Daily Disposable Dispensing Clinical Trial of Test Lens Against Stenfilcon A Lens

• Sponsor: Coopervision, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03024970
• Collaborator: (none)
• Enrollment: 72
• Locations: 2
• Arms: 2
• Duration (Months): 5.8
• Patients Per Site: 36
• Patients Per Site Per Month: 6.2

Study Details

Study Description

Brief Summary

The purpose of this study is to investigate the overall clinical performance of the test daily disposable stenfilcon A lens with solution additive (test) compared to the stenfilcon A lens (control).

Condition or Disease	Intervention/Treatment	Phase
Myopia	Device: stenfilcon A lens with solution additive (test); Device: stenfilcon A lens (control)	N/A

Detailed Description

This will be, prospective, multicenter, double-masked, randomized, bilateral, 1 month cross-over, dispensing study comparing the test lens against the stenfilcon A control lens with a study duration of approximately two months.

Each subject will be randomized to wear either the test or control as a matched pair first and subjects will be randomized based on the order in which the subject is enrolled and qualified into the study.

Study Design

• Study Type: Interventional
• Actual Enrollment: 72 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Daily Disposable Dispensing Clinical Trial of Test Lens Against Stenfilcon A Lens
• Study Start Date: Jan 1, 2017
• Actual Primary Completion Date: Apr 25, 2017
• Actual Study Completion Date: Jun 26, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: stenfilcon A lens with solution additive (test) Participants were randomized to wear the stenfilcon A lens with solution additive (test) for 1 month during the cross over study.	Device: stenfilcon A lens with solution additive (test); silicone hydrogel lens; Device: stenfilcon A lens (control); contact lens
Active Comparator: stenfilcon A lens (control) Participants were randomized to wear stenfilcon A (control) lens pair for 1 month during the cross over study.	Device: stenfilcon A lens with solution additive (test); silicone hydrogel lens; Device: stenfilcon A lens (control); contact lens

Outcome Measures

Primary Outcome Measures

1. Subjective Ratings on Comfort [Baseline]

   Subjects assessed comfort for test and control lens on a scale 0-10, 0=not comfortable 10=comfortable

2. Subjective Ratings on Comfort [1 Week]

   Subjects assessed comfort for test and control lens on a scale 0-10, 0=not comfortable 10=comfortable

3. Subjective Ratings on Comfort [1 Month]

   Subjects assessed comfort for test and control lens on a scale 0-10, 0=not comfortable 10=comfortable

4. Vision Satisfaction [Baseline]

   Subjective ratings on vision satisfaction was assessed for test and control lens using a 5- point Likert scale: 1- Strongly disagree, 2- disagree, 3- neutral, 4- agree, 5- strongly agree

5. Vision Satisfaction [1 week]

   Subjective ratings on vision satisfaction was assessed for test and control lens using a 5- point Likert scale: 1- Strongly disagree, 2- disagree, 3- neutral, 4- agree, 5- strongly agree

6. Vision Satisfaction [1 Month]

   Subjective ratings on vision satisfaction was assessed for test and control lens using a 5- point Likert scale: 1- Strongly disagree, 2- disagree, 3- neutral, 4- agree, 5- strongly agree

7. Visual Acuity On High Illumination High Contrast [Baseline]

   Visual acuity is assessed on high illumination high contrast logMAR charts for test and control lenses. Visual acuity of logMar of 0.0 is equivalent to 20/20 of Snellen. Each 0.1 addition in logMar is 1 line in Snellen chart.

8. Visual Acuity On High Illumination High Contrast [1 Week]

   Visual acuity is assessed on high illumination high contrast for test and control lens by LogMAR. Visual acuity of logMar of 0.0 is equivalent to 20/20 of Snellen. Each 0.1 addition in logMar is 1 line in Snellen chart.

9. Visual Acuity On High Illumination High Contrast [1 Month]

   Visual acuity is assessed on high illumination high contrast for test and control lens by LogMAR. Visual acuity of logMar of 0.0 is equivalent to 20/20 of Snellen. Each 0.1 addition in logMar is 1 line in Snellen chart.

10. Visual Acuity On Low Illumination High Contrast [Baseline]

    Visual acuity is assessed on low illumination high contrast for test and control lens by LogMAR. Visual acuity of logMar of 0.0 is equivalent to 20/20 of Snellen. Each 0.1 addition in logMar is 1 line in Snellen chart.

11. Visual Acuity On Low Illumination High Contrast [1 Week]

    Visual acuity is assessed on low illumination high contrast for test and control lens by LogMAR. Visual acuity of logMar of 0.0 is equivalent to 20/20 of Snellen. Each 0.1 addition in logMar is 1 line in Snellen chart.

12. Visual Acuity On Low Illumination High Contrast [1 Month]

    Visual acuity is assessed on low illumination high contrast for test and control lens by LogMAR. Visual acuity of logMar of 0.0 is equivalent to 20/20 of Snellen. Each 0.1 addition in logMar is 1 line in Snellen chart.

13. Overall Corneal Staining [One Week]

    Overall corneal staining is assessed for test and control lens in a scale of 0-4, 0=No staining,1=trace, 2=mild, 3=moderate, 4=Severe.

14. Overall Corneal Staining [One Month]

    Overall corneal staining is assessed for test and control lens in a scale of 0-4, 0=No staining,1=trace, 2=mild, 3=moderate, 4=Severe.

