Dispensing Study for the Phenacite Project

• Sponsor: Coopervision, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02436005
• Collaborator: (none)
• Enrollment: 25
• Location: 1
• Arms: 2
• Duration (Months): 3
• Patients Per Site Per Month: 8.4

Study Details

Study Description

Brief Summary

Dispensing Study for the Phenacite Project.

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

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

Detailed Description

Evaluate the objective and patient-reported visual acceptability of the Phenacite contact lens.

Study Design

• Study Type: Interventional
• Actual Enrollment: 25 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: Apr 1, 2015
• Actual Primary Completion Date: Jul 1, 2015
• Actual Study Completion Date: Jul 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Phenacite Subjects will be randomized to wear the Phenacite contact lenses binocularly.	Device: Phenacite; Subjects will be randomized to wear the Phenacite contact lenses binocularly.; Device: comfilcon A; Subjects will be randomized to wear the comfilcon A contact lenses binocularly.
Active Comparator: comfilcon A Subjects will be randomized to wear the comfilcon A contact lenses binocularly.	Device: Phenacite; Subjects will be randomized to wear the Phenacite contact lenses binocularly.; Device: comfilcon A; Subjects will be randomized to wear the comfilcon A contact lenses binocularly.

Outcome Measures

Primary Outcome Measures

1. Subjective Ratings of Lens Comfort [Baseline (after 15 minutes of lens dispense)]

   Subjective ratings of lens comfort. Comfort Scale (0,100; 0=extremely uncomfortable/cannot tolerate; 100 = extremely comfortable/cannot be felt)

2. Subjective Ratings of Lens Comfort [2 Weeks]

   Subjective ratings of lens comfort. Comfort Scale (0,100; 0=extremely uncomfortable/cannot tolerate; 100 = extremely comfortable/cannot be felt)

3. Over Refraction for Optimized Distance Acuity [2 weeks]

   Over Refraction for optimized distance acuity measured using logMAR

4. Binocular Distance Visual Acuity - High Illumination High Contrast [Baseline (after 5 minutes of lens dispense)]

   Binocular Distance Visual Acuity - High Illumination High Contrast was measured using logMAR

5. Binocular Distance Visual Acuity - High Illumination High Contrast [2 weeks]

   Binocular Distance Visual Acuity - High Illumination High Contrast was measured using logMAR

6. Binocular Distance Visual Acuity - Low Illumination High Contrast [Baseline (after 5 minutes of lens dispense)]

   Binocular Distance Visual Acuity - Low Illumination High Contrast was measured using logMAR

7. Binocular Distance Visual Acuity - Low Illumination High Contrast [2 weeks]

   Binocular Distance Visual Acuity - Low Illumination High Contrast was measured using logMAR

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

   Binocular Near Visual Acuity - High Illumination High Contrast was measured using logMAR

9. Binocular Near Visual Acuity - High Illumination High Contrast [2 weeks]

   Binocular Near Visual Acuity - High Illumination High Contrast was measured using logMAR

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

    Binocular Near Visual Acuity - Low Illumination High Contrast was measured using logMAR

11. Binocular Near Visual Acuity - Low Illumination High Contrast [2 weeks]

    Binocular Near Visual Acuity - Low Illumination High Contrast was measured using logMAR

Secondary Outcome Measures

1. Lens Fit - Post Blink Movement [Baseline (after 15 minutes of lens dispense)]

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

2. Lens Fit - Post Blink Movement [2 weeks]

   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 15 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 [2 weeks]

   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 15 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 [2 weeks]

   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 15 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 [2 weeks]

   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 Ratings for Vision Quality - Distance Vision [Baseline (after 15 minutes of lens dispense)]

   Patient subjective scoring using 0-100 continuous scale 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 Vision Quality - Distance Vision [2 weeks]

    Patient subjective scoring using 0-100 continuous scale 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

11. Subjective Ratings for Vision Quality - Near Vision [Baseline (after 15 minutes of lens dispense)]

    Patient subjective scoring using 0-100 continuous scale 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

12. Subjective Ratings for Vision Quality - Near Vision [2 weeks]

    Patient subjective scoring using 0-100 continuous scale 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

13. Subjective Ratings for Vision Quality - Computer Vision [Baseline (after 15 minutes of lens dispense)]

    Patient subjective scoring using 0-100 continuous scale for Computer 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

14. Subjective Ratings for Vision Quality - Computer Vision [2 weeks]

    Patient subjective scoring using 0-100 continuous scale for Computer 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

