Trial Outcomes & Findings for Dispensing Study for the Phenacite Project (NCT NCT02436005)

NCT ID: NCT02436005

Last Updated: 2020-11-18

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 25 participants
• Primary outcome timeframe: Baseline (after 15 minutes of lens dispense)
• Results posted on: 2020-11-18

Participant Flow

Participant milestones

Measure	Phenacite Then Comfilcon A 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	Comfilcon A Then Phenacite 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
First Intervention STARTED	12	13
First Intervention COMPLETED	12	13
First Intervention NOT COMPLETED	0	0
Second Intervention STARTED	12	13
Second Intervention COMPLETED	12	12
Second Intervention NOT COMPLETED	0	1

Reasons for withdrawal

Measure	Phenacite Then Comfilcon A 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	Comfilcon A Then Phenacite 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
Second Intervention Adverse Event	0	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Overall Study n=24 Participants 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
Age, Categorical <=18 years	0 Participants n=24 Participants
Age, Categorical Between 18 and 65 years	24 Participants n=24 Participants
Age, Categorical >=65 years	0 Participants n=24 Participants
Age, Continuous	27 years STANDARD_DEVIATION 5 • n=24 Participants
Sex: Female, Male Female	22 Participants n=24 Participants
Sex: Female, Male Male	2 Participants n=24 Participants
Region of Enrollment United States	24 participants n=24 Participants

PRIMARY outcome

Timeframe: Baseline (after 15 minutes of lens dispense)

Population: One subject was excluded from the analysis.

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

Outcome measures

Measure	Phenacite n=24 Participants Subjects will be randomized to wear the Phenacite contact lenses binocularly. Phenacite: contact lenses	Comfilcon A n=24 Participants Subjects will be randomized to wear the comfilcon A contact lenses binocularly. comfilcon A: contact lenses
Subjective Ratings of Lens Comfort	86.50 units on a scale Standard Deviation 14.99	90.13 units on a scale Standard Deviation 8.60

PRIMARY outcome

Timeframe: 2 Weeks

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

Outcome measures

Measure	Phenacite n=24 Participants Subjects will be randomized to wear the Phenacite contact lenses binocularly. Phenacite: contact lenses	Comfilcon A n=24 Participants Subjects will be randomized to wear the comfilcon A contact lenses binocularly. comfilcon A: contact lenses
Subjective Ratings of Lens Comfort	66.46 units on a scale Standard Deviation 25.22	71.71 units on a scale Standard Deviation 24.62

PRIMARY outcome

Timeframe: 2 weeks

Over Refraction for optimized distance acuity measured using logMAR

Outcome measures

Measure	Phenacite n=24 Participants Subjects will be randomized to wear the Phenacite contact lenses binocularly. Phenacite: contact lenses	Comfilcon A n=24 Participants Subjects will be randomized to wear the comfilcon A contact lenses binocularly. comfilcon A: contact lenses
Over Refraction for Optimized Distance Acuity OD (oculus dexter - right eye)	-0.10 logMAR Standard Deviation 0.09	0.00 logMAR Standard Deviation 0.00
Over Refraction for Optimized Distance Acuity OS (Oculus sinister - left eye)	-0.02 logMAR Standard Deviation 0.07	0.00 logMAR Standard Deviation 0.00

PRIMARY outcome

Timeframe: Baseline (after 5 minutes of lens dispense)

Population: One subject was excluded from the analysis.

