Effect of Eye Movement on Toric Lens Orientation and Visual Acuity

• Sponsor: Johnson & Johnson Vision Care, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00584831
• Collaborator: University of Manchester (Other)
• Enrollment: 40
• Location: 1
• Arms: 19
• Duration (Months): 4
• Patients Per Site Per Month: 9.9

Study Details

Study Description

Brief Summary

The relative performance of a new toric soft contact lens against toric contact lenses currently available in market, specifically for visual acuity and lens orientation. The study will be conducted in a staged approach (2 stages).

Condition or Disease	Intervention/Treatment	Phase
Astigmatism	Device: senofilcon A; Device: balafilcon A; Device: omafilcon A; Device: lotrafilcon B	N/A

Detailed Description

Non-dispensing, single-masked (subject-masked), randomised, controlled study. Two visits.

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Development and Implementation of a Clinical Test to Investigate the Change in Vision With Soft Toric Contact Lenses During Eye Movements
• Study Start Date: Oct 1, 2007
• Actual Primary Completion Date: Feb 1, 2008
• Actual Study Completion Date: Feb 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Group 2 LSBO contact lenses worn in this order: lotrafilcon B toric, senofilcon A toric, balafilcon A toric, omafilcon A toric	Device: senofilcon A; toric contact lens; Device: balafilcon A; toric contact lens; Device: omafilcon A; toric contact lens; Device: lotrafilcon B; toric contact lens
Active Comparator: Group 3 LOSB contact lenses worn in this order: lotrafilcon B toric, omafilcon A toric, senofilcon A toric, balafilcon A toric	Device: senofilcon A; toric contact lens; Device: balafilcon A; toric contact lens; Device: omafilcon A; toric contact lens; Device: lotrafilcon B; toric contact lens
Active Comparator: Group 4 LBSO contact lenses worn in this order: lotrafilcon B toric, balafilcon A toric, senofilcon A toric, omafilcon A toric	Device: senofilcon A; toric contact lens; Device: balafilcon A; toric contact lens; Device: omafilcon A; toric contact lens; Device: lotrafilcon B; toric contact lens
Active Comparator: Group 5 LBOS contact lenses worn in this order: lotrafilcon B toric, balafilcon A toric, omafilcon A toric, senofilcon A	Device: senofilcon A; toric contact lens; Device: balafilcon A; toric contact lens; Device: omafilcon A; toric contact lens; Device: lotrafilcon B; toric contact lens
Active Comparator: Group 6 SLOB contact lenses worn in this order: senofilcon A toric, lotrafilcon B toric, omafilcon A toric, balafilcon A toric	Device: senofilcon A; toric contact lens; Device: balafilcon A; toric contact lens; Device: omafilcon A; toric contact lens; Device: lotrafilcon B; toric contact lens
Active Comparator: Group 7 SLBO contact lenses worn in this order: senofilcon A toric, lotrafilcon B toric, balafilcon A toric, omafilcon A toric	Device: senofilcon A; toric contact lens; Device: balafilcon A; toric contact lens; Device: omafilcon A; toric contact lens; Device: lotrafilcon B; toric contact lens
Active Comparator: Group 8 SOLB contact lenses worn in this order: senofilcon A toric, omafilcon A toric, lotrafilcon B toric, balafilcon A toric	Device: senofilcon A; toric contact lens; Device: balafilcon A; toric contact lens; Device: omafilcon A; toric contact lens; Device: lotrafilcon B; toric contact lens
Active Comparator: Group 9 SBLO contact lenses worn in this order: senofilcon A toric, balafilcon A toric, lotrafilcon B toric, omafilcon A toric	Device: senofilcon A; toric contact lens; Device: balafilcon A; toric contact lens; Device: omafilcon A; toric contact lens; Device: lotrafilcon B; toric contact lens
Active Comparator: Group 10 SBOL contact lenses worn in this order: senofilcon A toric, balafilcon A toric, omafilcon A toric, lotrafilcon B toric	Device: senofilcon A; toric contact lens; Device: balafilcon A; toric contact lens; Device: omafilcon A; toric contact lens; Device: lotrafilcon B; toric contact lens