15. Subjective Ratings for Vision Quality - Overall Vision [Baseline (after 15 minutes of lens dispense)]

    Patient subjective scoring using 0-100 continuous scale for Overall 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

16. Subjective Ratings for Vision Quality - Overall Vision [2 weeks]

    Patient subjective scoring using 0-100 continuous scale for Overall 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

17. Corneal Staining Extent [2 weeks]

    Corneal staining extent was assessed 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

18. Conjunctival Staining [2 weeks]

    Conjunctival staining was assessed on a scale of 0-4, 0.50 steps (0-None, 1 - Minimal diffuse punctuate, 2- Coalescent Punctuate, 3- confluent, 4- Deep confluent

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• 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 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:

• 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 Visual Acuity

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

• Has participated in study CV-14-32.

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: Pete Kollbaun, OD PhD, CORL Indiana University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Coopervision, Inc.
• ClinicalTrials.gov Identifier: NCT02436005
• Other Study ID Numbers: CV-15-16
• First Posted: May 6, 2015
• Last Update Posted: Nov 18, 2020
• Last Verified: Oct 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Additional relevant MeSH terms: Refractive Errors

Study Results

Participant Flow

Arm/Group Title	Phenacite Then Comfilcon A	Comfilcon A Then Phenacite
Arm/Group Description	Subjects will be randomized to wear the Phenacite contact lenses binocularly for two weeks then cross-over to comfilcon A lenses for two weeks. Phenacite: contact lenses comfilcon A: Contact Lenses	Subjects will be randomized to wear comfilcon A contact lenses for two weeks then cross-over to Phenacite Lenses for two weeks. comfilcon A: Contact Lenses Phenacite : Contact Lenses
Period Title: First Intervention
STARTED	12	13
COMPLETED	12	13
NOT COMPLETED	0	0
Period Title: First Intervention
STARTED	12	13
COMPLETED	12	12
NOT COMPLETED	0	1

Baseline Characteristics

Arm/Group Title	Overall Study
Arm/Group Description	Subjects will be randomized to wear the Phenacite and comfilcon A contact lenses binocularly for two weeks. Phenacite: contact lenses (Not the final Design - Further clinical studies were conducted to validate the new design) comfilcon A: contact lenses
Overall Participants	24
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	24 100%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	27 (5)
Sex: Female, Male (Count of Participants)
Female	22 91.7%
Male	2 8.3%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (participants) [Number]
United States	24 100%

Outcome Measures

1. Primary Outcome

Title	Subjective Ratings of Lens Comfort
Description	Subjective ratings of lens comfort. Comfort Scale (0,100; 0=extremely uncomfortable/cannot tolerate; 100 = extremely comfortable/cannot be felt)
Time Frame	Baseline (after 15 minutes of lens dispense)

Outcome Measure Data

Analysis Population Description

One subject was excluded from the analysis.

Arm/Group Title	Phenacite	Comfilcon A
Arm/Group Description	Subjects will be randomized to wear the Phenacite contact lenses binocularly. Phenacite: contact lenses	Subjects will be randomized to wear the comfilcon A contact lenses binocularly. comfilcon A: contact lenses
Measure Participants	24	24
Mean (Standard Deviation) [units on a scale]	86.50 (14.99)	90.13 (8.60)

2. Primary Outcome

Title	Subjective Ratings of Lens Comfort
Description	Subjective ratings of lens comfort. Comfort Scale (0,100; 0=extremely uncomfortable/cannot tolerate; 100 = extremely comfortable/cannot be felt)
Time Frame	2 Weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Phenacite	Comfilcon A
Arm/Group Description	Subjects will be randomized to wear the Phenacite contact lenses binocularly. Phenacite: contact lenses	Subjects will be randomized to wear the comfilcon A contact lenses binocularly. comfilcon A: contact lenses
Measure Participants	24	24
Mean (Standard Deviation) [units on a scale]	66.46 (25.22)	71.71 (24.62)

3. Primary Outcome

Title	Over Refraction for Optimized Distance Acuity
Description	Over Refraction for optimized distance acuity measured using logMAR
Time Frame	2 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Phenacite	Comfilcon A
Arm/Group Description	Subjects will be randomized to wear the Phenacite contact lenses binocularly. Phenacite: contact lenses	Subjects will be randomized to wear the comfilcon A contact lenses binocularly. comfilcon A: contact lenses
Measure Participants	24	24
OD (oculus dexter - right eye)	-0.10 (0.09)	0.00 (0.00)
OS (Oculus sinister - left eye)	-0.02 (0.07)	0.00 (0.00)

4. Primary Outcome

Title	Binocular Distance Visual Acuity - High Illumination High Contrast
Description	Binocular Distance Visual Acuity - High Illumination High Contrast was measured using logMAR
Time Frame	Baseline (after 5 minutes of lens dispense)

Outcome Measure Data

Analysis Population Description

One subject was excluded from the analysis.

