Dispensing Study for a New Study Lens

• Sponsor: Coopervision, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02642991
• Collaborator: (none)
• Enrollment: 44
• Locations: 3
• Arms: 2
• Duration (Months): 4
• Patients Per Site: 14.7
• Patients Per Site Per Month: 3.7

Study Details

Study Description

Brief Summary

This study investigated the performance criteria over one week of daily wear to determine if the comfilcon A asphere lens (test) performed equivalently to the comfilcon A sphere (control) in terms of measurement and subjective ratings of visual performance.

Condition or Disease	Intervention/Treatment	Phase
Myopia	Device: Phenacite; Device: comfilcon A	N/A

Detailed Description

This study was a prospective, single site, daily wear, double masked, randomized bilateral cross over dispensing study of binocular wear of comfilcon A asphere lens (test) and comfilcon A sphere lens (control) over 1 week of daily wear.

Study Design

• Study Type: Interventional
• Actual Enrollment: 44 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Dispensing Study for The Phenacite Project
• Study Start Date: Nov 1, 2015
• Actual Primary Completion Date: Jan 1, 2016
• Actual Study Completion Date: Mar 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Phenacite Test lens then comfilcon A control lens Participants were randomized to wear Phenacite test lens for one week then cross-over to wear comfilcon A control lens for one week.	Device: Phenacite; contact lens; Device: comfilcon A; contact lens
Active Comparator: Comfilcon A control lens then Phenacite test Lens Participants were randomized to wear comfilcon A control lens for one week then cross over to Phenacite test lens for one week.	Device: Phenacite; contact lens; Device: comfilcon A; contact lens

Outcome Measures

Primary Outcome Measures

1. Distance Visual Acuity (VA) - High Illumination [Baseline (after 10 minutes of lens dispense)]

   Distance visual acuity High Illumination was assessed using logMAR

2. Distance Visual Acuity (VA) - High Illumination [1 week]

   Distance visual acuity High Illumination was assessed using logMAR

3. Near Visual Acuity (VA) - High Illumination [Baseline (after 10 minutes of lens dispense)]

   Near Visual Acuity (VA) - High Illumination assessed using logMAR

4. Near Visual Acuity (VA) - High Illumination [1 week]

   Near Visual Acuity (VA) - High Illumination assessed using logMAR

5. Distance Visual Acuity (VA) - Low Illumination [Baseline (after 10 minutes of lens dispense)]

   Distance Visual Acuity (VA) - Low Illumination assessed using logMAR

6. Distance Visual Acuity (VA) - Low Illumination [1 week]

   Distance Visual Acuity (VA) - Low Illumination assessed using logMAR

7. Near Visual Acuity (VA) - Low Illumination [Baseline (after 10 minutes of lens dispense)]

   Near Visual Acuity (VA) - Low illumination assessed using logMAR

8. Near Visual Acuity (VA) - Low Illumination [1 week]

   Near Visual Acuity (VA) - Low illumination assessed using logMAR

9. Quality of Distance Vision [Baseline (after 10 minutes of lens dispense)]

   Subjective scoring of Quality of Distance Vision assessed using 0-100 continuous scale: (0=extremely poor vision all of the time. 100=excellent vision all of the time)

10. Quality of Distance Vision [1 week]

    Subjective scoring of Quality of Distance Vision assessed using 0-100 continuous scale: (0=extremely poor vision all of the time. 100=excellent vision all of the time)

11. Quality of Near Vision [Baseline (After 10 minutes of lens dispense)]

    Patient subjective scoring for quality of near vision using 0-100 continuous scale: 0=extremely poor vision all of the time. 100=excellent vision all of the time

12. Quality of Near Vision [1 week]

    Patient subjective scoring for quality of near vision using 0-100 continuous scale: 0=extremely poor vision all of the time. 100=excellent vision all of the time

13. Quality of Vision With Digital Device Use [Baseline (After 10 minutes of lens dispense)]

    Subjective scoring of Quality of Vision with digital device use assessed using 0-100 continuous scale: (0=extremely poor vision all of the time. 100=excellent vision all of the time)

14. Quality of Vision With Digital Device Use [1 week]

    Subjective scoring of Quality of Vision with digital device use assessed using 0-100 continuous scale: (0=extremely poor vision all of the time. 100=excellent vision all of the time)

15. Quality of Intermediate Vision [Baseline (After 10 minutes of lens dispense)]

    Subjective scoring of Quality of Intermediate Vision assessed using 0-100 continuous scale: (0=extremely poor vision all of the time. 100=excellent vision all of the time)