15. Conjunctival Staining [1 Week]

    Conjunctival staining is assessed for test and control lens in 0.50 steps. Scale 0-4, 0=None, 4= Deep confluent

16. Conjunctival Staining [1 Month]

    Conjunctival staining is assessed for test and control lens in 0.50 steps. Scale 0-4, 0=None, 4= Deep confluent

17. Bulbar Hyperemia [1 Week]

    Bulbar hyperemia is assessed for test and control lens on a scale of 0-4,0.25 steps. (0=None, 1=Slight injection of conjunctival vessels, 2=Mild injection, 3=Moderate injection, 4=Severe injection)

18. Bulbar Hyperemia [1 Month]

    Bulbar hyperemia is assessed for test and control lens on a scale of 0-4,0.25 steps. (0=None, 1=Slight injection of conjunctival vessels, 2=Mild injection, 3=Moderate injection, 4=Severe injection)

19. Limbal Hyperemia [1 Week]

    Limbal hyperemia is assessed for test and control lens on a scale of 0-4,0.25 steps. (0=None, 1=Slight injection of conjunctival vessels, 2=Mild injection, 3=Moderate injection, 4=Severe injection)

20. Limbal Hyperemia [1 Month]

    Limbal hyperemia is assessed for test and control lens on a scale of 0-4,0.25 steps. (0=None, 1=Slight injection of conjunctival vessels, 2=Mild injection, 3=Moderate injection, 4=Severe injection)

21. Palpebral Hyperemia [1 Week]

    Palpebral hyperemia is assessed for test and control lens on a scale of 0-4,0.25 steps. (0=None, 1=Slight injection of conjunctival vessels, 2=Mild injection, 3=Moderate injection, 4=Severe injection)

22. Palpebral Hyperemia [1 Month]

    Palpebral hyperemia is assessed for test and control lens on a scale of 0-4,0.25 steps. (0=None, 1=Slight injection of conjunctival vessels, 2=Mild injection, 3=Moderate injection, 4=Severe injection)

Secondary Outcome Measures

1. Lens Fit Acceptance [Baseline]

   Overall fit acceptance is assessed for test and control lens. Scale 0-4, 0=can't be worn, 1=Poor, 2=Fair, 3=Good, 4=optimum.

2. Lens Fit Acceptance [1 week]

   Overall fit acceptance is assessed for test and control lens. Scale 0-4, 0=can't be worn, 1=Poor, 2=Fair, 3=Good, 4=optimum.

3. Lens Fit Acceptance [1 Month]

   Overall fit acceptance is assessed for test and control lens. Scale 0-4, 0=can't be worn, 1=Poor, 2=Fair, 3=Good, 4=optimum.

4. Handling Satisfaction [1 week]

   Handling satisfaction is assessed for test and control lens. 5 point Likert scale: 1- Strongly disagree, 2-disagree, 3-neutral, 4-agree, 5- strongly agree

5. Handling Satisfaction [1 Month]

   Handling satisfaction is assessed for test and control lens. 5 point Likert scale: 1- Strongly disagree, 2-disagree, 3-neutral, 4-agree, 5- strongly agree

6. Lens Surface - Wettability [Baseline]

   Wettability is assessed for test and control lens on a scale of 0-4, 0=Very poor, 4=Excellent

7. Lens Surface - Wettability [1 Week]

   Wettability is assessed for test and control lens on a scale of 0-4, 0=Very poor, 4=Excellent

8. Lens Surface - Wettability [1 Month]

   Wettability is assessed for test and control lens on a scale of 0-4, 0=Very poor, 4=Excellent

9. Lens Surface - Deposits [Baseline]

   Deposits are assessed for test and control lens. Scale 0-4, 0.25 steps. 0=Clean, no deposits, 4=Deposits of 0.5mm or larger or film covering more than 75% of surface.

10. Lens Surface - Deposits [1 week]

    Deposits are assessed for test and control lens. Scale 0-4, 0.25 steps. 0=Clean, no deposits, 4=Deposits of 0.5mm or larger or film covering more than 75% of surface.

11. Lens Surface - Deposits [1 Month]

    Deposits are assessed for test and control lens. Scale 0-4, 0.25 steps. 0=Clean, no deposits, 4=Deposits of 0.5mm or larger or film covering more than 75% of surface.

12. Subjective Ratings on Dryness [Baseline]

    Subjective ratings on dryness is assessed for test and control lens on a scale of 0-10, 0=dry, 10=not dry

13. Subjective Ratings on Dryness [1 week]

    Subjective ratings on dryness is assessed for test and control lens on a scale of 0-10, 0=dry, 10=not dry

14. Subjective Ratings on Dryness [1 Month]

    Subjective ratings on dryness is assessed for test and control lens on a scale of 0-10, 0=dry, 10=not dry

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• A person is eligible for inclusion in the study if he/she:

• Has had a self-reported oculo-visual examination in the last two years.

• Is at least 18 years of age and has full legal capacity to volunteer.

• Has read and understood the information consent letter.

• Is willing and able to follow instructions and maintain the appointment schedule.

• Is correctable to a visual acuity of 20/40 or better (in each eye) with their habitual vision correction or 20/20 best-corrected.

• Must achieve 20/30 or better (in each eye) with study lenses

• Requires spectacle lens powers between -0.75 and -6.50 diopters sphere (0.25D steps).

• Has no more than 0.75 diopters of refractive astigmatism.

• Currently wears soft contact lenses.

• Have clear corneas and no active ocular disease.

• Has not worn lenses for at least 12 hours before the examination

Exclusion Criteria:

• A person will be excluded from the study if he/she:

• Has never worn contact lenses before.

• Has any systemic disease affecting ocular health.

• Is using any systemic or topical medications that will affect ocular health.

• Has any ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of contact lenses.

• Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye.

• Has any clinically significant lid or conjunctival abnormalities, active neovascularization or any central corneal scars.

• Is aphakic.

• Has undergone corneal refractive surgery.

• Is pregnant, lactating, or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit).