Arm/Group Title	Phenacite	Comfilcon A
Arm/Group Description	Subjects will be randomized to wear the Phenacite contact lenses binocularly. Phenacite: contact lenses	Subjects will be randomized to wear the comfilcon A contact lenses binocularly. comfilcon A: contact lenses
Measure Participants	24	24
Mean (Standard Deviation) [logMAR]	-0.18 (0.06)	-0.21 (0.06)

5. Primary Outcome

Title	Binocular Distance Visual Acuity - High Illumination High Contrast
Description	Binocular Distance Visual Acuity - High Illumination High Contrast was measured using logMAR
Time Frame	2 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Phenacite	Comfilcon A
Arm/Group Description	Subjects will be randomized to wear the Phenacite contact lenses binocularly. Phenacite: contact lenses	Subjects will be randomized to wear the comfilcon A contact lenses binocularly. comfilcon A: contact lenses
Measure Participants	24	24
Mean (Standard Deviation) [logMAR]	-0.19 (0.07)	-0.20 (0.05)

6. Primary Outcome

Title	Binocular Distance Visual Acuity - Low Illumination High Contrast
Description	Binocular Distance Visual Acuity - Low Illumination High Contrast was measured using logMAR
Time Frame	Baseline (after 5 minutes of lens dispense)

Outcome Measure Data

Analysis Population Description

One subject was excluded from the analysis.

Arm/Group Title	Phenacite	Comfilcon A
Arm/Group Description	Subjects will be randomized to wear the Phenacite contact lenses binocularly. Phenacite: contact lenses	Subjects will be randomized to wear the comfilcon A contact lenses binocularly. comfilcon A: contact lenses
Measure Participants	24	24
Mean (Standard Deviation) [logMAR]	0.03 (0.08)	0.00 (0.07)

7. Primary Outcome

Title	Binocular Distance Visual Acuity - Low Illumination High Contrast
Description	Binocular Distance Visual Acuity - Low Illumination High Contrast was measured using logMAR
Time Frame	2 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Phenacite	Comfilcon A
Arm/Group Description	Subjects will be randomized to wear the Phenacite contact lenses binocularly. Phenacite: contact lenses	Subjects will be randomized to wear the comfilcon A contact lenses binocularly. comfilcon A: contact lenses
Measure Participants	24	24
Mean (Standard Deviation) [logMAR]	0.00 (0.09)	0.00 (0.06)

8. Primary Outcome

Title	Binocular Near Visual Acuity - High Illumination High Contrast
Description	Binocular Near Visual Acuity - High Illumination High Contrast was measured using logMAR
Time Frame	Baseline (after 5 minutes of lens dispense)

Outcome Measure Data

Analysis Population Description

One subject was excluded from the analysis.

Arm/Group Title	Phenacite	Comfilcon A
Arm/Group Description	Subjects will be randomized to wear the Phenacite contact lenses binocularly. Phenacite: contact lenses	Subjects will be randomized to wear the comfilcon A contact lenses binocularly. comfilcon A: contact lenses
Measure Participants	24	24
Mean (Standard Deviation) [logMAR]	-0.16 (0.06)	-0.19 (0.06)

9. Primary Outcome

Title	Binocular Near Visual Acuity - High Illumination High Contrast
Description	Binocular Near Visual Acuity - High Illumination High Contrast was measured using logMAR
Time Frame	2 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Phenacite	Comfilcon A
Arm/Group Description	Subjects will be randomized to wear the Phenacite contact lenses binocularly. Phenacite: contact lenses	Subjects will be randomized to wear the comfilcon A contact lenses binocularly. comfilcon A: contact lenses
Measure Participants	24	24
Mean (Standard Deviation) [logMAR]	-0.20 (0.06)	-0.18 (0.06)

10. Primary Outcome

Title	Binocular Near Visual Acuity - Low Illumination High Contrast
Description	Binocular Near Visual Acuity - Low Illumination High Contrast was measured using logMAR
Time Frame	Baseline (after 5 minutes of lens dispense)

Outcome Measure Data

Analysis Population Description

One subject was excluded from the analysis.

