Clinical Performance of Atypical Contact Lens Powers on Subjects With Astigmatism

• Sponsor: Johnson & Johnson Vision Care, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00697190
• Collaborator: (none)
• Enrollment: 39
• Location: 1
• Arms: 2
• Duration (Months): 4
• Patients Per Site Per Month: 9.7

Study Details

Study Description

Brief Summary

This study will evaluate the fitting characteristics and physiological response of two toric lenses manufactured by Vistakon.

Condition or Disease	Intervention/Treatment	Phase
Astigmatism	Device: senofilcon A toric; Device: galyfilcon A toric	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 39 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Study Start Date: May 1, 2008
• Actual Primary Completion Date: Sep 1, 2008
• Actual Study Completion Date: Sep 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: senofilcon A/galyfilcon A senofilcon A silicone hydrogel toric contact lenses will be worn first. galyfilcon A silicone hydrogel toric contact lenses will be worn second.	Device: senofilcon A toric; silicone hydrogel contact lens for patients with astigmatism; Other Names: Acuvue Oasys for Astigmatism ; Device: galyfilcon A toric; silicone hydrogel contact lens for patients with astigmatism; Other Names: Acuvue Advance for Astigmatism
Active Comparator: galyfilcon A/senofilcon A galyfilcon A silicone hydrogel toric contact lenses worn first. senofilcon A silicone hydrogel toric contact lenses worn second.	Device: senofilcon A toric; silicone hydrogel contact lens for patients with astigmatism; Other Names: Acuvue Oasys for Astigmatism ; Device: galyfilcon A toric; silicone hydrogel contact lens for patients with astigmatism; Other Names: Acuvue Advance for Astigmatism

Outcome Measures

Primary Outcome Measures

1. Assessment of Conjunctival Hyperemia in Subjects That Are High Myopes (Have a High Degree of Nearsightedness) [after 6 hours of wear]

   Conjunctival hyperemia measures the redness across the white of the eye. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.

2. Assessment of Conjunctival Hyperemia in Subjects That Are Hyperopes (Farsighted) [after 6 hours of wear]

   Conjunctival hyperemia measures the redness across the white of the eye. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.

3. Assessment of Conjunctival Hyperemia in Subjects That Are Oblique Astigmats (Have an Abnormally Curved Cornea) [after 6 hours of wear]

   Conjunctival hyperemia measures the redness across the white of the eye. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.

4. Assessment of Limbal Hyperemia in Subjects That Are High Myopes (Have a High Degree of Nearsightedness) [after 6 hours of wear]

   Limbal hyperemia measures the redness around the edge of the cornea. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.

5. Assessment of Limbal Hyperemia in Subjects That Are Hyperopes (Farsighted) [after 6 hours of wear]

   Limbal hyperemia measures the redness around the edge of the cornea. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.

6. Assessment of Limbal Hyperemia in Subjects That Are Oblique Astigmats (Have an Abnormally Curved Cornea) [after 6 hours of wear]

   Limbal hyperemia measures the redness around the edge of the cornea. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.

7. Assessment of Corneal Staining in Subjects That Are High Myopes (Have a High Degree of Nearsightedness) [after 6 hours of wear]

   Corneal staining measures changes to the surface of the cornea, as evaluated by the degree of staining with sodium fluorescein solution. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.

8. Assessment of Corneal Staining in Subjects That Are Hyperopes (Farsighted) [after 6 hours of wear]

   Corneal staining measures changes to the surface of the cornea, as evaluated by the degree of staining with sodium fluorescein solution. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.

9. Assessment of Corneal Staining in Subjects That Are Oblique Astigmats (Have an Abnormally Curved Cornea) [after 6 hours of wear]

   Corneal staining measures changes to the surface of the cornea, as evaluated by the degree of staining with sodium fluorescein solution. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.