Active Comparator: Group 11 OSLB contact lenses worn in this order: omafilcon A toric, senofilcon A toric, lotrafilcon B toric, balafilcon A toric	Device: senofilcon A; toric contact lens; Device: balafilcon A; toric contact lens; Device: omafilcon A; toric contact lens; Device: lotrafilcon B; toric contact lens
Active Comparator: Group 12 OSBL contact lenses worn in this order: omafilcon A toric, senofilcon A toric, balafilcon A toric, lotrafilcon B toric	Device: senofilcon A; toric contact lens; Device: balafilcon A; toric contact lens; Device: omafilcon A; toric contact lens; Device: lotrafilcon B; toric contact lens
Active Comparator: Group 13 OBLS contact lenses worn in this order: omafilcon A toric, balafilcon A toric, lotrafilcon B toric, senofilcon A toric	Device: senofilcon A; toric contact lens; Device: balafilcon A; toric contact lens; Device: omafilcon A; toric contact lens; Device: lotrafilcon B; toric contact lens
Active Comparator: Group 14 OBSL contact lenses worn in this order: omafilcon A toric, balafilcon A toric, senofilcon A toric, lotrafilcon B toric	Device: senofilcon A; toric contact lens; Device: balafilcon A; toric contact lens; Device: omafilcon A; toric contact lens; Device: lotrafilcon B; toric contact lens
Active Comparator: Group 15 BLSO contact lenses worn in this order: balafilcon A toric, lotrafilcon B toric, senofilcon A toric, omafilcon A toric	Device: senofilcon A; toric contact lens; Device: balafilcon A; toric contact lens; Device: omafilcon A; toric contact lens; Device: lotrafilcon B; toric contact lens
Active Comparator: Group 16 BLOS contact lenses worn in this order: balafilcon A toric, lotrafilcon B toric, omafilcon A toric, senofilcon A toric	Device: senofilcon A; toric contact lens; Device: balafilcon A; toric contact lens; Device: omafilcon A; toric contact lens; Device: lotrafilcon B; toric contact lens
Active Comparator: Group 17 BSOL contact lenses worn in this order: balafilcon A toric, senofilcon A toric, omafilcon A toric, lotrafilcon B toric	Device: senofilcon A; toric contact lens; Device: balafilcon A; toric contact lens; Device: omafilcon A; toric contact lens; Device: lotrafilcon B; toric contact lens
Active Comparator: Group 18 BOLS contact lenses worn in this order: balafilcon A toric, omafilcon A toric, lotrafilcon B toric, senofilcon A toric	Device: senofilcon A; toric contact lens; Device: balafilcon A; toric contact lens; Device: omafilcon A; toric contact lens; Device: lotrafilcon B; toric contact lens
Active Comparator: Group 19 BOSL contact lenses worn in this order: balafilcon A toric, omafilcon A toric, senofilcon A toric, lotrafilcon B toric	Device: senofilcon A; toric contact lens; Device: balafilcon A; toric contact lens; Device: omafilcon A; toric contact lens; Device: lotrafilcon B; toric contact lens
Active Comparator: Group 1 LSOB contact lenses worn in this order: lotrafilcon B toric/senofilcon A toric/omafilconA toric/balafilcon A toric	Device: senofilcon A; toric contact lens; Device: balafilcon A; toric contact lens; Device: omafilcon A; toric contact lens; Device: lotrafilcon B; toric contact lens

Outcome Measures

Primary Outcome Measures

1. Visual Acuity After Infero-temporal Version Movement. [10 minutes after insertion]

   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.

2. Visual Acuity After Infero-nasal Version Movement. [10 minutes after lens insertion]

   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.

3. Visual Acuity After Superior-temporal Version Movement [10 minutes after lens insertion]

   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.

4. Visual Acuity After Superior-nasal Version Movement. [10 minutes after lens insertion]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 39 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. They are aged between 18-39 years.

