Comparison of New Contact Lens With Current Marketed Lens

• Sponsor: Coopervision, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03360110
• Collaborator: (none)
• Enrollment: 53
• Location: 1
• Arms: 2
• Actual Duration (Months): 1.3
• Patients Per Site Per Month: 41.4

Study Details

Study Description

Brief Summary

The purpose of this study is to validate the clinical performance of a new contact lens design.

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

Detailed Description

Evaluate the clinical performance of its Phoebe contact lenses (Test) compared to the commercially available MyDay contact lenses (Control).

Study Design

• Study Type: Interventional
• Actual Enrollment: 53 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Masking Description: Double masked (participant, investigator)
• Primary Purpose: Treatment
• Official Title: Clinical Validation Study of Phoebe Lens
• Actual Study Start Date: Nov 6, 2017
• Actual Primary Completion Date: Dec 15, 2017
• Actual Study Completion Date: Dec 15, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Test lens Subjects randomized to wear pair of test lens either first or second	Device: Phoebe test lens; Daily disposable contact lens; Other Names: Test Lens Phoebe Contact Lens ; Device: stenfilcon A lens (control); Daily disposable contact lens; Other Names: MyDay daily disposable contact lens
Active Comparator: stenfilcon A lens (control) Subjects randomized to wear pair of control lens either first or second	Device: Phoebe test lens; Daily disposable contact lens; Other Names: Test Lens Phoebe Contact Lens ; Device: stenfilcon A lens (control); Daily disposable contact lens; Other Names: MyDay daily disposable contact lens

Outcome Measures

Primary Outcome Measures

1. Corneal Staining Extent [Baseline]

   Measurement of extent of corneal staining using Fluorescein, blue light, yellow filter, full beam, medium magnification on a scale 0-4 (0=no staining, 1 = 1-15% of area, 2= 16-30% of area, 3=31-45% of area, 4=>45% of area).

2. Corneal Staining Extent [Day 3]

   Measurement of extent of corneal staining using Fluorescein, blue light, yellow filter, full beam, medium magnification on a scale 0-4 (0=no staining, 1 = 1-15% of area, 2= 16-30% of area, 3=31-45% of area, 4=>45% of area).

3. Conjunctival Staining Score [Baseline]

   Amount of staining observed on the conjunctiva scored 0-4 (0=none, 4=Deep Confluent, in 0.50 steps

4. Conjunctival Staining Score [Day 3]

   Amount of staining observed on the conjunctiva scored 0-4 (0=none, 4=Deep Confluent, in 0.50 steps

5. Palpebral Hyperemia on Upper Lid [Baseline]

   Measurement of hyperemia of the palpebral conjunctiva; graded 0-4 (0=none, 4=severe) in 0.25 steps

6. Palpebral Hyperemia on Upper Lid [Day 3]

   Measurement of hyperemia of the palpebral conjunctiva; graded 0-4 (0=none, 4=severe) in 0.25 steps

7. Palpebral Hyperemia on Lower Lid [Baseline]

   Measurement of hyperemia of the palpebral conjunctiva; graded 0-4 (0=none, 4=severe) in 0.25 steps

8. Palpebral Hyperemia on Lower Lid [Day 3]

   Measurement of hyperemia of the palpebral conjunctiva; graded 0-4 (0=none, 4=severe) in 0.25 steps

9. Palpebral Roughness Grade - Upper Lid [Baseline]

   Measurement of smoothness of palpebral conjunctiva; graded 0-4 (0=smooth, 4=severe) in 0.25 steps

10. Palpebral Roughness Grade - Upper Lid [Day 3]

    Measurement of smoothness of palpebral conjunctiva; graded 0-4 (0=smooth, 4=severe) in 0.25 steps

11. Palpebral Roughness Grade - Lower Lid [Baseline]

    Measurement of smoothness of palpebral conjunctiva; graded 0-4 (0=smooth, 4=severe) in 0.25 steps

12. Palpebral Roughness Grade - Lower Lid [Day 3]

    Measurement of smoothness of palpebral conjunctiva; graded 0-4 (0=smooth, 4=severe) in 0.25 steps

Secondary Outcome Measures

1. Distance Visual Acuity [Baseline (at lens dispense)]

   Distance visual acuity recorded in logMAR.

