Trial Outcomes & Findings for Dispensing Study for a New Study Lens (NCT NCT02642991)
NCT ID: NCT02642991
Last Updated: 2020-12-01
Results Overview
Distance visual acuity High Illumination was assessed using logMAR
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
44 participants
Primary outcome timeframe
Baseline (after 10 minutes of lens dispense)
Results posted on
2020-12-01
Participant Flow
Participant milestones
| Measure |
Phenacite Test Lens Then Comfilcon A Control Lens
Participants were randomized to wear Phenacite test lens for one week then cross-over to wear comfilcon A control lens for one week.
Phenacite: contact lens
comfilcon A: contact lens
|
Comfilcon A Control Lens Then Phenacite Test Lens
Participants were randomized to wear comfilcon A control lens for one week then cross over to Phenacite test lens for one week.
Phenacite: contact lens
comfilcon A: contact lens
|
|---|---|---|
|
First Intervention
STARTED
|
22
|
22
|
|
First Intervention
COMPLETED
|
22
|
22
|
|
First Intervention
NOT COMPLETED
|
0
|
0
|
|
Second Intervention
STARTED
|
22
|
22
|
|
Second Intervention
COMPLETED
|
22
|
22
|
|
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=44 Participants
Subjects were randomized to wear phenacite study lens and comfilcon A control lens for one week.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=44 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
44 Participants
n=44 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=44 Participants
|
|
Age, Continuous
|
23.1 years
STANDARD_DEVIATION 3.5 • n=44 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=44 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=44 Participants
|
|
Region of Enrollment
Canada
|
16 participants
n=44 Participants
|
|
Region of Enrollment
United States
|
28 participants
n=44 Participants
|
PRIMARY outcome
Timeframe: Baseline (after 10 minutes of lens dispense)Distance visual acuity High Illumination was assessed using logMAR
Outcome measures
| Measure |
Phenacite Test Lens
n=44 Participants
Participants were randomized to wear Phenacite test lens for one week
Phenacite: contact lens
|
Comfilcon A Control Lens
n=44 Participants
Participants were randomized to wear comfilcon A control lens for one week
comfilcon A: contact lens
|
|---|---|---|
|
Distance Visual Acuity (VA) - High Illumination
Monocular
|
-0.10 logMAR
Standard Deviation 0.07
|
-0.11 logMAR
Standard Deviation 0.08
|
|
Distance Visual Acuity (VA) - High Illumination
Binocular
|
-0.15 logMAR
Standard Deviation 0.06
|
-0.17 logMAR
Standard Deviation 0.07
|
PRIMARY outcome
Timeframe: 1 weekDistance visual acuity High Illumination was assessed using logMAR
Outcome measures
| Measure |
Phenacite Test Lens
n=44 Participants
Participants were randomized to wear Phenacite test lens for one week
Phenacite: contact lens
|
Comfilcon A Control Lens
n=44 Participants
Participants were randomized to wear comfilcon A control lens for one week
comfilcon A: contact lens
|
|---|---|---|
|
Distance Visual Acuity (VA) - High Illumination
Monocular
|
-0.10 logMAR
Standard Deviation 0.08
|
-0.11 logMAR
Standard Deviation 0.08
|
|
Distance Visual Acuity (VA) - High Illumination
Binocular
|
-0.15 logMAR
Standard Deviation 0.07
|
-0.16 logMAR
Standard Deviation 0.06
|
PRIMARY outcome
Timeframe: Baseline (after 10 minutes of lens dispense)Near Visual Acuity (VA) - High Illumination assessed using logMAR
Outcome measures
| Measure |
Phenacite Test Lens
n=44 Participants
Participants were randomized to wear Phenacite test lens for one week
Phenacite: contact lens
|
Comfilcon A Control Lens
n=44 Participants
Participants were randomized to wear comfilcon A control lens for one week
comfilcon A: contact lens
|
|---|---|---|
|
Near Visual Acuity (VA) - High Illumination
Monocular
|
-0.07 logMAR
Standard Deviation 0.09
|
-0.08 logMAR
Standard Deviation 0.08
|
|
Near Visual Acuity (VA) - High Illumination
Binocular
|
-0.13 logMAR
Standard Deviation 0.09
|
-0.14 logMAR
Standard Deviation 0.08
|
PRIMARY outcome
Timeframe: 1 weekNear Visual Acuity (VA) - High Illumination assessed using logMAR
Outcome measures
| Measure |
Phenacite Test Lens
