Clinical Investigation of the AcrySof IQ Vivity Extended... | NCT04098367 | Trialant
NCT04098367
Sponsor
Alcon Research
Status
Completed
Last Update Posted
May 4, 2022Actual
Enrollment
222Actual
Phase
Not Applicable
Conditions
Aphakia
Interventions
VIVITY
SYMFONY
AT LARA
Cataract surgery
Countries
Australia
New Zealand
Protocol Section
Identification Module
NCT ID
Results Section
Participant Flow Module
Pre-assignment Details
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Derived Section
Miscellaneous Info Module
Version Holder
NCT04098367
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
ILI875-P001
Secondary IDs
Not provided
Brief Title
Clinical Investigation of the AcrySof IQ Vivity Extended Vision Intraocular Lens (IOL)
Official Title
A Prospective, Randomized, Controlled, Multi-Center Clinical Investigation of the AcrySof IQ Vivity Extended Vision IOL vs. TECNIS Symfony and AT LARA Extended Depth of Focus IOLs
Acronym
Not provided
Organization
Alcon ResearchINDUSTRY
Status Module
Record Verification Date
May 2022
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Nov 18, 2019Actual
Primary Completion Date
May 3, 2021Actual
Completion Date
Jul 22, 2021Actual
First Submitted Date
Sep 19, 2019
First Submission Date that Met QC Criteria
Sep 19, 2019
First Posted Date
Sep 23, 2019Actual
Results Waived
Not provided
Results First Submitted Date
Apr 5, 2022
Results First Submitted that Met QC Criteria
May 2, 2022
Results First Posted Date
May 4, 2022Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
May 2, 2022
Last Update Posted Date
May 4, 2022Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Alcon ResearchINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
No
Is FDA Regulated Device
Yes
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Yes
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this study is to compare the visual disturbance profile of an intraocular lens (IOL) using nondiffractive optics, the VIVITY IOL, to two diffractive IOLs in subjects requiring bilateral cataract surgery. IOLs are implantable medical devices intended for long-term use over the lifetime of the cataract patient.
Detailed Description
A total of 10 scheduled visits are planned. The visits include a screening visit, 2 operative visits, and 7 postoperative visits. Both eyes will be implanted. The second eye implant will occur within 7-21 days of the first eye implant. The primary endpoint data will be collected at the Month 3 visit. Individual subject participation is expected to last 6-7 months. This study will be conducted in Australia and New Zealand.
Conditions Module
Conditions
Aphakia
Keywords
Cataracts
Extracapsular cataract extraction
IOL
Extended depth of focus
Visual disturbances
Presbyopia
Intraocular lens
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Not Applicable
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
222Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
VIVITY
Experimental
VIVITY IOL implanted in the eye during cataract surgery
Device: VIVITY
Procedure: Cataract surgery
SYMFONY
Active Comparator
SYMFONY IOL implanted in the eye during cataract surgery
Device: SYMFONY
Procedure: Cataract surgery
AT LARA
Active Comparator
AT LARA implanted in the eye during cataract surgery
Device: AT LARA
Procedure: Cataract surgery
Interventions
Name
Type
Description
Arm Group Labels
Other Names
VIVITY
Device
Extended vision intraocular lens intended for primary implantation for the visual correction of aphakia in adult patients with less than 1.00 diopter of preoperative corneal astigmatism in whom a cataractous lens has been removed by extracapsular cataract extraction
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage of Subjects Not Bothered at All by Halos (QUVID Question 2.3)
QUVID is a patient-reported outcomes questionnaire that collects responses from the subject about vision-related experiences. A halo is a circular spreading of light around a light source, such as car headlights at night. Question 2 of QUVID asked the subject, "In the past 7 days, have you experienced halos?" Subjects responding "No" were automatically imputed as reporting, "0=Not bothered at all." Subjects responding "Yes" were then asked Question 2.3: "In the past 7 days, how much have your halos bothered you?" Subjects responded on a 5-point scale: 0=Not bothered at all; 1=Bothered a little bit; 2=Bothered somewhat; 3=Bothered quite a bit; 4=Bothered very much. Percentage was calculated as number of subjects with score of 0 divided by number of subjects with data regardless of response, times 100.