2. Distance Visual Acuity [Day 3]

   Distance visual acuity recorded in logMAR.

3. Near Visual Acuity [Baseline (at dispense)]

   Near visual acuity recorded in logMAR

4. Near Visual Acuity [Day 3]

   Near visual acuity recorded in logMAR

5. Vision Quality Rating [Baseline (at dispense)]

   Subjective vision quality rated on a 0-10 scale (0=extremely poor, 10=excellent)

6. Vision Quality Rating [Day 3]

   Subjective vision quality rated on a 0-10 scale (0=extremely poor, 10=excellent)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 35 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion criteria

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

• Between and 18 and 35 years of age and has full legal capacity to volunteer

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

• 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 20/25 or better (in each eye) with their habitual correction or 20/20 best corrected

• Has a Contact Lens Refraction between -1.00D and -6.00D

• Cylinder power ≤ -0.75DC in Spherical Cylindrical Refraction

• Currently wears soft contact lenses

• Is willing to wear lenses for a minimal of 8 hours a day and everyday during the course of the study

• Has clear corneas and no active ocular disease

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

Exclusion Criteria

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

• Has never worn contact lenses before

• Is wearing Monovision modality

• 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 participating in any other type of eye related clinical or research study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinical Optical Research Lab (CORL)	Bloomington	Indiana	United States	47405

Sponsors and Collaborators

• Coopervision, Inc.

Investigators

• Principal Investigator: Peter S Kolbaum, O.D., Ph.D., FAAO, FBCLA, Clinical Optics Research Lab (CORL), Indiana University

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Sep 28, 2017

More Information

Publications

None provided.

• Responsible Party: Coopervision, Inc.
• ClinicalTrials.gov Identifier: NCT03360110
• Other Study ID Numbers: CV-17-60
• First Posted: Dec 2, 2017
• Last Update Posted: Sep 2, 2020
• Last Verified: Aug 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
• Product Manufactured in and Exported from the U.S.: 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	Subjects randomized to wear pair of test lens, then control lens. Each lens type was worn for three days using a daily wear / daily replacement schedule. Phoebe test lens: Daily disposable contact lens stenfilcon A lens (control): Daily disposable contact lens	Subjects randomized to wear pair of control lens, then test lens. Each lens type was worn for three days using a daily wear / daily replacement schedule. Phoebe test lens: Daily disposable contact lens stenfilcon A lens (control): Daily disposable contact lens
Period Title: First Intervention
STARTED	27	26
COMPLETED	27	26
NOT COMPLETED	0	0
Period Title: First Intervention
STARTED	27	26
COMPLETED	27	26
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Overall Study
Arm/Group Description	Subjects randomized to wear pair of test/control lens either first or second, then wear other lens. Phoebe test lens: Daily disposable contact lens stenfilcon A lens (control): Daily disposable contact lens
Overall Participants	47
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	47 100%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	23 (3)
Sex: Female, Male (Count of Participants)
Female	35 74.5%
Male	12 25.5%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	0 0%
More than one race	0 0%
Unknown or Not Reported	47 100%
Region of Enrollment (participants) [Number]
United States	47 100%

Outcome Measures

1. Primary Outcome

Title	Corneal Staining Extent
Description	Measurement of extent of corneal staining using Fluorescein, blue light, yellow filter, full beam, medium magnification on a scale 0-4 (0=no staining, 1 = 1-15% of area, 2= 16-30% of area, 3=31-45% of area, 4=>45% of area).
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

There were 6 protocol deviations reported in this study and data from the 6 subjects were not used for data analyses.