• Have taken part in any other contact lens or care solution clinical trial or research, within one week prior to starting this study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinical Optical Research Lab (CORL)	Bloomington	Indiana	United States	47405
2	The Ocular Surface Institute (TOSI)	Houston	Texas	United States	77204

Sponsors and Collaborators

• Coopervision, Inc.

Investigators

• Principal Investigator: Pete Kollbaum, OD, PhD, Clinical Optics Research Lab (CORL) Indiana University School of Optometry.
• Principal Investigator: Eric Ritchey, OD, PhD, FAAO, University of Houston

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Aug 31, 2016

More Information

Publications

None provided.

• Responsible Party: Coopervision, Inc.
• ClinicalTrials.gov Identifier: NCT03024970
• Other Study ID Numbers: CV-16-60
• First Posted: Jan 19, 2017
• Last Update Posted: Jul 21, 2020
• Last Verified: Jul 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Additional relevant MeSH terms: Myopia

Study Results

Participant Flow

Arm/Group Title	Test Lens Then Control Lens	Control Lens Then Test Lens
Arm/Group Description	Participants were randomized to wear the stenfilcon A lens with solution additive (test) for 1 month during the cross over study. stenfilcon A lens with solution additive (test): contact lens stenfilcon A lens (Control): contact lens	Participants were randomized to wear stenfilcon A (control) lens pair for 1 month during the cross over study. stenfilcon A lens (control): contact lens stenfilcon A lens with solution additive (test): contact lens
Period Title: First Intervention
STARTED	34	38
COMPLETED	33	38
NOT COMPLETED	1	0
Period Title: First Intervention
STARTED	33	38
COMPLETED	32	38
NOT COMPLETED	1	0

Baseline Characteristics

Arm/Group Title	Overall Study
Arm/Group Description	Total Participants
Overall Participants	72
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	72 100%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	28 (7)
Sex: Female, Male (Count of Participants)
Female	59 81.9%
Male	13 18.1%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (participants) [Number]
United States	72 100%

Outcome Measures

1. Primary Outcome

Title	Subjective Ratings on Comfort
Description	Subjects assessed comfort for test and control lens on a scale 0-10, 0=not comfortable 10=comfortable
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stenfilcon A Lens With Solution Additive (Test)	Stenfilcon A Lens (Control)
Arm/Group Description	Participants were randomized to wear the stenfilcon A lens with solution additive (test) for 1 month during the cross over study. stenfilcon A lens with solution additive (test): silicone hydrogel lens	Participants were randomized to wear stenfilcon A (control) lens pair for 1 month during the cross over study. stenfilcon A lens (control): contact lens
Measure Participants	70	70
Mean (Standard Deviation) [units on a scale]	9.7 (0.6)	9.6 (0.7)

2. Primary Outcome

Title	Subjective Ratings on Comfort
Description	Subjects assessed comfort for test and control lens on a scale 0-10, 0=not comfortable 10=comfortable
Time Frame	1 Week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stenfilcon A Lens With Solution Additive (Test)	Stenfilcon A Lens (Control)
Arm/Group Description	Participants were randomized to wear the stenfilcon A lens with solution additive (test) for 1 month during the cross over study. stenfilcon A lens with solution additive (test): silicone hydrogel lens	Participants were randomized to wear stenfilcon A (control) lens pair for 1 month during the cross over study. stenfilcon A lens (control): contact lens
Measure Participants	70	70
Mean (Standard Deviation) [units on a scale]	9.1 (1.5)	9.0 (1.5)

3. Primary Outcome

Title	Subjective Ratings on Comfort
Description	Subjects assessed comfort for test and control lens on a scale 0-10, 0=not comfortable 10=comfortable
Time Frame	1 Month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stenfilcon A Lens With Solution Additive (Test)	Stenfilcon A Lens (Control)
Arm/Group Description	Participants were randomized to wear the stenfilcon A lens with solution additive (test) for 1 month during the cross over study. stenfilcon A lens with solution additive (test): silicone hydrogel lens	Participants were randomized to wear stenfilcon A (control) lens pair for 1 month during the cross over study. stenfilcon A lens (control): contact lens
Measure Participants	70	70
Mean (Standard Deviation) [units on a scale]	8.9 (1.7)	8.6 (1.9)

4. Primary Outcome

Title	Vision Satisfaction
Description	Subjective ratings on vision satisfaction was assessed for test and control lens using a 5- point Likert scale: 1- Strongly disagree, 2- disagree, 3- neutral, 4- agree, 5- strongly agree
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stenfilcon A Lens With Solution Additive (Test)	Stenfilcon A Lens (Control)
Arm/Group Description	Participants were randomized to wear the stenfilcon A lens with solution additive (test) for 1 month during the cross over study. stenfilcon A lens with solution additive (test): silicone hydrogel lens	Participants were randomized to wear stenfilcon A (control) lens pair for 1 month during the cross over study. stenfilcon A lens (control): contact lens
Measure Participants	70	70
Strongly disagree	0 0%	0 NaN
Disagree	0 0%	0 NaN
Neutral	6 8.3%	1 NaN
Agree	39 54.2%	39 NaN
Strongly agree	55 76.4%	60 NaN

5. Primary Outcome

Title	Vision Satisfaction
Description	Subjective ratings on vision satisfaction was assessed for test and control lens using a 5- point Likert scale: 1- Strongly disagree, 2- disagree, 3- neutral, 4- agree, 5- strongly agree
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stenfilcon A Lens With Solution Additive (Test)	Stenfilcon A Lens (Control)
Arm/Group Description	Participants were randomized to wear the stenfilcon A lens with solution additive (test) for 1 month during the cross over study. stenfilcon A lens with solution additive (test): silicone hydrogel lens	Participants were randomized to wear stenfilcon A (control) lens pair for 1 month during the cross over study. stenfilcon A lens (control): contact lens
Measure Participants	70	70
Strongly disagree	0 0%	1 NaN
Disagree	3 4.2%	1 NaN
Neutral	3 4.2%	4 NaN
Agree	29 40.3%	26 NaN
Strongly agree	65 90.3%	68 NaN