10. Assessment of Conjunctival Staining in Subjects That Are High Myopes (Have a High Degree of Nearsightedness) [after 6 hours of wear]

    Conjunctival staining measures the changes to the conjunctival surface as evaluated by the degree of staining with sodium fluorescein solution. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.

11. Assessment of Conjunctival Staining in Subjects That Are Hyperopes (Farsighted) [after 6 hours of wear]

    Conjunctival staining measures the changes to the conjunctival surface as evaluated by the degree of staining with sodium fluorescein solution. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.

12. Assessment of Conjunctival Staining in Subjects That Are Oblique Astigmats (Have an Abnormally Curved Cornea) [after 6 hours of wear]

    Conjunctival staining measures the changes to the conjunctival surface as evaluated by the degree of staining with sodium fluorescein solution. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.

13. Assessment of Papillary Conjunctivitis in Subjects That Are High Myopes (Have a High Degree of Nearsightedness) [after 6 hours of wear]

    Papillary conjunctivitis measures the changes to the conjunctival surface on the underside of the upper eyelid. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.

14. Assessment of Papillary Conjunctivitis in Subjects That Are Hyperopes (Farsighted) [after 6 hours of wear]

    Papillary conjunctivitis measures the changes to the conjunctival surface on the underside of the upper eyelid. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.

15. Assessment of Papillary Conjunctivitis in Subjects That Are Oblique Astigmats (Have an Abnormally Curved Cornea) [after 6 hours of wear]

    Papillary conjunctivitis measures the changes to the conjunctival surface on the underside of the upper eyelid. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Able to wear study lenses in parameters available.

• At least 18

• understand and sign informed consent

• willing to follow the protocol

• achieve at least 6/9 Visual Acuity (VA), both eyes (OU) with study lenses

• hyperopes: +2.00 to +4.00 with -0.75 D cylinder around 180, high myopes: -6.00 to -8.00 with -1.25 D cylinder around 180

• oblique axis: -2.00 to -4.00 with -0.75 D cyl around 45 or 135, have worn Soft Contact Lenses's within last 6 months

Exclusion Criteria:

• Any ocular or systemic disorder which may contraindicate Contact Lens (CL) wear

• any topical ocular medication

• aphakic

• corneal refractive surgery,

• corneal distortion from hard CL wear or keratoconus

• pregnant or lactating

• grade 2 or worse slit lamp signs

• infectious disease

• previous clinical study within 2 weeks

• don't agree to participate

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Eurolens Research	Manchester		United Kingdom

Sponsors and Collaborators

• Johnson & Johnson Vision Care, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Johnson & Johnson Vision Care, Inc.
• ClinicalTrials.gov Identifier: NCT00697190
• Other Study ID Numbers: CR-4523
• First Posted: Jun 13, 2008
• Last Update Posted: May 22, 2015
• Last Verified: May 1, 2015

• Additional relevant MeSH terms: Astigmatism

Study Results

Participant Flow

Arm/Group Title	Senofilcon A/Galyfilcon A	Galyfilcon A/Senofilcon A
Arm/Group Description	senofilcon A silicone hydrogel toric contact lenses will be worn first. galyfilcon A silicone hydrogel toric contact lenses will be worn second.	galyfilcon A silicone hydrogel toric contact lenses worn first. senofilcon A silicone hydrogel toric contact lenses worn second.
Period Title: First Intervention
STARTED	19	20
COMPLETED	19	20
NOT COMPLETED	0	0
Period Title: First Intervention
STARTED	18	20
COMPLETED	18	20
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	All Completed Subjects
Arm/Group Description	All subjects that completed the study were analyzed. One subject from the senofilcon A/ galyfilcon A arm dropped from the study between the first and second intervention. The subject moved out of town.
Overall Participants	38
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	31.4 (12.5)
Sex: Female, Male (Count of Participants)
Female	27 71.1%
Male	11 28.9%
Region of Enrollment (participants) [Number]
United Kingdom	38 100%

Outcome Measures

1. Primary Outcome

Title	Assessment of Conjunctival Hyperemia in Subjects That Are High Myopes (Have a High Degree of Nearsightedness)
Description	Conjunctival hyperemia measures the redness across the white of the eye. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.
Time Frame	after 6 hours of wear

Outcome Measure Data

Analysis Population Description

There were 11 subjects that were high myopes within the total completed population of 38.