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

Outcome measures

Measure	Phenacite n=24 Participants Subjects will be randomized to wear the Phenacite contact lenses binocularly. Phenacite: contact lenses	Comfilcon A n=24 Participants Subjects will be randomized to wear the comfilcon A contact lenses binocularly. comfilcon A: contact lenses
Binocular Distance Visual Acuity - High Illumination High Contrast	-0.18 logMAR Standard Deviation 0.06	-0.21 logMAR Standard Deviation 0.06

PRIMARY outcome

Timeframe: 2 weeks

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

Outcome measures

Measure	Phenacite n=24 Participants Subjects will be randomized to wear the Phenacite contact lenses binocularly. Phenacite: contact lenses	Comfilcon A n=24 Participants Subjects will be randomized to wear the comfilcon A contact lenses binocularly. comfilcon A: contact lenses
Binocular Distance Visual Acuity - High Illumination High Contrast	-0.19 logMAR Standard Deviation 0.07	-0.20 logMAR Standard Deviation 0.05

PRIMARY outcome

Timeframe: Baseline (after 5 minutes of lens dispense)

Population: One subject was excluded from the analysis.

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

Outcome measures

Measure	Phenacite n=24 Participants Subjects will be randomized to wear the Phenacite contact lenses binocularly. Phenacite: contact lenses	Comfilcon A n=24 Participants Subjects will be randomized to wear the comfilcon A contact lenses binocularly. comfilcon A: contact lenses
Binocular Distance Visual Acuity - Low Illumination High Contrast	0.03 logMAR Standard Deviation 0.08	0.00 logMAR Standard Deviation 0.07

PRIMARY outcome

Timeframe: 2 weeks

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

Outcome measures

Measure	Phenacite n=24 Participants Subjects will be randomized to wear the Phenacite contact lenses binocularly. Phenacite: contact lenses	Comfilcon A n=24 Participants Subjects will be randomized to wear the comfilcon A contact lenses binocularly. comfilcon A: contact lenses
Binocular Distance Visual Acuity - Low Illumination High Contrast	0.00 logMAR Standard Deviation 0.09	0.00 logMAR Standard Deviation 0.06

PRIMARY outcome

Timeframe: Baseline (after 5 minutes of lens dispense)

Population: One subject was excluded from the analysis.

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

Outcome measures

Measure	Phenacite n=24 Participants Subjects will be randomized to wear the Phenacite contact lenses binocularly. Phenacite: contact lenses	Comfilcon A n=24 Participants Subjects will be randomized to wear the comfilcon A contact lenses binocularly. comfilcon A: contact lenses
Binocular Near Visual Acuity - High Illumination High Contrast	-0.16 logMAR Standard Deviation 0.06	-0.19 logMAR Standard Deviation 0.06

PRIMARY outcome

Timeframe: 2 weeks

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

Outcome measures

Measure	Phenacite n=24 Participants Subjects will be randomized to wear the Phenacite contact lenses binocularly. Phenacite: contact lenses	Comfilcon A n=24 Participants Subjects will be randomized to wear the comfilcon A contact lenses binocularly. comfilcon A: contact lenses
Binocular Near Visual Acuity - High Illumination High Contrast	-0.20 logMAR Standard Deviation 0.06	-0.18 logMAR Standard Deviation 0.06

PRIMARY outcome

Timeframe: Baseline (after 5 minutes of lens dispense)

Population: One subject was excluded from the analysis.

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

Outcome measures

Measure	Phenacite n=24 Participants Subjects will be randomized to wear the Phenacite contact lenses binocularly. Phenacite: contact lenses	Comfilcon A n=24 Participants Subjects will be randomized to wear the comfilcon A contact lenses binocularly. comfilcon A: contact lenses
Binocular Near Visual Acuity - Low Illumination High Contrast	0.01 logMAR Standard Deviation 0.07	-0.01 logMAR Standard Deviation 0.10

PRIMARY outcome

Timeframe: 2 weeks

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

Outcome measures

Measure	Phenacite n=24 Participants Subjects will be randomized to wear the Phenacite contact lenses binocularly. Phenacite: contact lenses	Comfilcon A n=24 Participants Subjects will be randomized to wear the comfilcon A contact lenses binocularly. comfilcon A: contact lenses
Binocular Near Visual Acuity - Low Illumination High Contrast	-0.02 logMAR Standard Deviation 0.09	-0.03 logMAR Standard Deviation 0.08

