The Clinical Comparison of Senofilcon A and Stenfilcon A Contact Lenses

• Sponsor: Coopervision, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02643004
• Collaborator: (none)
• Enrollment: 70
• Location: 1
• Arms: 2
• Duration (Months): 5
• Patients Per Site Per Month: 14

Study Details

Study Description

Brief Summary

The objective of this study is to compare the clinical performance of senofilcon A lens with the stenfilcon A lens each for one week of daily disposable wear.

Condition or Disease	Intervention/Treatment	Phase
Myopia	Device: Senofilcon A; Device: Stenfilcon A	N/A

Detailed Description

The purpose of this bilateral cross-over study is to evaluate the clinical performance of senofilcon A lens with the stenfilcon A lens. In particular, the study will focus on ocular physiology, lens fit, lens surface, visual acuity, and subjective response.

Study Design

• Study Type: Interventional
• Actual Enrollment: 70 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: The Clinical Comparison of Senofilcon A and Stenfilcon A Contact Lenses
• Study Start Date: Dec 1, 2015
• Actual Primary Completion Date: Mar 1, 2016
• Actual Study Completion Date: May 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Senofilcon A Participants were randomized to wear senofilcon A lens pair for one week during the crossover study.	Device: Senofilcon A; contact lens
Active Comparator: Stenfilcon A Participants were randomized to wear stenfilcon A lens pair for one week during the crossover study.	Device: Stenfilcon A; contact lens

Outcome Measures

Primary Outcome Measures

1. Ocular Physiology [Baseline and 1 week]

   Ocular physiology assessment of senofilcon A and stenfilcon A lenses by biomicroscopy for the following: corneal staining, conjunctival hyperaemia, limbal hyperaemia, and conjunctival staining. Scale 0-4, 0.25 steps, 0=normal, 4=severe.

2. Overall Subjective Score of Lenses [Baseline and 1 week]

   Subjective responses will be evaluated for each pair using questionnaire. Scale 0-100, 0=extremely poor, 100=excellent.

3. Comfort [Baseline and 1 week]

   Subjective responses for comfort will be evaluated for each pair using questionnaire. Scale 0-100, 0=causes pain, cannot be tolerated, 100=excellent, cannot be felt.

4. Dryness [1 week]

   Subjective responses for dryness will be evaluated for each pair using questionnaire. Scale 0-100, 0=extremely poor, high levels of dryness, 100=excellent, no dryness.

5. Vision [Baseline and 1 week]

   Subjective responses for vision will be evaluated for each pair using questionnaire. Scale 0-100, 0=unacceptable, lens cannot be worn, 100=excellent.

Secondary Outcome Measures

1. Horizontal Centration [Baseline]

   Lens fit, horizontal centration will be assessed for senofilcon A and stenfilcon A at baseline for the following regions: extremely nasal, slightly nasal, optimum, slightly temporal, extremely nasal

2. Horizontal Centration [1 Week]

   Lens fit, horizontal centration, will be assessed for senofilcon A and stenfilcon A at 1 week for the following regions: extremely nasal, slightly nasal, optimum, slightly temporal, extremely nasal

3. Vertical Centration [Baseline]

   Lens fit, vertical centration, will be assessed for senofilcon A and stenfilcon A at baseline for the following regions: extremely nasal, slightly nasal, optimum, slightly temporal, extremely nasal

4. Vertical Centration [1 Week]

   Lens fit, vertical centration, will be assessed for senofilcon A and stenfilcon A at 1 week for the following regions: extremely nasal, slightly nasal, optimum, slightly temporal, extremely nasal

5. Lens Movement [Baseline]

   Lens movement assessed for stenfilcon A and senofilcon A at baseline using the following evaluations: extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive.

6. Lens Movement [1 Week]

   Lens movement assessed for stenfilcon A and senofilcon A at 1 week using the following evaluations: extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive.

7. Visual Acuity [Baseline and 1 week]

   Measurement of visual acuity (VA) for senofilcon A and stenfilcon A assessed at baseline and 1 week using logMAR VA chart.