Arm/Group Title	Phenacite	Comfilcon A
Arm/Group Description	Subjects will be randomized to wear the Phenacite contact lenses binocularly. Phenacite: contact lenses	Subjects will be randomized to wear the comfilcon A contact lenses binocularly. comfilcon A: contact lenses
Measure Participants	24	24
Mean (Standard Deviation) [logMAR]	0.01 (0.07)	-0.01 (0.10)

11. Primary Outcome

Title	Binocular Near Visual Acuity - Low Illumination High Contrast
Description	Binocular Near Visual Acuity - Low Illumination High Contrast was measured using logMAR
Time Frame	2 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Phenacite	Comfilcon A
Arm/Group Description	Subjects will be randomized to wear the Phenacite contact lenses binocularly. Phenacite: contact lenses	Subjects will be randomized to wear the comfilcon A contact lenses binocularly. comfilcon A: contact lenses
Measure Participants	24	24
Mean (Standard Deviation) [logMAR]	-0.02 (0.09)	-0.03 (0.08)

12. Secondary Outcome

Title	Lens Fit - Post Blink Movement
Description	Investigator assessment of Amount of movement (to the nearest 0.1mm) immediately after the blink (0.1mm steps)
Time Frame	Baseline (after 15 minutes of lens dispense)

Outcome Measure Data

Analysis Population Description

One Subject was excluded from the analysis

Arm/Group Title	Phenacite	Comfilcon A
Arm/Group Description	Subjects will be randomized to wear the Phenacite contact lenses binocularly. Phenacite: contact lenses	Subjects will be randomized to wear the comfilcon A contact lenses binocularly. comfilcon A: contact lenses
Measure Participants	24	24
OD (oculus dexter - right eye)	0.23 (0.07)	0.20 (0.06)
OS(oculus sinister - left eye)	0.23 (0.07)	0.22 (0.07)

13. Secondary Outcome

Title	Lens Fit - Post Blink Movement
Description	Investigator assessment of Amount of movement (to the nearest 0.1mm) immediately after the blink (0.1mm steps)
Time Frame	2 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Phenacite	Comfilcon A
Arm/Group Description	Subjects will be randomized to wear the Phenacite contact lenses binocularly. Phenacite: contact lenses	Subjects will be randomized to wear the comfilcon A contact lenses binocularly. comfilcon A: contact lenses
Measure Participants	24	24
OD (oculus dexter - right eye)	0.24 (0.09)	0.23 (0.08)
OS (oculus sinister - left eye)	0.25 (0.08)	0.24 (0.07)

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 15 minutes of lens dispense)

Outcome Measure Data

Analysis Population Description

One Subject was excluded from the analysis

Arm/Group Title	Phenacite	Comfilcon A
Arm/Group Description	Subjects will be randomized to wear the Phenacite contact lenses binocularly. Phenacite: contact lenses	Subjects will be randomized to wear the comfilcon A contact lenses binocularly. comfilcon A: contact lenses
Measure Participants	24	24
OD (oculus Dexter - Right eye)	50.43 (5.09)	51.52 (5.40)
OS (Oculus Sinister - Left eye)	49.78 (4.77)	50.65 (4.73)

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	2 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Phenacite	Comfilcon A
Arm/Group Description	Subjects will be randomized to wear the Phenacite contact lenses binocularly. Phenacite: contact lenses	Subjects will be randomized to wear the comfilcon A contact lenses binocularly. comfilcon A: contact lenses
Measure Participants	24	24
OD (oculus dexter - right eye)	52.83 (7.64)	49.35 (4.50)
OS (Oculus Sinister - Left Eye)	51.30 (5.94)	48.70 (4.23)

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 15 minutes of lens dispense)

Outcome Measure Data

Analysis Population Description

One Subject was excluded from the analysis

Arm/Group Title	Phenacite	Comfilcon A
Arm/Group Description	Subjects will be randomized to wear the Phenacite contact lenses binocularly. Phenacite: contact lenses	Subjects will be randomized to wear the comfilcon A contact lenses binocularly. comfilcon A: contact lenses
Measure Participants	24	24
OD (oculus dexter - Right Eye)	3.07 (0.34)	2.99 (0.36)
OS (Oculus Sinister - Left eye)	3.09 (0.32)	3.01 (0.35)