Arm/Group Title	Phoebe Test Lens	Stenfilcon A Control Lens
Arm/Group Description	Subjects randomized to wear pair of test lens, then control lens. Each lens type was worn for three days using a daily wear / daily replacement schedule. Phoebe test lens: Daily disposable contact lens stenfilcon A lens (control): Daily disposable contact lens	Subjects randomized to wear pair of control lens, then test lens. Each lens type was worn for three days using a daily wear / daily replacement schedule. Phoebe test lens: Daily disposable contact lens stenfilcon A lens (control): Daily disposable contact lens
Measure Participants	47	47
Measure Eyes	94	94
Mean (Standard Deviation) [units on a scale]	0.04 (0.09)	0.04 (0.09)

2. Primary Outcome

Title	Corneal Staining Extent
Description	Measurement of extent of corneal staining using Fluorescein, blue light, yellow filter, full beam, medium magnification on a scale 0-4 (0=no staining, 1 = 1-15% of area, 2= 16-30% of area, 3=31-45% of area, 4=>45% of area).
Time Frame	Day 3

Outcome Measure Data

Analysis Population Description

There were 6 protocol deviations reported in this study and data from the 6 subjects were not used for data analyses.

Arm/Group Title	Phoebe Test Lens	Stenfilcon A Control Lens
Arm/Group Description	Subjects randomized to wear pair of test lens, then control lens. Each lens type was worn for three days using a daily wear / daily replacement schedule. Phoebe test lens: Daily disposable contact lens stenfilcon A lens (control): Daily disposable contact lens	Subjects randomized to wear pair of control lens, then test lens. Each lens type was worn for three days using a daily wear / daily replacement schedule. Phoebe test lens: Daily disposable contact lens stenfilcon A lens (control): Daily disposable contact lens
Measure Participants	47	47
Measure Eyes	94	94
Mean (Standard Deviation) [units on a scale]	0.07 (0.13)	0.07 (0.12)

3. Primary Outcome

Title	Conjunctival Staining Score
Description	Amount of staining observed on the conjunctiva scored 0-4 (0=none, 4=Deep Confluent, in 0.50 steps
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

There were 6 protocol deviations reported in this study and data from the 6 subjects were not used for data analyses.

Arm/Group Title	Phoebe Test Lens	Stenfilcon A Control Lens
Arm/Group Description	Subjects randomized to wear pair of test lens, then control lens. Each lens type was worn for three days using a daily wear / daily replacement schedule. Phoebe test lens: Daily disposable contact lens stenfilcon A lens (control): Daily disposable contact lens	Subjects randomized to wear pair of control lens, then test lens. Each lens type was worn for three days using a daily wear / daily replacement schedule. Phoebe test lens: Daily disposable contact lens stenfilcon A lens (control): Daily disposable contact lens
Measure Participants	47	47
Measure Eyes	94	94
Mean (Standard Deviation) [score on a scale]	0.18 (0.21)	0.18 (0.21)

4. Primary Outcome

Title	Conjunctival Staining Score
Description	Amount of staining observed on the conjunctiva scored 0-4 (0=none, 4=Deep Confluent, in 0.50 steps
Time Frame	Day 3

Outcome Measure Data

Analysis Population Description

There were 6 protocol deviations reported in this study and data from the 6 subjects were not used for data analyses.

Arm/Group Title	Phoebe Test Lens	Stenfilcon A Control Lens
Arm/Group Description	Subjects randomized to wear pair of test lens, then control lens. Each lens type was worn for three days using a daily wear / daily replacement schedule. Phoebe test lens: Daily disposable contact lens stenfilcon A lens (control): Daily disposable contact lens	Subjects randomized to wear pair of control lens, then test lens. Each lens type was worn for three days using a daily wear / daily replacement schedule. Phoebe test lens: Daily disposable contact lens stenfilcon A lens (control): Daily disposable contact lens
Measure Participants	47	47
Measure Eyes	94	94
Mean (Standard Deviation) [score on a scale]	0.26 (0.26)	0.29 (0.28)

5. Primary Outcome

Title	Palpebral Hyperemia on Upper Lid
Description	Measurement of hyperemia of the palpebral conjunctiva; graded 0-4 (0=none, 4=severe) in 0.25 steps
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

There were 6 protocol deviations reported in this study and data from the 6 subjects were not used for data analyses.