16. Quality of Intermediate Vision [1 week]

    Subjective scoring of Quality of Intermediate Vision assessed using 0-100 continuous scale: (0=extremely poor vision all of the time. 100=excellent vision all of the time)

17. Overall Vision Quality [Baseline (After 10 minutes of lens dispense)]

    Subjective scoring of overall vision quality assessed using 0-100 continuous scale: (0=extremely poor vision all of the time. 100=excellent vision all of the time)

18. Overall Vision Quality [1 week]

    Subjective scoring of overall vision quality assessed using 0-100 continuous scale: (0=extremely poor vision all of the time. 100=excellent vision all of the time)

Secondary Outcome Measures

1. Biomicroscopy Findings - Bulbar Hyperemia [1 week]

   Bulbar hyperemia assessment using 5 categories: (0=None, 1= Slight injection to conjunctival vessels, 2= Mild injection, 3= Moderate injection, 4= Severe injection) in (0.25 steps)

2. Biomicroscopy Findings- Limbal Hyperemia [1 week]

   Investigator assessment using 5 categories: (0=None, 1= Slight injection to conjunctival vessels, 2= Mild injection, 3= Moderate injection, 4= Severe injection) in (0.25 steps)

3. Biomicroscopy Findings - Corneal Staining Extent [1 week]

   Investigator Assessment on Biomicroscopy Findings - Corneal Staining Extent on a scale of 0-4 : 0=No staining, 1=1-15% of area, 2=16-30% of area, 3=31-45% of area, 4= >45% of area

4. Ghosting - Distance Vision [1 week]

   Patient subjective scoring using 0-100 continuous scale:0=Intolerable;100=Not noticable

5. Ghosting - Near Vision [1 week]

   Patient subjective scoring using 0-100 continuous scale:0=Intolerable;100=Not noticable

6. Overall Comfort [Baseline (After 10 minutes of lens dispense)]

   Patient subjective scoring using 0-100 continuous scale, 0= cannot be worn, 100= cannot be felt ever.

7. Overall Comfort [1 week]

   Patient subjective scoring for overall comfort using 0-100 continuous scale, 0= cannot be worn, 100= cannot be felt ever.

8. Overall Dryness [Baseline (after 10 minutes of lens dispense)]

   Patient subjective scoring for overall dryness using 0-100 continuous scale, 0=cannot be worn, 100=no dryness experienced at any time.

9. Overall Dryness [1 week]

   Patient subjective scoring for overall dryness using 0-100 continuous scale, 0=cannot be worn, 100=no dryness experienced at any time.

10. Lens Preference - Overall Vision Preference [1 week]

    Subjective rating of lens preference for overall vision preference (Phenacite, comfilcon A, No preference)

11. Subjective Ratings of Change in Frequency of Tiredness [1 week]

    Subjective rating of change in eye fatigue frequency of tiredness assessed using Eye fatigue Experience Questionnaire (EFEG)

12. Subjective Ratings of Change in Severity of Tiredness [1 week]

    Subjective rating of change in eye fatigue severity of tiredness assessed using Eye fatigue Experience Questionnaire (EFEG)

13. Subjective Ratings of Change in Bothersome Rating for Tiredness [1 week]

    Subjective rating of change in eye fatigue bothersome rating for tiredness assessed using Eye fatigue Experience Questionnaire (EFEG)

14. Subjective Ratings of Change in Frequency of Dryness [1 week]

    Subjective rating of change in eye fatigue frequency of dryness assessed using Eye fatigue Experience Questionnaire (EFEG)

15. Subjective Ratings of Change in Severity of Dryness [1 week]

    Subjective rating of change in eye fatigue severity of dryness assessed using Eye fatigue Experience Questionnaire (EFEG)

16. Subjective Ratings of Change in Bothersome Rating of Dryness [1 week]

    Subjective rating of change in eye fatigue bothersome rating for dryness assessed using Eye fatigue Experience Questionnaire (EFEG)

17. Subjective Questionnaire Response - Eye Strain [1 week]

    Subjective questionnaire response for " My eyes don't feel strained while wearing these lenses" - Agree, Disagree

18. Subjective Questionnaire Response - Eye Feel Good [1 week]

    Subjective questionnaire response for " These lenses make my eyes feel good" - Agree, Disagree

19. Subjective Questionnaire Response - Eye Feel Relaxed [1 week]

    Subjective questionnaire response for " These lenses make my eyes feel relaxed" - Agree, Disagree

20. Subjective Questionnaire Response - Vision [1 week]

    Subjective questionnaire response for " These lenses help my vision" - Agree, Disagree

21. Subjective Questionnaire Response - Eye Tired [1 week]

    Subjective questionnaire response for " These lenses make my eyes feel less tired" - Agree, Disagree