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	2 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Phenacite	Comfilcon A
Arm/Group Description	Subjects will be randomized to wear the Phenacite contact lenses binocularly. Phenacite: contact lenses	Subjects will be randomized to wear the comfilcon A contact lenses binocularly. comfilcon A: contact lenses
Measure Participants	24	24
OD (oculus dexter - right eye)	2.91 (0.35)	3.08 (0.31)
OS (oculus sinister - left eye)	3.00 (0.33)	3.10 (0.28)

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 15 minutes of lens dispense)

Outcome Measure Data

Analysis Population Description

One Subject was excluded from the analysis

Arm/Group Title	Phenacite	Comfilcon A
Arm/Group Description	Subjects will be randomized to wear the Phenacite contact lenses binocularly. Phenacite: contact lenses	Subjects will be randomized to wear the comfilcon A contact lenses binocularly. comfilcon A: contact lenses
Measure Participants	24	24
OD (oculus dexter - right eye)	3.35 (0.25)	3.30 (0.32)
OS ( oculus sinister - Left Eye)	3.37 (0.24)	3.30 (0.28)

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	2 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Phenacite	Comfilcon A
Arm/Group Description	Subjects will be randomized to wear the Phenacite contact lenses binocularly. Phenacite: contact lenses	Subjects will be randomized to wear the comfilcon A contact lenses binocularly. comfilcon A: contact lenses
Measure Participants	24	24
OD (oculus dexter- right eye)	3.25 (0.35)	3.34 (0.34)
OS (oculus sinister - left eye)	3.32 (0.32)	3.36 (0.36)

20. Secondary Outcome

Title	Subjective Ratings for Vision Quality - Distance Vision
Description	Patient subjective scoring using 0-100 continuous scale 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	Baseline (after 15 minutes of lens dispense)

Outcome Measure Data

Analysis Population Description

One Subject was excluded from the analysis

Arm/Group Title	Phenacite	Comfilcon A
Arm/Group Description	Subjects will be randomized to wear the Phenacite contact lenses binocularly. Phenacite: contact lenses	Subjects will be randomized to wear the comfilcon A contact lenses binocularly. comfilcon A: contact lenses
Measure Participants	24	24
Mean (Standard Deviation) [units on a scale]	86.58 (17.13)	91.3 (10.64)

21. Secondary Outcome

Title	Subjective Ratings for Vision Quality - Distance Vision
Description	Patient subjective scoring using 0-100 continuous scale 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	2 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Phenacite	Comfilcon A
Arm/Group Description	Subjects will be randomized to wear the Phenacite contact lenses binocularly. Phenacite: contact lenses	Subjects will be randomized to wear the comfilcon A contact lenses binocularly. comfilcon A: contact lenses
Measure Participants	24	24
Mean (Standard Deviation) [units on a scale]	85.33 (20.5)	88.88 (15.34)

22. Secondary Outcome

Title	Subjective Ratings for Vision Quality - Near Vision
Description	Patient subjective scoring using 0-100 continuous scale 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	Baseline (after 15 minutes of lens dispense)

Outcome Measure Data

Analysis Population Description

One Subject was excluded from the analysis

Arm/Group Title	Phenacite	Comfilcon A
Arm/Group Description	Subjects will be randomized to wear the Phenacite contact lenses binocularly. Phenacite: contact lenses	Subjects will be randomized to wear the comfilcon A contact lenses binocularly. comfilcon A: contact lenses
Measure Participants	24	24
Mean (Standard Deviation) [units on a scale]	92.00 (11.16)	92.63 (7.70)

23. Secondary Outcome

Title	Subjective Ratings for Vision Quality - Near Vision
Description	Patient subjective scoring using 0-100 continuous scale 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	2 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Phenacite	Comfilcon A
Arm/Group Description	Subjects will be randomized to wear the Phenacite contact lenses binocularly. Phenacite: contact lenses	Subjects will be randomized to wear the comfilcon A contact lenses binocularly. comfilcon A: contact lenses
Measure Participants	24	24
Mean (Standard Deviation) [units on a scale]	84.83 (23.88)	85.88 (21.67)

24. Secondary Outcome

Title	Subjective Ratings for Vision Quality - Computer Vision
Description	Patient subjective scoring using 0-100 continuous scale for Computer 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	Baseline (after 15 minutes of lens dispense)

