Trial Outcomes & Findings for Effect of Eye Movement on Toric Lens Orientation and Visual Acuity (NCT NCT00584831)
NCT ID: NCT00584831
Last Updated: 2015-05-21
Results Overview
logarithm of the minimum angle of resolution (logMar) ideal is 0.0 and represents 20/20 Snellen acuity. logMar values \> 0.00 indicate vision poorer than the ideal and values \<0.00 indicate vision greater than the ideal.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
40 participants
Primary outcome timeframe
10 minutes after insertion
Results posted on
2015-05-21
Participant Flow
Participant milestones
| Measure |
Group1 LSOB
lotrafilcon b toric, senofilcon A toric, omafilcon A toric, balafilcon A toric
|
Group 2 LSBO
lotrafilcon B toric, senofilcon A toric, balafilcon A toric, omafilcon A toric
|
Group 4 LBSO
lotrafilcon B toric, balafilcon A toric, senofilcon A toric, omafilcon A toric
|
Group 5 LBOS
lotrafilcon B toric, balafilcon A toric, omafilcon A toric, senofilcon A
|
Group 7 SLBO
senofilcon A toric, lotrafilcon B toric, balafilcon A toric, omafilcon A toric
|
Group 8 SOLB
senofilcon A toric, omafilcon A toric, lotrafilcon B toric, balafilcon A toric
|
Group 9 SBLO
senofilcon A toric, balafilcon A toric, lotrafilcon B toric, omafilcon A toric
|
Group 10 SBOL
senofilcon A toric, balafilcon A toric, omafilcon A toric, lotrafilcon B toric
|
Group 11 OSLB
omafilcon A toric, senofilcon A toric, lotrafilcon B toric, balafilcon A toric
|
Group 12 OSBL
omafilcon A toric, senofilcon A toric, balafilcon A toric, lotrafilcon B toric
|
Group 13 OBLS
omafilcon A toric, balafilcon A toric, lotrafilcon B toric, senofilcon A toric
|
Group 14 OBSL
omafilcon A toric, balafilcon A toric, senofilcon A toric, lotrafilcon B toric
|
Group 15 BLSO
balafilcon A toric, lotrafilcon B toric, senofilcon A toric, omafilcon A toric
|
Group 16 BLOS
balafilcon A toric, lotrafilcon B toric, omafilcon A toric, senofilcon A toric
|
Group 18 BOLS
balafilcon A toric, omafilcon A toric, lotrafilcon B toric, senofilcon A toric
|
Group 19 BOSL
balafilcon A toric, omafilcon A toric, senofilcon A toric, lotrafilcon B toric
|
Group 3 LOSB
lotrafilcon B toric, omafilcon A toric, senofilcon A toric, balafilcon A toric
|
Group 6 SLOB
senofilcon A toric, lotrafilcon b toric, omafilcon A toric, balafilcon A toric
|
Group 17 BSOL
balafilcon A toric, senofilcon A toric,omafilcon A toric, lotrafilcon b toric
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Intervention 1
STARTED
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3
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2
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2
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6
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2
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2
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1
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2
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1
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Intervention 1
COMPLETED
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1
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3
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6
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2
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1
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2
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1
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3
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1
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4
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1
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1
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Intervention 1
NOT COMPLETED
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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Intervention 2
STARTED
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1
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3
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1
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2
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1
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6
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2
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Intervention 2
COMPLETED
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1
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1
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6
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2
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1
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2
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1
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3
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1
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4
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1
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1
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Intervention 2
NOT COMPLETED
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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Intervention 3
STARTED
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1
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3
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2
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1
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2
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1
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6
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1
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1
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1
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Intervention 3
COMPLETED
|
1
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3
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1
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2
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1
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6
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2
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2
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2
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1
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2
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1
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3
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1
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1
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1
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Intervention 3
NOT COMPLETED
|
0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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Intervention 4
STARTED
|
1
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3
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2
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1
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2
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1
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6
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2
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3
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2
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2
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1
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2
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1
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2
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1
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4
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1
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1
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Intervention 4
COMPLETED
|
1
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3
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2
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1
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2
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1
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6
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2
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3
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2
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2
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1
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2
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1
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2
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1
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4
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1
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1
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Intervention 4
NOT COMPLETED
|
0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Eye Movement on Toric Lens Orientation and Visual Acuity
Baseline characteristics by cohort
| Measure |
Total Study Population
n=40 Participants
|
|---|---|
|
Age, Continuous
|
28.3 years
STANDARD_DEVIATION 7.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
40 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 10 minutes after insertionlogarithm of the minimum angle of resolution (logMar) ideal is 0.0 and represents 20/20 Snellen acuity. logMar values \> 0.00 indicate vision poorer than the ideal and values \<0.00 indicate vision greater than the ideal.
