Trial Outcomes & Findings for One Week Assessment of The Phenacite Lens (NCT NCT02553395)

NCT ID: NCT02553395

Last Updated: 2020-12-22

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 30 participants
• Primary outcome timeframe: Baseline - After 5 minutes of lens settling
• Results posted on: 2020-12-22

Participant Flow

Participant milestones

Measure	Comfilcon A Contact Lens Then Phenacite 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	Phenacite Contact Lens Then Comfilcon A 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
First Intervention STARTED	18	12
First Intervention COMPLETED	18	12
First Intervention NOT COMPLETED	0	0
Second Intervention STARTED	18	12
Second Intervention COMPLETED	18	12
Second Intervention NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Overall Study n=30 Participants Subjects were randomized to wear test lens for one week and then cross-over to control lens for one week.
Age, Categorical <=18 years	0 Participants n=30 Participants
Age, Categorical Between 18 and 65 years	30 Participants n=30 Participants
Age, Categorical >=65 years	0 Participants n=30 Participants
Age, Continuous	25 years STANDARD_DEVIATION 3 • n=30 Participants
Sex: Female, Male Female	24 Participants n=30 Participants
Sex: Female, Male Male	6 Participants n=30 Participants
Region of Enrollment United States	30 participants n=30 Participants

PRIMARY outcome

Timeframe: Baseline - After 5 minutes of lens settling

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

Outcome measures

Measure	Phenacite Contact Lens n=30 Participants Subjects were randomized to wear test contact lens for one week. Phenacite: Contact lens	Comfilcon A Contact Lens n=30 Participants Subjects were randomized to wear control contact lens for one week. comfilcon A: contact lens
Binocular Distance Visual Acuity (VA) - High Illumination High Contrast	-0.22 logMAR Standard Deviation 0.05	-0.24 logMAR Standard Deviation 0.05

PRIMARY outcome

Timeframe: 1 week

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

Outcome measures

Measure	Phenacite Contact Lens n=30 Participants Subjects were randomized to wear test contact lens for one week. Phenacite: Contact lens	Comfilcon A Contact Lens n=30 Participants Subjects were randomized to wear control contact lens for one week. comfilcon A: contact lens
Binocular Distance Visual Acuity (VA) -High Illumination High Contrast	-0.20 logMAR Standard Deviation 0.05	-0.22 logMAR Standard Deviation 0.06

PRIMARY outcome

Timeframe: 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)

Outcome measures

Measure	Phenacite Contact Lens n=30 Participants Subjects were randomized to wear test contact lens for one week. Phenacite: Contact lens	Comfilcon A Contact Lens n=30 Participants Subjects were randomized to wear control contact lens for one week. comfilcon A: contact lens
Binocular Near Visual Acuity (VA) - High Illumination High Contrast	-0.18 logMAR Standard Deviation 0.06	-0.19 logMAR Standard Deviation 0.07

PRIMARY outcome

Timeframe: 1-week

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

Outcome measures

Measure	Phenacite Contact Lens n=30 Participants Subjects were randomized to wear test contact lens for one week. Phenacite: Contact lens	Comfilcon A Contact Lens n=30 Participants Subjects were randomized to wear control contact lens for one week. comfilcon A: contact lens
Binocular Near Visual Acuity (VA) - High Illumination High Contrast	-0.19 logMAR Standard Deviation 0.06	-0.19 logMAR Standard Deviation 0.06

PRIMARY outcome

Timeframe: 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)

Outcome measures

Measure	Phenacite Contact Lens n=30 Participants Subjects were randomized to wear test contact lens for one week. Phenacite: Contact lens	Comfilcon A Contact Lens n=30 Participants Subjects were randomized to wear control contact lens for one week. comfilcon A: contact lens
Binocular Distance Visual Acuity (VA) - Low Illumination High Contrast	-0.02 LogMAR Standard Deviation 0.05	-0.04 LogMAR Standard Deviation 0.07

PRIMARY outcome

Timeframe: 1 week

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

Outcome measures

Measure	Phenacite Contact Lens n=30 Participants Subjects were randomized to wear test contact lens for one week. Phenacite: Contact lens	Comfilcon A Contact Lens n=30 Participants Subjects were randomized to wear control contact lens for one week. comfilcon A: contact lens
Binocular Distance Visual Acuity (VA) - Low Illumination High Contrast	0.00 LogMAR Standard Deviation 0.08	-0.04 LogMAR Standard Deviation 0.06

PRIMARY outcome

Timeframe: 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)

Outcome measures

Measure	Phenacite Contact Lens n=30 Participants Subjects were randomized to wear test contact lens for one week. Phenacite: Contact lens	Comfilcon A Contact Lens n=30 Participants Subjects were randomized to wear control contact lens for one week. comfilcon A: contact lens
Binocular Near Visual Acuity (VA) - Low Illumination High Contrast	-0.00 LogMAR Standard Deviation 0.07	0.00 LogMAR Standard Deviation 0.07