Month 3 postoperative (Day 120-180 from second eye surgery)
Secondary Outcomes
Measure
Description
Time Frame
Percentage of Subjects Not Bothered at All by Glare (QUVID Question 3.3)
Glare is a wide dispersion of light, such as an intensified reflection of the sun off a glass building. Question 3 of QUVID asked the subject, "In the past 7 days, have you experienced glare?" Subjects responding "No" were automatically imputed as reporting, "0=Not bothered at all." Subjects responding "Yes" were then asked Question 3.3: "In the past 7 days, how much has your glare bothered you?" Subjects responded on a 5-point scale: 0=Not bothered at all; 1=Bothered a little bit; 2=Bothered somewhat; 3=Bothered quite a bit; 4=Bothered very much. Percentage was calculated as number of subjects with score of 0 divided by number of subjects with data regardless of response, times 100.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Planned cataract removal in both eyes.
Willing and able to complete all required postoperative visits.
Able to understand, read and write English and willing to sign an approved statement of informed consent.
Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
Women of childbearing potential, pregnant, intend to become pregnant, breastfeeding.
Any eye condition, disease or pathology, other than cataract, that is expected to reduce postoperative best corrected distance visual acuity, as specified in the protocol.
Ocular trauma or ocular surface disease that would affect study measurements.
Patients who desire monovision correction.
Other protocol-specified exclusion criteria may apply.
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
22 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Clinical Trial Lead, Surgical
Alcon Research, LLC
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Alcon Investigator 8047
Charlestown
New South Wales
2290
Australia
Alcon Investigator 6667
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
Plan to Share IPD
No
Description
Not provided
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
Of the 222 enrolled, 24 subjects were exited as screen failures prior to randomization. Of the 198 subjects randomized, both eyes from five subjects and second eyes from 2 subjects (i.e., 5 first eyes, 7 second eyes) were discontinued after randomization and prior to attempted implantation. This reporting group includes all randomized and implanted subjects (193).
Recruitment Details
Participants were recruited from nine investigative sites located in Australia and three investigative sites located in New Zealand.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
VIVITY
VIVITY IOL implanted in the eye during cataract surgery
FG001
SYMFONY
SYMFONY IOL implanted in the eye during cataract surgery
FG002
AT LARA
AT LARA implanted in the eye during cataract surgery
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
FG00063 subjects
FG00165 subjects
FG00265 subjects
First Eye Implanted
FG00063 subjects
FG00165 subjects
FG00265 subjects
Second Eye Implanted
FG00063 subjects
FG00165 subjects
FG00263 subjects
COMPLETED
FG00061 subjects
FG00160 subjects
FG00261 subjects
NOT COMPLETED
FG0002 subjects
FG0015 subjects
FG0024 subjects
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0021 subjects
Lost to Follow-up
FG000
Baseline Characteristics Module
Baseline Analysis Population Description
All Implanted Analysis Set (AAS): All eyes with successful study IOL implantation in one or more eye.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
VIVITY
VIVITY IOL implanted in the eye during cataract surgery
BG001
SYMFONY
SYMFONY IOL implanted in the eye during cataract surgery
Denominators
Units
Counts
Participants
BG000
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Outcome Measures Module
Outcome Measures
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Percentage of Subjects Not Bothered at All by Halos (QUVID Question 2.3)
QUVID is a patient-reported outcomes questionnaire that collects responses from the subject about vision-related experiences. A halo is a circular spreading of light around a light source, such as car headlights at night. Question 2 of QUVID asked the subject, "In the past 7 days, have you experienced halos?" Subjects responding "No" were automatically imputed as reporting, "0=Not bothered at all." Subjects responding "Yes" were then asked Question 2.3: "In the past 7 days, how much have your halos bothered you?" Subjects responded on a 5-point scale: 0=Not bothered at all; 1=Bothered a little bit; 2=Bothered somewhat; 3=Bothered quite a bit; 4=Bothered very much. Percentage was calculated as number of subjects with score of 0 divided by number of subjects with data regardless of response, times 100.
