One Week Assessment of The Phenacite Lens

• Sponsor: Coopervision, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02553395
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arms: 2
• Duration (Days): 30
• Patients Per Site Per Month: 30.4

Study Details

Study Description

Brief Summary

This study will investigate performance criteria over one week of daily wear to determine if the Study Test contact lens performs equivalently to the comfilcon A contact lenses in terms of subjective ratings and of visual performance.

The study test lens was not the final optical design and the study results were not used for the design validation.

Condition or Disease	Intervention/Treatment	Phase
Myopia	Device: Phenacite (Test) contact lens; Device: comfilcon A contact lens	N/A

Detailed Description

This will be double-masked, randomized, bilateral crossover study comparing the Study Test lens against the comfilcon A control lens, each worn over one week of daily wear.

The study test lens was not the final optical design and the study results were not used for the design validation.

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Other
• Official Title: One Week Assessment of The Phenacite Lens
• Study Start Date: Sep 1, 2015
• Actual Primary Completion Date: Sep 1, 2015
• Actual Study Completion Date: Oct 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Phenacite contact lens Study Test Contact Lens	Device: Phenacite (Test) contact lens
Active Comparator: comfilcon A contact lens Control Contact Lens	Device: comfilcon A contact lens

Outcome Measures

Primary Outcome Measures

1. Binocular Distance Visual Acuity (VA) - High Illumination High Contrast [Baseline - After 5 minutes of lens settling]

   Binocular Distance visual acuity High Illumination High Contrast was assessed using logMAR (0.02 logMAR= 1 letter)

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

   Binocular Distance visual acuity High Illumination High Contrast was assessed using logMAR (0.02 logMAR= 1 letter)

3. Binocular Near Visual Acuity (VA) - High Illumination High Contrast [Baseline - after 5 minutes of lens dispense]

   Binocular Near Visual Acuity High Illumination High Contrast was assessed on logMAR VA (0.02 logMAR= 1 letter)

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

   Binocular Near Visual Acuity High Illumination High Contrast was assessed on logMAR VA (0.02 logMAR= 1 letter)

5. Binocular Distance Visual Acuity (VA) - Low Illumination High Contrast [Baseline (After 5 minutes of lens settling)]

   Binocular Distance Visual Acuity (VA) - Low Illumination High Contrast was assessed using logMAR VA (0.02 logMAR= 1 letter)

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

   Binocular Distance Visual Acuity (VA) - Low Illumination High Contrast was assessed using logMAR VA (0.02 logMAR= 1 letter)

7. Binocular Near Visual Acuity (VA) - Low Illumination High Contrast [Baseline (after 5 minutes of lens settling)]

   Binocular Near Visual Acuity (VA) - Low Illumination High Contrast was assessed using logMAR VA (0.02 logMAR= 1 letter)

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

   Binocular Near Visual Acuity (VA) - Low Illumination High Contrast was assessed using logMAR VA (0.02 logMAR= 1 letter)

9. Subjective Ratings for Distance Quality of Vision [1 week]

   Patient subjective scoring using anchors on the scale to provide a score between 0-100 for Distance Quality of Vision: (0=extremely poor vision all of the time. Cannot function; 20= Frequently annoying vision problems; 40=Occasionally annoying vision problems; 60=occasionally noticeable but not annoying vision problems; 80=rarely noticeable vision problems; 100=excellent vision all of the time)

10. Subjective Ratings for Intermediate Quality of Vision [1 week]

    Patient subjective scoring using anchors on the scale to provide a score between 0-100 for Intermediate Quality of Vision: (0=extremely poor vision all of the time. Cannot function; 20= Frequently annoying vision problems; 40=Occasionally annoying vision problems; 60=occasionally noticeable but not annoying vision problems; 80=rarely noticeable vision problems; 100=excellent vision all of the time)

11. Subjective Ratings for Near Quality of Vision [1 week]

    Patient subjective scoring using anchors on the scale to provide a score between 0-100 for Near Quality of Vision: (0=extremely poor vision all of the time. Cannot function; 20= Frequently annoying vision problems; 40=Occasionally annoying vision problems; 60=occasionally noticeable but not annoying vision problems; 80=rarely noticeable vision problems; 100=excellent vision all of the time)