n=44 Participants
Participants were randomized to wear Phenacite test lens for one week
Phenacite: contact lens
|
Comfilcon A Control Lens
n=44 Participants
Participants were randomized to wear comfilcon A control lens for one week
comfilcon A: contact lens
|
|---|---|---|
|
Near Visual Acuity (VA) - High Illumination
Monocular
|
-0.06 logMAR
Standard Deviation 0.10
|
-0.07 logMAR
Standard Deviation 0.09
|
|
Near Visual Acuity (VA) - High Illumination
Binocular
|
-0.11 logMAR
Standard Deviation 0.09
|
-0.13 logMAR
Standard Deviation 0.10
|
PRIMARY outcome
Timeframe: Baseline (after 10 minutes of lens dispense)Distance Visual Acuity (VA) - Low Illumination assessed using logMAR
Outcome measures
| Measure |
Phenacite Test Lens
n=44 Participants
Participants were randomized to wear Phenacite test lens for one week
Phenacite: contact lens
|
Comfilcon A Control Lens
n=44 Participants
Participants were randomized to wear comfilcon A control lens for one week
comfilcon A: contact lens
|
|---|---|---|
|
Distance Visual Acuity (VA) - Low Illumination
Monocular
|
0.07 logMAR
Standard Deviation 0.08
|
0.05 logMAR
Standard Deviation 0.08
|
|
Distance Visual Acuity (VA) - Low Illumination
Binocular
|
0.02 logMAR
Standard Deviation 0.06
|
0.00 logMAR
Standard Deviation 0.06
|
PRIMARY outcome
Timeframe: 1 weekDistance Visual Acuity (VA) - Low Illumination assessed using logMAR
Outcome measures
| Measure |
Phenacite Test Lens
n=44 Participants
Participants were randomized to wear Phenacite test lens for one week
Phenacite: contact lens
|
Comfilcon A Control Lens
n=44 Participants
Participants were randomized to wear comfilcon A control lens for one week
comfilcon A: contact lens
|
|---|---|---|
|
Distance Visual Acuity (VA) - Low Illumination
Monocular
|
0.06 logMAR
Standard Deviation 0.08
|
0.05 logMAR
Standard Deviation 0.10
|
|
Distance Visual Acuity (VA) - Low Illumination
Binocular
|
-0.01 logMAR
Standard Deviation 0.06
|
0.01 logMAR
Standard Deviation 0.07
|
PRIMARY outcome
Timeframe: Baseline (after 10 minutes of lens dispense)Near Visual Acuity (VA) - Low illumination assessed using logMAR
Outcome measures
| Measure |
Phenacite Test Lens
n=44 Participants
Participants were randomized to wear Phenacite test lens for one week
Phenacite: contact lens
|
Comfilcon A Control Lens
n=44 Participants
Participants were randomized to wear comfilcon A control lens for one week
comfilcon A: contact lens
|
|---|---|---|
|
Near Visual Acuity (VA) - Low Illumination
Monocular
|
0.15 logMAR
Standard Deviation 0.16
|
0.14 logMAR
Standard Deviation 0.15
|
|
Near Visual Acuity (VA) - Low Illumination
Binocular
|
0.10 logMAR
Standard Deviation 0.16
|
0.08 logMAR
Standard Deviation 0.15
|
PRIMARY outcome
Timeframe: 1 weekNear Visual Acuity (VA) - Low illumination assessed using logMAR
Outcome measures
| Measure |
Phenacite Test Lens
n=44 Participants
Participants were randomized to wear Phenacite test lens for one week
Phenacite: contact lens
|
Comfilcon A Control Lens
n=44 Participants
Participants were randomized to wear comfilcon A control lens for one week
comfilcon A: contact lens
|
|---|---|---|
|
Near Visual Acuity (VA) - Low Illumination
Monocular
|
0.16 logMAR
Standard Deviation 0.17
|
0.18 logMAR
Standard Deviation 0.17
|
|
Near Visual Acuity (VA) - Low Illumination
Binocular
|
0.09 logMAR
Standard Deviation 0.16
|
0.11 logMAR
Standard Deviation 0.17
|
PRIMARY outcome
Timeframe: Baseline (after 10 minutes of lens dispense)Subjective scoring of Quality of Distance Vision assessed using 0-100 continuous scale: (0=extremely poor vision all of the time. 100=excellent vision all of the time)
Outcome measures
| Measure |
Phenacite Test Lens
n=44 Participants
Participants were randomized to wear Phenacite test lens for one week
Phenacite: contact lens
|
Comfilcon A Control Lens
n=44 Participants
Participants were randomized to wear comfilcon A control lens for one week
comfilcon A: contact lens
|
|---|---|---|
|
Quality of Distance Vision
|
91 units on a scale
Standard Deviation 9
|
88 units on a scale
Standard Deviation 15
|
PRIMARY outcome