AAS with data at Month 3 postoperative visit
Posted
Number
percentage of subjects
Month 3 postoperative (Day 120-180 from second eye surgery)
ID
Title
Description
OG000
Adverse Events Module
Frequency Threshold
5
Time Frame
Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months.
Description
An AE was defined at any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users, or other persons, whether or not related to the test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Pretreatment
All subjects prior to with attempted implantation with any IOL (successful or aborted implant)
AcrySofâ„¢ IQ Vivityâ„¢ Extended Vision IOL Model DFT015
SYMFONY
Device
Extended range of vision intraocular lens indicated for primary implantation for the visual correction of aphakia in adult patients with less than 1.00 diopter of pre-existing corneal astigmatism in whom a cataractous lens has been removed
SYMFONY
TECNIS Symfony® Extended Range of Vision IOL Model ZXR00
AT LARA
Device
Extended depth of focus intraocular lens indicated for implantation for the visual correction of aphakia in patients with and without presbyopia in whom a cataractous lens has been removed by extracapsular cataract extraction
AT LARA
AT LARA® extended depth of focus IOL Model 829MP
Cataract surgery
Procedure
Cataract removal by routine small incision surgery
AT LARA
SYMFONY
VIVITY
Month 3 postoperative (Day 120-180 from second eye surgery)
Percentage of Subjects Not Bothered at All by Starbursts (QUVID Question 1.3)
A starburst is a star-shaped spreading of light around a light source, such as car headlights at night. Question 1 of QUVID asked the subject, "In the past 7 days, have you experienced starbursts?" Subjects responding "No" were automatically imputed as reporting, "0=Not bothered at all." Subjects responding "Yes" were then asked Question 1.3: "In the past 7 days, how much have your starbursts bothered you?" Subjects responded on a 5-point scale: 0=Not bothered at all; 1=Bothered a little bit; 2=Bothered somewhat; 3=Bothered quite a bit; 4=Bothered very much. Percentage was calculated as number of subjects with score of 0 divided by number of subjects with data regardless of response, times 100.
Month 3 postoperative (Day 120-180 from second eye surgery)
Sydney
New South Wales
2067
Australia
Alcon Investigator 7678
Sydney
New South Wales
2150
Australia
Alcon Investigator 8052
Eastwood
South Australia
5063
Australia
Alcon Investigator 7130
Hobart
Tasmania
7000
Australia
Alcon Investigator 8010
Essendon
Victoria
3040
Australia
Alcon Investigator 7813
Footscray
Victoria
3011
Australia
Alcon Investigator 1702
Mornington
Victoria
3931
Australia
Alcon Investigator 8051
Murdoch
Western Australia
6150
Australia
Alcon Investigator 8056
Auckland
1050
New Zealand
Alcon Investigator 8050
Auckland
New Zealand
Alcon Investigator 3656
Wellington
6011
New Zealand
1 subjects
FG0015 subjects
FG0022 subjects
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0021 subjects
Sick . Could not attend visit
FG0001 subjects
FG0010 subjects
FG0020 subjects
BG002
AT LARA
AT LARA implanted in the eye during cataract surgery
BG003
Total
Total of all reporting groups
63
BG00165
BG00265
BG003193
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00067.2± 8.07
BG00167.0± 9.25
BG00266.1± 8.60
BG00366.7± 8.63
Sex: Female, Male
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Female
BG00038
BG00136
BG00240
BG003114
Male
BG00025
BG00129
BG00225
BG00379
Race/Ethnicity, Customized
Count of Participants
Participants
No
Title
Denominators
Categories
White (Caucasian)
Title
Measurements
BG00058
BG00147
BG00254
BG003159
Black
Title
Measurements
BG0001
BG0012
BG0020
BG003
Indigenous or Other Pacific Islander
Title
Measurements
BG0000
BG0012
BG0021
BG003
Asian
Title
Measurements
BG0002
BG0016
BG0027
BG003
Other
Title
Measurements
BG0002
BG0018
BG0023
BG003
VIVITY
VIVITY IOL implanted in the eye during cataract surgery
OG001
SYMFONY
SYMFONY IOL implanted in the eye during cataract surgery
OG002
AT LARA
AT LARA implanted in the eye during cataract surgery
Units
Counts
Participants
OG00063
OG00165
OG00263
Title
Denominators
Categories
Title
Measurements
OG00088.7
OG00158.1
OG00258.6
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Miettinen-Nurminen
Difference in percentage
30.6
2-Sided
97.5
13.34
46.79
VIVITY minus SYMFONY
Superiority
Superiority is concluded if the lower limit of the two-sided 97.5% confidence interval exceeds zero.