8. Lens Surface - Deposition [Baseline]

   Lens surface for senofilcon A and stenfilcon A is assessed at baseline. Grades 0-4, 0=normal, 1=trace, 2=mild, 3=moderate, 4=severe

9. Lens Surface - Deposition [1 week]

   Lens surface for senofilcon A and stenfilcon A is assessed at 1 week. Grades 0-4, 0=normal, 1=trace, 2=mild, 3=moderate, 4=severe

10. Lens Surface - Debris [Baseline]

    Lens debris for senofilcon A and stenfilcon A is assessed at baseline. Grades 0-4, 0=normal, 1=trace, 2=mild, 3=moderate, 4=severe

11. Lens Surface - Debris [1 week]

    Lens debris for senofilcon A and stenfilcon A is assessed at 1 week. Grades 0-4, 0=normal, 1=trace, 2=mild, 3=moderate, 4=severe

12. Lens Surface - Wettability [Baseline]

    Lens wettability for senofilcon A and stenfilcon A is assessed at baseline. Grades 0-4, 0=normal, 1=trace, 2=mild, 3=moderate, 4=severe

13. Lens Surface - Wettability [1 week]

    Lens wettability for senofilcon A and stenfilcon A is assessed at 1 week. Grades 0-4, 0=normal, 1=trace, 2=mild, 3=moderate, 4=severe

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion criteria

Subjects will only be eligible for the study if:

• They are of legal age (18) and capacity to volunteer.

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

• They are willing and able to follow the protocol.

• They agree not to participate in other clinical research for the duration of this study.

• They have a contact lens spherical prescription between -1.00 to - 6.00D (inclusive)

• They have a spectacle cylindrical correction of -0.75D or less in each eye.

• At dispensing, they can attain at least 0.10 logMAR distance high contrast visual acuity in each eye with the study lenses within the available power range.

• They currently use soft contact lenses or have done so in the previous six months.

• They are willing to comply with the wear schedule (at least six days per week and for at least eight hours per day).

Exclusion criteria

Subjects will not be eligible to take part in the study if:

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

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

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

• They have had cataract surgery.

• They have had corneal refractive surgery.

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

• They are pregnant or lactating.

• They have any ocular abnormality which would, in the opinion of the investigator, normally contraindicate contact lens wear.

• They have any infectious disease which would, in the opinion of the investigator, contraindicate contact lens wear or pose a risk to study personnel; or they have any immunosuppressive disease (e.g. HIV), or a history of anaphylaxis or severe allergic reaction.

• They have taken part in any other contact lens or care solution clinical trial or research, within two weeks prior to starting this study.

• They currently wear either MyDay (daily) or the Acuvue Oasys (2 weekly) lens.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Eurolens Research - The University of Manchester	Manchester		United Kingdom	M13 9PL

Sponsors and Collaborators

• Coopervision, Inc.

Investigators

• Principal Investigator: Carole Maldonado-Codinal, PhD, Eurolens Research, University of Manchester

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Coopervision, Inc.
• ClinicalTrials.gov Identifier: NCT02643004
• Other Study ID Numbers: EX-MKTG-62
• First Posted: Dec 30, 2015
• Last Update Posted: Aug 23, 2017
• Last Verified: Jul 1, 2017

• Additional relevant MeSH terms: Myopia

Study Results

Participant Flow

Arm/Group Title	Senofilcon A, Then Stenfilcon A	Stenfilcon A, Then Senofilcon A
Arm/Group Description	Participants were randomized to wear senofilcon A lens pair for one week during the crossover study. Senofilcon A: contact lens Stenfilcon A: contact lens	Participants were randomized to wear stenfilcon A lens pair for one week during the crossover study. Stenfilcon A: contact lens Senofilcon A: contact lens
Period Title: First Intervention (One Week)
STARTED	35	35
COMPLETED	35	35
NOT COMPLETED	0	0
Period Title: First Intervention (One Week)
STARTED	35	35
COMPLETED	35	35
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Overall Baseline Characteristics
Arm/Group Description	Participants were randomized to wear senofilcon A or stenfilcon A lens pair for one week during the crossover study. Senofilcon A: contact lens Stenfilcon A: contact lens
Overall Participants	70
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	30.6 (10.8)
Sex: Female, Male (Count of Participants)
Female	44 62.9%
Male	26 37.1%