6. Primary Outcome

Title	Vision Satisfaction
Description	Subjective ratings on vision satisfaction was assessed for test and control lens using a 5- point Likert scale: 1- Strongly disagree, 2- disagree, 3- neutral, 4- agree, 5- strongly agree
Time Frame	1 Month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stenfilcon A Lens With Solution Additive (Test)	Stenfilcon A Lens (Control)
Arm/Group Description	Participants were randomized to wear the stenfilcon A lens with solution additive (test) for 1 month during the cross over study. stenfilcon A lens with solution additive (test): silicone hydrogel lens	Participants were randomized to wear stenfilcon A (control) lens pair for 1 month during the cross over study. stenfilcon A lens (control): contact lens
Measure Participants	70	70
Strongly disagree	3 4.2%	1 NaN
Disagree	1 1.4%	3 NaN
Neutral	4 5.6%	9 NaN
Agree	34 47.2%	26 NaN
Strongly agree	58 80.6%	61 NaN

7. Primary Outcome

Title	Visual Acuity On High Illumination High Contrast
Description	Visual acuity is assessed on high illumination high contrast logMAR charts for test and control lenses. Visual acuity of logMar of 0.0 is equivalent to 20/20 of Snellen. Each 0.1 addition in logMar is 1 line in Snellen chart.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stenfilcon A Lens With Solution Additive (Test)	Stenfilcon A Lens (Control)
Arm/Group Description	Participants were randomized to wear the stenfilcon A lens with solution additive (test) for 1 month during the cross over study. stenfilcon A lens with solution additive (test): silicone hydrogel lens	Participants were randomized to wear stenfilcon A (control) lens pair for 1 month during the cross over study. stenfilcon A lens (control): contact lens
Measure Participants	70	70
Mean (Standard Deviation) [LogMAR]	-0.20 (0.06)	-0.21 (0.06)

8. Primary Outcome

Title	Visual Acuity On High Illumination High Contrast
Description	Visual acuity is assessed on high illumination high contrast for test and control lens by LogMAR. Visual acuity of logMar of 0.0 is equivalent to 20/20 of Snellen. Each 0.1 addition in logMar is 1 line in Snellen chart.
Time Frame	1 Week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stenfilcon A Lens With Solution Additive (Test)	Stenfilcon A Lens (Control)
Arm/Group Description	Participants were randomized to wear the stenfilcon A lens with solution additive (test) for 1 month during the cross over study. stenfilcon A lens with solution additive (test): silicone hydrogel lens	Participants were randomized to wear stenfilcon A (control) lens pair for 1 month during the cross over study. stenfilcon A lens (control): contact lens
Measure Participants	70	70
Mean (Standard Deviation) [LogMAR]	-0.21 (0.06)	-0.20 (0.06)

9. Primary Outcome

Title	Visual Acuity On High Illumination High Contrast
Description	Visual acuity is assessed on high illumination high contrast for test and control lens by LogMAR. Visual acuity of logMar of 0.0 is equivalent to 20/20 of Snellen. Each 0.1 addition in logMar is 1 line in Snellen chart.
Time Frame	1 Month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stenfilcon A Lens With Solution Additive (Test)	Stenfilcon A Lens (Control)
Arm/Group Description	Participants were randomized to wear the stenfilcon A lens with solution additive (test) for 1 month during the cross over study. stenfilcon A lens with solution additive (test): silicone hydrogel lens	Participants were randomized to wear stenfilcon A (control) lens pair for 1 month during the cross over study. stenfilcon A lens (control): contact lens
Measure Participants	70	70
Mean (Standard Deviation) [LogMAR]	-0.21 (0.07)	-0.20 (0.05)

10. Primary Outcome

Title	Visual Acuity On Low Illumination High Contrast
Description	Visual acuity is assessed on low illumination high contrast for test and control lens by LogMAR. Visual acuity of logMar of 0.0 is equivalent to 20/20 of Snellen. Each 0.1 addition in logMar is 1 line in Snellen chart.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stenfilcon A Lens With Solution Additive (Test)	Stenfilcon A Lens (Control)
Arm/Group Description	Participants were randomized to wear the stenfilcon A lens with solution additive (test) for 1 month during the cross over study. stenfilcon A lens with solution additive (test): silicone hydrogel lens	Participants were randomized to wear stenfilcon A (control) lens pair for 1 month during the cross over study. stenfilcon A lens (control): contact lens
Measure Participants	70	70
Mean (Standard Deviation) [LogMAR]	-0.08 (0.09)	-0.09 (0.09)

11. Primary Outcome

Title	Visual Acuity On Low Illumination High Contrast
Description	Visual acuity is assessed on low illumination high contrast for test and control lens by LogMAR. Visual acuity of logMar of 0.0 is equivalent to 20/20 of Snellen. Each 0.1 addition in logMar is 1 line in Snellen chart.
Time Frame	1 Week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stenfilcon A Lens With Solution Additive (Test)	Stenfilcon A Lens (Control)
Arm/Group Description	Participants were randomized to wear the stenfilcon A lens with solution additive (test) for 1 month during the cross over study. stenfilcon A lens with solution additive (test): silicone hydrogel lens	Participants were randomized to wear stenfilcon A (control) lens pair for 1 month during the cross over study. stenfilcon A lens (control): contact lens
Measure Participants	70	70
Mean (Standard Deviation) [LogMAR]	-0.09 (0.10)	-0.09 (0.09)