Secondary Outcome Measures

1. Post Blink Movement - [Baseline (After 5 minutes of lens dispense)]

   Post blink movement was assessed by the investigator by the amount of movement (to the nearest 0.1mm) immediately after the blink (0.1mm steps)

2. Post Blink Movement [1 week]

   Investigator assessment of Amount of movement (to the nearest 0.1mm) immediately after the blink (0.1mm steps)

3. Push - Up Test for Lens Tightness [Baseline (After 5 minutes of lens dispense)]

   Investigator assessment using Continuous Scale 0-100% (1% steps): 0%=Falls from cornea without lid support, 50%=Optimum, 100%=No movement

4. Push - Up Test for Lens Tightness [1 week]

   Investigator assessment using Continuous Scale 0-100% (1% steps): 0%=Falls from cornea without lid support, 50%=Optimum, 100%=No movement

5. Lens Mobility Rating [Baseline (after 5 minutes of lens dispense)]

   Investigator assessment using 5 Categories in 0.50 steps: 0=Immobile - no lag in any versions, 1=Restricted - no lag in some directions but slight lag (0-0.25mm) in others, 2=Secure - slight lag (0.25-0.5mm in each version), 3=Unrestricted - freely lags in a controlled manner on all versions, but not excessive (0.5-1.0mm), 4=Very mobile - excessive lag (>1mm) on versions in all directions in 0.25 steps

6. Lens Mobility Rating [1 week]

   Investigator assessment using 5 Categories in 0.50 steps: 0=Immobile - no lag in any versions, 1=Restricted - no lag in some directions but slight lag (0-0.25mm) in others, 2=Secure - slight lag (0.25-0.5mm in each version), 3=Unrestricted - freely lags in a controlled manner on all versions, but not excessive (0.5-1.0mm), 4=Very mobile - excessive lag (>1mm) on versions in all directions in 0.25 steps

7. Overall Lens Fit Acceptance [Baseline (After 5 minutes of lens dispense)]

   Investigator assessment using 5 Categories in 0.25 steps: 0=Can't be worn, 1=Poor - should not be dispensed although no immediate danger, 2=Fair, 3=Good, 4=Optimum in 0.25 steps

8. Overall Lens Fit Acceptance [1 week]

   Investigator assessment using 5 Categories in 0.25 steps: 0=Can't be worn,, 1=Poor - should not be dispensed although no immediate danger, 2=Fair, 3=Good, 4=Optimum in 0.25 steps

9. Subjective Lens Preference - Distance Vision [1 week]

   Patient subjective preference: Phenacite lens, comfilcon A or No Preference

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

    Patient subjective preference: Phenacite test lens, comfilcon A or No Preference

11. Subjective Lens Preference - Comfort [1 week]

    Patient subjective preference: Phenacite test lens, comfilcon A or No Preference

12. Subjective Overall Lens Preference [1 week]

    Patient subjective overall preference: Phenacite test lens, comfilcon A or No Preference

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 (Diopter) and -4.50D

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

• 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.

• 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 Optics Research Lab (CORL) Indiana University School of Optometry, Indiana University	Bloomington	Indiana	United States	47405

Sponsors and Collaborators

• Coopervision, Inc.

Investigators

• Principal Investigator: Peter Kollbaum, OD, PhD, Clinical Optics Research Lab (CORL)

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Coopervision, Inc.
• ClinicalTrials.gov Identifier: NCT02553395
• Other Study ID Numbers: CV-15-40
• First Posted: Sep 17, 2015
• Last Update Posted: Dec 22, 2020
• Last Verified: Nov 1, 2020