Arm/Group Title	Phoebe Test Lens: Upper Lid	Stenfilcon A Control Lens: Upper Lid
Arm/Group Description	Subjects randomized to wear pair of test lens, then control lens. Each lens type was worn for three days using a daily wear / daily replacement schedule. Upper lid was assessed for palpebral hyperemia. Phoebe test lens: Daily disposable contact lens stenfilcon A lens (control): Daily disposable contact lens	Subjects randomized to wear pair of control lens, then test lens. Each lens type was worn for three days using a daily wear / daily replacement schedule. Upper lid was assessed for palpebral hyperemia. Phoebe test lens: Daily disposable contact lens stenfilcon A lens (control): Daily disposable contact lens
Measure Participants	47	47
Measure Eyes	94	94
Mean (Standard Deviation) [units on a scale]	0.96 (0.39)	0.96 (0.39)

6. Primary Outcome

Title	Palpebral Hyperemia on Upper Lid
Description	Measurement of hyperemia of the palpebral conjunctiva; graded 0-4 (0=none, 4=severe) in 0.25 steps
Time Frame	Day 3

Outcome Measure Data

Analysis Population Description

There were 6 protocol deviations reported in this study and data from the 6 subjects were not used for data analyses.

Arm/Group Title	Phoebe Test Lens: Upper Lid	Stenfilcon A Control Lens: Upper Lid
Arm/Group Description	Subjects randomized to wear pair of test lens, then control lens. Each lens type was worn for three days using a daily wear / daily replacement schedule. Upper lid was assessed for palpebral hyperemia. Phoebe test lens: Daily disposable contact lens stenfilcon A lens (control): Daily disposable contact lens	Subjects randomized to wear pair of control lens, then test lens. Each lens type was worn for three days using a daily wear / daily replacement schedule. Upper lid was assessed for palpebral hyperemia. Phoebe test lens: Daily disposable contact lens stenfilcon A lens (control): Daily disposable contact lens
Measure Participants	47	47
Measure Eyes	94	94
Mean (Standard Deviation) [units on a scale]	1.05 (0.40)	1.06 (0.38)

7. Primary Outcome

Title	Palpebral Hyperemia on Lower Lid
Description	Measurement of hyperemia of the palpebral conjunctiva; graded 0-4 (0=none, 4=severe) in 0.25 steps
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

There were 6 protocol deviations reported in this study and data from the 6 subjects were not used for data analyses.

Arm/Group Title	Phoebe Test Lens: Lower Lid	Stenfilcon A Control Lens: Lower Lid
Arm/Group Description	Subjects randomized to wear pair of test lens, then control lens. Each lens type was worn for three days using a daily wear / daily replacement schedule. Lower lid was assessed for palpebral hyperemia. Phoebe test lens: Daily disposable contact lens stenfilcon A lens (control): Daily disposable contact lens	Subjects randomized to wear pair of control lens, then test lens. Each lens type was worn for three days using a daily wear / daily replacement schedule. Lower lid was assessed for palpebral hyperemia. Phoebe test lens: Daily disposable contact lens stenfilcon A lens (control): Daily disposable contact lens
Measure Participants	47	47
Measure Eyes	94	94
Mean (Standard Deviation) [units on a scale]	0.96 (0.39)	0.96 (0.39)

8. Primary Outcome

Title	Palpebral Hyperemia on Lower Lid
Description	Measurement of hyperemia of the palpebral conjunctiva; graded 0-4 (0=none, 4=severe) in 0.25 steps
Time Frame	Day 3

Outcome Measure Data

Analysis Population Description

There were 6 protocol deviations reported in this study and data from the 6 subjects were not used for data analyses.

Arm/Group Title	Phoebe Test Lens: Lower Lid	Stenfilcon A Control Lens: Lower Lid
Arm/Group Description	Subjects randomized to wear pair of test lens, then control lens. Each lens type was worn for three days using a daily wear / daily replacement schedule. Lower lid was assessed for palpebral hyperemia. Phoebe test lens: Daily disposable contact lens stenfilcon A lens (control): Daily disposable contact lens	Subjects randomized to wear pair of control lens, then test lens. Each lens type was worn for three days using a daily wear / daily replacement schedule. Lower lid was assessed for palpebral hyperemia. Phoebe test lens: Daily disposable contact lens stenfilcon A lens (control): Daily disposable contact lens
Measure Participants	47	47
Measure Eyes	94	94
Mean (Standard Deviation) [units on a scale]	1.05 (0.40)	1.06 (0.38)

9. Primary Outcome

Title	Palpebral Roughness Grade - Upper Lid
Description	Measurement of smoothness of palpebral conjunctiva; graded 0-4 (0=smooth, 4=severe) in 0.25 steps
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

There were 6 protocol deviations reported in this study and data from the 6 subjects were not used for data analyses.