SECONDARY outcome

Timeframe: Baseline (after 15 minutes of lens dispense)

Population: One Subject was excluded from the analysis

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

Outcome measures

Measure	Phenacite n=24 Participants Subjects will be randomized to wear the Phenacite contact lenses binocularly. Phenacite: contact lenses	Comfilcon A n=24 Participants Subjects will be randomized to wear the comfilcon A contact lenses binocularly. comfilcon A: contact lenses
Lens Fit - Post Blink Movement OD (oculus dexter - right eye)	0.23 mm Standard Deviation 0.07	0.20 mm Standard Deviation 0.06
Lens Fit - Post Blink Movement OS(oculus sinister - left eye)	0.23 mm Standard Deviation 0.07	0.22 mm Standard Deviation 0.07

SECONDARY outcome

Timeframe: 2 weeks

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

Outcome measures

Measure	Phenacite n=24 Participants Subjects will be randomized to wear the Phenacite contact lenses binocularly. Phenacite: contact lenses	Comfilcon A n=24 Participants Subjects will be randomized to wear the comfilcon A contact lenses binocularly. comfilcon A: contact lenses
Lens Fit - Post Blink Movement OD (oculus dexter - right eye)	0.24 mm Standard Deviation 0.09	0.23 mm Standard Deviation 0.08
Lens Fit - Post Blink Movement OS (oculus sinister - left eye)	0.25 mm Standard Deviation 0.08	0.24 mm Standard Deviation 0.07

SECONDARY outcome

Timeframe: Baseline (after 15 minutes of lens dispense)

Population: One Subject was excluded from the analysis

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 n=24 Participants Subjects will be randomized to wear the Phenacite contact lenses binocularly. Phenacite: contact lenses	Comfilcon A n=24 Participants Subjects will be randomized to wear the comfilcon A contact lenses binocularly. comfilcon A: contact lenses
Push - Up Test for Lens Tightness OD (oculus Dexter - Right eye)	50.43 mm Standard Deviation 5.09	51.52 mm Standard Deviation 5.40
Push - Up Test for Lens Tightness OS (Oculus Sinister - Left eye)	49.78 mm Standard Deviation 4.77	50.65 mm Standard Deviation 4.73

SECONDARY outcome

Timeframe: 2 weeks

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 n=24 Participants Subjects will be randomized to wear the Phenacite contact lenses binocularly. Phenacite: contact lenses	Comfilcon A n=24 Participants Subjects will be randomized to wear the comfilcon A contact lenses binocularly. comfilcon A: contact lenses
Push - Up Test for Lens Tightness OD (oculus dexter - right eye)	52.83 mm Standard Deviation 7.64	49.35 mm Standard Deviation 4.50
Push - Up Test for Lens Tightness OS (Oculus Sinister - Left Eye)	51.30 mm Standard Deviation 5.94	48.70 mm Standard Deviation 4.23

SECONDARY outcome

Timeframe: Baseline (after 15 minutes of lens dispense)

Population: One Subject was excluded from the analysis

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 n=24 Participants Subjects will be randomized to wear the Phenacite contact lenses binocularly. Phenacite: contact lenses	Comfilcon A n=24 Participants Subjects will be randomized to wear the comfilcon A contact lenses binocularly. comfilcon A: contact lenses
Lens Mobility Rating OD (oculus dexter - Right Eye)	3.07 units on a scale Standard Deviation 0.34	2.99 units on a scale Standard Deviation 0.36
Lens Mobility Rating OS (Oculus Sinister - Left eye)	3.09 units on a scale Standard Deviation 0.32	3.01 units on a scale Standard Deviation 0.35