PRIMARY outcome

Timeframe: 1week

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

Outcome measures

Measure	Phenacite Contact Lens n=30 Participants Subjects were randomized to wear test contact lens for one week. Phenacite: Contact lens	Comfilcon A Contact Lens n=30 Participants Subjects were randomized to wear control contact lens for one week. comfilcon A: contact lens
Binocular Near Visual Acuity (VA) - Low Illumination High Contrast	-0.01 LogMAR Standard Deviation 0.08	-0.00 LogMAR Standard Deviation 0.06

PRIMARY outcome

Timeframe: 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)

Outcome measures

Measure	Phenacite Contact Lens n=30 Participants Subjects were randomized to wear test contact lens for one week. Phenacite: Contact lens	Comfilcon A Contact Lens Subjects were randomized to wear control contact lens for one week. comfilcon A: contact lens
Subjective Ratings for Distance Quality of Vision Phenacite Test Contact Lens	85 score on a scale Standard Deviation 15	—
Subjective Ratings for Distance Quality of Vision comfilcon A control lens	91 score on a scale Standard Deviation 9	—

PRIMARY outcome

Timeframe: 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)

Outcome measures

Measure	Phenacite Contact Lens n=30 Participants Subjects were randomized to wear test contact lens for one week. Phenacite: Contact lens	Comfilcon A Contact Lens Subjects were randomized to wear control contact lens for one week. comfilcon A: contact lens
Subjective Ratings for Intermediate Quality of Vision Phenacite Test Lens	91 score on a scale Standard Deviation 10	—
Subjective Ratings for Intermediate Quality of Vision comfilcon A control lens	95 score on a scale Standard Deviation 7	—

PRIMARY outcome

Timeframe: 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)

Outcome measures

Measure	Phenacite Contact Lens n=30 Participants Subjects were randomized to wear test contact lens for one week. Phenacite: Contact lens	Comfilcon A Contact Lens Subjects were randomized to wear control contact lens for one week. comfilcon A: contact lens
Subjective Ratings for Near Quality of Vision Phenacite Test Lens	92 score on a scale Standard Deviation 11	—
Subjective Ratings for Near Quality of Vision comfilcon A control lens	95 score on a scale Standard Deviation 6	—

SECONDARY outcome

Timeframe: 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)

Outcome measures

Measure	Phenacite Contact Lens n=30 Participants Subjects were randomized to wear test contact lens for one week. Phenacite: Contact lens	Comfilcon A Contact Lens n=30 Participants Subjects were randomized to wear control contact lens for one week. comfilcon A: contact lens
Post Blink Movement - Right eye	0.23 mm Standard Deviation 0.06	0.24 mm Standard Deviation 0.08
Post Blink Movement - Left eye	0.23 mm Standard Deviation 0.06	0.25 mm Standard Deviation 0.08

SECONDARY outcome

Timeframe: 1 week

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

Outcome measures

Measure	Phenacite Contact Lens n=30 Participants Subjects were randomized to wear test contact lens for one week. Phenacite: Contact lens	Comfilcon A Contact Lens n=30 Participants Subjects were randomized to wear control contact lens for one week. comfilcon A: contact lens
Post Blink Movement Right eye	0.24 mm Standard Deviation 0.06	0.24 mm Standard Deviation 0.07
Post Blink Movement Left Eye	0.25 mm Standard Deviation 0.08	0.25 mm Standard Deviation 0.06

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Phenacite Contact Lens n=30 Participants Subjects were randomized to wear test contact lens for one week. Phenacite: Contact lens	Comfilcon A Contact Lens n=30 Participants Subjects were randomized to wear control contact lens for one week. comfilcon A: contact lens
Push - Up Test for Lens Tightness Right eye	50.83 units on a scale Standard Deviation 4.17	49.67 units on a scale Standard Deviation 2.92
Push - Up Test for Lens Tightness Left Eye	50.33 units on a scale Standard Deviation 4.14	49.17 units on a scale Standard Deviation 3.49

SECONDARY outcome

Timeframe: 1 week

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

Outcome measures

Measure	Phenacite Contact Lens n=30 Participants Subjects were randomized to wear test contact lens for one week. Phenacite: Contact lens	Comfilcon A Contact Lens n=30 Participants Subjects were randomized to wear control contact lens for one week. comfilcon A: contact lens
Push - Up Test for Lens Tightness Right Eye	50.33 units on a scale Standard Deviation 4.14	49.17 units on a scale Standard Deviation 3.73
Push - Up Test for Lens Tightness Left eye	49.33 units on a scale Standard Deviation 6.53	49.17 units on a scale Standard Deviation 2.65

