
0/4 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
|
Eye disorders
Pupillary deformity
|
0.00%
0/9 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
0.00%
0/9 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
0.00%
0/8 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
0.00%
0/4 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
25.0%
1/4 • Number of events 1 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
0.00%
0/4 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
|
Eye disorders
Retinal artery occlusion
|
0.00%
0/9 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
0.00%
0/9 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
0.00%
0/8 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
0.00%
0/4 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
0.00%
0/4 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
25.0%
1/4 • Number of events 1 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
|
Eye disorders
Retinal oedema
|
0.00%
0/9 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
0.00%
0/9 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
0.00%
0/8 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
0.00%
0/4 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
25.0%
1/4 • Number of events 1 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
0.00%
0/4 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
|
Eye disorders
Retinal tear
|
0.00%
0/9 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
0.00%
0/9 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
0.00%
0/8 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
0.00%
0/4 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
0.00%
0/4 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
25.0%
1/4 • Number of events 1 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
|
Eye disorders
Blepharitis
|
11.1%
1/9 • Number of events 1 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
0.00%
0/9 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
12.5%
1/8 • Number of events 1 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
0.00%
0/4 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
0.00%
0/4 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
0.00%
0/4 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
|
Eye disorders
Dry eye
|
0.00%
0/9 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
0.00%
0/9 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
12.5%
1/8 • Number of events 1 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
0.00%
0/4 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
0.00%
0/4 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
0.00%
0/4 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
|
Eye disorders
Eye irritation
|
11.1%
1/9 • Number of events 1 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
0.00%
0/9 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
12.5%
1/8 • Number of events 1 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
0.00%
0/4 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
0.00%
0/4 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
0.00%
0/4 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
|
Eye disorders
Lens dislocation
|
0.00%
0/9 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
0.00%
0/9 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
12.5%
1/8 • Number of events 2 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
0.00%
0/4 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
0.00%
0/4 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
0.00%
0/4 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
|
Investigations
Intraocular pressure increased
|
22.2%
2/9 • Number of events 2 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
22.2%
2/9 • Number of events 3 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
25.0%
2/8 • Number of events 2 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
75.0%
3/4 • Number of events 3 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
50.0%
2/4 • Number of events 3 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
50.0%
2/4 • Number of events 2 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/9 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
0.00%
0/9 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
0.00%
0/8 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
0.00%
0/4 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
0.00%
0/4 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
25.0%
1/4 • Number of events 1 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
|
Infections and infestations
Eye infection
|
0.00%
0/9 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
0.00%
0/9 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
0.00%
0/8 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
25.0%
1/4 • Number of events 2 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
0.00%
0/4 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
0.00%
0/4 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/9 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
0.00%
0/9 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
0.00%
0/8 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
0.00%
0/4 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
0.00%
0/4 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
25.0%
1/4 • Number of events 1 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
|
Infections and infestations
Dacryocistitis
|
0.00%
0/9 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
11.1%
1/9 • Number of events 2 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
0.00%
0/8 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
0.00%
0/4 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
0.00%
0/4 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
0.00%
0/4 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
|
Nervous system disorders
Headache
|
0.00%
0/9 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
0.00%
0/9 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
12.5%
1/8 • Number of events 1 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
25.0%
1/4 • Number of events 1 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
25.0%
1/4 • Number of events 2 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
0.00%
0/4 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/9 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
11.1%
1/9 • Number of events 1 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
0.00%
0/8 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
0.00%
0/4 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
0.00%
0/4 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
0.00%
0/4 • Adverse Events (AEs) were collected from study drug administration through last subject follow-up visit (42 days (+ 3 days) post-surgery).
Only treatment emergent AEs, defined as events with an onset on or after the date of study drug injection were included in the AE summaries. For the control arm (Group 6), AEs on or after the Baseline visit were considered treatment emergent in order to compare with the treatment groups.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60