Outcome Measures

1. Primary Outcome

Title	Ocular Physiology
Description	Ocular physiology assessment of senofilcon A and stenfilcon A lenses by biomicroscopy for the following: corneal staining, conjunctival hyperaemia, limbal hyperaemia, and conjunctival staining. Scale 0-4, 0.25 steps, 0=normal, 4=severe.
Time Frame	Baseline and 1 week

Outcome Measure Data

Analysis Population Description

Protocol deviations occurred for 2 participants and therefore resulted in incomplete data sets.

Arm/Group Title	Senofilcon A	Stenfilcon A
Arm/Group Description	Participants were randomized to wear senofilcon A lens pair for one week during the crossover study. Senofilcon A: contact lens	Participants were randomized to wear stenfilcon A lens pair for one week during the crossover study. Stenfilcon A: contact lens
Measure Participants	70	70
Baseline - Corneal staining	0.13 (0.30)	0.13 (0.30)
1 week - Corneal staining	0.21 (0.34)	0.15 (0.29)
Baseline - Conjunctival staining	0.21 (0.30)	0.21 (0.30)
1 week - Conjunctival staining	0.82 (0.51)	0.48 (0.43)
Baseline - Conjunctival hyperaemia	0.81 (0.23)	0.81 (0.23)
1 week - Conjunctival hyperaemia	0.82 (0.25)	0.86 (0.24)
Baseline - Limbal hyperaemia	0.70 (0.28)	0.70 (0.28)
1 week - Limbal hyperaemia	0.69 (0.26)	0.75 (0.26)

2. Primary Outcome

Title	Overall Subjective Score of Lenses
Description	Subjective responses will be evaluated for each pair using questionnaire. Scale 0-100, 0=extremely poor, 100=excellent.
Time Frame	Baseline and 1 week

Outcome Measure Data

Analysis Population Description

A protocol deviation occurred for 1 participant and therefore resulted in incomplete data sets.

Arm/Group Title	Senofilcon A	Stenfilcon A
Arm/Group Description	Participants were randomized to wear senofilcon A lens pair for one week during the crossover study. Senofilcon A: contact lens	Participants were randomized to wear stenfilcon A lens pair for one week during the crossover study. Stenfilcon A: contact lens
Measure Participants	70	70
Baseline	92.3 (8.8)	89.4 (11.1)
1 week	87.0 (13.1)	80.0 (18.3)

3. Primary Outcome

Title	Comfort
Description	Subjective responses for comfort will be evaluated for each pair using questionnaire. Scale 0-100, 0=causes pain, cannot be tolerated, 100=excellent, cannot be felt.
Time Frame	Baseline and 1 week

Outcome Measure Data

Analysis Population Description

A protocol deviation occurred for 1 participant and therefore resulted in incomplete data sets.

Arm/Group Title	Senofilcon A	Stenfilcon A
Arm/Group Description	Participants were randomized to wear senofilcon A lens pair for one week during the crossover study. Senofilcon A: contact lens	Participants were randomized to wear stenfilcon A lens pair for one week during the crossover study. Stenfilcon A: contact lens
Measure Participants	70	70
Baseline	90.8 (10.2)	90.5 (10.7)
1 week	87.0 (11.5)	82.1 (14.0)

4. Primary Outcome

Title	Dryness
Description	Subjective responses for dryness will be evaluated for each pair using questionnaire. Scale 0-100, 0=extremely poor, high levels of dryness, 100=excellent, no dryness.
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

A protocol deviation occurred for 1 participant and therefore resulted in incomplete data sets.