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:

• Oculo-visual examination in the last two years

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

• Has read and understood the informed 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

• Currently wears, or has previously successfully worn, soft contact lenses between -1.00D (Diopoter) and -4.00D

• Spherical Contact Lens Rx between -1.00 and -4.00 and spectacle cylinder <-0.75

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

• Has a subjective response at baseline, which indicates suitability for this study

• Currently spends a minimum of 4 hours a day; 5 days a week on digital devices and can replicate this time during the study period

• Is willing and able to wear the study contact lenses a minimum of 10 hours per day; 5 days a week

Exclusion Criteria:

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

• Has never worn contact lenses before

• Any systemic disease affecting ocular health

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

• Has known sensitivity to the diagnostic pharmaceuticals or study products used in this study.

• Has any ocular pathology or anomaly that would affect the wearing of the lenses

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

• Is aphakic

• Has anisometropia of >1.00

• Has undergone corneal refractive surgery

• Has strabismus

• Has any ocular amblyopia >= 1line of HC (High Contrast) Visual Acuity

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

• Has previously participated in study of the Phenacite lenses

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California	Berkeley	California	United States	94720
2	CORL, Indiana University	Bloomington	Indiana	United States	47405
3	Center for Contact Lens Research, University of Waterloo	Waterloo	Ontario	Canada	N2L 3G1

Sponsors and Collaborators

• Coopervision, Inc.

Investigators

• Principal Investigator: Lyndon Jones, CCLR, University of Waterloo
• Principal Investigator: Pete Kollbaum, OD, PhD, CORL, Indiana University
• Principal Investigator: Meng Lin, OD, PhD, CRC, University of California, Berkeley

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Coopervision, Inc.
• ClinicalTrials.gov Identifier: NCT02642991
• Other Study ID Numbers: CV-15-41; NCT02642341; NCT02642354
• First Posted: Dec 30, 2015
• Last Update Posted: Dec 1, 2020
• Last Verified: Nov 1, 2020

• 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	Phenacite Test Lens Then Comfilcon A Control Lens	Comfilcon A Control Lens Then Phenacite Test Lens
Arm/Group Description	Participants were randomized to wear Phenacite test lens for one week then cross-over to wear comfilcon A control lens for one week. Phenacite: contact lens comfilcon A: contact lens	Participants were randomized to wear comfilcon A control lens for one week then cross over to Phenacite test lens for one week. Phenacite: contact lens comfilcon A: contact lens
Period Title: First Intervention
STARTED	22	22
COMPLETED	22	22
NOT COMPLETED	0	0
Period Title: First Intervention
STARTED	22	22
COMPLETED	22	22
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Overall Study
Arm/Group Description	Subjects were randomized to wear phenacite study lens and comfilcon A control lens for one week.
Overall Participants	44
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	44 100%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	23.1 (3.5)
Sex: Female, Male (Count of Participants)
Female	34 77.3%
Male	10 22.7%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (participants) [Number]
Canada	16 36.4%
United States	28 63.6%

Outcome Measures

1. Primary Outcome

Title	Distance Visual Acuity (VA) - High Illumination
Description	Distance visual acuity High Illumination was assessed using logMAR
Time Frame	Baseline (after 10 minutes of lens dispense)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Phenacite Test Lens	Comfilcon A Control Lens
Arm/Group Description	Participants were randomized to wear Phenacite test lens for one week Phenacite: contact lens	Participants were randomized to wear comfilcon A control lens for one week comfilcon A: contact lens
Measure Participants	44	44
Monocular	-0.10 (0.07)	-0.11 (0.08)
Binocular	-0.15 (0.06)	-0.17 (0.07)

2. Primary Outcome

Title	Distance Visual Acuity (VA) - High Illumination
Description	Distance visual acuity High Illumination was assessed using logMAR
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Phenacite Test Lens	Comfilcon A Control Lens
Arm/Group Description	Participants were randomized to wear Phenacite test lens for one week Phenacite: contact lens	Participants were randomized to wear comfilcon A control lens for one week comfilcon A: contact lens
Measure Participants	44	44
Monocular	-0.10 (0.08)	-0.11 (0.08)
Binocular	-0.15 (0.07)	-0.16 (0.06)

3. Primary Outcome

Title	Near Visual Acuity (VA) - High Illumination
Description	Near Visual Acuity (VA) - High Illumination assessed using logMAR
Time Frame	Baseline (after 10 minutes of lens dispense)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Phenacite Test Lens	Comfilcon A Control Lens
Arm/Group Description	Participants were randomized to wear Phenacite test lens for one week Phenacite: contact lens	Participants were randomized to wear comfilcon A control lens for one week comfilcon A: contact lens
Measure Participants	44	44
Monocular	-0.07 (0.09)	-0.08 (0.08)
Binocular	-0.13 (0.09)	-0.14 (0.08)

