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Evaluation of Orientation and Visual Acuity of Four Toric Soft Contact Lenses When Head is Tilted at 90 Degrees

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00583908
Recruitment Status : Completed
First Posted : January 2, 2008
Results First Posted : September 28, 2009
Last Update Posted : May 21, 2015
Sponsor:
Collaborator:
Visioncare Research Ltd.
Information provided by (Responsible Party):
Johnson & Johnson Vision Care, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition Astigmatism
Interventions Device: senofilcon A
Device: balafilcon A toric
Device: lotrafilcon B toric
Device: omafilcon A
Enrollment 14
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Lotrafilcon B / Senofilcon A / Balafilcon A / Omafilcon A Lotrafilcon B / Omafilcon A / Senofilcon A / Balafilcon A Lotrafilcon B / Balafilcon A / Senofilcon A / Omafilcon A Senofilcon A / Lotrafilcon B / Omafilcon A / Balafilcon A Senofilcon A / Omafilcon A / Balafilcon A / Lotrafilcon B Senofilcon A / Balafilcon A / Lotrafilcon B / Omafilcon A Omafilcon A / Lotrafilcon B / Senofilcon A / Balafilcon A Balafilcon A / Lotrafilcon B / Senofilcon A / Omafilcon A Balafilcon A / Lotrafilcon B / Omafilcon A / Senofilcon A Balafilcon A / Senofilcon A / Lotrafilcon B / Omafilcon A Balafilcon A / Senofilcon A / Omafilcon A / Lotrafilcon A Balafilcon A / Omafilcon A / Lotrafilcon B / Senofilcon A
Hide Arm/Group Description All lenses were toric lenses. The order of lenses in the title relates to the period of administration. All lenses were toric lenses. The order of lenses in the title relates to the period of administration. All lenses were toric lenses. The order of lenses in the title relates to the period of administration. All lenses were toric lenses. The order of lenses in the title relates to the period of administration. All lenses were toric lenses. The order of lenses in the title relates to the period of administration. All lenses were toric lenses. The order of lenses in the title relates to the period of administration. All lenses were toric lenses. The order of lenses in the title relates to the period of administration. All lenses were toric lenses. The order of lenses in the title relates to the period of administration. All lenses were toric lenses. The order of lenses in the title relates to the period of administration. All lenses were toric lenses. The order of lenses in the title relates to the period of administration. All lenses were toric lenses. The order of lenses in the title relates to the period of administration. All lenses were toric lenses. The order of lenses in the title relates to the period of administration.
Period Title: Period 1 - First Intervention
Started 1 2 1 1 2 1 1 1 1 1 1 1
Completed 1 2 1 1 2 1 1 1 1 1 1 1
Not Completed 0 0 0 0 0 0 0 0 0 0 0 0
Period Title: Period 2 - Second Intervention
Started 1 2 1 1 2 1 1 1 1 1 1 1
Completed 1 2 1 1 2 1 1 1 1 1 1 1
Not Completed 0 0 0 0 0 0 0 0 0 0 0 0
Period Title: Period 3 - Third Intervention
Started 1 2 1 1 2 1 1 1 1 1 1 1
Completed 1 2 1 1 2 1 1 1 1 1 1 1
Not Completed 0 0 0 0 0 0 0 0 0 0 0 0
Period Title: Period 4 - Fourth Intervention
Started 1 2 1 1 2 1 1 1 1 1 1 1
Completed 1 2 1 1 2 1 1 1 1 1 1 1
Not Completed 0 0 0 0 0 0 0 0 0 0 0 0
Arm/Group Title Overall Study Population
Hide Arm/Group Description Summary for overall study population
Overall Number of Baseline Participants 14
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 14 participants
42.1  (6.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants
Female
9
  64.3%
Male
5
  35.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United Kingdom Number Analyzed 14 participants
14
1.Primary Outcome
Title Lens Orientation During Head Tilt.
Hide Description Degree of lens rotation on the eye with the head tilted.