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Phenacite n=24 Participants Subjects will be randomized to wear the Phenacite contact lenses binocularly. Phenacite: contact lenses	Comfilcon A n=24 Participants Subjects will be randomized to wear the comfilcon A contact lenses binocularly. comfilcon A: contact lenses
Lens Mobility Rating OD (oculus dexter - right eye)	2.91 units on a scale Standard Deviation 0.35	3.08 units on a scale Standard Deviation 0.31
Lens Mobility Rating OS (oculus sinister - left eye)	3.00 units on a scale Standard Deviation 0.33	3.10 units on a scale Standard Deviation 0.28

SECONDARY outcome

Timeframe: Baseline (after 15 minutes of lens dispense)

Population: One Subject was excluded from the analysis

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 n=24 Participants Subjects will be randomized to wear the Phenacite contact lenses binocularly. Phenacite: contact lenses	Comfilcon A n=24 Participants Subjects will be randomized to wear the comfilcon A contact lenses binocularly. comfilcon A: contact lenses
Overall Lens Fit Acceptance OD (oculus dexter - right eye)	3.35 units on a scale Standard Deviation 0.25	3.30 units on a scale Standard Deviation 0.32
Overall Lens Fit Acceptance OS ( oculus sinister - Left Eye)	3.37 units on a scale Standard Deviation 0.24	3.30 units on a scale Standard Deviation 0.28

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Phenacite n=24 Participants Subjects will be randomized to wear the Phenacite contact lenses binocularly. Phenacite: contact lenses	Comfilcon A n=24 Participants Subjects will be randomized to wear the comfilcon A contact lenses binocularly. comfilcon A: contact lenses
Overall Lens Fit Acceptance OS (oculus sinister - left eye)	3.32 units on a scale Standard Deviation 0.32	3.36 units on a scale Standard Deviation 0.36
Overall Lens Fit Acceptance OD (oculus dexter- right eye)	3.25 units on a scale Standard Deviation 0.35	3.34 units on a scale Standard Deviation 0.34

SECONDARY outcome

Timeframe: Baseline (after 15 minutes of lens dispense)

Population: One Subject was excluded from the analysis

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

Outcome measures

Measure	Phenacite n=24 Participants Subjects will be randomized to wear the Phenacite contact lenses binocularly. Phenacite: contact lenses	Comfilcon A n=24 Participants Subjects will be randomized to wear the comfilcon A contact lenses binocularly. comfilcon A: contact lenses
Subjective Ratings for Vision Quality - Distance Vision	86.58 units on a scale Standard Deviation 17.13	91.3 units on a scale Standard Deviation 10.64

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Phenacite n=24 Participants Subjects will be randomized to wear the Phenacite contact lenses binocularly. Phenacite: contact lenses	Comfilcon A n=24 Participants Subjects will be randomized to wear the comfilcon A contact lenses binocularly. comfilcon A: contact lenses
Subjective Ratings for Vision Quality - Distance Vision	85.33 units on a scale Standard Deviation 20.5	88.88 units on a scale Standard Deviation 15.34

SECONDARY outcome

Timeframe: Baseline (after 15 minutes of lens dispense)

Population: One Subject was excluded from the analysis

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

Outcome measures

Measure	Phenacite n=24 Participants Subjects will be randomized to wear the Phenacite contact lenses binocularly. Phenacite: contact lenses	Comfilcon A n=24 Participants Subjects will be randomized to wear the comfilcon A contact lenses binocularly. comfilcon A: contact lenses
Subjective Ratings for Vision Quality - Near Vision	92.00 units on a scale Standard Deviation 11.16	92.63 units on a scale Standard Deviation 7.70

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Phenacite n=24 Participants Subjects will be randomized to wear the Phenacite contact lenses binocularly. Phenacite: contact lenses	Comfilcon A n=24 Participants Subjects will be randomized to wear the comfilcon A contact lenses binocularly. comfilcon A: contact lenses
Subjective Ratings for Vision Quality - Near Vision	84.83 units on a scale Standard Deviation 23.88	85.88 units on a scale Standard Deviation 21.67

SECONDARY outcome

Timeframe: Baseline (after 15 minutes of lens dispense)