2. They understand their rights as a research subject and are willing to sign a Statement of Informed Consent.

3. They are willing and able to follow the protocol.

4. They can attain at least 6/9 in each eye with their spectacle refraction.

5. They have successfully worn contact lenses within six months of starting the study.

6. They can be fitted with toric soft contact lenses to match the available power range.

Exclusion Criteria:

1. They have an ocular disorder which would normally contra-indicate contact lens wear.

2. They have a systemic disorder which would normally contra-indicate contact lens wear.

3. They are using any topical medication such as eye drops or ointment.

4. They are aphakic.

5. They have had corneal refractive surgery.

6. They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.

7. They are pregnant or lactating.

8. They have grade 2 or greater of any of the following ocular surface signs: corneal oedema, corneal vascularisation, corneal staining, tarsal conjunctival changes or any other abnormality which would normally contraindicate contact lens wear.

9. They have taken part in any other clinical trial or research, within two weeks prior to starting this study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Eurolens Research, The University of Manchester Dpt. of Optometry & Neuroscience	Manchester		United Kingdom	M60 1QD

Sponsors and Collaborators

• Johnson & Johnson Vision Care, Inc.
• University of Manchester

Investigators

• Principal Investigator: Philip Morgan, PhD MCOptom, Eurolens Research, The University of Manchester Dpt. of Optometry and Neuroscience

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Johnson & Johnson Vision Care, Inc.
• ClinicalTrials.gov Identifier: NCT00584831
• Other Study ID Numbers: CR-0725; J07-416
• First Posted: Jan 2, 2008
• Last Update Posted: May 21, 2015
• Last Verified: May 1, 2015

• Keywords provided by Johnson & Johnson Vision Care, Inc.: astigmatism; visual acuity; orientation; contact lenses
• Additional relevant MeSH terms: Astigmatism

Study Results

Participant Flow

Arm/Group Title	Group1 LSOB	Group 2 LSBO	Group 4 LBSO	Group 5 LBOS	Group 7 SLBO	Group 8 SOLB	Group 9 SBLO	Group 10 SBOL	Group 11 OSLB	Group 12 OSBL	Group 13 OBLS	Group 14 OBSL	Group 15 BLSO	Group 16 BLOS	Group 18 BOLS	Group 19 BOSL	Group 3 LOSB	Group 6 SLOB	Group 17 BSOL
Arm/Group Description	lotrafilcon b toric, senofilcon A toric, omafilcon A toric, balafilcon A toric	lotrafilcon B toric, senofilcon A toric, balafilcon A toric, omafilcon A toric	lotrafilcon B toric, balafilcon A toric, senofilcon A toric, omafilcon A toric	lotrafilcon B toric, balafilcon A toric, omafilcon A toric, senofilcon A	senofilcon A toric, lotrafilcon B toric, balafilcon A toric, omafilcon A toric	senofilcon A toric, omafilcon A toric, lotrafilcon B toric, balafilcon A toric	senofilcon A toric, balafilcon A toric, lotrafilcon B toric, omafilcon A toric	senofilcon A toric, balafilcon A toric, omafilcon A toric, lotrafilcon B toric	omafilcon A toric, senofilcon A toric, lotrafilcon B toric, balafilcon A toric	omafilcon A toric, senofilcon A toric, balafilcon A toric, lotrafilcon B toric	omafilcon A toric, balafilcon A toric, lotrafilcon B toric, senofilcon A toric	omafilcon A toric, balafilcon A toric, senofilcon A toric, lotrafilcon B toric	balafilcon A toric, lotrafilcon B toric, senofilcon A toric, omafilcon A toric	balafilcon A toric, lotrafilcon B toric, omafilcon A toric, senofilcon A toric	balafilcon A toric, omafilcon A toric, lotrafilcon B toric, senofilcon A toric	balafilcon A toric, omafilcon A toric, senofilcon A toric, lotrafilcon B toric	lotrafilcon B toric, omafilcon A toric, senofilcon A toric, balafilcon A toric	senofilcon A toric, lotrafilcon b toric, omafilcon A toric, balafilcon A toric	balafilcon A toric, senofilcon A toric,omafilcon A toric, lotrafilcon b toric
Period Title: Intervention 1
STARTED	1	3	2	1	2	1	6	2	4	2	2	1	2	1	3	1	4	1	1
COMPLETED	1	3	2	1	2	1	6	2	4	2	2	1	2	1	3	1	4	1	1
NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Period Title: Intervention 1
STARTED	1	3	2	1	2	1	6	2	4	2	2	1	2	1	3	1	4	1	1
COMPLETED	1	3	2	1	2	1	6	2	4	2	2	1	2	1	3	1	4	1	1
NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Period Title: Intervention 1
STARTED	1	3	2	1	2	1	6	2	4	2	2	1	2	1	3	1	4	1	1
COMPLETED	1	3	2	1	2	1	6	2	4	2	2	1	2	1	3	1	4	1	1
NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Period Title: Intervention 1
STARTED	1	3	2	1	2	1	6	2	3	2	2	1	2	1	2	1	4	1	1
COMPLETED	1	3	2	1	2	1	6	2	3	2	2	1	2	1	2	1	4	1	1
NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0