Time Frame after fit of each of the four lens insertions
Hide Outcome Measure Data
Hide Analysis Population Description
Only participants who completed the study per protocol. Some participants had missing data for some lenses.
Arm/Group Title Senofilcon A Toric Balafilcon A Toric Lotrafilcon B Toric Omafilcon A Toric
Hide Arm/Group Description:
senofilcon A toric worn in either the first, second, third or fourth periods.
balafilcon A toric worn in either the first, second, third or fourth periods
lotrafilcon B toric worn in either the first, second, third, or fourth periods.
omafilcon A toric worn in either the first, second, third, or fourth periods.
Overall Number of Participants Analyzed 13 13 13 11
Mean (Standard Deviation)
Unit of Measure: Degree of rotation
12.2  (10.7) 39.7  (18.5) 27.6  (22.7) 39.3  (15.9)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Senofilcon A Toric, Balafilcon A Toric
Comments Alternative Hypothesis was senofilcon A toric was superior to balafilcon A toric by having less degrees of rotation
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Paired t-test
Method t-test, 1 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -27.5
Parameter Dispersion
Type: Standard Deviation
Value: 17.1
Estimation Comments mean difference was senofilcon A minus balafilcon A
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Senofilcon A Toric, Lotrafilcon B Toric
Comments Hypothesis was senofilcon A toric was superior to lotrafilcon B toric by having less degree of rotation
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0002
Comments paired t-test
Method t-test, 1 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -15.4
Parameter Dispersion
Type: Standard Deviation
Value: 17.8
Estimation Comments mean difference is senofilcon A minus lotrafilcon B
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Senofilcon A Toric, Omafilcon A Toric
Comments Hypothesis was senofilcon A toric was superior to omafilcon A toric by having less degree of rotation
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments paired t-test
Method t-test, 1 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -27.0
Parameter Dispersion
Type: Standard Deviation
Value: 12.4
Estimation Comments Mean difference is senofilcon A minus omafilcon A
2.Primary Outcome
Title Visual Acuity During Head Tilt
Hide Description

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.

Time Frame after each of the four lens insertions
Hide Outcome Measure Data
Hide Analysis Population Description
Only participants who completed the study per protocol. Some participants had missing data for some of the lenses.
Arm/Group Title Senofilcon A Toric Balafilcon A Toric Lotrafilcon B Toric Omafilcon A Toric
Hide Arm/Group Description:
senofilcon A toric worn in either the first, second, third or fourth periods.
balafilcon A toric worn in either the first, second, third or fourth periods
lotrafilcon B toric worn in either the first, second, third, or fourth periods.
omafilcon A toric worn in either the first, second, third, or fourth periods.
Overall Number of Participants Analyzed 13 13 13 11
Mean (Standard Deviation)
Unit of Measure: logMAR units
0.02  (0.06) 0.15  (0.20) 0.07  (0.10) 0.11  (0.14)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Senofilcon A Toric, Balafilcon A Toric
Comments Alternative hypothesis was senofilcon A toric was superior to balafilcon A toric by having a lower logMAR score
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0083
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.13
Parameter Dispersion
Type: Standard Deviation
Value: 0.15
Estimation Comments Mean difference was senofilcon A minus balafilcon A
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Senofilcon A Toric, Lotrafilcon B Toric
Comments Alternative hypothesis was senofilcon A toric was superior to lotrafilcon B toric by having a lower logMAR score
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.052
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.06
Parameter Dispersion
Type: Standard Deviation
Value: 0.09
Estimation Comments Mean difference was senofilcon A minus lotrafilcon B
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Senofilcon A Toric, Omafilcon A Toric
Comments Alternative hypothesis was senofilcon A toric was superior to omafilcon A toric by having a lower logMAR score
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.015
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.13
Parameter Dispersion
Type: Standard Deviation
Value: 0.14
Estimation Comments Mean difference was senofilcon A minus omafilcon A
3.Secondary Outcome
Title Degree of Lens Rotation in Superior Gaze.