• Additional relevant MeSH terms: Myopia

Study Results

Participant Flow

Arm/Group Title	Phenacite Contact Lens Then Comfilcon A	Comfilcon A Contact Lens Then Phenacite Contact Lens
Arm/Group Description	Subjects were randomized to wear test lenses for one week and then cross-over to comfilcon A contact lens for one week. Phenacite : Contact Lens comfilcon A: contact lens	Subjects were randomized to wear comfilcon A lenses for one week and then cross-over to test contact lens for one week. comfilcon A: contact lens Phenacite : Contact Lens
Period Title: First Intervention
STARTED	12	18
COMPLETED	12	18
NOT COMPLETED	0	0
Period Title: First Intervention
STARTED	12	18
COMPLETED	12	18
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Overall Study
Arm/Group Description	Subjects were randomized to wear test lens for one week and then cross-over to control lens for one week.
Overall Participants	30
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	30 100%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	25 (3)
Sex: Female, Male (Count of Participants)
Female	24 80%
Male	6 20%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (participants) [Number]
United States	30 100%

Outcome Measures

1. Primary Outcome

Title	Binocular Distance Visual Acuity (VA) - High Illumination High Contrast
Description	Binocular Distance visual acuity High Illumination High Contrast was assessed using logMAR (0.02 logMAR= 1 letter)
Time Frame	Baseline - After 5 minutes of lens settling

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Phenacite Contact Lens	Comfilcon A Contact Lens
Arm/Group Description	Subjects were randomized to wear test contact lens for one week. Phenacite: Contact lens	Subjects were randomized to wear control contact lens for one week. comfilcon A: contact lens
Measure Participants	30	30
Mean (Standard Deviation) [logMAR]	-0.22 (0.05)	-0.24 (0.05)

2. Primary Outcome

Title	Binocular Distance Visual Acuity (VA) -High Illumination High Contrast
Description	Binocular Distance visual acuity High Illumination High Contrast was assessed using logMAR (0.02 logMAR= 1 letter)
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Phenacite Contact Lens	Comfilcon A Contact Lens
Arm/Group Description	Subjects were randomized to wear test contact lens for one week. Phenacite: Contact lens	Subjects were randomized to wear control contact lens for one week. comfilcon A: contact lens
Measure Participants	30	30
Mean (Standard Deviation) [logMAR]	-0.20 (0.05)	-0.22 (0.06)

3. Primary Outcome

Title	Binocular Near Visual Acuity (VA) - High Illumination High Contrast
Description	Binocular Near Visual Acuity High Illumination High Contrast was assessed on logMAR VA (0.02 logMAR= 1 letter)
Time Frame	Baseline - after 5 minutes of lens dispense

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Phenacite Contact Lens	Comfilcon A Contact Lens
Arm/Group Description	Subjects were randomized to wear test contact lens for one week. Phenacite: Contact lens	Subjects were randomized to wear control contact lens for one week. comfilcon A: contact lens
Measure Participants	30	30
Mean (Standard Deviation) [logMAR]	-0.18 (0.06)	-0.19 (0.07)

4. Primary Outcome

Title	Binocular Near Visual Acuity (VA) - High Illumination High Contrast
Description	Binocular Near Visual Acuity High Illumination High Contrast was assessed on logMAR VA (0.02 logMAR= 1 letter)
Time Frame	1-week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Phenacite Contact Lens	Comfilcon A Contact Lens
Arm/Group Description	Subjects were randomized to wear test contact lens for one week. Phenacite: Contact lens	Subjects were randomized to wear control contact lens for one week. comfilcon A: contact lens
Measure Participants	30	30
Mean (Standard Deviation) [logMAR]	-0.19 (0.06)	-0.19 (0.06)

5. Primary Outcome

Title	Binocular Distance Visual Acuity (VA) - Low Illumination High Contrast
Description	Binocular Distance Visual Acuity (VA) - Low Illumination High Contrast was assessed using logMAR VA (0.02 logMAR= 1 letter)
Time Frame	Baseline (After 5 minutes of lens settling)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Phenacite Contact Lens	Comfilcon A Contact Lens
Arm/Group Description	Subjects were randomized to wear test contact lens for one week. Phenacite: Contact lens	Subjects were randomized to wear control contact lens for one week. comfilcon A: contact lens
Measure Participants	30	30
Mean (Standard Deviation) [LogMAR]	-0.02 (0.05)	-0.04 (0.07)