4. Primary Outcome

Title	Near Visual Acuity (VA) - High Illumination
Description	Near Visual Acuity (VA) - High Illumination assessed using logMAR
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Phenacite Test Lens	Comfilcon A Control Lens
Arm/Group Description	Participants were randomized to wear Phenacite test lens for one week Phenacite: contact lens	Participants were randomized to wear comfilcon A control lens for one week comfilcon A: contact lens
Measure Participants	44	44
Monocular	-0.06 (0.10)	-0.07 (0.09)
Binocular	-0.11 (0.09)	-0.13 (0.10)

5. Primary Outcome

Title	Distance Visual Acuity (VA) - Low Illumination
Description	Distance Visual Acuity (VA) - Low Illumination assessed using logMAR
Time Frame	Baseline (after 10 minutes of lens dispense)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Phenacite Test Lens	Comfilcon A Control Lens
Arm/Group Description	Participants were randomized to wear Phenacite test lens for one week Phenacite: contact lens	Participants were randomized to wear comfilcon A control lens for one week comfilcon A: contact lens
Measure Participants	44	44
Monocular	0.07 (0.08)	0.05 (0.08)
Binocular	0.02 (0.06)	0.00 (0.06)

6. Primary Outcome

Title	Distance Visual Acuity (VA) - Low Illumination
Description	Distance Visual Acuity (VA) - Low Illumination assessed using logMAR
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Phenacite Test Lens	Comfilcon A Control Lens
Arm/Group Description	Participants were randomized to wear Phenacite test lens for one week Phenacite: contact lens	Participants were randomized to wear comfilcon A control lens for one week comfilcon A: contact lens
Measure Participants	44	44
Monocular	0.06 (0.08)	0.05 (0.10)
Binocular	-0.01 (0.06)	0.01 (0.07)

7. Primary Outcome

Title	Near Visual Acuity (VA) - Low Illumination
Description	Near Visual Acuity (VA) - Low illumination assessed using logMAR
Time Frame	Baseline (after 10 minutes of lens dispense)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Phenacite Test Lens	Comfilcon A Control Lens
Arm/Group Description	Participants were randomized to wear Phenacite test lens for one week Phenacite: contact lens	Participants were randomized to wear comfilcon A control lens for one week comfilcon A: contact lens
Measure Participants	44	44
Monocular	0.15 (0.16)	0.14 (0.15)
Binocular	0.10 (0.16)	0.08 (0.15)

8. Primary Outcome

Title	Near Visual Acuity (VA) - Low Illumination
Description	Near Visual Acuity (VA) - Low illumination assessed using logMAR
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Phenacite Test Lens	Comfilcon A Control Lens
Arm/Group Description	Participants were randomized to wear Phenacite test lens for one week Phenacite: contact lens	Participants were randomized to wear comfilcon A control lens for one week comfilcon A: contact lens
Measure Participants	44	44
Monocular	0.16 (0.17)	0.18 (0.17)
Binocular	0.09 (0.16)	0.11 (0.17)

9. Primary Outcome

Title	Quality of Distance Vision
Description	Subjective scoring of Quality of Distance Vision assessed using 0-100 continuous scale: (0=extremely poor vision all of the time. 100=excellent vision all of the time)
Time Frame	Baseline (after 10 minutes of lens dispense)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Phenacite Test Lens	Comfilcon A Control Lens
Arm/Group Description	Participants were randomized to wear Phenacite test lens for one week Phenacite: contact lens	Participants were randomized to wear comfilcon A control lens for one week comfilcon A: contact lens
Measure Participants	44	44
Mean (Standard Deviation) [units on a scale]	91 (9)	88 (15)

10. Primary Outcome

Title	Quality of Distance Vision
Description	Subjective scoring of Quality of Distance Vision assessed using 0-100 continuous scale: (0=extremely poor vision all of the time. 100=excellent vision all of the time)
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Phenacite Test Lens	Comfilcon A Control Lens
Arm/Group Description	Participants were randomized to wear Phenacite test lens for one week Phenacite: contact lens	Participants were randomized to wear comfilcon A control lens for one week comfilcon A: contact lens
Measure Participants	44	44
Mean (Standard Deviation) [units on a scale]	87 (16)	90 (12)