Hide Description Degree of lens rotation while participant is gazing up.
Time Frame After each of the four lens insertions
Hide Outcome Measure Data
Hide Analysis Population Description
Only participants who completed the study per protocol. Some participants had missing data for some lenses.
Arm/Group Title Senofilcon A Toric Balafilcon A Toric Lotrafilcon B Toric Omafilcon A Toric
Hide Arm/Group Description:
senofilcon A toric worn in either the first, second, third or fourth periods.
balafilcon A toric worn in either the first, second, third or fourth periods
lotrafilcon B toric worn in either the first, second, third, or fourth periods.
omafilcon A toric worn in either the first, second, third, or fourth periods.
Overall Number of Participants Analyzed 13 13 13 11
Mean (Standard Deviation)
Unit of Measure: Degree of rotation
3.3  (3.8) 6.0  (4.7) 3.7  (2.6) 6.5  (7.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Senofilcon A Toric, Balafilcon A Toric
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.16
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.7
Parameter Dispersion
Type: Standard Deviation
Value: 6.5
Estimation Comments Mean difference is senofilcon A minus balafilcon A
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Senofilcon A Toric, Lotrafilcon B Toric
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.73
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.3
Parameter Dispersion
Type: Standard Deviation
Value: 3.5
Estimation Comments Mean difference is senofilcon A minus lotrafilcon B
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Senofilcon A Toric, Omafilcon A Toric
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.044
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.3
Parameter Dispersion
Type: Standard Deviation
Value: 4.4
Estimation Comments Mean difference was senofilcon A minus omafilcon A
4.Secondary Outcome
Title Degree of Lens Rotation in Superior-temporal Gaze.
Hide Description Degree of lens rotation while participant is gazing up and out(towards the temple).
Time Frame After each of 4 lens insertions.,
Hide Outcome Measure Data
Hide Analysis Population Description
Only participants who completed the study per protocol. Some participants had missing data for some lenses.
Arm/Group Title Senofilcon A Toric Balafilcon A Toric Lotrafilcon B Toric Omafilcon A Toric
Hide Arm/Group Description:
senofilcon A toric worn in either the first, second, third or fourth periods.
balafilcon A toric worn in either the first, second, third or fourth periods
lotrafilcon B toric worn in either the first, second, third, or fourth periods.
omafilcon A toric worn in either the first, second, third, or fourth periods.
Overall Number of Participants Analyzed 13 13 13 11
Mean (Standard Deviation)
Unit of Measure: Degree of rotation
6.3  (5.5) 9.4  (5.4) 4.9  (2.3) 8.6  (5.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Senofilcon A Toric, Balafilcon A Toric
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.044
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value -3.1
Parameter Dispersion
Type: Standard Deviation
Value: 5.0
Estimation Comments Mean difference is senofilcon A minus balafilcon A
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Senofilcon A Toric, Lotrafilcon B Toric
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.31
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.4
Parameter Dispersion
Type: Standard Deviation
Value: 4.7
Estimation Comments Mean difference is senofilcon A minus lotrafilcon B
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Senofilcon A Toric, Omafilcon A Toric
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.44
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.5
Parameter Dispersion
Type: Standard Deviation
Value: 5.9
Estimation Comments Mean difference is senofilcon A minus omafilcon A
5.Secondary Outcome
Title Degree of Lens Rotation in Superior-nasal Gaze.
Hide Description Degree of lens rotation while participant is gazing up and in(towards the nose).
Time Frame After each of the four lens insertions
Hide Outcome Measure Data
Hide Analysis Population Description
Only participants who completed the study per protocol. Some participants had missing data for some lenses.
Arm/Group Title Senofilcon A Toric Balafilcon A Toric Lotrafilcon B Toric Omafilcon A Toric
Hide Arm/Group Description:
senofilcon A toric worn in either the first, second, third or fourth periods.
balafilcon A toric worn in either the first, second, third or fourth periods
lotrafilcon B toric worn in either the first, second, third, or fourth periods.
omafilcon A toric worn in either the first, second, third, or fourth periods.