Arm/Group Title	Senofilcon A	Galyfilcon A
Arm/Group Description	This group represents all high myope subjects that completed the study and wore senofilcon A toric contact lenses as first or second intervention.	This group represents all high myope subjects that completed the study and wore galyfilcon A toric contact lenses as first or second intervention.
Measure Participants	11	11
Least Squares Mean (Standard Error) [Units on a scale]	1.10 (0.05)	1.23 (0.05)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Senofilcon A, Galyfilcon A
	Comments	Alternative hypothesis is that senoflicon A toric is non-inferior to galyfilcon A toric in conjunctival hyperemia.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority margin = 0.33
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.13
	Confidence Interval	(2-Sided) 97.5%; -0.29 to 0.04
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.09
	Estimation Comments	The mean difference is calculated as senofilcon A toric minus galyfilcon A toric.

2. Primary Outcome

Title	Assessment of Conjunctival Hyperemia in Subjects That Are Hyperopes (Farsighted)
Description	Conjunctival hyperemia measures the redness across the white of the eye. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.
Time Frame	after 6 hours of wear

Outcome Measure Data

Analysis Population Description

There were 14 subjects that were hyperopes within the total completed population of 38.

Arm/Group Title	Senofilcon A	Galyfilcon A
Arm/Group Description	This group represents all hyperope subjects that completed the study and wore senofilcon A toric contact lenses as first or second intervention.	This group represents all hyperope subjects that completed the study and wore galyfilcon A toric contact lenses as first or second intervention.
Measure Participants	14	14
Least Squares Mean (Standard Error) [Units on a scale]	1.16 (0.07)	1.18 (0.05)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Senofilcon A, Galyfilcon A
	Comments	Alternative hypothesis is that senofilcon A toric is non-inferior to galyfilcon A toric in conjunctival hyperemia.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority margin = 0.33
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.02
	Confidence Interval	(2-Sided) 97.5%; -0.10 to 0.06
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.04
	Estimation Comments	The mean difference is calculated as senofilcon A toric minus galyfilcon A toric.

3. Primary Outcome

Title	Assessment of Conjunctival Hyperemia in Subjects That Are Oblique Astigmats (Have an Abnormally Curved Cornea)
Description	Conjunctival hyperemia measures the redness across the white of the eye. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.
Time Frame	after 6 hours of wear

Outcome Measure Data

Analysis Population Description

There were 13 subjects that were oblique astigmats within the total completed population of 38.

Arm/Group Title	Senofilcon A	Galyfilcon A
Arm/Group Description	This group represents all oblique astigmat subjects that completed the study and wore senofilcon A toric contact lenses as first or second intervention.	This group represents all oblique astigmat subjects that completed the study and wore galyfilcon A toric contact lenses as first or second intervention.
Measure Participants	13	13
Least Squares Mean (Standard Error) [Units on a scale]	1.08 (0.07)	1.14 (0.08)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Senofilcon A, Galyfilcon A
	Comments	Alternative hypothesis is that senofilcon A toric is non-inferior to galyfilcon A toric in conjunctival hyperemia.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority margin = 0.33
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.07
	Confidence Interval	(2-Sided) 97.5%; -0.23 to 0.10
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.08
	Estimation Comments	The mean difference is calculated as senofilcon A toric minus galyfilcon A toric.

4. Primary Outcome

Title	Assessment of Limbal Hyperemia in Subjects That Are High Myopes (Have a High Degree of Nearsightedness)
Description	Limbal hyperemia measures the redness around the edge of the cornea. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.
Time Frame	after 6 hours of wear

Outcome Measure Data

Analysis Population Description

There were 11 subjects that were high myopes within the total completed population of 38.