12. Primary Outcome

Title	Visual Acuity On Low Illumination High Contrast
Description	Visual acuity is assessed on low illumination high contrast for test and control lens by LogMAR. Visual acuity of logMar of 0.0 is equivalent to 20/20 of Snellen. Each 0.1 addition in logMar is 1 line in Snellen chart.
Time Frame	1 Month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stenfilcon A Lens With Solution Additive (Test)	Stenfilcon A Lens (Control)
Arm/Group Description	Participants were randomized to wear the stenfilcon A lens with solution additive (test) for 1 month during the cross over study. stenfilcon A lens with solution additive (test): silicone hydrogel lens	Participants were randomized to wear stenfilcon A (control) lens pair for 1 month during the cross over study. stenfilcon A lens (control): contact lens
Measure Participants	70	70
Mean (Standard Deviation) [LogMAR]	-0.09 (0.10)	-0.09 (0.09)

13. Primary Outcome

Title	Overall Corneal Staining
Description	Overall corneal staining is assessed for test and control lens in a scale of 0-4, 0=No staining,1=trace, 2=mild, 3=moderate, 4=Severe.
Time Frame	One Week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stenfilcon A Lens With Solution Additive (Test)	Stenfilcon A Lens (Control)
Arm/Group Description	Participants were randomized to wear the stenfilcon A lens with solution additive (test) for 1 month during the cross over study. stenfilcon A lens with solution additive (test): silicone hydrogel lens	Participants were randomized to wear stenfilcon A (control) lens pair for 1 month during the cross over study. stenfilcon A lens (control): contact lens
Measure Participants	70	70
Measure Eyes	140	140
Grade 0	55 76.4%	57 NaN
Garde 1	31 43.1%	27 NaN
Grade 2	14 19.4%	14 NaN
Grade 3	0 0%	2 NaN
Grade 4	0 0%	0 NaN

14. Primary Outcome

Title	Overall Corneal Staining
Description	Overall corneal staining is assessed for test and control lens in a scale of 0-4, 0=No staining,1=trace, 2=mild, 3=moderate, 4=Severe.
Time Frame	One Month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stenfilcon A Lens With Solution Additive (Test)	Stenfilcon A Lens (Control)
Arm/Group Description	Participants were randomized to wear the stenfilcon A lens with solution additive (test) for 1 month during the cross over study. stenfilcon A lens with solution additive (test): silicone hydrogel lens	Participants were randomized to wear stenfilcon A (control) lens pair for 1 month during the cross over study. stenfilcon A lens (control): contact lens
Measure Participants	70	70
Measure Eyes	140	140
Grade 0	54 75%	58 NaN
Garde 1	33 45.8%	30 NaN
Grade 2	13 18.1%	11 NaN
Grade 3	0 0%	1 NaN
Grade 4	0 0%	0 NaN

15. Primary Outcome

Title	Conjunctival Staining
Description	Conjunctival staining is assessed for test and control lens in 0.50 steps. Scale 0-4, 0=None, 4= Deep confluent
Time Frame	1 Week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stenfilcon A Lens With Solution Additive (Test)	Stenfilcon A Lens (Control)
Arm/Group Description	Participants were randomized to wear the stenfilcon A lens with solution additive (test) for 1 month during the cross over study. stenfilcon A lens with solution additive (test): silicone hydrogel lens	Participants were randomized to wear stenfilcon A (control) lens pair for 1 month during the cross over study. stenfilcon A lens (control): contact lens
Measure Participants	70	70
Measure Eyes	140	140
Mean (Standard Deviation) [units on a scale]	0.36 (0.45)	0.39 (0.43)

16. Primary Outcome

Title	Conjunctival Staining
Description	Conjunctival staining is assessed for test and control lens in 0.50 steps. Scale 0-4, 0=None, 4= Deep confluent
Time Frame	1 Month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stenfilcon A Lens With Solution Additive (Test)	Stenfilcon A Lens (Control)
Arm/Group Description	Participants were randomized to wear the stenfilcon A lens with solution additive (test) for 1 month during the cross over study. stenfilcon A lens with solution additive (test): silicone hydrogel lens	Participants were randomized to wear stenfilcon A (control) lens pair for 1 month during the cross over study. stenfilcon A lens (control): contact lens
Measure Participants	70	70
Measure Eyes	140	140
Mean (Standard Deviation) [units on a scale]	0.42 (0.37)	0.45 (0.43)

17. Primary Outcome

Title	Bulbar Hyperemia
Description	Bulbar hyperemia is assessed for test and control lens on a scale of 0-4,0.25 steps. (0=None, 1=Slight injection of conjunctival vessels, 2=Mild injection, 3=Moderate injection, 4=Severe injection)
Time Frame	1 Week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stenfilcon A Lens With Solution Additive (Test)	Stenfilcon A Lens (Control)
Arm/Group Description	Participants were randomized to wear the stenfilcon A lens with solution additive (test) for 1 month during the cross over study. stenfilcon A lens with solution additive (test): silicone hydrogel lens	Participants were randomized to wear stenfilcon A (control) lens pair for 1 month during the cross over study. stenfilcon A lens (control): contact lens
Measure Participants	70	70
Measure Eyes	140	140
Mean (Standard Deviation) [units on a scale]	1.32 (0.85)	1.28 (0.78)