Timeframe: 1 weekSubjective scoring of Quality of Distance Vision assessed using 0-100 continuous scale: (0=extremely poor vision all of the time. 100=excellent vision all of the time)
Outcome measures
| Measure |
Phenacite Test Lens
n=44 Participants
Participants were randomized to wear Phenacite test lens for one week
Phenacite: contact lens
|
Comfilcon A Control Lens
n=44 Participants
Participants were randomized to wear comfilcon A control lens for one week
comfilcon A: contact lens
|
|---|---|---|
|
Quality of Distance Vision
|
87 units on a scale
Standard Deviation 16
|
90 units on a scale
Standard Deviation 12
|
PRIMARY outcome
Timeframe: Baseline (After 10 minutes of lens dispense)Patient subjective scoring for quality of near vision using 0-100 continuous scale: 0=extremely poor vision all of the time. 100=excellent vision all of the time
Outcome measures
| Measure |
Phenacite Test Lens
n=44 Participants
Participants were randomized to wear Phenacite test lens for one week
Phenacite: contact lens
|
Comfilcon A Control Lens
n=44 Participants
Participants were randomized to wear comfilcon A control lens for one week
comfilcon A: contact lens
|
|---|---|---|
|
Quality of Near Vision
|
94 units on a scale
Standard Deviation 8
|
91 units on a scale
Standard Deviation 11
|
PRIMARY outcome
Timeframe: 1 weekPatient subjective scoring for quality of near vision using 0-100 continuous scale: 0=extremely poor vision all of the time. 100=excellent vision all of the time
Outcome measures
| Measure |
Phenacite Test Lens
n=44 Participants
Participants were randomized to wear Phenacite test lens for one week
Phenacite: contact lens
|
Comfilcon A Control Lens
n=44 Participants
Participants were randomized to wear comfilcon A control lens for one week
comfilcon A: contact lens
|
|---|---|---|
|
Quality of Near Vision
|
90 units on a scale
Standard Deviation 12
|
90 units on a scale
Standard Deviation 12
|
PRIMARY outcome
Timeframe: Baseline (After 10 minutes of lens dispense)Subjective scoring of Quality of Vision with digital device use assessed using 0-100 continuous scale: (0=extremely poor vision all of the time. 100=excellent vision all of the time)
Outcome measures
| Measure |
Phenacite Test Lens
n=44 Participants
Participants were randomized to wear Phenacite test lens for one week
Phenacite: contact lens
|
Comfilcon A Control Lens
n=44 Participants
Participants were randomized to wear comfilcon A control lens for one week
comfilcon A: contact lens
|
|---|---|---|
|
Quality of Vision With Digital Device Use
|
96 units on a scale
Standard Deviation 8
|
94 units on a scale
Standard Deviation 7
|
PRIMARY outcome
Timeframe: 1 weekSubjective scoring of Quality of Vision with digital device use assessed using 0-100 continuous scale: (0=extremely poor vision all of the time. 100=excellent vision all of the time)
Outcome measures
| Measure |
Phenacite Test Lens
n=44 Participants
Participants were randomized to wear Phenacite test lens for one week
Phenacite: contact lens
|
Comfilcon A Control Lens
n=44 Participants
Participants were randomized to wear comfilcon A control lens for one week
comfilcon A: contact lens
|
|---|---|---|
|
Quality of Vision With Digital Device Use
|
91 units on a scale
Standard Deviation 13
|
90 units on a scale
Standard Deviation 12
|
PRIMARY outcome
Timeframe: Baseline (After 10 minutes of lens dispense)Subjective scoring of Quality of Intermediate Vision assessed using 0-100 continuous scale: (0=extremely poor vision all of the time. 100=excellent vision all of the time)
Outcome measures
| Measure |
Phenacite Test Lens
n=44 Participants
Participants were randomized to wear Phenacite test lens for one week
Phenacite: contact lens
|
Comfilcon A Control Lens
n=44 Participants
Participants were randomized to wear comfilcon A control lens for one week
comfilcon A: contact lens
|
|---|---|---|
|
Quality of Intermediate Vision
|
97 units on a scale
Standard Deviation 6
|
93 units on a scale
Standard Deviation 9
|
PRIMARY outcome
Timeframe: 1 weekSubjective scoring of Quality of Intermediate Vision assessed using 0-100 continuous scale: (0=extremely poor vision all of the time. 100=excellent vision all of the time)
Outcome measures
| Measure |
Phenacite Test Lens