OG000
OG002
Miettinen-Nurminen
Difference in percentage
30.1
2-Sided
97.5
12.54
46.68
VIVITY minus AT LARA
Superiority
Superiority is concluded if the lower limit of the two-sided 97.5% confidence interval exceeds zero.
Secondary
Percentage of Subjects Not Bothered at All by Glare (QUVID Question 3.3)
Glare is a wide dispersion of light, such as an intensified reflection of the sun off a glass building. Question 3 of QUVID asked the subject, "In the past 7 days, have you experienced glare?" Subjects responding "No" were automatically imputed as reporting, "0=Not bothered at all." Subjects responding "Yes" were then asked Question 3.3: "In the past 7 days, how much has your glare bothered you?" Subjects responded on a 5-point scale: 0=Not bothered at all; 1=Bothered a little bit; 2=Bothered somewhat; 3=Bothered quite a bit; 4=Bothered very much. Percentage was calculated as number of subjects with score of 0 divided by number of subjects with data regardless of response, times 100.
AAS with data at Month 3 postoperative visit
Posted
Number
percentage of subjects
Month 3 postoperative (Day 120-180 from second eye surgery)
ID
Title
Description
OG000
VIVITY
VIVITY IOL implanted in the eye during cataract surgery
OG001
SYMFONY
SYMFONY IOL implanted in the eye during cataract surgery
OG002
AT LARA
AT LARA implanted in the eye during cataract surgery
Units
Counts
Participants
OG00062
OG00163
OG00260
Title
Denominators
Categories
Title
Measurements
OG00053.2
OG00155.6
OG00235.0
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Miettinen-Nurminen
Difference in percentage
-2.3
2-Sided
97.5
-21.91
17.42
VIVITY minus SYMFONY
Superiority
Superiority is concluded if the lower limit of the two-sided 97.5% confidence interval exceeds zero.
OG000
OG002
Secondary
Percentage of Subjects Not Bothered at All by Starbursts (QUVID Question 1.3)
A starburst is a star-shaped spreading of light around a light source, such as car headlights at night. Question 1 of QUVID asked the subject, "In the past 7 days, have you experienced starbursts?" Subjects responding "No" were automatically imputed as reporting, "0=Not bothered at all." Subjects responding "Yes" were then asked Question 1.3: "In the past 7 days, how much have your starbursts bothered you?" Subjects responded on a 5-point scale: 0=Not bothered at all; 1=Bothered a little bit; 2=Bothered somewhat; 3=Bothered quite a bit; 4=Bothered very much. Percentage was calculated as number of subjects with score of 0 divided by number of subjects with data regardless of response, times 100.
AAS with data at Month 3 postoperative visit
Posted
Number
percentage of subjects
Month 3 postoperative (Day 120-180 from second eye surgery)
ID
Title
Description
OG000
VIVITY
VIVITY IOL implanted in the eye during cataract surgery
OG001
SYMFONY
SYMFONY IOL implanted in the eye during cataract surgery
OG002
AT LARA
AT LARA implanted in the eye during cataract surgery
Units
Counts
Participants
OG00062
OG00163
OG00260
Title
Denominators
Categories
Title
Measurements
OG00079.0
OG00155.6
OG00238.3
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Miettinen-Nurminen
Difference in percentage
23.5
2-Sided
97.5
4.66
40.86
VIVITY minus SYMFONY
Superiority
Superiority is concluded if the lower limit of the two-sided 97.5% confidence interval exceeds zero.
