Trial Outcomes & Findings for Clinical Trial of Intravitreal Microplasmin in Infants and Children Scheduled for Vitrectomy (NCT NCT00986362)
NCT ID: NCT00986362
Last Updated: 2014-12-17
Results Overview
Percentage of eyes with total macular PVD (to the vascular ridge in eyes with ROP) at the beginning of vitrectomy or after application of suction, as assessed by masked surgeon observation under the operating microscope.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
24 participants
Primary outcome timeframe
Beginning of vitrectomy or after application of suction
Results posted on
2014-12-17
Participant Flow
First subject was recruited on 10 Feb 2010 and last subject completed the study on 14 Dec 2011. 24 study eyes (16 ocriplasmin, 8 placebo) were evaluated during the study. 22 subjects were enrolled in the study. 2 subjects were treated in both eyes.
Participant milestones
| Measure |
Ocriplasmin
Ocriplasmin : 175µg ocriplasmin intravitreal injection
|
Placebo
Placebo : Placebo intravitreal injection
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
8
|
|
Overall Study
COMPLETED
|
14
|
7
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
Ocriplasmin
Ocriplasmin : 175µg ocriplasmin intravitreal injection
|
Placebo
Placebo : Placebo intravitreal injection
|
|---|---|---|
|
Overall Study
Death
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
Clinical Trial of Intravitreal Microplasmin in Infants and Children Scheduled for Vitrectomy
Baseline characteristics by cohort
| Measure |
Ocriplasmin
n=16 Participants
Ocriplasmin : 175µg ocriplasmin intravitreal injection
|
Placebo
n=8 Participants
Placebo : Placebo intravitreal injection
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
6.1 years
STANDARD_DEVIATION 6.40 • n=5 Participants
|
8.0 years
STANDARD_DEVIATION 6.61 • n=7 Participants
|
6.8 years
STANDARD_DEVIATION 6.39 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Beginning of vitrectomy or after application of suctionPopulation: Study eyes were analysed according to the Intent-to-Treat (ITT) principle, i.e. as randomised regardless of treatment received. The primary endpoint was evaluated using the Full Analysis Set (FAS), with missing data imputed using the Last Observation Carried Forward (LOCF) method. 1 subject contributed 1 eye to both treatment groups
Percentage of eyes with total macular PVD (to the vascular ridge in eyes with ROP) at the beginning of vitrectomy or after application of suction, as assessed by masked surgeon observation under the operating microscope.
Outcome measures
| Measure |
Ocriplasmin
n=16 Eyes
Ocriplasmin : 175µg ocriplasmin intravitreal injection
|
Placebo
n=8 Eyes
Placebo : Placebo intravitreal injection
|
|---|---|---|
|
Percentage of Eyes With Total Macular Posterior Vitreous Detachment (PVD).
|
50 percentage of eyes
|
62.5 percentage of eyes
|
Adverse Events
Ocriplasmin
Serious events: 2 serious events
Other events: 15 other events
Deaths: 0 deaths
Placebo
Serious events: 2 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ocriplasmin
n=16 participants at risk
Ocriplasmin : 175µg ocriplasmin intravitreal injection
|
Placebo
n=8 participants at risk
Placebo : Placebo intravitreal injection
|
|---|---|---|
|
Infections and infestations
Shunt infection
|
0.00%
0/16 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
12.5%
1/8 • Number of events 1 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/16 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
12.5%
1/8 • Number of events 2 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.00%
0/16 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
12.5%
1/8 • Number of events 3 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/16 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
12.5%
1/8 • Number of events 1 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
|
Nervous system disorders
Encephalopathy
|
12.5%
2/16 • Number of events 2 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
0.00%
0/8 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
|
Nervous system disorders
Convulsion
|
6.2%
1/16 • Number of events 1 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
0.00%
0/8 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
|
General disorders
Device malfunction
|
6.2%
1/16 • Number of events 2 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
0.00%
0/8 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
Other adverse events
| Measure |
Ocriplasmin
n=16 participants at risk
Ocriplasmin : 175µg ocriplasmin intravitreal injection
|
Placebo
n=8 participants at risk
Placebo : Placebo intravitreal injection
|
|---|---|---|
|
Eye disorders
Eye pain
|
75.0%
12/16 • Number of events 12 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
50.0%
4/8 • Number of events 4 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
|
Eye disorders
Eyelid oedema
|
37.5%
6/16 • Number of events 6 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
62.5%
5/8 • Number of events 5 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
|
Eye disorders
Conjunctival haemorrhage
|
43.8%
7/16 • Number of events 7 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
50.0%
4/8 • Number of events 4 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
|
Eye disorders
Anterior chamber cell
|
31.2%
5/16 • Number of events 5 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
37.5%
3/8 • Number of events 3 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
|
Eye disorders
Anterior chamber flare
|
31.2%
5/16 • Number of events 7 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
37.5%
3/8 • Number of events 4 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
|
Eye disorders
Conjunctival hyperaemia
|
18.8%
3/16 • Number of events 3 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
37.5%
3/8 • Number of events 3 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
|
Eye disorders
Maculopathy
|
37.5%
6/16 • Number of events 10 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
37.5%
3/8 • Number of events 5 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
|
Eye disorders
Corneal epithelium defect
|
6.2%
1/16 • Number of events 1 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
25.0%
2/8 • Number of events 2 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
|
Eye disorders
Retinal detachment
|
25.0%
4/16 • Number of events 5 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