6. Primary Outcome

Title	Binocular Distance Visual Acuity (VA) - Low Illumination High Contrast
Description	Binocular Distance Visual Acuity (VA) - Low Illumination High Contrast was assessed using logMAR VA (0.02 logMAR= 1 letter)
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Phenacite Contact Lens	Comfilcon A Contact Lens
Arm/Group Description	Subjects were randomized to wear test contact lens for one week. Phenacite: Contact lens	Subjects were randomized to wear control contact lens for one week. comfilcon A: contact lens
Measure Participants	30	30
Mean (Standard Deviation) [LogMAR]	0.00 (0.08)	-0.04 (0.06)

7. Primary Outcome

Title	Binocular Near Visual Acuity (VA) - Low Illumination High Contrast
Description	Binocular Near Visual Acuity (VA) - Low Illumination High Contrast was assessed using logMAR VA (0.02 logMAR= 1 letter)
Time Frame	Baseline (after 5 minutes of lens settling)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Phenacite Contact Lens	Comfilcon A Contact Lens
Arm/Group Description	Subjects were randomized to wear test contact lens for one week. Phenacite: Contact lens	Subjects were randomized to wear control contact lens for one week. comfilcon A: contact lens
Measure Participants	30	30
Mean (Standard Deviation) [LogMAR]	-0.00 (0.07)	0.00 (0.07)

8. Primary Outcome

Title	Binocular Near Visual Acuity (VA) - Low Illumination High Contrast
Description	Binocular Near Visual Acuity (VA) - Low Illumination High Contrast was assessed using logMAR VA (0.02 logMAR= 1 letter)
Time Frame	1week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Phenacite Contact Lens	Comfilcon A Contact Lens
Arm/Group Description	Subjects were randomized to wear test contact lens for one week. Phenacite: Contact lens	Subjects were randomized to wear control contact lens for one week. comfilcon A: contact lens
Measure Participants	30	30
Mean (Standard Deviation) [LogMAR]	-0.01 (0.08)	-0.00 (0.06)

9. Primary Outcome

Title	Subjective Ratings for Distance Quality of Vision
Description	Patient subjective scoring using anchors on the scale to provide a score between 0-100 for Distance Quality of Vision: (0=extremely poor vision all of the time. Cannot function; 20= Frequently annoying vision problems; 40=Occasionally annoying vision problems; 60=occasionally noticeable but not annoying vision problems; 80=rarely noticeable vision problems; 100=excellent vision all of the time)
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 test lens for one week and then cross-over to control lens for one week.
Measure Participants	30
Phenacite Test Contact Lens	85 (15)
comfilcon A control lens	91 (9)

10. Primary Outcome

Title	Subjective Ratings for Intermediate Quality of Vision
Description	Patient subjective scoring using anchors on the scale to provide a score between 0-100 for Intermediate Quality of Vision: (0=extremely poor vision all of the time. Cannot function; 20= Frequently annoying vision problems; 40=Occasionally annoying vision problems; 60=occasionally noticeable but not annoying vision problems; 80=rarely noticeable vision problems; 100=excellent vision all of the time)
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 test lens for one week and then cross-over to control lens for one week.
Measure Participants	30
Phenacite Test Lens	91 (10)
comfilcon A control lens	95 (7)

11. Primary Outcome

Title	Subjective Ratings for Near Quality of Vision
Description	Patient subjective scoring using anchors on the scale to provide a score between 0-100 for Near Quality of Vision: (0=extremely poor vision all of the time. Cannot function; 20= Frequently annoying vision problems; 40=Occasionally annoying vision problems; 60=occasionally noticeable but not annoying vision problems; 80=rarely noticeable vision problems; 100=excellent vision all of the time)
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 test lens for one week and then cross-over to control lens for one week.
Measure Participants	30
Phenacite Test Lens	92 (11)
comfilcon A control lens	95 (6)