Arm/Group Title	Senofilcon A	Stenfilcon A
Arm/Group Description	Participants were randomized to wear senofilcon A lens pair for one week during the crossover study. Senofilcon A: contact lens	Participants were randomized to wear stenfilcon A lens pair for one week during the crossover study. Stenfilcon A: contact lens
Measure Participants	70	69
Mean (Standard Deviation) [units on a scale]	82.3 (14.3)	77.7 (17.8)

5. Primary Outcome

Title	Vision
Description	Subjective responses for vision will be evaluated for each pair using questionnaire. Scale 0-100, 0=unacceptable, lens cannot be worn, 100=excellent.
Time Frame	Baseline and 1 week

Outcome Measure Data

Analysis Population Description

A protocol deviation occurred for 1 participant and therefore resulted in incomplete data sets.

Arm/Group Title	Senofilcon A	Stenfilcon A
Arm/Group Description	Participants were randomized to wear senofilcon A lens pair for one week during the crossover study. Senofilcon A: contact lens	Participants were randomized to wear stenfilcon A lens pair for one week during the crossover study. Stenfilcon A: contact lens
Measure Participants	70	70
Baseline	94.7 (6.8)	91.9 (9.5)
1 week	93.4 (7.9)	88.4 (12.4)

6. Secondary Outcome

Title	Horizontal Centration
Description	Lens fit, horizontal centration will be assessed for senofilcon A and stenfilcon A at baseline for the following regions: extremely nasal, slightly nasal, optimum, slightly temporal, extremely nasal
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Senofilcon A	Stenfilcon A
Arm/Group Description	Participants were randomized to wear senofilcon A lens pair for one week during the crossover study. Senofilcon A: contact lens	Participants were randomized to wear stenfilcon A lens pair for one week during the crossover study. Stenfilcon A: contact lens
Measure Participants	70	70
Extremely nasal	0	0
Slightly nasal	3	6
Optimum	61	73
Slightly temporal	36	21
Extremely temporal	0	0

7. Secondary Outcome

Title	Horizontal Centration
Description	Lens fit, horizontal centration, will be assessed for senofilcon A and stenfilcon A at 1 week for the following regions: extremely nasal, slightly nasal, optimum, slightly temporal, extremely nasal
Time Frame	1 Week

Outcome Measure Data

Analysis Population Description

A protocol deviation occurred for 2 participants and therefore resulted in incomplete data sets.

Arm/Group Title	Senofilcon A	Stenfilcon A
Arm/Group Description	Participants were randomized to wear senofilcon A lens pair for one week during the crossover study. Senofilcon A: contact lens	Participants were randomized to wear stenfilcon A lens pair for one week during the crossover study. Stenfilcon A: contact lens
Measure Participants	69	69
Extremely nasal	0.0	0.0
Slightly nasal	1.4	7.0
Optimum	72.5	70.0
Slightly temporal	26.1	23.0
Extremely temporal	0.0	0.0

8. Secondary Outcome

Title	Vertical Centration
Description	Lens fit, vertical centration, will be assessed for senofilcon A and stenfilcon A at baseline for the following regions: extremely nasal, slightly nasal, optimum, slightly temporal, extremely nasal
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Senofilcon A	Stenfilcon A
Arm/Group Description	Participants were randomized to wear senofilcon A lens pair for one week during the crossover study. Senofilcon A: contact lens	Participants were randomized to wear stenfilcon A lens pair for one week during the crossover study. Stenfilcon A: contact lens
Measure Participants	70	70
Extremely nasal	0.0	0.0
Slightly nasal	17.0	15.7
Optimum	64.0	65.7
Slightly temporal	19.0	18.6
Extremely temporal	0.0	0.0

9. Secondary Outcome

Title	Vertical Centration
Description	Lens fit, vertical centration, will be assessed for senofilcon A and stenfilcon A at 1 week for the following regions: extremely nasal, slightly nasal, optimum, slightly temporal, extremely nasal
Time Frame	1 Week

Outcome Measure Data

Analysis Population Description

A protocol deviation occurred for 2 participants and therefore resulted in incomplete data sets.