18. Primary Outcome

Title	Bulbar Hyperemia
Description	Bulbar hyperemia is assessed for test and control lens on a scale of 0-4,0.25 steps. (0=None, 1=Slight injection of conjunctival vessels, 2=Mild injection, 3=Moderate injection, 4=Severe injection)
Time Frame	1 Month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stenfilcon A Lens With Solution Additive (Test)	Stenfilcon A Lens (Control)
Arm/Group Description	Participants were randomized to wear the stenfilcon A lens with solution additive (test) for 1 month during the cross over study. stenfilcon A lens with solution additive (test): silicone hydrogel lens	Participants were randomized to wear stenfilcon A (control) lens pair for 1 month during the cross over study. stenfilcon A lens (control): contact lens
Measure Participants	70	70
Measure Eyes	140	140
Mean (Standard Deviation) [units on a scale]	1.36 (0.81)	1.33 (0.82)

19. Primary Outcome

Title	Limbal Hyperemia
Description	Limbal hyperemia is assessed for test and control lens on a scale of 0-4,0.25 steps. (0=None, 1=Slight injection of conjunctival vessels, 2=Mild injection, 3=Moderate injection, 4=Severe injection)
Time Frame	1 Week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stenfilcon A Lens With Solution Additive (Test)	Stenfilcon A Lens (Control)
Arm/Group Description	Participants were randomized to wear the stenfilcon A lens with solution additive (test) for 1 month during the cross over study. stenfilcon A lens with solution additive (test): silicone hydrogel lens	Participants were randomized to wear stenfilcon A (control) lens pair for 1 month during the cross over study. stenfilcon A lens (control): contact lens
Measure Participants	70	70
Measure Eyes	140	140
Mean (Standard Deviation) [units on a scale]	0.85 (0.64)	0.89 (0.68)

20. Primary Outcome

Title	Limbal Hyperemia
Description	Limbal hyperemia is assessed for test and control lens on a scale of 0-4,0.25 steps. (0=None, 1=Slight injection of conjunctival vessels, 2=Mild injection, 3=Moderate injection, 4=Severe injection)
Time Frame	1 Month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stenfilcon A Lens With Solution Additive (Test)	Stenfilcon A Lens (Control)
Arm/Group Description	Participants were randomized to wear the stenfilcon A lens with solution additive (test) for 1 month during the cross over study. stenfilcon A lens with solution additive (test): silicone hydrogel lens	Participants were randomized to wear stenfilcon A (control) lens pair for 1 month during the cross over study. stenfilcon A lens (control): contact lens
Measure Participants	70	70
Measure Eyes	140	140
Mean (Standard Deviation) [units on a scale]	0.90 (0.66)	0.78 (0.67)

21. Primary Outcome

Title	Palpebral Hyperemia
Description	Palpebral hyperemia is assessed for test and control lens on a scale of 0-4,0.25 steps. (0=None, 1=Slight injection of conjunctival vessels, 2=Mild injection, 3=Moderate injection, 4=Severe injection)
Time Frame	1 Week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stenfilcon A Lens With Solution Additive (Test)	Stenfilcon A Lens (Control)
Arm/Group Description	Participants were randomized to wear the stenfilcon A lens with solution additive (test) for 1 month during the cross over study. stenfilcon A lens with solution additive (test): silicone hydrogel lens	Participants were randomized to wear stenfilcon A (control) lens pair for 1 month during the cross over study. stenfilcon A lens (control): contact lens
Measure Participants	70	70
Measure Eyes	140	140
Mean (Standard Deviation) [units on a scale]	0.89 (0.65)	0.88 (0.63)

22. Primary Outcome

Title	Palpebral Hyperemia
Description	Palpebral hyperemia is assessed for test and control lens on a scale of 0-4,0.25 steps. (0=None, 1=Slight injection of conjunctival vessels, 2=Mild injection, 3=Moderate injection, 4=Severe injection)
Time Frame	1 Month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stenfilcon A Lens With Solution Additive (Test)	Stenfilcon A Lens (Control)
Arm/Group Description	Participants were randomized to wear the stenfilcon A lens with solution additive (test) for 1 month during the cross over study. stenfilcon A lens with solution additive (test): silicone hydrogel lens	Participants were randomized to wear stenfilcon A (control) lens pair for 1 month during the cross over study. stenfilcon A lens (control): contact lens
Measure Participants	70	70
Measure Eyes	140	140
Mean (Standard Deviation) [units on a scale]	1.02 (0.63)	0.93 (0.55)

23. Secondary Outcome

Title	Lens Fit Acceptance
Description	Overall fit acceptance is assessed for test and control lens. Scale 0-4, 0=can't be worn, 1=Poor, 2=Fair, 3=Good, 4=optimum.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stenfilcon A Lens With Solution Additive (Test)	Stenfilcon A Lens (Control)
Arm/Group Description	Participants were randomized to wear the stenfilcon A lens with solution additive (test) for 1 month during the cross over study. stenfilcon A lens with solution additive (test): silicone hydrogel lens	Participants were randomized to wear stenfilcon A (control) lens pair for 1 month during the cross over study. stenfilcon A lens (control): contact lens
Measure Participants	70	70
Measure Eyes	140	140
Mean (Standard Deviation) [units on a scale]	3.4 (0.3)	3.3 (0.3)

24. Secondary Outcome

Title	Lens Fit Acceptance
Description	Overall fit acceptance is assessed for test and control lens. Scale 0-4, 0=can't be worn, 1=Poor, 2=Fair, 3=Good, 4=optimum.
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stenfilcon A Lens With Solution Additive (Test)	Stenfilcon A Lens (Control)
Arm/Group Description	Participants were randomized to wear the stenfilcon A lens with solution additive (test) for 1 month during the cross over study. stenfilcon A lens with solution additive (test): silicone hydrogel lens	Participants were randomized to wear stenfilcon A (control) lens pair for 1 month during the cross over study. stenfilcon A lens (control): contact lens
Measure Participants	70	70
Measure Eyes	140	140
Mean (Standard Deviation) [units on a scale]	3.3 (0.3)	3.3 (0.3)