0.00%
0/8 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
|
Eye disorders
Vitreous haemorrhage
|
25.0%
4/16 • Number of events 4 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
12.5%
1/8 • Number of events 1 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
|
Eye disorders
Retinal disorder
|
18.8%
3/16 • Number of events 3 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
0.00%
0/8 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
|
Eye disorders
Blepharospasm
|
12.5%
2/16 • Number of events 2 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
0.00%
0/8 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
|
Eye disorders
Chorioretinal disorder
|
0.00%
0/16 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
12.5%
1/8 • Number of events 1 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
|
Eye disorders
Chromatopsia
|
0.00%
0/16 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
12.5%
1/8 • Number of events 1 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
|
Eye disorders
Conjunctival oedema
|
12.5%
2/16 • Number of events 2 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
12.5%
1/8 • Number of events 1 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
|
Eye disorders
Corneal disorder
|
6.2%
1/16 • Number of events 1 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
12.5%
1/8 • Number of events 1 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
|
Eye disorders
Corneal oedema
|
6.2%
1/16 • Number of events 1 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
12.5%
1/8 • Number of events 1 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
|
Eye disorders
Corneal thickening
|
0.00%
0/16 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
12.5%
1/8 • Number of events 1 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
|
Eye disorders
Cyclitic membrane
|
12.5%
2/16 • Number of events 2 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
0.00%
0/8 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
|
Eye disorders
Glaucomatous optic disc atrophy
|
0.00%
0/16 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
12.5%
1/8 • Number of events 1 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
|
Eye disorders
Hypotony of eye
|
12.5%
2/16 • Number of events 3 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
0.00%
0/8 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
|
Eye disorders
Macular oedema
|
12.5%
2/16 • Number of events 2 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
12.5%
1/8 • Number of events 1 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
|
Eye disorders
Ocular discomfort
|
6.2%
1/16 • Number of events 1 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
12.5%
1/8 • Number of events 1 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
|
Eye disorders
Optic atrophy
|
12.5%
2/16 • Number of events 2 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
0.00%
0/8 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
|
Eye disorders
Optic nerve disorder
|
6.2%
1/16 • Number of events 1 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
12.5%
1/8 • Number of events 1 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
|
Eye disorders
Photophobia
|
6.2%
1/16 • Number of events 1 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
12.5%
1/8 • Number of events 1 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
|
Eye disorders
Retinal oedema
|
12.5%
2/16 • Number of events 3 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
12.5%
1/8 • Number of events 2 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
|
Eye disorders
Retinal pigment epitheliopathy
|
12.5%
2/16 • Number of events 2 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
12.5%
1/8 • Number of events 1 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
|
Eye disorders
Retinal tear
|
12.5%
2/16 • Number of events 2 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
0.00%
0/8 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
|
Eye disorders
Vision blurred
|
0.00%
0/16 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
12.5%
1/8 • Number of events 1 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
|
Eye disorders
Angle closure glaucoma
|
6.2%
1/16 • Number of events 1 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
0.00%
0/8 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
|
Eye disorders
Anterior chamber fibrin
|
6.2%
1/16 • Number of events 2 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
0.00%
0/8 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
|
Eye disorders
Cataract subcapsular
|
6.2%
1/16 • Number of events 1 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
0.00%
0/8 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
|
Eye disorders
Ciliary zonular dehiscence
|
6.2%
1/16 • Number of events 1 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
0.00%
0/8 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
|
Eye disorders
Conjunctivitis
|
6.2%
1/16 • Number of events 1 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
0.00%
0/8 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
|
Eye disorders
Corneal opacity
|
6.2%
1/16 • Number of events 2 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
0.00%
0/8 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
|
Eye disorders
Eye irritation
|
6.2%
1/16 • Number of events 1 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
0.00%
0/8 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
|
Eye disorders
Foreign body sensation in eyes
|
6.2%
1/16 • Number of events 1 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
0.00%
0/8 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
|
Eye disorders
Hyphaema
|
6.2%
1/16 • Number of events 3 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
0.00%
0/8 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
|
Eye disorders
Iris adhesions
|
6.2%
1/16 • Number of events 1 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
0.00%
0/8 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
|
Eye disorders
Iris bombe
|
6.2%
1/16 • Number of events 1 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
0.00%
0/8 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
|
Eye disorders
Iris neovascularization
|
6.2%
1/16 • Number of events 1 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
0.00%
0/8 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