11. Primary Outcome

Title	Quality of Near Vision
Description	Patient subjective scoring for quality of near vision using 0-100 continuous scale: 0=extremely poor vision all of the time. 100=excellent vision all of the time
Time Frame	Baseline (After 10 minutes of lens dispense)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Phenacite Test Lens	Comfilcon A Control Lens
Arm/Group Description	Participants were randomized to wear Phenacite test lens for one week Phenacite: contact lens	Participants were randomized to wear comfilcon A control lens for one week comfilcon A: contact lens
Measure Participants	44	44
Mean (Standard Deviation) [units on a scale]	94 (8)	91 (11)

12. Primary Outcome

Title	Quality of Near Vision
Description	Patient subjective scoring for quality of near vision using 0-100 continuous scale: 0=extremely poor vision all of the time. 100=excellent vision all of the time
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Phenacite Test Lens	Comfilcon A Control Lens
Arm/Group Description	Participants were randomized to wear Phenacite test lens for one week Phenacite: contact lens	Participants were randomized to wear comfilcon A control lens for one week comfilcon A: contact lens
Measure Participants	44	44
Mean (Standard Deviation) [units on a scale]	90 (12)	90 (12)

13. Primary Outcome

Title	Quality of Vision With Digital Device Use
Description	Subjective scoring of Quality of Vision with digital device use assessed using 0-100 continuous scale: (0=extremely poor vision all of the time. 100=excellent vision all of the time)
Time Frame	Baseline (After 10 minutes of lens dispense)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Phenacite Test Lens	Comfilcon A Control Lens
Arm/Group Description	Participants were randomized to wear Phenacite test lens for one week Phenacite: contact lens	Participants were randomized to wear comfilcon A control lens for one week comfilcon A: contact lens
Measure Participants	44	44
Mean (Standard Deviation) [units on a scale]	96 (8)	94 (7)

14. Primary Outcome

Title	Quality of Vision With Digital Device Use
Description	Subjective scoring of Quality of Vision with digital device use assessed using 0-100 continuous scale: (0=extremely poor vision all of the time. 100=excellent vision all of the time)
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Phenacite Test Lens	Comfilcon A Control Lens
Arm/Group Description	Participants were randomized to wear Phenacite test lens for one week Phenacite: contact lens	Participants were randomized to wear comfilcon A control lens for one week comfilcon A: contact lens
Measure Participants	44	44
Mean (Standard Deviation) [units on a scale]	91 (13)	90 (12)

15. Primary Outcome

Title	Quality of Intermediate Vision
Description	Subjective scoring of Quality of Intermediate Vision assessed using 0-100 continuous scale: (0=extremely poor vision all of the time. 100=excellent vision all of the time)
Time Frame	Baseline (After 10 minutes of lens dispense)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Phenacite Test Lens	Comfilcon A Control Lens
Arm/Group Description	Participants were randomized to wear Phenacite test lens for one week Phenacite: contact lens	Participants were randomized to wear comfilcon A control lens for one week comfilcon A: contact lens
Measure Participants	44	44
Mean (Standard Deviation) [units on a scale]	97 (6)	93 (9)

16. Primary Outcome

Title	Quality of Intermediate Vision
Description	Subjective scoring of Quality of Intermediate Vision assessed using 0-100 continuous scale: (0=extremely poor vision all of the time. 100=excellent vision all of the time)
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Phenacite Test Lens	Comfilcon A Control Lens
Arm/Group Description	Participants were randomized to wear Phenacite test lens for one week Phenacite: contact lens	Participants were randomized to wear comfilcon A control lens for one week comfilcon A: contact lens
Measure Participants	44	44
Mean (Standard Deviation) [units on a scale]	92 (11)	92 (10)

17. Primary Outcome

Title	Overall Vision Quality
Description	Subjective scoring of overall vision quality assessed using 0-100 continuous scale: (0=extremely poor vision all of the time. 100=excellent vision all of the time)
Time Frame	Baseline (After 10 minutes of lens dispense)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Phenacite Test Lens	Comfilcon A Control Lens
Arm/Group Description	Participants were randomized to wear Phenacite test lens for one week Phenacite: contact lens	Participants were randomized to wear comfilcon A control lens for one week comfilcon A: contact lens
Measure Participants	44	44
Mean (Standard Deviation) [units on a scale]	95 (6)	89 (13)

18. Primary Outcome

Title	Overall Vision Quality
Description	Subjective scoring of overall vision quality assessed using 0-100 continuous scale: (0=extremely poor vision all of the time. 100=excellent vision all of the time)
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Phenacite Test Lens	Comfilcon A Control Lens
Arm/Group Description	Participants were randomized to wear Phenacite test lens for one week Phenacite: contact lens	Participants were randomized to wear comfilcon A control lens for one week comfilcon A: contact lens
Measure Participants	44	44
Mean (Standard Deviation) [units on a scale]	88 (15)	89 (12)