OG000
OG002
0
193
0
193
0
193
EG001
VIVITY First Eye
All eyes that had contact with the VIVITY IOL (successful or aborted implant)
0
63
1
63
7
63
EG002
VIVITY Second Eye
All eyes that had contact with the VIVITY IOL (successful or aborted implant)
0
63
0
63
7
63
EG003
VIVITY Systemic
All subjects that had contact with the VIVITY IOL (successful or aborted implant)
0
63
0
63
0
63
EG004
SYMFONY First Eye
All eyes that had contact with the SYMFONY IOL (successful or aborted implant)
0
65
1
65
12
65
EG005
SYMFONY Second Eye
All eyes that had contact with the SYMFONY IOL (successful or aborted implant)
0
65
3
65
10
65
EG006
SYMFONY Systemic
All subjects that had contact with the SYMFONY IOL (successful or aborted implant)
0
65
1
65
0
65
EG007
AT LARA First Eye
All eyes that had contact with the AT LARA IOL (successful or aborted implant)
0
65
3
65
17
65
EG008
AT LARA Second Eye
All eyes that had contact with the AT LARA IOL (successful or aborted implant)
0
63
2
63
16
63
EG009
AT LARA Systemic
All subjects that had contact with the AT LARA IOL (successful or aborted implant)
0
65
4
65
0
65
EG0000 events0 affected193 at risk
EG0010 events0 affected63 at risk
EG0020 events0 affected63 at risk
EG0030 events0 affected63 at risk
EG0040 events0 affected65 at risk
EG0050 events0 affected65 at risk
EG0061 events1 affected65 at risk
EG0070 events0 affected65 at risk
EG0080 events0 affected63 at risk
EG0091 events1 affected65 at risk
Coronary artery disease
Cardiac disorders
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected63 at risk
EG0020 events0 affected63 at risk
EG0030 events0 affected63 at risk
EG0040 events0 affected65 at risk
EG0050 events0 affected65 at risk
EG0060 events0 affected65 at risk
EG0070 events0 affected65 at risk
EG0080 events0 affected63 at risk
EG0091 events1 affected65 at risk
Cystoid macular oedema
Eye disorders
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected63 at risk
EG0020 events0 affected63 at risk
EG0030 events0 affected63 at risk
EG0040 events0 affected65 at risk
EG0052 events2 affected65 at risk
EG0060 events0 affected65 at risk
EG0071 events1 affected65 at risk
EG0081 events1 affected63 at risk
EG0090 events0 affected65 at risk
Halo vision
Eye disorders
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected63 at risk
EG0020 events0 affected63 at risk
EG0030 events0 affected63 at risk
EG0040 events0 affected65 at risk
EG0051 events1 affected65 at risk
EG0060 events0 affected65 at risk
EG0070 events0 affected65 at risk
EG0080 events0 affected63 at risk
EG0090 events0 affected65 at risk
Macular fibrosis
Eye disorders
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected193 at risk
EG0011 events1 affected63 at risk
EG0020 events0 affected63 at risk
EG0030 events0 affected63 at risk
EG0040 events0 affected65 at risk
EG0050 events0 affected65 at risk
EG0060 events0 affected65 at risk
EG0070 events0 affected65 at risk
EG0080 events0 affected63 at risk
EG0090 events0 affected65 at risk
Visual impairment
Eye disorders
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected63 at risk
EG0020 events0 affected63 at risk
EG0030 events0 affected63 at risk
EG0041 events1 affected65 at risk
EG0051 events1 affected65 at risk
EG0060 events0 affected65 at risk
EG0070 events0 affected65 at risk
EG0080 events0 affected63 at risk
EG0090 events0 affected65 at risk
Fall
Injury, poisoning and procedural complications
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected63 at risk
EG0020 events0 affected63 at risk
EG0030 events0 affected63 at risk
EG0040 events0 affected65 at risk
EG0050 events0 affected65 at risk
EG0060 events0 affected65 at risk
EG0070 events0 affected65 at risk
EG0080 events0 affected63 at risk
EG0091 events1 affected65 at risk
Posterior capsule rupture
Injury, poisoning and procedural complications
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected63 at risk
EG0020 events0 affected63 at risk
EG0030 events0 affected63 at risk
EG0040 events0 affected65 at risk
EG0050 events0 affected65 at risk
EG0060 events0 affected65 at risk