Arm/Group Title	Phoebe Test Lens: Upper Lid	Stenfilcon A Control Lens: Upper Lid
Arm/Group Description	Subjects randomized to wear pair of test lens, then control lens. Each lens type was worn for three days using a daily wear / daily replacement schedule. Upper lid was assessed for palpebral roughness. Phoebe test lens: Daily disposable contact lens stenfilcon A lens (control): Daily disposable contact lens	Subjects randomized to wear pair of control lens, then test lens. Each lens type was worn for three days using a daily wear / daily replacement schedule. Upper lid was assessed for palpebral roughness. Phoebe test lens: Daily disposable contact lens stenfilcon A lens (control): Daily disposable contact lens
Measure Participants	47	47
Measure Eyes	94	94
Mean (Standard Deviation) [units on a scale]	1.09 (0.51)	1.09 (0.51)

10. Primary Outcome

Title	Palpebral Roughness Grade - Upper Lid
Description	Measurement of smoothness of palpebral conjunctiva; graded 0-4 (0=smooth, 4=severe) in 0.25 steps
Time Frame	Day 3

Outcome Measure Data

Analysis Population Description

There were 6 protocol deviations reported in this study and data from the 6 subjects were not used for data analyses.

Arm/Group Title	Phoebe Test Lens: Upper Lid	Stenfilcon A Control Lens: Upper Lid
Arm/Group Description	Subjects randomized to wear pair of test lens, then control lens. Each lens type was worn for three days using a daily wear / daily replacement schedule. Upper lid was assessed for palpebral roughness. Phoebe test lens: Daily disposable contact lens stenfilcon A lens (control): Daily disposable contact lens	Subjects randomized to wear pair of control lens, then test lens. Each lens type was worn for three days using a daily wear / daily replacement schedule. Upper lid was assessed for palpebral roughness. Phoebe test lens: Daily disposable contact lens stenfilcon A lens (control): Daily disposable contact lens
Measure Participants	47	47
Measure Eyes	94	94
Mean (Standard Deviation) [units on a scale]	1.26 (0.53)	1.20 (0.46)

11. Primary Outcome

Title	Palpebral Roughness Grade - Lower Lid
Description	Measurement of smoothness of palpebral conjunctiva; graded 0-4 (0=smooth, 4=severe) in 0.25 steps
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

There were 6 protocol deviations reported in this study and data from the 6 subjects were not used for data analyses.

Arm/Group Title	Phoebe Test Lens: Lower Lid	Stenfilcon A Control Lens: Lower Lid
Arm/Group Description	Subjects randomized to wear pair of test lens, then control lens. Each lens type was worn for three days using a daily wear / daily replacement schedule. Lower lid was assessed for palpebral roughness. Phoebe test lens: Daily disposable contact lens stenfilcon A lens (control): Daily disposable contact lens	Subjects randomized to wear pair of control lens, then test lens. Each lens type was worn for three days using a daily wear / daily replacement schedule. Lower lid was assessed for palpebral roughness. Phoebe test lens: Daily disposable contact lens stenfilcon A lens (control): Daily disposable contact lens
Measure Participants	47	47
Measure Eyes	94	94
Mean (Standard Deviation) [units on a scale]	1.07 (0.50)	1.07 (0.50)

12. Primary Outcome

Title	Palpebral Roughness Grade - Lower Lid
Description	Measurement of smoothness of palpebral conjunctiva; graded 0-4 (0=smooth, 4=severe) in 0.25 steps
Time Frame	Day 3

Outcome Measure Data

Analysis Population Description

There were 6 protocol deviations reported in this study and data from the 6 subjects were not used for data analyses.