Arm/Group Title	Senofilcon A	Galyfilcon A
Arm/Group Description	This group represents all high myope subjects that completed the study and wore senofilcon A toric contact lenses as first or second intervention.	This group represents all high myope subjects that completed the study and wore galyfilcon A toric contact lenses as first or second intervention.
Measure Participants	11	11
Least Squares Mean (Standard Error) [Units on a scale]	0.97 (0.05)	1.07 (0.07)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Senofilcon A, Galyfilcon A
	Comments	Alternative hypothesis is that senofilcon A toric is non-inferior to galyfilcon A toric in limbal hyperemia.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferior margin = 0.33
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.11
	Confidence Interval	(2-Sided) 97.5%; -0.25 to 0.04
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.08
	Estimation Comments	The mean difference is calculated as senofilcon A toric minus galyfilcon A toric.

5. Primary Outcome

Title	Assessment of Limbal Hyperemia in Subjects That Are Hyperopes (Farsighted)
Description	Limbal hyperemia measures the redness around the edge of the cornea. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.
Time Frame	after 6 hours of wear

Outcome Measure Data

Analysis Population Description

There were 14 subjects that were hyperopes within the total completed population of 38.

Arm/Group Title	Senofilcon A	Galyfilcon A
Arm/Group Description	This group represents all hyperope subjects that completed the study and wore senofilcon A toric contact lenses as first or second intervention.	This group represents all hyperope subjects that completed the study and wore galyfilcon A toric contact lenses as first or second intervention.
Measure Participants	14	14
Least Squares Mean (Standard Error) [Units on a scale]	0.95 (0.06)	1.00 (0.06)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Senofilcon A, Galyfilcon A
	Comments	Alternative hypothesis is that senofilcon A toric is non-inferior to galyfilcon A toric in limbal hyperemia.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferior margin = 0.33
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.05
	Confidence Interval	(2-Sided) 97.5%; -0.16 to 0.07
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.06
	Estimation Comments	The mean difference is calculated as senofilcon A toric minus galyfilcon A toric.

6. Primary Outcome

Title	Assessment of Limbal Hyperemia in Subjects That Are Oblique Astigmats (Have an Abnormally Curved Cornea)
Description	Limbal hyperemia measures the redness around the edge of the cornea. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.
Time Frame	after 6 hours of wear

Outcome Measure Data

Analysis Population Description

There were 13 subjects that were oblique astigmats within the total completed population of 38.

Arm/Group Title	Senofilcon A	Galyfilcon A
Arm/Group Description	This group represents all oblique astigmat subjects that completed the study and wore senofilcon A toric contact lenses as first or second intervention.	This group represents all oblique astigmat subjects that completed the study and wore galyfilcon A toric contact lenses as first or second intervention.
Measure Participants	13	13
Least Squares Mean (Standard Error) [Units on a scale]	1.01 (0.08)	1.06 (0.07)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Senofilcon A, Galyfilcon A
	Comments	Alternative hypothesis is that senofilcon A toric is non-inferior to galyfilcon A toric in limbal hyperemia.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority margin = 0.33
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.06
	Confidence Interval	(2-Sided) 97.5%; -0.25 to 0.14
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.10
	Estimation Comments	The mean difference is calculated as senofilcon A toric minus galyfilcon A toric.

7. Primary Outcome

Title	Assessment of Corneal Staining in Subjects That Are High Myopes (Have a High Degree of Nearsightedness)
Description	Corneal staining measures changes to the surface of the cornea, as evaluated by the degree of staining with sodium fluorescein solution. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.
Time Frame	after 6 hours of wear

Outcome Measure Data

Analysis Population Description

There were 11 subjects that were high myopes within the total completed population of 38.