Outcome Measure Data

Analysis Population Description

One Subject was excluded from the analysis

Arm/Group Title	Phenacite	Comfilcon A
Arm/Group Description	Subjects will be randomized to wear the Phenacite contact lenses binocularly. Phenacite: contact lenses	Subjects will be randomized to wear the comfilcon A contact lenses binocularly. comfilcon A: contact lenses
Measure Participants	24	24
Mean (Standard Deviation) [units on a scale]	92.79 (10.75)	93.17 (8.91)

25. Secondary Outcome

Title	Subjective Ratings for Vision Quality - Computer Vision
Description	Patient subjective scoring using 0-100 continuous scale for Computer 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	2 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Phenacite	Comfilcon A
Arm/Group Description	Subjects will be randomized to wear the Phenacite contact lenses binocularly. Phenacite: contact lenses	Subjects will be randomized to wear the comfilcon A contact lenses binocularly. comfilcon A: contact lenses
Measure Participants	24	24
Mean (Standard Deviation) [units on a scale]	85.04 (21.27)	89.08 (15.06)

26. Secondary Outcome

Title	Subjective Ratings for Vision Quality - Overall Vision
Description	Patient subjective scoring using 0-100 continuous scale for Overall 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	Baseline (after 15 minutes of lens dispense)

Outcome Measure Data

Analysis Population Description

One Subject was excluded from the analysis

Arm/Group Title	Phenacite	Comfilcon A
Arm/Group Description	Subjects will be randomized to wear the Phenacite contact lenses binocularly. Phenacite: contact lenses	Subjects will be randomized to wear the comfilcon A contact lenses binocularly. comfilcon A: contact lenses
Measure Participants	24	24
Mean (Standard Deviation) [units on a scale]	91.00 (10.64)	92.67 (7.41)

27. Secondary Outcome

Title	Subjective Ratings for Vision Quality - Overall Vision
Description	Patient subjective scoring using 0-100 continuous scale for Overall 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	2 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Phenacite	Comfilcon A
Arm/Group Description	Subjects will be randomized to wear the Phenacite contact lenses binocularly. Phenacite: contact lenses	Subjects will be randomized to wear the comfilcon A contact lenses binocularly. comfilcon A: contact lenses
Measure Participants	24	24
Mean (Standard Deviation) [units on a scale]	85.96 (17.66)	88.63 (14.36)

28. Secondary Outcome

Title	Corneal Staining Extent
Description	Corneal staining extent was assessed 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	2 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Phenacite	Comfilcon A
Arm/Group Description	Subjects will be randomized to wear the Phenacite contact lenses binocularly. Phenacite: contact lenses	Subjects will be randomized to wear the comfilcon A contact lenses binocularly. comfilcon A: contact lenses
Measure Participants	24	24
Central	0.02 (0.14)	0.00 (0.00)
Nasal	0.00 (0.00)	0.00 (0.00)
Temporal	0.00 (0.00)	0.00 (0.00)
Superior	0.00 (0.00)	0.04 (0.20)
Inferior	0.21 (0.50)	0.42 (0.58)

29. Secondary Outcome

Title	Conjunctival Staining
Description	Conjunctival staining was assessed on a scale of 0-4, 0.50 steps (0-None, 1 - Minimal diffuse punctuate, 2- Coalescent Punctuate, 3- confluent, 4- Deep confluent
Time Frame	2 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Phenacite	Comfilcon A
Arm/Group Description	Subjects will be randomized to wear the Phenacite contact lenses binocularly. Phenacite: contact lenses	Subjects will be randomized to wear the comfilcon A contact lenses binocularly. comfilcon A: contact lenses
Measure Participants	24	24
Nasal	0.48 (0.46)	0.38 (0.57)
Temporal	0.11 (0.36)	0.18 (0.43)
Superior	0.00 (0.00)	0.05 (0.26)
Inferior	0.02 (0.10)	0.10 (0.27)

Adverse Events

Time Frame	From dispense up to two weeks on each study lenses, a total of four weeks.
Arm/Group Title	Phenacite		Comfilcon A
Arm/Group Description	Subjects will be randomized to wear the Phenacite contact lenses binocularly for two weeks. Phenacite: contact lenses		Subjects will be randomized to wear comfilcon A contact lenses binocularly for two weeks. comfilcon A: contact lenses binocularly.
All Cause Mortality
	Phenacite		Comfilcon A
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/25 (0%)		0/25 (0%)
Serious Adverse Events
	Phenacite		Comfilcon A
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/25 (0%)		0/25 (0%)
Other (Not Including Serious) Adverse Events
	Phenacite		Comfilcon A
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/25 (0%)		0/25 (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.