19. Secondary Outcome

Title	Biomicroscopy Findings - Bulbar Hyperemia
Description	Bulbar hyperemia assessment using 5 categories: (0=None, 1= Slight injection to conjunctival vessels, 2= Mild injection, 3= Moderate injection, 4= Severe injection) in (0.25 steps)
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Phenacite Test Lens	Comfilcon A Control Lens
Arm/Group Description	Participants were randomized to wear Phenacite test lens for one week Phenacite: contact lens	Participants were randomized to wear comfilcon A control lens for one week comfilcon A: contact lens
Measure Participants	44	44
Mean (Standard Deviation) [units on a scale]	1.24 (0.67)	1.37 (0.82)

20. Secondary Outcome

Title	Biomicroscopy Findings- Limbal Hyperemia
Description	Investigator assessment using 5 categories: (0=None, 1= Slight injection to conjunctival vessels, 2= Mild injection, 3= Moderate injection, 4= Severe injection) in (0.25 steps)
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Phenacite Test Lens	Comfilcon A Control Lens
Arm/Group Description	Participants were randomized to wear Phenacite test lens for one week Phenacite: contact lens	Participants were randomized to wear comfilcon A control lens for one week comfilcon A: contact lens
Measure Participants	44	44
Mean (Standard Deviation) [units on a scale]	0.98 (0.69)	1.21 (0.89)

21. Secondary Outcome

Title	Biomicroscopy Findings - Corneal Staining Extent
Description	Investigator Assessment on Biomicroscopy Findings - Corneal Staining Extent on a scale of 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	1 week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Phenacite Test Lens	Comfilcon A Control Lens
Arm/Group Description	Participants were randomized to wear Phenacite test lens for one week Phenacite: contact lens	Participants were randomized to wear comfilcon A control lens for one week comfilcon A: contact lens
Measure Participants	44	44
Central	0.05 (0.21)	0.10 (0.34)
Nasal	0.14 (0.34)	0.16 (0.39)
Temporal	0.07 (0.26)	0.03 (0.20)
Superior	0.13 (0.37)	0.19 (0.40)
Inferior	0.34 (0.58)	0.51 (0.74)

22. Secondary Outcome

Title	Ghosting - Distance Vision
Description	Patient subjective scoring using 0-100 continuous scale:0=Intolerable;100=Not noticable
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Phenacite Test Lens	Comfilcon A Control Lens
Arm/Group Description	Participants were randomized to wear Phenacite test lens for one week Phenacite: contact lens	Participants were randomized to wear comfilcon A control lens for one week comfilcon A: contact lens
Measure Participants	44	44
Mean (Standard Deviation) [units on a scale]	93 (12)	93 (12)

23. Secondary Outcome

Title	Ghosting - Near Vision
Description	Patient subjective scoring using 0-100 continuous scale:0=Intolerable;100=Not noticable
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Phenacite Test Lens	Comfilcon A Control Lens
Arm/Group Description	Participants were randomized to wear Phenacite test lens for one week Phenacite: contact lens	Participants were randomized to wear comfilcon A control lens for one week comfilcon A: contact lens
Measure Participants	44	44
Mean (Standard Deviation) [units on a scale]	93 (10)	93 (10)

24. Secondary Outcome

Title	Overall Comfort
Description	Patient subjective scoring using 0-100 continuous scale, 0= cannot be worn, 100= cannot be felt ever.
Time Frame	Baseline (After 10 minutes of lens dispense)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Phenacite Test Lens	Comfilcon A Control Lens
Arm/Group Description	Participants were randomized to wear Phenacite test lens for one week Phenacite: contact lens	Participants were randomized to wear comfilcon A control lens for one week comfilcon A: contact lens
Measure Participants	44	44
Mean (Standard Deviation) [units on a scale]	91 (8)	89 (12)

25. Secondary Outcome

Title	Overall Comfort
Description	Patient subjective scoring for overall comfort using 0-100 continuous scale, 0= cannot be worn, 100= cannot be felt ever.
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Phenacite Test Lens	Comfilcon A Control Lens
Arm/Group Description	Participants were randomized to wear Phenacite test lens for one week Phenacite: contact lens	Participants were randomized to wear comfilcon A control lens for one week comfilcon A: contact lens
Measure Participants	44	44
Mean (Standard Deviation) [units on a scale]	78 (23)	79 (19)