Population: One Subject was excluded from the analysis

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

Outcome measures

Measure	Phenacite n=24 Participants Subjects will be randomized to wear the Phenacite contact lenses binocularly. Phenacite: contact lenses	Comfilcon A n=24 Participants Subjects will be randomized to wear the comfilcon A contact lenses binocularly. comfilcon A: contact lenses
Subjective Ratings for Vision Quality - Computer Vision	92.79 units on a scale Standard Deviation 10.75	93.17 units on a scale Standard Deviation 8.91

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Phenacite n=24 Participants Subjects will be randomized to wear the Phenacite contact lenses binocularly. Phenacite: contact lenses	Comfilcon A n=24 Participants Subjects will be randomized to wear the comfilcon A contact lenses binocularly. comfilcon A: contact lenses
Subjective Ratings for Vision Quality - Computer Vision	85.04 units on a scale Standard Deviation 21.27	89.08 units on a scale Standard Deviation 15.06

SECONDARY outcome

Timeframe: Baseline (after 15 minutes of lens dispense)

Population: One Subject was excluded from the analysis

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

Outcome measures

Measure	Phenacite n=24 Participants Subjects will be randomized to wear the Phenacite contact lenses binocularly. Phenacite: contact lenses	Comfilcon A n=24 Participants Subjects will be randomized to wear the comfilcon A contact lenses binocularly. comfilcon A: contact lenses
Subjective Ratings for Vision Quality - Overall Vision	91.00 units on a scale Standard Deviation 10.64	92.67 units on a scale Standard Deviation 7.41

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Phenacite n=24 Participants Subjects will be randomized to wear the Phenacite contact lenses binocularly. Phenacite: contact lenses	Comfilcon A n=24 Participants Subjects will be randomized to wear the comfilcon A contact lenses binocularly. comfilcon A: contact lenses
Subjective Ratings for Vision Quality - Overall Vision	85.96 units on a scale Standard Deviation 17.66	88.63 units on a scale Standard Deviation 14.36

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Phenacite n=24 Participants Subjects will be randomized to wear the Phenacite contact lenses binocularly. Phenacite: contact lenses	Comfilcon A n=24 Participants Subjects will be randomized to wear the comfilcon A contact lenses binocularly. comfilcon A: contact lenses
Corneal Staining Extent Central	0.02 units on a scale Standard Deviation 0.14	0.00 units on a scale Standard Deviation 0.00
Corneal Staining Extent Nasal	0.00 units on a scale Standard Deviation 0.00	0.00 units on a scale Standard Deviation 0.00
Corneal Staining Extent Temporal	0.00 units on a scale Standard Deviation 0.00	0.00 units on a scale Standard Deviation 0.00
Corneal Staining Extent Superior	0.00 units on a scale Standard Deviation 0.00	0.04 units on a scale Standard Deviation 0.20
Corneal Staining Extent Inferior	0.21 units on a scale Standard Deviation 0.50	0.42 units on a scale Standard Deviation 0.58

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Phenacite n=24 Participants Subjects will be randomized to wear the Phenacite contact lenses binocularly. Phenacite: contact lenses	Comfilcon A n=24 Participants Subjects will be randomized to wear the comfilcon A contact lenses binocularly. comfilcon A: contact lenses
Conjunctival Staining Nasal	0.48 units on a scale Standard Deviation 0.46	0.38 units on a scale Standard Deviation 0.57
Conjunctival Staining Temporal	0.11 units on a scale Standard Deviation 0.36	0.18 units on a scale Standard Deviation 0.43
Conjunctival Staining Superior	0.00 units on a scale Standard Deviation 0.00	0.05 units on a scale Standard Deviation 0.26
Conjunctival Staining Inferior	0.02 units on a scale Standard Deviation 0.10	0.10 units on a scale Standard Deviation 0.27

Adverse Events

Phenacite

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Comfilcon A

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