Overall Number of Participants Analyzed 13 13 13 11
Mean (Standard Deviation)
Unit of Measure: Degree of rotation
6.2  (5.4) 5.6  (3.6) 6.9  (4.8) 5.8  (4.9)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Senofilcon A Toric, Balafilcon A Toric
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.78
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.5
Parameter Dispersion
Type: Standard Deviation
Value: 6.5
Estimation Comments Mean difference is senofilcon A minus balafilcon A
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Senofilcon A Toric, Lotrafilcon B Toric
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.68
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.7
Parameter Dispersion
Type: Standard Deviation
Value: 6.3
Estimation Comments Mean difference is senofilcon A minus lotrafilcon B
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Senofilcon A Toric, Omafilcon A Toric
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.78
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.4
Parameter Dispersion
Type: Standard Deviation
Value: 7.6
Estimation Comments Mean difference is senofilcon A minus omafilcon A
6.Secondary Outcome
Title Degree of Lens Rotation in Temporal Gaze.
Hide Description Degree of lens rotation while participant is gazing out(towards the temple).
Time Frame After each of the four lens insertions
Hide Outcome Measure Data
Hide Analysis Population Description
Only participants who completed the study per protocol. Some participants had missing data for some lenses.
Arm/Group Title Senofilcon A Toric Balafilcon A Toric Lotrafilcon B Toric Omafilcon A Toric
Hide Arm/Group Description:
senofilcon A toric worn in either the first, second, third or fourth periods.
balafilcon A toric worn in either the first, second, third or fourth periods
lotrafilcon B toric worn in either the first, second, third, or fourth periods.
omafilcon A toric worn in either the first, second, third, or fourth periods.
Overall Number of Participants Analyzed 13 13 13 11
Mean (Standard Deviation)
Unit of Measure: Degree of rotation
4.1  (3.1) 7.2  (5.8) 2.8  (2.2) 6.6  (5.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Senofilcon A Toric, Balafilcon A Toric
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.11
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.1
Parameter Dispersion
Type: Standard Deviation
Value: 6.5
Estimation Comments Mean difference is senofilcon A minus balafilcon A
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Senofilcon A Toric, Lotrafilcon B Toric
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.31
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.3
Parameter Dispersion
Type: Standard Deviation
Value: 4.3
Estimation Comments Mean difference is senofilcon A minus lotrafilcon B
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Senofilcon A Toric, Omafilcon A Toric
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.16
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value -3.0
Parameter Dispersion
Type: Standard Deviation
Value: 6.3
Estimation Comments Mean difference is senofilcon A minus omafilcon A
7.Secondary Outcome
Title Degree of Lens Rotation in Nasal Gaze.
Hide Description Degree of lens rotation while participant is gazing in(towards the nose).
Time Frame After each of the four lens insertions
Hide Outcome Measure Data
Hide Analysis Population Description
Only participants who completed the study per protocol. Some participants had missing data for some lenses.
Arm/Group Title Senofilcon A Toric Balafilcon A Toric Lotrafilcon B Toric Omafilcon A Toric
Hide Arm/Group Description:
senofilcon A toric worn in either the first, second, third or fourth periods.
balafilcon A toric worn in either the first, second, third or fourth periods
lotrafilcon B toric worn in either the first, second, third, or fourth periods.
omafilcon A toric worn in either the first, second, third, or fourth periods.