Outcome measures
| Measure |
Lotrafilcon B
n=35 Participants
lotrafilcon b toric
|
Senofilcon A
n=35 Participants
senofilcon A toric
|
Omafilcon A
n=35 Participants
omafilcon A toric
|
Balafilcon A
n=35 Participants
balafilcon A toric
|
|---|---|---|---|---|
|
Visual Acuity After Infero-temporal Version Movement.
|
0.12 LogMAR units
Standard Deviation 0.16
|
0.1 LogMAR units
Standard Deviation 0.15
|
0.16 LogMAR units
Standard Deviation 0.17
|
0.14 LogMAR units
Standard Deviation 0.19
|
PRIMARY outcome
Timeframe: 10 minutes after lens insertionlogarithm of the minimum angle of resolution (logMar) ideal is 0.0 and represents 20/20 Snellen acuity. logMar values \> 0.00 indicate vision poorer than the ideal and values \<0.00 indicate vision greater than the ideal.
Outcome measures
| Measure |
Lotrafilcon B
n=35 Participants
lotrafilcon b toric
|
Senofilcon A
n=35 Participants
senofilcon A toric
|
Omafilcon A
n=35 Participants
omafilcon A toric
|
Balafilcon A
n=35 Participants
balafilcon A toric
|
|---|---|---|---|---|
|
Visual Acuity After Infero-nasal Version Movement.
|
0.12 LogMAR units
Standard Deviation 0.16
|
0.11 LogMAR units
Standard Deviation 0.16
|
0.14 LogMAR units
Standard Deviation 0.17
|
0.15 LogMAR units
Standard Deviation 0.20
|
PRIMARY outcome
Timeframe: 10 minutes after lens insertionlogarithm of the minimum angle of resolution (logMar) ideal is 0.0 and represents 20/20 Snellen acuity. logMar values \> 0.00 indicate vision poorer than the ideal and values \<0.00 indicate vision greater than the ideal.
Outcome measures
| Measure |
Lotrafilcon B
n=35 Participants
lotrafilcon b toric
|
Senofilcon A
n=35 Participants
senofilcon A toric
|
Omafilcon A
n=35 Participants
omafilcon A toric
|
Balafilcon A
n=35 Participants
balafilcon A toric
|
|---|---|---|---|---|
|
Visual Acuity After Superior-temporal Version Movement
|
0.11 LogMAR units
Standard Deviation 0.15
|
0.08 LogMAR units
Standard Deviation 0.14
|
0.13 LogMAR units
Standard Deviation 0.17
|
0.14 LogMAR units
Standard Deviation 0.20
|
PRIMARY outcome
Timeframe: 10 minutes after lens insertionlogarithm of the minimum angle of resolution (logMar) ideal is 0.0 and represents 20/20 Snellen acuity. logMar values \> 0.00 indicate vision poorer than the ideal and values \<0.00 indicate vision greater than the ideal.
Outcome measures
| Measure |
Lotrafilcon B
n=35 Participants
lotrafilcon b toric
|
Senofilcon A
n=35 Participants
senofilcon A toric
|
Omafilcon A
n=35 Participants
omafilcon A toric
|
Balafilcon A
n=35 Participants
balafilcon A toric
|
|---|---|---|---|---|
|
Visual Acuity After Superior-nasal Version Movement.
|
0.14 LogMAR units
Standard Deviation 0.15
|
0.10 LogMAR units
Standard Deviation 0.15
|
0.15 LogMAR units
Standard Deviation 0.16
|
0.16 LogMAR units
Standard Deviation 0.19
|
Adverse Events
Lotrafilcon B
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Senofilcon A
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Omafilcon A
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Balafilcon A
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The PI may not publish, divulge, reveal, disclose, or use the data and or results of the study without prior written consent of Vistakon.
- Publication restrictions are in place
Restriction type: OTHER