12. Secondary Outcome

Title	Post Blink Movement -
Description	Post blink movement was assessed by the investigator by the amount of movement (to the nearest 0.1mm) immediately after the blink (0.1mm steps)
Time Frame	Baseline (After 5 minutes of lens dispense)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Phenacite Contact Lens	Comfilcon A Contact Lens
Arm/Group Description	Subjects were randomized to wear test contact lens for one week. Phenacite: Contact lens	Subjects were randomized to wear control contact lens for one week. comfilcon A: contact lens
Measure Participants	30	30
Right eye	0.23 (0.06)	0.24 (0.08)
Left eye	0.23 (0.06)	0.25 (0.08)

13. Secondary Outcome

Title	Post Blink Movement
Description	Investigator assessment of Amount of movement (to the nearest 0.1mm) immediately after the blink (0.1mm steps)
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Phenacite Contact Lens	Comfilcon A Contact Lens
Arm/Group Description	Subjects were randomized to wear test contact lens for one week. Phenacite: Contact lens	Subjects were randomized to wear control contact lens for one week. comfilcon A: contact lens
Measure Participants	30	30
Right eye	0.24 (0.06)	0.24 (0.07)
Left Eye	0.25 (0.08)	0.25 (0.06)

14. Secondary Outcome

Title	Push - Up Test for Lens Tightness
Description	Investigator assessment using Continuous Scale 0-100% (1% steps): 0%=Falls from cornea without lid support, 50%=Optimum, 100%=No movement
Time Frame	Baseline (After 5 minutes of lens dispense)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Phenacite Contact Lens	Comfilcon A Contact Lens
Arm/Group Description	Subjects were randomized to wear test contact lens for one week. Phenacite: Contact lens	Subjects were randomized to wear control contact lens for one week. comfilcon A: contact lens
Measure Participants	30	30
Right eye	50.83 (4.17)	49.67 (2.92)
Left Eye	50.33 (4.14)	49.17 (3.49)

15. Secondary Outcome

Title	Push - Up Test for Lens Tightness
Description	Investigator assessment using Continuous Scale 0-100% (1% steps): 0%=Falls from cornea without lid support, 50%=Optimum, 100%=No movement
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Phenacite Contact Lens	Comfilcon A Contact Lens
Arm/Group Description	Subjects were randomized to wear test contact lens for one week. Phenacite: Contact lens	Subjects were randomized to wear control contact lens for one week. comfilcon A: contact lens
Measure Participants	30	30
Right Eye	50.33 (4.14)	49.17 (3.73)
Left eye	49.33 (6.53)	49.17 (2.65)

16. Secondary Outcome

Title	Lens Mobility Rating
Description	Investigator assessment using 5 Categories in 0.50 steps: 0=Immobile - no lag in any versions, 1=Restricted - no lag in some directions but slight lag (0-0.25mm) in others, 2=Secure - slight lag (0.25-0.5mm in each version), 3=Unrestricted - freely lags in a controlled manner on all versions, but not excessive (0.5-1.0mm), 4=Very mobile - excessive lag (>1mm) on versions in all directions in 0.25 steps
Time Frame	Baseline (after 5 minutes of lens dispense)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Phenacite Contact Lens	Comfilcon A Contact Lens
Arm/Group Description	Subjects were randomized to wear test contact lens for one week. Phenacite: Contact lens	Subjects were randomized to wear control contact lens for one week. comfilcon A: contact lens
Measure Participants	30	30
Right eye	2.97 (0.20)	3.00 (0.26)
Left eye	2.97 (0.22)	3.02 (0.25)

17. Secondary Outcome

Title	Lens Mobility Rating
Description	Investigator assessment using 5 Categories in 0.50 steps: 0=Immobile - no lag in any versions, 1=Restricted - no lag in some directions but slight lag (0-0.25mm) in others, 2=Secure - slight lag (0.25-0.5mm in each version), 3=Unrestricted - freely lags in a controlled manner on all versions, but not excessive (0.5-1.0mm), 4=Very mobile - excessive lag (>1mm) on versions in all directions in 0.25 steps
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Phenacite Contact Lens	Comfilcon A Contact Lens
Arm/Group Description	Subjects were randomized to wear test contact lens for one week. Phenacite: Contact lens	Subjects were randomized to wear control contact lens for one week. comfilcon A: contact lens
Measure Participants	30	30
Right Eye	2.98 (0.25)	3.04 (0.16)
Left eye	3.02 (0.31)	3.04 (0.16)