Overall Number of Participants Analyzed 13 13 13 11
Mean (Standard Deviation)
Unit of Measure: Degree of rotation
3.2  (3.3) 7.1  (5.9) 2.4  (1.3) 3.3  (3.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Senofilcon A Toric, Balafilcon A Toric
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.061
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.9
Parameter Dispersion
Type: Standard Deviation
Value: 6.8
Estimation Comments Mean difference is senofilcon A minus balafilcon A
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Senofilcon A Toric, Lotrafilcon B Toric
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.47
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.8
Parameter Dispersion
Type: Standard Deviation
Value: 3.9
Estimation Comments Mean difference is senofilcon A minus lotrafilcon B
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Senofilcon A Toric, Omafilcon A Toric
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.38
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.0
Parameter Dispersion
Type: Standard Deviation
Value: 3.6
Estimation Comments Mean difference is senofilcon A minus omafilcon A
8.Secondary Outcome
Title Degree of Lens Rotation Inferior-temporal Gaze.
Hide Description Degree of lens rotation while participant is gazing down and out.
Time Frame After each of the four lens insertions
Hide Outcome Measure Data
Hide Analysis Population Description
Only participants who completed the study per protocol. Some participants had missing data for some of the lenses.
Arm/Group Title Senofilcon A Toric Balafilcon A Toric Lotrafilcon B Toric Omafilcon A Toric
Hide Arm/Group Description:
senofilcon A toric worn in either the first, second, third or fourth periods.
balafilcon A toric worn in either the first, second, third or fourth periods
lotrafilcon B toric worn in either the first, second, third, or fourth periods.
omafilcon A toric worn in either the first, second, third, or fourth periods.
Overall Number of Participants Analyzed 13 13 13 11
Mean (Standard Deviation)
Unit of Measure: Degree of rotation
3.9  (3.9) 5.3  (4.1) 3.7  (2.8) 2.5  (2.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Senofilcon A Toric, Balafilcon A Toric
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.17
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.4
Parameter Dispersion
Type: Standard Deviation
Value: 3.5
Estimation Comments Mean difference is senofilcon A minus balafilcon A
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Senofilcon A Toric, Lotrafilcon B Toric
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.89
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.2
Parameter Dispersion
Type: Standard Deviation
Value: 5.0
Estimation Comments Mean difference is senofilcon A minus lotrafilcon B
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Senofilcon A Toric, Omafilcon A Toric
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.56
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.1
Parameter Dispersion
Type: Standard Deviation
Value: 5.8
Estimation Comments Mean difference is senofilcon A minus omafilcon A
9.Secondary Outcome
Title Degree of Lens Rotation in Inferior-nasal Gaze.
Hide Description Degree of lens rotation while participant is gazing down and in.
Time Frame After each of the four lens insertions
Hide Outcome Measure Data
Hide Analysis Population Description
Only participants who completed the study per protocol. Some participants had missing data for some of the lenses.
Arm/Group Title Senofilcon A Toric Balafilcon A Toric Lotrafilcon B Toric Omafilcon A Toric
Hide Arm/Group Description:
senofilcon A toric worn in either the first, second, third or fourth periods.
balafilcon A toric worn in either the first, second, third or fourth periods
lotrafilcon B toric worn in either the first, second, third, or fourth periods.
omafilcon A toric worn in either the first, second, third, or fourth periods.
Overall Number of Participants Analyzed 13 13 13 11
Mean (Standard Deviation)
Unit of Measure: Degree of rotation
3.0  (1.6) 9.0  (6.9) 5.9  (2.9) 9.5  (5.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Senofilcon A Toric, Balafilcon A Toric
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0080
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -6.0
Parameter Dispersion
Type: Standard Deviation
Value: 6.8
Estimation Comments Mean difference is senofilcon A minus balafilcon A
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Senofilcon A Toric, Lotrafilcon B Toric
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0049
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.9
Parameter Dispersion
Type: Standard Deviation
Value: 3.1
Estimation Comments Mean difference is senofilcon A minus lotrafilcon B
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Senofilcon A Toric, Omafilcon A Toric
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0058
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -6.4
Parameter Dispersion
Type: Standard Deviation
Value: 5.6
Estimation Comments Mean difference is senofilcon A minus omafilcon A
10.Secondary Outcome
Title Degree of Lens Rotation in Inferior Gaze.