Arm/Group Title	Senofilcon A	Galyfilcon A
Arm/Group Description	This group represents all high myope subjects that completed the study and wore senofilcon A toric contact lenses as first or second intervention.	This group represents all high myope subjects that completed the study and wore galyfilcon A toric contact lenses as first or second intervention.
Measure Participants	11	11
Least Squares Mean (Standard Error) [Units on a scale]	0.40 (0.07)	0.22 (0.05)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Senofilcon A, Galyfilcon A
	Comments	Alternative hypothesis is that senofilcon A toric is non-inferior to galyfilcon A toric in corneal staining.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority margin = 0.33
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.18
	Confidence Interval	(2-Sided) 97.5%; 0.04 to 0.32
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.07
	Estimation Comments	The mean difference is calculated as senofilcon A toric minus galyfilcon A toric.

8. Primary Outcome

Title	Assessment of Corneal Staining in Subjects That Are Hyperopes (Farsighted)
Description	Corneal staining measures changes to the surface of the cornea, as evaluated by the degree of staining with sodium fluorescein solution. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.
Time Frame	after 6 hours of wear

Outcome Measure Data

Analysis Population Description

There were 14 subjects that were hyperopes within the total completed population of 38.

Arm/Group Title	Senofilcon A	Galyfilcon A
Arm/Group Description	This group represents all hyperope subjects that completed the study and wore senofilcon A toric contact lenses as first or second intervention.	This group represents all hyperope subjects that completed the study and wore galyfilcon A toric contact lenses as first or second intervention.
Measure Participants	14	14
Least Squares Mean (Standard Error) [Units on a scale]	0.19 (0.07)	0.28 (0.09)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Senofilcon A, Galyfilcon A
	Comments	Alternative hypothesis is that senofilcon A toric is non-inferior to galyfilcon A toric in corneal staining.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferior margin = 0.33
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.09
	Confidence Interval	(2-Sided) 97.5%; -0.26 to 0.08
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.08
	Estimation Comments	The mean difference is calculated as senofilcon A toric minus galyfilcon A toric.

9. Primary Outcome

Title	Assessment of Corneal Staining in Subjects That Are Oblique Astigmats (Have an Abnormally Curved Cornea)
Description	Corneal staining measures changes to the surface of the cornea, as evaluated by the degree of staining with sodium fluorescein solution. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.
Time Frame	after 6 hours of wear

Outcome Measure Data

Analysis Population Description

There were 13 subjects that were oblique astigmats within the total completed population of 38.

Arm/Group Title	Senofilcon A	Galyfilcon A
Arm/Group Description	This group represents all oblique astigmat subjects that completed the study and wore senofilcon A toric contact lenses as first or second intervention.	This group represents all oblique astigmat subjects that completed the study and wore galyfilcon A toric contact lenses as first or second intervention.
Measure Participants	13	13
Least Squares Mean (Standard Error) [Units on a scale]	0.35 (0.08)	0.18 (0.08)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Senofilcon A, Galyfilcon A
	Comments	Alternative hypothesis is that senofilcon A toric is non-inferior to galyfilcon A toric in corneal staining.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferior margin = 0.33
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Median Difference (Final Values)
	Estimated Value	0.17
	Confidence Interval	() 97.5%; 0.02 to 0.33
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.08
	Estimation Comments	The mean difference is calculated as senofilcon A toric minus galyfilcon A toric.

10. Primary Outcome

Title	Assessment of Conjunctival Staining in Subjects That Are High Myopes (Have a High Degree of Nearsightedness)
Description	Conjunctival staining measures the changes to the conjunctival surface as evaluated by the degree of staining with sodium fluorescein solution. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.
Time Frame	after 6 hours of wear

Outcome Measure Data

Analysis Population Description

There were 11 subjects that were high myopes within the total completed population of 38.