Baseline Characteristics

Arm/Group Title	Total Study Population
Arm/Group Description
Overall Participants	40
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	28.3 (7.9)
Sex: Female, Male (Count of Participants)
Female	28 70%
Male	12 30%
Region of Enrollment (participants) [Number]
United Kingdom	40 100%

Outcome Measures

1. Primary Outcome

Title	Visual Acuity After Infero-temporal Version Movement.
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	10 minutes after insertion

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lotrafilcon B	Senofilcon A	Omafilcon A	Balafilcon A
Arm/Group Description	lotrafilcon b toric	senofilcon A toric	omafilcon A toric	balafilcon A toric
Measure Participants	35	35	35	35
Mean (Standard Deviation) [LogMAR units]	0.12 (0.16)	0.1 (0.15)	0.16 (0.17)	0.14 (0.19)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Lotrafilcon B, Senofilcon A
	Comments	Hypothesis is that visual acuity is the same for all lens types.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	The non-inferiority margin is 0.05
Statistical Test of Hypothesis	p-Value	0.02
	Comments
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.03
	Confidence Interval	() 95%; to
	Parameter Dispersion	Type: Standard Deviation; Value: 0.16
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Lotrafilcon B, Omafilcon A
	Comments	Hyposthesis is that visual acuity is the same for all lens types.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	The non-inferiority margin is 0.05
Statistical Test of Hypothesis	p-Value	0.02
	Comments
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.04
	Confidence Interval	() 95%; to
	Parameter Dispersion	Type: Standard Deviation; Value: 0.18
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Lotrafilcon B, Balafilcon A
	Comments	Hypothesis is that visual acuity is the same for all lens types.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	The non-inferiority margin is 0.05
Statistical Test of Hypothesis	p-Value	0.02
	Comments
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.02
	Confidence Interval	() 95%; to
	Parameter Dispersion	Type: Standard Deviation; Value: 0.20
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Senofilcon A, Omafilcon A
	Comments	Hypothesis is that visual acuity is the same for all lens types.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	The non-inferiority margin is 0.05
Statistical Test of Hypothesis	p-Value	0.02
	Comments
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.06
	Confidence Interval	() 95%; to
	Parameter Dispersion	Type: Standard Deviation; Value: 0.17
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Senofilcon A, Balafilcon A
	Comments	Hypothesis is that visual acuity is the same for all lens types.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	The non-inferiority margin is 0.05
Statistical Test of Hypothesis	p-Value	0.02
	Comments
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.04
	Confidence Interval	() 95%; to
	Parameter Dispersion	Type: Standard Deviation; Value: 0.18
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Omafilcon A, Balafilcon A
	Comments	Hypothesis is that visual acuity is the same for all lens types.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	The non-inferiority margin is 0.05
Statistical Test of Hypothesis	p-Value	0.02
	Comments
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.02
	Confidence Interval	() 95%; to
	Parameter Dispersion	Type: Standard Deviation; Value: 0.18
	Estimation Comments

2. Primary Outcome

Title	Visual Acuity After Infero-nasal Version Movement.
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	10 minutes after lens insertion