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Phenacite Contact Lens n=30 Participants Subjects were randomized to wear test contact lens for one week. Phenacite: Contact lens	Comfilcon A Contact Lens n=30 Participants Subjects were randomized to wear control contact lens for one week. comfilcon A: contact lens
Lens Mobility Rating Right eye	2.97 units on a scale Standard Deviation 0.20	3.00 units on a scale Standard Deviation 0.26
Lens Mobility Rating Left eye	2.97 units on a scale Standard Deviation 0.22	3.02 units on a scale Standard Deviation 0.25

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Phenacite Contact Lens n=30 Participants Subjects were randomized to wear test contact lens for one week. Phenacite: Contact lens	Comfilcon A Contact Lens n=30 Participants Subjects were randomized to wear control contact lens for one week. comfilcon A: contact lens
Lens Mobility Rating Right Eye	2.98 units on a scale Standard Deviation 0.25	3.04 units on a scale Standard Deviation 0.16
Lens Mobility Rating Left eye	3.02 units on a scale Standard Deviation 0.31	3.04 units on a scale Standard Deviation 0.16

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Phenacite Contact Lens n=30 Participants Subjects were randomized to wear test contact lens for one week. Phenacite: Contact lens	Comfilcon A Contact Lens n=30 Participants Subjects were randomized to wear control contact lens for one week. comfilcon A: contact lens
Overall Lens Fit Acceptance Right Eye	3.48 units on a scale Standard Deviation 0.22	3.42 units on a scale Standard Deviation 0.36
Overall Lens Fit Acceptance Left Eye	3.46 units on a scale Standard Deviation 0.22	3.44 units on a scale Standard Deviation 0.33

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Phenacite Contact Lens n=30 Participants Subjects were randomized to wear test contact lens for one week. Phenacite: Contact lens	Comfilcon A Contact Lens n=30 Participants Subjects were randomized to wear control contact lens for one week. comfilcon A: contact lens
Overall Lens Fit Acceptance Right eye	3.42 units on a scale Standard Deviation 0.28	3.48 units on a scale Standard Deviation 0.28
Overall Lens Fit Acceptance Left Eye	3.35 units on a scale Standard Deviation 0.52	3.49 units on a scale Standard Deviation 0.28

SECONDARY outcome

Timeframe: 1 week

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

Outcome measures

Measure	Phenacite Contact Lens n=30 Participants Subjects were randomized to wear test contact lens for one week. Phenacite: Contact lens	Comfilcon A Contact Lens Subjects were randomized to wear control contact lens for one week. comfilcon A: contact lens
Subjective Lens Preference - Distance Vision Phenacite Lens	17 percentage of participants	—
Subjective Lens Preference - Distance Vision comfilcon A	50 percentage of participants	—
Subjective Lens Preference - Distance Vision No preference	33 percentage of participants	—

SECONDARY outcome

Timeframe: 1 week

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

Outcome measures

Measure	Phenacite Contact Lens n=30 Participants Subjects were randomized to wear test contact lens for one week. Phenacite: Contact lens	Comfilcon A Contact Lens Subjects were randomized to wear control contact lens for one week. comfilcon A: contact lens
Subjective Lens Preference -Overall Vision Preference Phenacite	27 percentage of participants	—
Subjective Lens Preference -Overall Vision Preference comfilcon A	56 percentage of participants	—
Subjective Lens Preference -Overall Vision Preference No Preference	17 percentage of participants	—

SECONDARY outcome

Timeframe: 1 week

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

Outcome measures

Measure	Phenacite Contact Lens n=30 Participants Subjects were randomized to wear test contact lens for one week. Phenacite: Contact lens	Comfilcon A Contact Lens Subjects were randomized to wear control contact lens for one week. comfilcon A: contact lens
Subjective Lens Preference - Comfort Phenacite	43 percentage of participants	—
Subjective Lens Preference - Comfort comfilcon A	40 percentage of participants	—
Subjective Lens Preference - Comfort No preference	17 percentage of participants	—

SECONDARY outcome

Timeframe: 1 week

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

Outcome measures

Measure	Phenacite Contact Lens n=30 Participants Subjects were randomized to wear test contact lens for one week. Phenacite: Contact lens	Comfilcon A Contact Lens Subjects were randomized to wear control contact lens for one week. comfilcon A: contact lens
Subjective Overall Lens Preference Phenacite	33 percentage of participants	—
Subjective Overall Lens Preference comfilcon A	57 percentage of participants	—
Subjective Overall Lens Preference No preference	10 percentage of participants	—

Adverse Events

Phenacite Contact Lens

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Comfilcon A Contact Lens

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Paul Chamberlain

CooperVision Inc.

Phone: 925 730-6754

Email: PChamberlain@coopervision.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place