Hide Description Degree of lens rotation while participant is gazing down.
Time Frame After each of the four lens insertions
Hide Outcome Measure Data
Hide Analysis Population Description
Only participants who completed the study per protocol. Some participants had missing data for some of the lenses.
Arm/Group Title Senofilcon A Toric Balafilcon A Toric Lotrafilcon B Toric Omafilcon A Toric
Hide Arm/Group Description:
senofilcon A toric worn in either the first, second, third or fourth periods.
balafilcon A toric worn in either the first, second, third or fourth periods
lotrafilcon B toric worn in either the first, second, third, or fourth periods.
omafilcon A toric worn in either the first, second, third, or fourth periods.
Overall Number of Participants Analyzed 13 13 13 11
Mean (Standard Deviation)
Unit of Measure: Degree of rotation
3.9  (4.3) 5.0  (4.0) 4.2  (6.3) 2.4  (1.9)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Senofilcon A Toric, Balafilcon A Toric
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.27
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.2
Parameter Dispersion
Type: Standard Deviation
Value: 3.7
Estimation Comments Mean difference is senofilcon A minus balafilcon A
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Senofilcon A Toric, Lotrafilcon B Toric
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.85
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.3
Parameter Dispersion
Type: Standard Deviation
Value: 6.0
Estimation Comments Mean difference is senofilocon A minus lotrafilcon B
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Senofilcon A Toric, Omafilcon A Toric
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.73
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.3
Parameter Dispersion
Type: Standard Deviation
Value: 2.6
Estimation Comments Mean difference is senofilcon A minus omifilcon A
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Lotrafilcon B / Senofilcon A / Balafilcon A / Omafilcon A Lotrafilcon B / Omafilcon A / Senofilcon A / Balafilcon A Lotrafilcon B / Balafilcon A / Senofilcon A / Omafilcon A Senofilcon A / Lotrafilcon B / Omafilcon A / Balafilcon A Senofilcon A / Omafilcon A / Balafilcon A / Lotrafilcon B Senofilcon A / Balafilcon A / Lotrafilcon B / Omafilcon A Omafilcon A / Lotrafilcon B / Senofilcon A / Balafilcon A Balafilcon A / Lotrafilcon B / Senofilcon A / Omafilcon A Balafilcon A / Lotrafilcon B / Omafilcon A / Senofilcon A Balafilcon A / Senofilcon A / Lotrafilcon B / Omafilcon A Balafilcon A / Senofilcon A / Omafilcon A / Lotrafilcon A Balafilcon A / Omafilcon A / Lotrafilcon B / Senofilcon A
Hide Arm/Group Description All lenses were toric lenses. The order of lenses in the title relates to the period of administration. All lenses were toric lenses. The order of lenses in the title relates to the period of administration. All lenses were toric lenses. The order of lenses in the title relates to the period of administration. All lenses were toric lenses. The order of lenses in the title relates to the period of administration. All lenses were toric lenses. The order of lenses in the title relates to the period of administration. All lenses were toric lenses. The order of lenses in the title relates to the period of administration. All lenses were toric lenses. The order of lenses in the title relates to the period of administration. All lenses were toric lenses. The order of lenses in the title relates to the period of administration. All lenses were toric lenses. The order of lenses in the title relates to the period of administration. All lenses were toric lenses. The order of lenses in the title relates to the period of administration. All lenses were toric lenses. The order of lenses in the title relates to the period of administration. All lenses were toric lenses. The order of lenses in the title relates to the period of administration.