Arm/Group Title	Senofilcon A	Stenfilcon A
Arm/Group Description	Participants were randomized to wear senofilcon A lens pair for one week during the crossover study. Senofilcon A: contact lens	Participants were randomized to wear stenfilcon A lens pair for one week during the crossover study. Stenfilcon A: contact lens
Measure Participants	69	69
Extremely nasal	0.0	0.0
Slightly nasal	20.3	23.0
Optimum	65.2	65.0
Slightly temporal	14.5	12.0
Extremely temporal	0.0	0.0

10. Secondary Outcome

Title	Lens Movement
Description	Lens movement assessed for stenfilcon A and senofilcon A at baseline using the following evaluations: extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Senofilcon A	Stenfilcon A
Arm/Group Description	Participants were randomized to wear senofilcon A lens pair for one week during the crossover study. Senofilcon A: contact lens	Participants were randomized to wear stenfilcon A lens pair for one week during the crossover study. Stenfilcon A: contact lens
Measure Participants	70	70
Extremely inadequate	0	0
Slightly inadequate	29	3
Optimum	67	64
Slightly excessive	4	33
Extremely excessive	0	0

11. Secondary Outcome

Title	Lens Movement
Description	Lens movement assessed for stenfilcon A and senofilcon A at 1 week using the following evaluations: extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive.
Time Frame	1 Week

Outcome Measure Data

Analysis Population Description

A protocol deviation occurred for 2 participants and therefore resulted in incomplete data sets.

Arm/Group Title	Senofilcon A	Stenfilcon A
Arm/Group Description	Participants were randomized to wear senofilcon A lens pair for one week during the crossover study. Senofilcon A: contact lens	Participants were randomized to wear stenfilcon A lens pair for one week during the crossover study. Stenfilcon A: contact lens
Measure Participants	69	69
Extremely inadequate	0	0
Slightly inadequate	42	7
Optimum	57	65
Slightly excessive	1	28
Extremely excessive	0	0

12. Secondary Outcome

Title	Visual Acuity
Description	Measurement of visual acuity (VA) for senofilcon A and stenfilcon A assessed at baseline and 1 week using logMAR VA chart.
Time Frame	Baseline and 1 week

Outcome Measure Data

Analysis Population Description

Protocol deviations occurred and therefore resulted in incomplete data sets.

Arm/Group Title	Senofilcon A	Stenfilcon A
Arm/Group Description	Participants were randomized to wear senofilcon A lens pair for one week during the crossover study. Senofilcon A: contact lens	Participants were randomized to wear stenfilcon A lens pair for one week during the crossover study. Stenfilcon A: contact lens
Measure Participants	70	70
Baseline: High Contrast	-0.14 (0.07)	-0.11 (0.08)
Baseline: Low Contrast	0.12 (0.10)	0.16 (0.10)
1 week: High Contrast	-0.13 (0.07)	-0.10 (0.09)
1 week: Low Contrast	0.13 (0.09)	0.17 (0.09)

13. Secondary Outcome

Title	Lens Surface - Deposition
Description	Lens surface for senofilcon A and stenfilcon A is assessed at baseline. Grades 0-4, 0=normal, 1=trace, 2=mild, 3=moderate, 4=severe
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Senofilcon A	Stenfilcon A
Arm/Group Description	Participants were randomized to wear senofilcon A lens pair for one week during the crossover study. Senofilcon A: contact lens	Participants were randomized to wear stenfilcon A lens pair for one week during the crossover study. Stenfilcon A: contact lens
Measure Participants	70	70
Normal	94	97
Trace	6	3
Mild	0	0
Moderate	0	0
Severe	0	0

14. Secondary Outcome

Title	Lens Surface - Deposition
Description	Lens surface for senofilcon A and stenfilcon A is assessed at 1 week. Grades 0-4, 0=normal, 1=trace, 2=mild, 3=moderate, 4=severe
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

A protocol deviation occurred for 2 participants and therefore resulted in incomplete data sets.