26. Secondary Outcome

Title	Overall Dryness
Description	Patient subjective scoring for overall dryness using 0-100 continuous scale, 0=cannot be worn, 100=no dryness experienced at any time.
Time Frame	Baseline (after 10 minutes of lens dispense)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Phenacite Test Lens	Comfilcon A Control Lens
Arm/Group Description	Participants were randomized to wear Phenacite test lens for one week Phenacite: contact lens	Participants were randomized to wear comfilcon A control lens for one week comfilcon A: contact lens
Measure Participants	44	44
Mean (Standard Deviation) [units on a scale]	92 (12)	92 (12)

27. Secondary Outcome

Title	Overall Dryness
Description	Patient subjective scoring for overall dryness using 0-100 continuous scale, 0=cannot be worn, 100=no dryness experienced at any time.
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Phenacite Test Lens	Comfilcon A Control Lens
Arm/Group Description	Participants were randomized to wear Phenacite test lens for one week Phenacite: contact lens	Participants were randomized to wear comfilcon A control lens for one week comfilcon A: contact lens
Measure Participants	44	44
Mean (Standard Deviation) [units on a scale]	76 (23)	77 (21)

28. Secondary Outcome

Title	Lens Preference - Overall Vision Preference
Description	Subjective rating of lens preference for overall vision preference (Phenacite, comfilcon A, No preference)
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Overall Study
Arm/Group Description	Subjects were randomized to wear phenacite study lens and comfilcon A control lens for one week.
Measure Participants	44
Phenacite	14 31.8%
comfilcon A	25 56.8%
No Preference	5 11.4%

29. Secondary Outcome

Title	Subjective Ratings of Change in Frequency of Tiredness
Description	Subjective rating of change in eye fatigue frequency of tiredness assessed using Eye fatigue Experience Questionnaire (EFEG)
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Phenacite	Comfilcon A
Arm/Group Description	Subjects were randomized to wear phenacite study lens for one week. Phenacite: contact lens	Subjects were randomized to wear comfilcon A contact lens for one week. comfilcon A : contact lens
Measure Participants	44	44
Much Better	11 25%	18 NaN
Better	50 113.6%	39 NaN
No Difference	36 81.8%	39 NaN
Worse	0 0%	4 NaN
Much Worse	4 9.1%	0 NaN

30. Secondary Outcome

Title	Subjective Ratings of Change in Severity of Tiredness
Description	Subjective rating of change in eye fatigue severity of tiredness assessed using Eye fatigue Experience Questionnaire (EFEG)
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Phenacite	Comfilcon A
Arm/Group Description	Subjects were randomized to wear phenacite study lens for one week. Phenacite: contact lens	Subjects were randomized to wear comfilcon A contact lens for one week. comfilcon A : contact lens
Measure Participants	44	44
Much Better	17 38.6%	17 NaN
Better	48 109.1%	39 NaN
No Difference	26 59.1%	35 NaN
Worse	4 9.1%	9 NaN
Much Worse	4 9.1%	0 NaN

31. Secondary Outcome

Title	Subjective Ratings of Change in Bothersome Rating for Tiredness
Description	Subjective rating of change in eye fatigue bothersome rating for tiredness assessed using Eye fatigue Experience Questionnaire (EFEG)
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Phenacite	Comfilcon A
Arm/Group Description	Subjects were randomized to wear phenacite study lens for one week. Phenacite: contact lens	Subjects were randomized to wear comfilcon A contact lens for one week. comfilcon A : contact lens
Measure Participants	44	44
Much Better	20 45.5%	10 NaN
Better	45 102.3%	45 NaN
No Difference	35 79.5%	40 NaN
Worse	0 0%	5 NaN
Much Worse	0 0%	0 NaN

32. Secondary Outcome

Title	Subjective Ratings of Change in Frequency of Dryness
Description	Subjective rating of change in eye fatigue frequency of dryness assessed using Eye fatigue Experience Questionnaire (EFEG)
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Phenacite	Comfilcon A
Arm/Group Description	Subjects were randomized to wear phenacite study lens for one week. Phenacite: contact lens	Subjects were randomized to wear comfilcon A contact lens for one week. comfilcon A : contact lens
Measure Participants	44	44
Much Better	15 34.1%	20 NaN
Better	35 79.5%	15 NaN
No Difference	25 56.8%	35 NaN
Worse	15 34.1%	25 NaN
Much Worse	10 22.7%	5 NaN