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lotrafilcon B	Senofilcon A	Omafilcon A	Balafilcon A
Arm/Group Description	lotrafilcon b toric	senofilcon A toric	omafilcon A toric	balafilcon A toric
Measure Participants	35	35	35	35
Mean (Standard Deviation) [LogMAR units]	0.12 (0.16)	0.11 (0.16)	0.14 (0.17)	0.15 (0.20)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Lotrafilcon B, Senofilcon A
	Comments	Hypothesis is that visual acuity is the same for all lens types.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	The non-inferiority margin is 0.05
Statistical Test of Hypothesis	p-Value	0.02
	Comments
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.02
	Confidence Interval	() 95%; to
	Parameter Dispersion	Type: Standard Deviation; Value: 0.16
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Lotrafilcon B, Omafilcon A
	Comments	Hypothesis is that visual acuity is the same for all lens types.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	The non-inferiority margin is 0.05
Statistical Test of Hypothesis	p-Value	0.02
	Comments
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.01
	Confidence Interval	() 95%; to
	Parameter Dispersion	Type: Standard Deviation; Value: 0.17
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Lotrafilcon B, Balafilcon A
	Comments	Hypothesis is that visual acuity is the same for all lens types.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	The non-inferiority margin is 0.05
Statistical Test of Hypothesis	p-Value	0.02
	Comments
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.03
	Confidence Interval	() 95%; to
	Parameter Dispersion	Type: Standard Deviation; Value: 0.17
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Senofilcon A, Omafilcon A
	Comments	Hypothesis is that visual acuity is the same for all lens types.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	The non-inferiority margin is 0.05
Statistical Test of Hypothesis	p-Value	0.02
	Comments
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.03
	Confidence Interval	() 95%; to
	Parameter Dispersion	Type: Standard Deviation; Value: 0.19
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Senofilcon A, Balafilcon A
	Comments	Hypothesis is that visual acuity is the same for all lens types.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	The non-inferiority margin is 0.05
Statistical Test of Hypothesis	p-Value	0.02
	Comments
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.04
	Confidence Interval	() 95%; to
	Parameter Dispersion	Type: Standard Deviation; Value: 0.20
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Omafilcon A, Balafilcon A
	Comments	Hypothesis is that visual acuity is the same for all lens types.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	The non-inferiority margin is 0.05
Statistical Test of Hypothesis	p-Value	0.02
	Comments
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.02
	Confidence Interval	() 95%; to
	Parameter Dispersion	Type: Standard Deviation; Value: 0.17
	Estimation Comments

3. Primary Outcome

Title	Visual Acuity After Superior-temporal Version Movement
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	10 minutes after lens insertion

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lotrafilcon B	Senofilcon A	Omafilcon A	Balafilcon A
Arm/Group Description	lotrafilcon b toric	senofilcon A toric	omafilcon A toric	balafilcon A toric
Measure Participants	35	35	35	35
Mean (Standard Deviation) [LogMAR units]	0.11 (0.15)	0.08 (0.14)	0.13 (0.17)	0.14 (0.20)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Lotrafilcon B, Senofilcon A
	Comments	Hypothesis is that visual acuity is the same for all lens types.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	The non-inferiority margin is 0.05
Statistical Test of Hypothesis	p-Value	0.02
	Comments
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.03
	Confidence Interval	() 95%; to
	Parameter Dispersion	Type: Standard Deviation; Value: 0.13
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Lotrafilcon B, Omafilcon A
	Comments	Hypothesis is that visual acuity is the same for all lens types.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	The non-inferiority margin is 0.05
Statistical Test of Hypothesis	p-Value	0.02
	Comments
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.01
	Confidence Interval	() 95%; to
	Parameter Dispersion	Type: Standard Deviation; Value: 0.15
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Lotrafilcon B, Balafilcon A
	Comments	Hypothesis is that visual acuity is the same for all lens types.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	The non-inferiority margin is 0.05
Statistical Test of Hypothesis	p-Value	0.02
	Comments
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.02
	Confidence Interval	() 95%; to
	Parameter Dispersion	Type: Standard Deviation; Value: 0.17
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Senofilcon A, Omafilcon A
	Comments	Hypothesis is that visual acuity is the same for all lens types.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	The non-inferiority margin is 0.05
Statistical Test of Hypothesis	p-Value	0.02
	Comments
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.04
	Confidence Interval	() 95%; to
	Parameter Dispersion	Type: Standard Deviation; Value: 0.15
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Senofilcon A, Balafilcon A
	Comments	Hypothesis is that visual acuity is the same for all lens types.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	The non-inferiority margin is 0.05
Statistical Test of Hypothesis	p-Value	0.02
	Comments
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.06
	Confidence Interval	() 95%; to
	Parameter Dispersion	Type: Standard Deviation; Value: 0.17
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Omafilcon A, Balafilcon A
	Comments	Hypothesis is that visual acuity is the same for all lens types.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	The non-inferiority margin is 0.05
Statistical Test of Hypothesis	p-Value	0.02
	Comments
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.01
	Confidence Interval	() 95%; to
	Parameter Dispersion	Type: Standard Deviation; Value: 0.18
	Estimation Comments