Arm/Group Title	Senofilcon A	Galyfilcon A
Arm/Group Description	This group represents all high myope subjects that completed the study and wore senofilcon A toric contact lenses as first or second intervention.	This group represents all high myope subjects that completed the study and wore galyfilcon A toric contact lenses as first or second intervention.
Measure Participants	11	11
Least Squares Mean (Standard Error) [Units on a scale]	1.68 (0.09)	1.69 (0.14)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Senofilcon A, Galyfilcon A
	Comments	Alternative hypothesis is that senofilcon A toric is non-inferior to galyfilcon A toric in conjunctival staining.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority margin = 0.33
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.01
	Confidence Interval	(2-Sided) 97.5%; -0.27 to 0.26
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.13
	Estimation Comments	The mean difference is calculated as senofilcon A toric minus galyfilcon A toric.

11. Primary Outcome

Title	Assessment of Conjunctival Staining in Subjects That Are Hyperopes (Farsighted)
Description	Conjunctival staining measures the changes to the conjunctival surface as evaluated by the degree of staining with sodium fluorescein solution. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.
Time Frame	after 6 hours of wear

Outcome Measure Data

Analysis Population Description

There were 14 subjects that were hyperopes within the total completed population of 38.

Arm/Group Title	Senofilcon A	Galyfilcon A
Arm/Group Description	This group represents all hyperope subjects that completed the study and wore senofilcon A toric contact lenses as first or second intervention.	This group represents all hyperope subjects that completed the study and wore galyfilcon A toric contact lenses as first or second intervention.
Measure Participants	14	14
Least Squares Mean (Standard Error) [Units on a scale]	0.96 (0.10)	1.17 (0.08)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Senofilcon A, Galyfilcon A
	Comments	Alternative hypothesis is that senofilcon A toric is non-inferior to galyfilcon A toric in conjunctival staining.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferior margin = 0.33
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.21
	Confidence Interval	(2-Sided) 97.5%; -0.34 to -0.08
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.07
	Estimation Comments	The mean difference is calculated as senofilcon A toric minus galyfilcon A toric.

12. Primary Outcome

Title	Assessment of Conjunctival Staining in Subjects That Are Oblique Astigmats (Have an Abnormally Curved Cornea)
Description	Conjunctival staining measures the changes to the conjunctival surface as evaluated by the degree of staining with sodium fluorescein solution. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.
Time Frame	after 6 hours of wear

Outcome Measure Data

Analysis Population Description

There were 13 subjects that were oblique astigmats within the total completed population of 38.

Arm/Group Title	Senofilcon A	Galyfilcon A
Arm/Group Description	This group represents all oblique astigmat subjects that completed the study and wore senofilcon A toric contact lenses as first or second intervention.	This group represents all oblique astigmat subjects that completed the study and wore galyfilcon A toric contact lenses as first or second intervention.
Measure Participants	13	13
Least Squares Mean (Standard Error) [Units on a scale]	1.12 (0.09)	1.42 (0.08)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Senofilcon A, Galyfilcon A
	Comments	Alternative hypothesis is that senofilcon A toric is non-inferior to galyfilcon A toric in conjunctival staining.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferior margin = 0.33
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.34
	Confidence Interval	(2-Sided) 97.5%; -0.54 to -0.15
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.10
	Estimation Comments	The mean difference is calculated as senofilcon A toric minus galyfilcon A toric.

13. Primary Outcome

Title	Assessment of Papillary Conjunctivitis in Subjects That Are High Myopes (Have a High Degree of Nearsightedness)
Description	Papillary conjunctivitis measures the changes to the conjunctival surface on the underside of the upper eyelid. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.
Time Frame	after 6 hours of wear

Outcome Measure Data

Analysis Population Description

There were 11 subjects that were high myopes within the total completed population of 38.