|
Eye disorders
Lacrimal haemorrahge
|
6.2%
1/16 • Number of events 1 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
0.00%
0/8 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
|
Eye disorders
Lens dislocation
|
6.2%
1/16 • Number of events 1 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
0.00%
0/8 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
|
Eye disorders
Macular degeneration
|
6.2%
1/16 • Number of events 1 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
0.00%
0/8 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
|
Eye disorders
Macular hole
|
6.2%
1/16 • Number of events 1 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
0.00%
0/8 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
|
Eye disorders
Optic nerve sheath haemorrhage
|
6.2%
1/16 • Number of events 1 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
0.00%
0/8 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
|
Eye disorders
Pupillary disorder
|
6.2%
1/16 • Number of events 1 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
0.00%
0/8 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
|
Eye disorders
Retinal haemorrhage
|
6.2%
1/16 • Number of events 1 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
0.00%
0/8 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
|
Eye disorders
Retinopathy of prematurity
|
6.2%
1/16 • Number of events 1 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
0.00%
0/8 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
|
Eye disorders
Subretinal fibrosis
|
6.2%
1/16 • Number of events 1 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
0.00%
0/8 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
|
Eye disorders
Vitreous adhesions
|
6.2%
1/16 • Number of events 1 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
0.00%
0/8 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
|
Eye disorders
Vitreous disorder
|
6.2%
1/16 • Number of events 1 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
0.00%
0/8 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
|
Eye disorders
Vitreous floaters
|
6.2%
1/16 • Number of events 1 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
0.00%
0/8 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/16 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
25.0%
2/8 • Number of events 2 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
|
Infections and infestations
Sinusitis
|
12.5%
2/16 • Number of events 2 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
0.00%
0/8 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/16 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
12.5%
1/8 • Number of events 1 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
|
Infections and infestations
Otitis media
|
6.2%
1/16 • Number of events 1 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
0.00%
0/8 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
|
Infections and infestations
Shunt infection
|
6.2%
1/16 • Number of events 1 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
0.00%
0/8 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
|
Investigations
Intraocular pressure increased
|
12.5%
2/16 • Number of events 2 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
37.5%
3/8 • Number of events 3 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
|
Injury, poisoning and procedural complications
Foreign body in eye
|
18.8%
3/16 • Number of events 4 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
0.00%
0/8 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
|
Injury, poisoning and procedural complications
Optic nerve injury
|
6.2%
1/16 • Number of events 1 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
0.00%
0/8 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
|
Injury, poisoning and procedural complications
Retinal scar
|
6.2%
1/16 • Number of events 1 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
0.00%
0/8 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
|
Gastrointestinal disorders
Constipation
|
6.2%
1/16 • Number of events 1 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
12.5%
1/8 • Number of events 1 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
|
Gastrointestinal disorders
Vomiting
|
12.5%
2/16 • Number of events 2 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
0.00%
0/8 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
|
Gastrointestinal disorders
Nausea
|
6.2%
1/16 • Number of events 1 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
0.00%
0/8 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary dysplasia
|
6.2%
1/16 • Number of events 1 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
12.5%
1/8 • Number of events 1 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/16 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
12.5%
1/8 • Number of events 1 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
6.2%
1/16 • Number of events 1 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
0.00%
0/8 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
|
Nervous system disorders
Headache
|
12.5%
2/16 • Number of events 2 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
0.00%
0/8 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
|
Nervous system disorders
Convulsion
|
6.2%
1/16 • Number of events 1 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
0.00%
0/8 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
6.2%
1/16 • Number of events 1 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
12.5%
1/8 • Number of events 1 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
|
General disorders
Device malfunction
|
6.2%
1/16 • Number of events 2 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
0.00%
0/8 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
|
Immune system disorders
Hypersensitivity
|
6.2%
1/16 • Number of events 1 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
0.00%
0/8 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
6.2%
1/16 • Number of events 1 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
0.00%
0/8 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).
The reporting for the study was made based in number of eyes and not in the number of participants, therefore the number of "participants" at risk in the AE section is actually the number of "eyes" at risk.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60