18. Secondary Outcome

Title	Overall Lens Fit Acceptance
Description	Investigator assessment using 5 Categories in 0.25 steps: 0=Can't be worn, 1=Poor - should not be dispensed although no immediate danger, 2=Fair, 3=Good, 4=Optimum in 0.25 steps
Time Frame	Baseline (After 5 minutes of lens dispense)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Phenacite Contact Lens	Comfilcon A Contact Lens
Arm/Group Description	Subjects were randomized to wear test contact lens for one week. Phenacite: Contact lens	Subjects were randomized to wear control contact lens for one week. comfilcon A: contact lens
Measure Participants	30	30
Right Eye	3.48 (0.22)	3.42 (0.36)
Left Eye	3.46 (0.22)	3.44 (0.33)

19. Secondary Outcome

Title	Overall Lens Fit Acceptance
Description	Investigator assessment using 5 Categories in 0.25 steps: 0=Can't be worn,, 1=Poor - should not be dispensed although no immediate danger, 2=Fair, 3=Good, 4=Optimum in 0.25 steps
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Phenacite Contact Lens	Comfilcon A Contact Lens
Arm/Group Description	Subjects were randomized to wear test contact lens for one week. Phenacite: Contact lens	Subjects were randomized to wear control contact lens for one week. comfilcon A: contact lens
Measure Participants	30	30
Right eye	3.42 (0.28)	3.48 (0.28)
Left Eye	3.35 (0.52)	3.49 (0.28)

20. Secondary Outcome

Title	Subjective Lens Preference - Distance Vision
Description	Patient subjective preference: Phenacite lens, comfilcon A or 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 test lens for one week and then cross-over to control lens for one week.
Measure Participants	30
Phenacite Lens	17 56.7%
comfilcon A	50 166.7%
No preference	33 110%

21. Secondary Outcome

Title	Subjective Lens Preference -Overall Vision Preference
Description	Patient subjective preference: Phenacite test lens, comfilcon A or 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 test lens for one week and then cross-over to control lens for one week.
Measure Participants	30
Phenacite	27 90%
comfilcon A	56 186.7%
No Preference	17 56.7%

22. Secondary Outcome

Title	Subjective Lens Preference - Comfort
Description	Patient subjective preference: Phenacite test lens, comfilcon A or 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 test lens for one week and then cross-over to control lens for one week.
Measure Participants	30
Phenacite	43 143.3%
comfilcon A	40 133.3%
No preference	17 56.7%

23. Secondary Outcome

Title	Subjective Overall Lens Preference
Description	Patient subjective overall preference: Phenacite test lens, comfilcon A or 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 test lens for one week and then cross-over to control lens for one week.
Measure Participants	30
Phenacite	33 110%
comfilcon A	57 190%
No preference	10 33.3%

Adverse Events

Time Frame	From dispense up to one week on each study lens, a total of 2 weeks.
Arm/Group Title	Phenacite Contact Lens		Comfilcon A Contact Lens
Arm/Group Description	Subjects were randomized to wear test contact lens for one week. Phenacite: Contact lens		Subjects were randomized to wear control contact lens for one week. comfilcon A: contact lens
All Cause Mortality
	Phenacite Contact Lens		Comfilcon A Contact Lens
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/30 (0%)		0/30 (0%)
Serious Adverse Events
	Phenacite Contact Lens		Comfilcon A Contact Lens
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/30 (0%)		0/30 (0%)
Other (Not Including Serious) Adverse Events
	Phenacite Contact Lens		Comfilcon A Contact Lens
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/30 (0%)		0/30 (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.