EG0071 events1 affected65 at risk
EG0080 events0 affected63 at risk
EG0090 events0 affected65 at risk
Intraocular pressure increased
Investigations
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected63 at risk
EG0020 events0 affected63 at risk
EG0030 events0 affected63 at risk
EG0040 events0 affected65 at risk
EG0050 events0 affected65 at risk
EG0060 events0 affected65 at risk
EG0071 events1 affected65 at risk
EG0080 events0 affected63 at risk
EG0090 events0 affected65 at risk
Paracentesis
Investigations
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected63 at risk
EG0020 events0 affected63 at risk
EG0030 events0 affected63 at risk
EG0040 events0 affected65 at risk
EG0050 events0 affected65 at risk
EG0060 events0 affected65 at risk
EG0071 events1 affected65 at risk
EG0081 events1 affected63 at risk
EG0090 events0 affected65 at risk
Carotid artery aneurysm
Nervous system disorders
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected63 at risk
EG0020 events0 affected63 at risk
EG0030 events0 affected63 at risk
EG0040 events0 affected65 at risk
EG0050 events0 affected65 at risk
EG0060 events0 affected65 at risk
EG0070 events0 affected65 at risk
EG0080 events0 affected63 at risk
EG0091 events1 affected65 at risk
Angioplasty
Surgical and medical procedures
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected63 at risk
EG0020 events0 affected63 at risk
EG0030 events0 affected63 at risk
EG0040 events0 affected65 at risk
EG0050 events0 affected65 at risk
EG0060 events0 affected65 at risk
EG0070 events0 affected65 at risk
EG0080 events0 affected63 at risk
EG0091 events1 affected65 at risk
Lens extraction
Surgical and medical procedures
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected63 at risk
EG0020 events0 affected63 at risk
EG0030 events0 affected63 at risk
EG0040 events0 affected65 at risk
EG0051 events1 affected65 at risk
EG0060 events0 affected65 at risk
EG0070 events0 affected65 at risk
EG0080 events0 affected63 at risk
EG0090 events0 affected65 at risk
Parathyroidectomy
Surgical and medical procedures
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected63 at risk
EG0020 events0 affected63 at risk
EG0030 events0 affected63 at risk
EG0040 events0 affected65 at risk
EG0050 events0 affected65 at risk
EG0060 events0 affected65 at risk
EG0070 events0 affected65 at risk
EG0080 events0 affected63 at risk
EG0091 events1 affected65 at risk
Retinal operation
Surgical and medical procedures
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected193 at risk
EG0011 events1 affected63 at risk
EG0020 events0 affected63 at risk
EG0030 events0 affected63 at risk
EG0040 events0 affected65 at risk
EG0050 events0 affected65 at risk
EG0060 events0 affected65 at risk
EG0070 events0 affected65 at risk
EG0080 events0 affected63 at risk
EG0090 events0 affected65 at risk
Vitrectomy
Surgical and medical procedures
MedDRA (22.0)
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected63 at risk
EG0020 events0 affected63 at risk
EG0030 events0 affected63 at risk
EG0040 events0 affected65 at risk
EG0050 events0 affected65 at risk
EG0060 events0 affected65 at risk
EG0071 events1 affected65 at risk
EG0080 events0 affected63 at risk
EG0090 events0 affected65 at risk
EG0000 events0 affected193 at risk
EG0017 events7 affected63 at risk
EG0027 events7 affected63 at risk
EG0030 events0 affected63 at risk
EG00412 events12 affected65 at risk
EG00510 events10 affected65 at risk
EG0060 events0 affected65 at risk
EG00719 events17 affected65 at risk
EG00817 events16 affected63 at risk
EG0090 events0 affected65 at risk
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
3
3
15
13
Miettinen-Nurminen
Difference in percentage
8.2
2-Sided
97.5
-12.00
27.80
VIVITY minus AT LARA
Superiority
Superiority is concluded if the lower limit of the two-sided 97.5% confidence interval exceeds zero.
Miettinen-Nurminen
Difference in percentage
40.7
2-Sided
97.5
21.16
57.22
VIVITY minus AT LARA
Superiority
Superiority is concluded if the lower limit of the two-sided 97.5% confidence interval exceeds zero.