25. Secondary Outcome

Title	Lens Fit Acceptance
Description	Overall fit acceptance is assessed for test and control lens. Scale 0-4, 0=can't be worn, 1=Poor, 2=Fair, 3=Good, 4=optimum.
Time Frame	1 Month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stenfilcon A Lens With Solution Additive (Test)	Stenfilcon A Lens (Control)
Arm/Group Description	Participants were randomized to wear the stenfilcon A lens with solution additive (test) for 1 month during the cross over study. stenfilcon A lens with solution additive (test): silicone hydrogel lens	Participants were randomized to wear stenfilcon A (control) lens pair for 1 month during the cross over study. stenfilcon A lens (control): contact lens
Measure Participants	70	70
Measure Eyes	140	140
Mean (Standard Deviation) [units on a scale]	3.3 (0.3)	3.2 (0.5)

26. Secondary Outcome

Title	Handling Satisfaction
Description	Handling satisfaction is assessed for test and control lens. 5 point Likert scale: 1- Strongly disagree, 2-disagree, 3-neutral, 4-agree, 5- strongly agree
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stenfilcon A Lens With Solution Additive (Test)	Stenfilcon A Lens (Control)
Arm/Group Description	Participants were randomized to wear the stenfilcon A lens with solution additive (test) for 1 month during the cross over study. stenfilcon A lens with solution additive (test): silicone hydrogel lens	Participants were randomized to wear stenfilcon A (control) lens pair for 1 month during the cross over study. stenfilcon A lens (control): contact lens
Measure Participants	70	70
Strongly disagree	0 0%	0 NaN
Disagree	0 0%	1 NaN
Neutral	3 4.2%	1 NaN
Agree	25 34.7%	23 NaN
Strongly Agree	72 100%	75 NaN

27. Secondary Outcome

Title	Handling Satisfaction
Description	Handling satisfaction is assessed for test and control lens. 5 point Likert scale: 1- Strongly disagree, 2-disagree, 3-neutral, 4-agree, 5- strongly agree
Time Frame	1 Month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stenfilcon A Lens With Solution Additive (Test)	Stenfilcon A Lens (Control)
Arm/Group Description	Participants were randomized to wear the stenfilcon A lens with solution additive (test) for 1 month during the cross over study. stenfilcon A lens with solution additive (test): silicone hydrogel lens	Participants were randomized to wear stenfilcon A (control) lens pair for 1 month during the cross over study. stenfilcon A lens (control): contact lens
Measure Participants	70	70
Strongly disagree	0 0%	1 NaN
Disagree	0 0%	4 NaN
Neutral	1 1.4%	0 NaN
Agree	30 41.7%	23 NaN
Strongly Agree	69 95.8%	72 NaN

28. Secondary Outcome

Title	Lens Surface - Wettability
Description	Wettability is assessed for test and control lens on a scale of 0-4, 0=Very poor, 4=Excellent
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stenfilcon A Lens With Solution Additive (Test)	Stenfilcon A Lens (Control)
Arm/Group Description	Participants were randomized to wear the stenfilcon A lens with solution additive (test) for 1 month during the cross over study. stenfilcon A lens with solution additive (test): silicone hydrogel lens	Participants were randomized to wear stenfilcon A (control) lens pair for 1 month during the cross over study. stenfilcon A lens (control): contact lens
Measure Participants	70	70
Measure Eyes	140	140
Mean (Standard Deviation) [units on a scale]	3.52 (0.36)	3.52 (0.35)

29. Secondary Outcome

Title	Lens Surface - Wettability
Description	Wettability is assessed for test and control lens on a scale of 0-4, 0=Very poor, 4=Excellent
Time Frame	1 Week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stenfilcon A Lens With Solution Additive (Test)	Stenfilcon A Lens (Control)
Arm/Group Description	Participants were randomized to wear the stenfilcon A lens with solution additive (test) for 1 month during the cross over study. stenfilcon A lens with solution additive (test): silicone hydrogel lens	Participants were randomized to wear stenfilcon A (control) lens pair for 1 month during the cross over study. stenfilcon A lens (control): contact lens
Measure Participants	70	70
Measure Eyes	140	140
Mean (Standard Deviation) [units on a scale]	3.47 (0.46)	3.33 (0.48)

30. Secondary Outcome

Title	Lens Surface - Wettability
Description	Wettability is assessed for test and control lens on a scale of 0-4, 0=Very poor, 4=Excellent
Time Frame	1 Month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stenfilcon A Lens With Solution Additive (Test)	Stenfilcon A Lens (Control)
Arm/Group Description	Participants were randomized to wear the stenfilcon A lens with solution additive (test) for 1 month during the cross over study. stenfilcon A lens with solution additive (test): silicone hydrogel lens	Participants were randomized to wear stenfilcon A (control) lens pair for 1 month during the cross over study. stenfilcon A lens (control): contact lens
Measure Participants	70	70
Measure Eyes	140	140
Mean (Standard Deviation) [units on a scale]	3.37 (0.43)	3.38 (0.44)

31. Secondary Outcome

Title	Lens Surface - Deposits
Description	Deposits are assessed for test and control lens. Scale 0-4, 0.25 steps. 0=Clean, no deposits, 4=Deposits of 0.5mm or larger or film covering more than 75% of surface.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stenfilcon A Lens With Solution Additive (Test)	Stenfilcon A Lens (Control)
Arm/Group Description	Participants were randomized to wear the stenfilcon A lens with solution additive (test) for 1 month during the cross over study. stenfilcon A lens with solution additive (test): silicone hydrogel lens	Participants were randomized to wear stenfilcon A (control) lens pair for 1 month during the cross over study. stenfilcon A lens (control): contact lens
Measure Participants	70	70
Measure Eyes	140	140
Mean (Standard Deviation) [units on a scale]	0.03 (0.15)	0.02 (0.15)