Arm/Group Title	Phoebe Test Lens: Lower Lid	Stenfilcon A Control Lens: Lower Lid
Arm/Group Description	Subjects randomized to wear pair of test lens, then control lens. Each lens type was worn for three days using a daily wear / daily replacement schedule. Lower lid was assessed for palpebral roughness. Phoebe test lens: Daily disposable contact lens stenfilcon A lens (control): Daily disposable contact lens	Subjects randomized to wear pair of control lens, then test lens. Each lens type was worn for three days using a daily wear / daily replacement schedule. Lower lid was assessed for palpebral roughness. Phoebe test lens: Daily disposable contact lens stenfilcon A lens (control): Daily disposable contact lens
Measure Participants	47	47
Measure Eyes	94	94
Mean (Standard Deviation) [units on a scale]	1.23 (0.52)	1.20 (0.46)

13. Secondary Outcome

Title	Distance Visual Acuity
Description	Distance visual acuity recorded in logMAR.
Time Frame	Baseline (at lens dispense)

Outcome Measure Data

Analysis Population Description

There were 6 protocol deviations reported in this study and data from the 6 subjects were not used for data analyses.

Arm/Group Title	Phoebe Test Lens: Dispense	Stenfilcon A Control Lens: Dispense
Arm/Group Description	Subjects randomized to wear pair of test lens, then control lens. Each lens type was worn for three days using a daily wear / daily replacement schedule. Phoebe test lens: Daily disposable contact lens stenfilcon A lens (control): Daily disposable contact lens	Subjects randomized to wear pair of control lens, then test lens. Each lens type was worn for three days using a daily wear / daily replacement schedule. Phoebe test lens: Daily disposable contact lens stenfilcon A lens (control): Daily disposable contact lens
Measure Participants	47	47
High Illumination High Contrast, Binocular	-0.23 (0.06)	-0.22 (0.06)
Low Illumination High Contrast, Binocular	-0.03 (0.08)	-0.03 (0.07)

14. Secondary Outcome

Title	Distance Visual Acuity
Description	Distance visual acuity recorded in logMAR.
Time Frame	Day 3

Outcome Measure Data

Analysis Population Description

There were 6 protocol deviations reported in this study and data from the 6 subjects were not used for data analyses.

Arm/Group Title	Phoebe Test Lens: 3 Days	Stenfilcon A Control Lens: 3 Days
Arm/Group Description	Subjects randomized to wear pair of test lens, then control lens. Each lens type was worn for three days using a daily wear / daily replacement schedule. Phoebe test lens: Daily disposable contact lens stenfilcon A lens (control): Daily disposable contact lens	Subjects randomized to wear pair of control lens, then test lens. Each lens type was worn for three days using a daily wear / daily replacement schedule. Phoebe test lens: Daily disposable contact lens stenfilcon A lens (control): Daily disposable contact lens
Measure Participants	47	47
High Illumination High Contrast, Binocular	-0.23 (0.06)	-0.22 (0.06)
Low Illumination High Contrast, Binocular	-0.04 (0.06)	-0.04 (0.07)

15. Secondary Outcome

Title	Near Visual Acuity
Description	Near visual acuity recorded in logMAR
Time Frame	Baseline (at dispense)

Outcome Measure Data

Analysis Population Description

There were 6 protocol deviations reported in this study and data from the 6 subjects were not used for data analyses.

Arm/Group Title	Phoebe Test Lens: Dispense	Stenfilcon A Control Lens: Dispense
Arm/Group Description	Subjects randomized to wear pair of test lens, then control lens. Each lens type was worn for three days using a daily wear / daily replacement schedule. Phoebe test lens: Daily disposable contact lens stenfilcon A lens (control): Daily disposable contact lens	Subjects randomized to wear pair of control lens, then test lens. Each lens type was worn for three days using a daily wear / daily replacement schedule. Phoebe test lens: Daily disposable contact lens stenfilcon A lens (control): Daily disposable contact lens
Measure Participants	47	47
High Illumination High Contrast, Binocular	-0.16 (0.07)	-0.16 (0.06)
Low Illumination High Contrast, Binocular	0.09 (0.10)	0.06 (0.09)

16. Secondary Outcome

Title	Near Visual Acuity
Description	Near visual acuity recorded in logMAR
Time Frame	Day 3

Outcome Measure Data

Analysis Population Description

There were 6 protocol deviations reported in this study and data from the 6 subjects were not used for data analyses.