Arm/Group Title	Senofilcon A	Stenfilcon A
Arm/Group Description	Participants were randomized to wear senofilcon A lens pair for one week during the crossover study. Senofilcon A: contact lens	Participants were randomized to wear stenfilcon A lens pair for one week during the crossover study. Stenfilcon A: contact lens
Measure Participants	69	69
Normal	91.3	99.0
Trace	7.2	1.0
Mild	1.4	0.0
Moderate	0.0	0.0
Severe	0.0	0.0

15. Secondary Outcome

Title	Lens Surface - Debris
Description	Lens debris for senofilcon A and stenfilcon A is assessed at baseline. Grades 0-4, 0=normal, 1=trace, 2=mild, 3=moderate, 4=severe
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Senofilcon A	Stenfilcon A
Arm/Group Description	Participants were randomized to wear senofilcon A lens pair for one week during the crossover study. Senofilcon A: contact lens	Participants were randomized to wear stenfilcon A lens pair for one week during the crossover study. Stenfilcon A: contact lens
Measure Participants	70	70
Normal	82.9	93.0
Trace	14.3	7.0
Mild	1.4	0.0
Moderate	1.4	0.0
Severe	0.0	0.0

16. Secondary Outcome

Title	Lens Surface - Debris
Description	Lens debris for senofilcon A and stenfilcon A is assessed at 1 week. Grades 0-4, 0=normal, 1=trace, 2=mild, 3=moderate, 4=severe
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

A protocol deviation occurred for 2 participants and therefore resulted in incomplete data sets.

Arm/Group Title	Senofilcon A	Stenfilcon A
Arm/Group Description	Participants were randomized to wear senofilcon A lens pair for one week during the crossover study. Senofilcon A: contact lens	Participants were randomized to wear stenfilcon A lens pair for one week during the crossover study. Stenfilcon A: contact lens
Measure Participants	69	69
Normal	84.1	96.0
Trace	14.5	4.0
Mild	1.4	0.0
Moderate	0.0	0.0
Severe	0.0	0.0

17. Secondary Outcome

Title	Lens Surface - Wettability
Description	Lens wettability for senofilcon A and stenfilcon A is assessed at baseline. Grades 0-4, 0=normal, 1=trace, 2=mild, 3=moderate, 4=severe
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Senofilcon A	Stenfilcon A
Arm/Group Description	Participants were randomized to wear senofilcon A lens pair for one week during the crossover study. Senofilcon A: contact lens	Participants were randomized to wear stenfilcon A lens pair for one week during the crossover study. Stenfilcon A: contact lens
Measure Participants	70	70
Normal	79	86
Trace	20	11
Mild	1	3
Moderate	0	0
Severe	0	0

18. Secondary Outcome

Title	Lens Surface - Wettability
Description	Lens wettability for senofilcon A and stenfilcon A is assessed at 1 week. Grades 0-4, 0=normal, 1=trace, 2=mild, 3=moderate, 4=severe
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

A protocol deviation occurred for 2 participants and therefore resulted in incomplete data sets.

Arm/Group Title	Senofilcon A	Stenfilcon A
Arm/Group Description	Participants were randomized to wear senofilcon A lens pair for one week during the crossover study. Senofilcon A: contact lens	Participants were randomized to wear stenfilcon A lens pair for one week during the crossover study. Stenfilcon A: contact lens
Measure Participants	69	69
Normal	81.2	71.0
Trace	15.9	25.0
Mild	1.4	4.0
Moderate	1.4	0.0
Severe	0.0	0.0

Adverse Events

Arm/Group Title	Senofilcon A		Stenfilcon A
Arm/Group Description	Participants were randomized to wear senofilcon A lens pair for one week during the crossover study. Senofilcon A: contact lens		Participants were randomized to wear stenfilcon A lens pair for one week during the crossover study. Stenfilcon A: contact lens
All Cause Mortality
	Senofilcon A		Stenfilcon A
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Senofilcon A		Stenfilcon A
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/70 (0%)		0/70 (0%)
Other (Not Including Serious) Adverse Events
	Senofilcon A		Stenfilcon A
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/70 (0%)		0/70 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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