Arm/Group Title	Senofilcon A	Galyfilcon A
Arm/Group Description	This group represents all high myope subjects that completed the study and wore senofilcon A toric contact lenses as first or second intervention.	This group represents all high myope subjects that completed the study and wore galyfilcon A toric contact lenses as first or second intervention.
Measure Participants	11	11
Least Squares Mean (Standard Error) [Units on a scale]	1.09 (0.07)	1.08 (0.07)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Senofilcon A, Galyfilcon A
	Comments	Alternative hypothesis is that senofilcon A toric is non-inferior to galyfilcon A toric in papillary conjunctivitis.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority margin = 0.33
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.01
	Confidence Interval	(2-Sided) 97.5%; -0.12 to 0.14
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.07
	Estimation Comments	The mean difference is calculated as senofilcon A toric minus galyfilcon A toric.

14. Primary Outcome

Title	Assessment of Papillary Conjunctivitis in Subjects That Are Hyperopes (Farsighted)
Description	Papillary conjunctivitis measures the changes to the conjunctival surface on the underside of the upper eyelid. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.
Time Frame	after 6 hours of wear

Outcome Measure Data

Analysis Population Description

There were 14 subjects that were hyperopes within the total completed population of 38.

Arm/Group Title	Senofilcon A	Galyfilcon A
Arm/Group Description	This group represents all hyperope subjects that completed the study and wore senofilcon A toric contact lenses as first or second intervention.	This group represents all hyperope subjects that completed the study and wore galyfilcon A toric contact lenses as first or second intervention.
Measure Participants	14	14
Least Squares Mean (Standard Error) [Units on a scale]	1.12 (0.06)	1.21 (0.09)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Senofilcon A, Galyfilcon A
	Comments	Alternative hypothesis is that senofilcon A toric is non-inferior to galyfilcon A toric in papillary conjunctivitis.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferior margin = 0.33
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.09
	Confidence Interval	(2-Sided) 97.5%; -0.23 to 0.05
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.07
	Estimation Comments	The mean difference is calculated as senofilcon A toric minus galyfilcon A toric.

15. Primary Outcome

Title	Assessment of Papillary Conjunctivitis in Subjects That Are Oblique Astigmats (Have an Abnormally Curved Cornea)
Description	Papillary conjunctivitis measures the changes to the conjunctival surface on the underside of the upper eyelid. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.
Time Frame	after 6 hours of wear

Outcome Measure Data

Analysis Population Description

There were 13 subjects that were oblique astigmats within the total completed population of 38.

Arm/Group Title	Senofilcon A	Galyfilcon A
Arm/Group Description	This group represents all oblique astigmat subjects that completed the study and wore senofilcon A toric contact lenses as first or second intervention.	This group represents all oblique astigmat subjects that completed the study and wore galyfilcon A toric contact lenses as first or second intervention.
Measure Participants	13	13
Least Squares Mean (Standard Error) [Units on a scale]	1.01 (0.05)	1.10 (0.04)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Senofilcon A, Galyfilcon A
	Comments	Alternative hypothesis is that senofilcon A toric is non-inferior to galyfilcon A toric in papillary conjunctivitis.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferior margin = 0.33
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.09
	Confidence Interval	(2-Sided) 97.5%; -0.20 to 0.02
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.06
	Estimation Comments	The mean difference is calculated as senofilcon A toric minus galyfilcon A toric.

Adverse Events

Arm/Group Title	Senofilcon A		Galyfilcon A
Arm/Group Description	senofilcon A silicone hydrogel toric contact lenses worn in the first or second intervention.		galyfilcon A silicone hydrogel toric contact lenses worn in the first or second intervention.
All Cause Mortality
	Senofilcon A		Galyfilcon A
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Senofilcon A		Galyfilcon A
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/19 (0%)		0/20 (0%)
Other (Not Including Serious) Adverse Events
	Senofilcon A		Galyfilcon A
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/19 (5.3%)		2/20 (10%)
Eye disorders
asymptomatic infiltrative event	1/19 (5.3%)	1	0/20 (0%)	0
non-significant corneal infiltrate event	0/19 (0%)	0	2/20 (10%)	2

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.