33. Secondary Outcome

Title	Subjective Ratings of Change in Severity of Dryness
Description	Subjective rating of change in eye fatigue severity of dryness assessed using Eye fatigue Experience Questionnaire (EFEG)
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Phenacite	Comfilcon A
Arm/Group Description	Subjects were randomized to wear phenacite study lens for one week. Phenacite: contact lens	Subjects were randomized to wear comfilcon A contact lens for one week. comfilcon A : contact lens
Measure Participants	44	44
Much Better	9 20.5%	5 NaN
Better	41 93.2%	41 NaN
No Difference	32 72.7%	27 NaN
Worse	9 20.5%	23 NaN
Much Worse	9 20.5%	5 NaN

34. Secondary Outcome

Title	Subjective Ratings of Change in Bothersome Rating of Dryness
Description	Subjective rating of change in eye fatigue bothersome rating for dryness assessed using Eye fatigue Experience Questionnaire (EFEG)
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Phenacite	Comfilcon A
Arm/Group Description	Subjects were randomized to wear phenacite study lens for one week. Phenacite: contact lens	Subjects were randomized to wear comfilcon A contact lens for one week. comfilcon A : contact lens
Measure Participants	44	44
Much Better	15 34.1%	10 NaN
Better	40 90.9%	40 NaN
No Difference	25 56.8%	25 NaN
Worse	15 34.1%	20 NaN
Much Worse	5 11.4%	5 NaN

35. Secondary Outcome

Title	Subjective Questionnaire Response - Eye Strain
Description	Subjective questionnaire response for " My eyes don't feel strained while wearing these lenses" - Agree, Disagree
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Phenacite	Comfilcon A
Arm/Group Description	Subjects were randomized to wear phenacite study lens for one week. Phenacite: contact lens	Subjects were randomized to wear comfilcon A contact lens for one week. comfilcon A : contact lens
Measure Participants	44	44
Agree	75 170.5%	75 NaN
Disagree	25 56.8%	25 NaN

36. Secondary Outcome

Title	Subjective Questionnaire Response - Eye Feel Good
Description	Subjective questionnaire response for " These lenses make my eyes feel good" - Agree, Disagree
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Phenacite	Comfilcon A
Arm/Group Description	Subjects were randomized to wear phenacite study lens for one week. Phenacite: contact lens	Subjects were randomized to wear comfilcon A contact lens for one week. comfilcon A : contact lens
Measure Participants	44	44
Agree	86 195.5%	71 NaN
Disagree	14 31.8%	29 NaN

37. Secondary Outcome

Title	Subjective Questionnaire Response - Eye Feel Relaxed
Description	Subjective questionnaire response for " These lenses make my eyes feel relaxed" - Agree, Disagree
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Phenacite	Comfilcon A
Arm/Group Description	Subjects were randomized to wear phenacite study lens for one week. Phenacite: contact lens	Subjects were randomized to wear comfilcon A contact lens for one week. comfilcon A : contact lens
Measure Participants	44	44
Agree	79 179.5%	79 NaN
Disagree	21 47.7%	21 NaN

38. Secondary Outcome

Title	Subjective Questionnaire Response - Vision
Description	Subjective questionnaire response for " These lenses help my vision" - Agree, Disagree
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Phenacite	Comfilcon A
Arm/Group Description	Subjects were randomized to wear phenacite study lens for one week. Phenacite: contact lens	Subjects were randomized to wear comfilcon A contact lens for one week. comfilcon A : contact lens
Measure Participants	44	44
Agree	96 218.2%	96 NaN
Disagree	4 9.1%	4 NaN

39. Secondary Outcome

Title	Subjective Questionnaire Response - Eye Tired
Description	Subjective questionnaire response for " These lenses make my eyes feel less tired" - Agree, Disagree
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Phenacite	Comfilcon A
Arm/Group Description	Subjects were randomized to wear phenacite study lens for one week. Phenacite: contact lens	Subjects were randomized to wear comfilcon A contact lens for one week. comfilcon A : contact lens
Measure Participants	44	44
Agree	82 186.4%	75 NaN
Disagree	18 40.9%	25 NaN

Adverse Events

Time Frame	From dispense up to one week on each study lenses, a total of two weeks
Arm/Group Title	Phenacite Test Lens		Comfilcon A Control Lens
Arm/Group Description	Participants were randomized to wear Phenacite test lens for one week. Phenacite: contact lens		Participants were randomized to wear comfilcon A control lens for one week. comfilcon A: contact lens
All Cause Mortality
	Phenacite Test Lens		Comfilcon A Control Lens
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/44 (0%)		0/44 (0%)
Serious Adverse Events
	Phenacite Test Lens		Comfilcon A Control Lens
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/44 (0%)		0/44 (0%)
Other (Not Including Serious) Adverse Events
	Phenacite Test Lens		Comfilcon A Control Lens
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/44 (0%)		0/44 (0%)

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.