Arm/Group Title	Phoebe Test Lens: 3 Days	Stenfilcon A Control Lens: 3 Days
Arm/Group Description	Subjects randomized to wear pair of test lens, then control lens. Each lens type was worn for three days using a daily wear / daily replacement schedule. Phoebe test lens: Daily disposable contact lens stenfilcon A lens (control): Daily disposable contact lens	Subjects randomized to wear pair of control lens, then test lens. Each lens type was worn for three days using a daily wear / daily replacement schedule. Phoebe test lens: Daily disposable contact lens stenfilcon A lens (control): Daily disposable contact lens
Measure Participants	47	47
High Illumination High Contrast, Binocular	-0.17 (0.07)	-0.19 (0.07)
Low Illumination High Contrast, Binocular	0.06 (0.09)	0.04 (0.09)

17. Secondary Outcome

Title	Vision Quality Rating
Description	Subjective vision quality rated on a 0-10 scale (0=extremely poor, 10=excellent)
Time Frame	Baseline (at dispense)

Outcome Measure Data

Analysis Population Description

There were 6 protocol deviations reported in this study and data from the 6 subjects were not used for data analyses.

Arm/Group Title	Phoebe Test Lens	Stenfilcon A Control Lens
Arm/Group Description	Subjects randomized to wear pair of test lens, then control lens. Each lens type was worn for three days using a daily wear / daily replacement schedule. Phoebe test lens: Daily disposable contact lens stenfilcon A lens (control): Daily disposable contact lens	Subjects randomized to wear pair of control lens, then test lens. Each lens type was worn for three days using a daily wear / daily replacement schedule. Phoebe test lens: Daily disposable contact lens stenfilcon A lens (control): Daily disposable contact lens
Measure Participants	47	47
Mean (Standard Deviation) [units on a scale]	9.2 (1.0)	9.3 (0.07)

18. Secondary Outcome

Title	Vision Quality Rating
Description	Subjective vision quality rated on a 0-10 scale (0=extremely poor, 10=excellent)
Time Frame	Day 3

Outcome Measure Data

Analysis Population Description

There were 6 protocol deviations reported in this study and data from the 6 subjects were not used for data analyses.

Arm/Group Title	Phoebe Test Lens	Stenfilcon A Control Lens
Arm/Group Description	Subjects randomized to wear pair of test lens, then control lens. Each lens type was worn for three days using a daily wear / daily replacement schedule. Phoebe test lens: Daily disposable contact lens stenfilcon A lens (control): Daily disposable contact lens	Subjects randomized to wear pair of control lens, then test lens. Each lens type was worn for three days using a daily wear / daily replacement schedule. Phoebe test lens: Daily disposable contact lens stenfilcon A lens (control): Daily disposable contact lens
Measure Participants	47	47
Mean (Standard Deviation) [units on a scale]	9.3 (0.9)	9.2 (1.0)

Adverse Events

Time Frame	From dispense up to three days for each intervention.
Arm/Group Title	Test Lens		Stenfilcon A Lens (Control)
Arm/Group Description	Subjects were randomized to wear pair of test lens for 3 days. Phoebe test lens: Daily disposable contact lens		Subjects were randomized to wear pair of control lens for 3 days. stenfilcon A lens (control): Daily disposable contact lens
All Cause Mortality
	Test Lens		Stenfilcon A Lens (Control)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/53 (0%)		0/53 (0%)
Serious Adverse Events
	Test Lens		Stenfilcon A Lens (Control)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/53 (0%)		0/53 (0%)
Other (Not Including Serious) Adverse Events
	Test Lens		Stenfilcon A Lens (Control)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/53 (0%)		0/53 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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