All-Cause Mortality
Lotrafilcon B / Senofilcon A / Balafilcon A / Omafilcon A Lotrafilcon B / Omafilcon A / Senofilcon A / Balafilcon A Lotrafilcon B / Balafilcon A / Senofilcon A / Omafilcon A Senofilcon A / Lotrafilcon B / Omafilcon A / Balafilcon A Senofilcon A / Omafilcon A / Balafilcon A / Lotrafilcon B Senofilcon A / Balafilcon A / Lotrafilcon B / Omafilcon A Omafilcon A / Lotrafilcon B / Senofilcon A / Balafilcon A Balafilcon A / Lotrafilcon B / Senofilcon A / Omafilcon A Balafilcon A / Lotrafilcon B / Omafilcon A / Senofilcon A Balafilcon A / Senofilcon A / Lotrafilcon B / Omafilcon A Balafilcon A / Senofilcon A / Omafilcon A / Lotrafilcon A Balafilcon A / Omafilcon A / Lotrafilcon B / Senofilcon A
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
Lotrafilcon B / Senofilcon A / Balafilcon A / Omafilcon A Lotrafilcon B / Omafilcon A / Senofilcon A / Balafilcon A Lotrafilcon B / Balafilcon A / Senofilcon A / Omafilcon A Senofilcon A / Lotrafilcon B / Omafilcon A / Balafilcon A Senofilcon A / Omafilcon A / Balafilcon A / Lotrafilcon B Senofilcon A / Balafilcon A / Lotrafilcon B / Omafilcon A Omafilcon A / Lotrafilcon B / Senofilcon A / Balafilcon A Balafilcon A / Lotrafilcon B / Senofilcon A / Omafilcon A Balafilcon A / Lotrafilcon B / Omafilcon A / Senofilcon A Balafilcon A / Senofilcon A / Lotrafilcon B / Omafilcon A Balafilcon A / Senofilcon A / Omafilcon A / Lotrafilcon A Balafilcon A / Omafilcon A / Lotrafilcon B / Senofilcon A
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/1 (0.00%)   0/2 (0.00%)   0/1 (0.00%)   0/1 (0.00%)   0/1 (0.00%)   0/1 (0.00%)   0/1 (0.00%)   0/1 (0.00%)   0/1 (0.00%)   0/1 (0.00%)   0/1 (0.00%)   0/1 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Lotrafilcon B / Senofilcon A / Balafilcon A / Omafilcon A Lotrafilcon B / Omafilcon A / Senofilcon A / Balafilcon A Lotrafilcon B / Balafilcon A / Senofilcon A / Omafilcon A Senofilcon A / Lotrafilcon B / Omafilcon A / Balafilcon A Senofilcon A / Omafilcon A / Balafilcon A / Lotrafilcon B Senofilcon A / Balafilcon A / Lotrafilcon B / Omafilcon A Omafilcon A / Lotrafilcon B / Senofilcon A / Balafilcon A Balafilcon A / Lotrafilcon B / Senofilcon A / Omafilcon A Balafilcon A / Lotrafilcon B / Omafilcon A / Senofilcon A Balafilcon A / Senofilcon A / Lotrafilcon B / Omafilcon A Balafilcon A / Senofilcon A / Omafilcon A / Lotrafilcon A Balafilcon A / Omafilcon A / Lotrafilcon B / Senofilcon A
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/1 (0.00%)   0/1 (0.00%)   0/1 (0.00%)   0/1 (0.00%)   0/1 (0.00%)   0/1 (0.00%)   0/1 (0.00%)   0/1 (0.00%)   0/1 (0.00%)   0/1 (0.00%)   0/1 (0.00%)   0/1 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The PI may not publish, divulge, reveal, disclose, or use the data and or results of the study without prior written consent of Vistakon.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Kurt Moody, OD FAAO
Organization: Vistakon
Phone: 904-443-3088
EMail: kmoody1@its.jnj.com
Layout table for additonal information
Responsible Party: Johnson & Johnson Vision Care, Inc.
ClinicalTrials.gov Identifier: NCT00583908    
Other Study ID Numbers: CR-0710 pt 3
ETOR-507(under GNR-011)
First Submitted: December 21, 2007
First Posted: January 2, 2008
Results First Submitted: August 18, 2009
Results First Posted: September 28, 2009
Last Update Posted: May 21, 2015