32. Secondary Outcome

Title	Lens Surface - Deposits
Description	Deposits are assessed for test and control lens. Scale 0-4, 0.25 steps. 0=Clean, no deposits, 4=Deposits of 0.5mm or larger or film covering more than 75% of surface.
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stenfilcon A Lens With Solution Additive (Test)	Stenfilcon A Lens (Control)
Arm/Group Description	Participants were randomized to wear the stenfilcon A lens with solution additive (test) for 1 month during the cross over study. stenfilcon A lens with solution additive (test): silicone hydrogel lens	Participants were randomized to wear stenfilcon A (control) lens pair for 1 month during the cross over study. stenfilcon A lens (control): contact lens
Measure Participants	70	70
Measure Eyes	140	140
Mean (Standard Deviation) [units on a scale]	0.04 (0.20)	0.04 (0.19)

33. Secondary Outcome

Title	Lens Surface - Deposits
Description	Deposits are assessed for test and control lens. Scale 0-4, 0.25 steps. 0=Clean, no deposits, 4=Deposits of 0.5mm or larger or film covering more than 75% of surface.
Time Frame	1 Month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stenfilcon A Lens With Solution Additive (Test)	Stenfilcon A Lens (Control)
Arm/Group Description	Participants were randomized to wear the stenfilcon A lens with solution additive (test) for 1 month during the cross over study. stenfilcon A lens with solution additive (test): silicone hydrogel lens	Participants were randomized to wear stenfilcon A (control) lens pair for 1 month during the cross over study. stenfilcon A lens (control): contact lens
Measure Participants	70	70
Measure Eyes	140	140
Mean (Standard Deviation) [units on a scale]	0.06 (0.27)	0.02 (0.15)

34. Secondary Outcome

Title	Subjective Ratings on Dryness
Description	Subjective ratings on dryness is assessed for test and control lens on a scale of 0-10, 0=dry, 10=not dry
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stenfilcon A Lens With Solution Additive (Test)	Stenfilcon A Lens (Control)
Arm/Group Description	Participants were randomized to wear the stenfilcon A lens with solution additive (test) for 1 month during the cross over study. stenfilcon A lens with solution additive (test): silicone hydrogel lens	Participants were randomized to wear stenfilcon A (control) lens pair for 1 month during the cross over study. stenfilcon A lens (control): contact lens
Measure Participants	70	70
Mean (Standard Deviation) [units on a scale]	9.6 (1.3)	9.5 (0.9)

35. Secondary Outcome

Title	Subjective Ratings on Dryness
Description	Subjective ratings on dryness is assessed for test and control lens on a scale of 0-10, 0=dry, 10=not dry
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stenfilcon A Lens With Solution Additive (Test)	Stenfilcon A Lens (Control)
Arm/Group Description	Participants were randomized to wear the stenfilcon A lens with solution additive (test) for 1 month during the cross over study. stenfilcon A lens with solution additive (test): silicone hydrogel lens	Participants were randomized to wear stenfilcon A (control) lens pair for 1 month during the cross over study. stenfilcon A lens (control): contact lens
Measure Participants	70	70
Mean (Standard Deviation) [units on a scale]	8.8 (1.8)	8.8 (1.6)

36. Secondary Outcome

Title	Subjective Ratings on Dryness
Description	Subjective ratings on dryness is assessed for test and control lens on a scale of 0-10, 0=dry, 10=not dry
Time Frame	1 Month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stenfilcon A Lens With Solution Additive (Test)	Stenfilcon A Lens (Control)
Arm/Group Description	Participants were randomized to wear the stenfilcon A lens with solution additive (test) for 1 month during the cross over study. stenfilcon A lens with solution additive (test): silicone hydrogel lens	Participants were randomized to wear stenfilcon A (control) lens pair for 1 month during the cross over study. stenfilcon A lens (control): contact lens
Measure Participants	70	70
Mean (Standard Deviation) [units on a scale]	8.3 (2.1)	8.1 (2.3)

Adverse Events

Time Frame	From baseline up to 1 month on each pair of lenses.
Arm/Group Title	Stenfilcon A Lens With Solution Additive (Test)		Stenfilcon A Lens (Control)
Arm/Group Description	Participants were randomized to wear the stenfilcon A lens with solution additive (test) for 1 month during the cross over study. stenfilcon A lens with solution additive (test): silicone hydrogel lens		Participants were randomized to wear stenfilcon A (control) lens pair for 1 month during the cross over study. stenfilcon A lens (control): contact lens
All Cause Mortality
	Stenfilcon A Lens With Solution Additive (Test)		Stenfilcon A Lens (Control)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/72 (0%)		0/72 (0%)
Serious Adverse Events
	Stenfilcon A Lens With Solution Additive (Test)		Stenfilcon A Lens (Control)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/72 (0%)		0/72 (0%)
Other (Not Including Serious) Adverse Events
	Stenfilcon A Lens With Solution Additive (Test)		Stenfilcon A Lens (Control)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/72 (1.4%)		5/72 (6.9%)
Eye disorders
Corneal Staining	1/72 (1.4%)	1	2/72 (2.8%)	2
Subconjuctival Hyperemia	0/72 (0%)	0	2/72 (2.8%)	2
Epithelial defect	0/72 (0%)	0	1/72 (1.4%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.