4. Primary Outcome

Title	Visual Acuity After Superior-nasal Version Movement.
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	10 minutes after lens insertion

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lotrafilcon B	Senofilcon A	Omafilcon A	Balafilcon A
Arm/Group Description	lotrafilcon b toric	senofilcon A toric	omafilcon A toric	balafilcon A toric
Measure Participants	35	35	35	35
Mean (Standard Deviation) [LogMAR units]	0.14 (0.15)	0.10 (0.15)	0.15 (0.16)	0.16 (0.19)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Lotrafilcon B, Senofilcon A
	Comments	Hypothesis is that visual acuity is the same for all lens types.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	The non-inferiority margin is 0.05
Statistical Test of Hypothesis	p-Value	0.02
	Comments
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.04
	Confidence Interval	() 95%; to
	Parameter Dispersion	Type: Standard Deviation; Value: 0.17
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Lotrafilcon B, Omafilcon A
	Comments	Hypothesis is that visual acuity is the same for all lens types.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	The non-inferiority margin is 0.05
Statistical Test of Hypothesis	p-Value	0.02
	Comments
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.01
	Confidence Interval	() 95%; to
	Parameter Dispersion	Type: Standard Deviation; Value: 0.19
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Lotrafilcon B, Balafilcon A
	Comments	Hypothesis is that visual acuity is the same for all lens types.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	The non-inferiority margin is 0.05
Statistical Test of Hypothesis	p-Value	0.02
	Comments
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.02
	Confidence Interval	() 95%; to
	Parameter Dispersion	Type: Standard Deviation; Value: 0.20
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Senofilcon A, Omafilcon A
	Comments	Hypothesis is that visual acuity is the same for all lens types.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	The non-inferiority margin is 0.05
Statistical Test of Hypothesis	p-Value	0.02
	Comments
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.05
	Confidence Interval	() 95%; to
	Parameter Dispersion	Type: Standard Deviation; Value: 0.15
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Senofilcon A, Balafilcon A
	Comments	Hypothesis is that visual acuity is the same for all lens types.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	The non-inferiority margin is 0.05
Statistical Test of Hypothesis	p-Value	0.02
	Comments
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.06
	Confidence Interval	() 95%; to
	Parameter Dispersion	Type: Standard Deviation; Value: 0.18
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Omafilcon A, Balafilcon A
	Comments	Hypothesis is that visual acuity is the same for all lens types.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	The non-inferiority margin is 0.05
Statistical Test of Hypothesis	p-Value	0.02
	Comments
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.01
	Confidence Interval	() 95%; to
	Parameter Dispersion	Type: Standard Deviation; Value: 0.18
	Estimation Comments

Adverse Events

Arm/Group Title	Lotrafilcon B		Senofilcon A		Omafilcon A		Balafilcon A
Arm/Group Description	lotrafilcon b toric contact lens		senofilcon A toric contact lens		omafilcon A toric contact lens		balafilcon A toric contact lens
All Cause Mortality
	Lotrafilcon B		Senofilcon A		Omafilcon A		Balafilcon A
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Lotrafilcon B		Senofilcon A		Omafilcon A		Balafilcon A
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/40 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)
Other (Not Including Serious) Adverse Events
	Lotrafilcon B		Senofilcon A		Omafilcon A		Balafilcon A
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/40 (0%)		0/40 (0%)		0/40 (0%)		0/40 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The PI may not publish, divulge, reveal, disclose, or use the data and or results of the study without prior written consent of Vistakon.