n=44 Participants
Participants were randomized to wear Phenacite test lens for one week
Phenacite: contact lens
|
Comfilcon A Control Lens
n=44 Participants
Participants were randomized to wear comfilcon A control lens for one week
comfilcon A: contact lens
|
|---|---|---|
|
Quality of Intermediate Vision
|
92 units on a scale
Standard Deviation 11
|
92 units on a scale
Standard Deviation 10
|
PRIMARY outcome
Timeframe: Baseline (After 10 minutes of lens dispense)Subjective scoring of overall vision quality assessed using 0-100 continuous scale: (0=extremely poor vision all of the time. 100=excellent vision all of the time)
Outcome measures
| Measure |
Phenacite Test Lens
n=44 Participants
Participants were randomized to wear Phenacite test lens for one week
Phenacite: contact lens
|
Comfilcon A Control Lens
n=44 Participants
Participants were randomized to wear comfilcon A control lens for one week
comfilcon A: contact lens
|
|---|---|---|
|
Overall Vision Quality
|
95 units on a scale
Standard Deviation 6
|
89 units on a scale
Standard Deviation 13
|
PRIMARY outcome
Timeframe: 1 weekSubjective scoring of overall vision quality assessed using 0-100 continuous scale: (0=extremely poor vision all of the time. 100=excellent vision all of the time)
Outcome measures
| Measure |
Phenacite Test Lens
n=44 Participants
Participants were randomized to wear Phenacite test lens for one week
Phenacite: contact lens
|
Comfilcon A Control Lens
n=44 Participants
Participants were randomized to wear comfilcon A control lens for one week
comfilcon A: contact lens
|
|---|---|---|
|
Overall Vision Quality
|
88 units on a scale
Standard Deviation 15
|
89 units on a scale
Standard Deviation 12
|
SECONDARY outcome
Timeframe: 1 weekBulbar hyperemia assessment using 5 categories: (0=None, 1= Slight injection to conjunctival vessels, 2= Mild injection, 3= Moderate injection, 4= Severe injection) in (0.25 steps)
Outcome measures
| Measure |
Phenacite Test Lens
n=44 Participants
Participants were randomized to wear Phenacite test lens for one week
Phenacite: contact lens
|
Comfilcon A Control Lens
n=44 Participants
Participants were randomized to wear comfilcon A control lens for one week
comfilcon A: contact lens
|
|---|---|---|
|
Biomicroscopy Findings - Bulbar Hyperemia
|
1.24 units on a scale
Standard Deviation 0.67
|
1.37 units on a scale
Standard Deviation 0.82
|
SECONDARY outcome
Timeframe: 1 weekInvestigator assessment using 5 categories: (0=None, 1= Slight injection to conjunctival vessels, 2= Mild injection, 3= Moderate injection, 4= Severe injection) in (0.25 steps)
Outcome measures
| Measure |
Phenacite Test Lens
n=44 Participants
Participants were randomized to wear Phenacite test lens for one week
Phenacite: contact lens
|
Comfilcon A Control Lens
n=44 Participants
Participants were randomized to wear comfilcon A control lens for one week
comfilcon A: contact lens
|
|---|---|---|
|
Biomicroscopy Findings- Limbal Hyperemia
|
0.98 units on a scale
Standard Deviation 0.69
|
1.21 units on a scale
Standard Deviation 0.89
|
SECONDARY outcome
Timeframe: 1 weekInvestigator Assessment on Biomicroscopy Findings - Corneal Staining Extent on a scale of 0-4 : 0=No staining, 1=1-15% of area, 2=16-30% of area, 3=31-45% of area, 4= \>45% of area
Outcome measures
| Measure |
Phenacite Test Lens
n=44 Participants
Participants were randomized to wear Phenacite test lens for one week
Phenacite: contact lens
|
Comfilcon A Control Lens
n=44 Participants
Participants were randomized to wear comfilcon A control lens for one week
comfilcon A: contact lens
|
|---|---|---|
|
Biomicroscopy Findings - Corneal Staining Extent
Central
|
0.05 units on a scale
Standard Deviation 0.21
|
0.10 units on a scale
Standard Deviation 0.34
|
|
Biomicroscopy Findings - Corneal Staining Extent
Nasal
|
0.14 units on a scale
Standard Deviation 0.34
|
0.16 units on a scale
Standard Deviation 0.39
|
|
Biomicroscopy Findings - Corneal Staining Extent
Temporal
|
0.07 units on a scale
Standard Deviation 0.26
|
0.03 units on a scale
Standard Deviation 0.20
|
|
Biomicroscopy Findings - Corneal Staining Extent
Superior
|
0.13 units on a scale
Standard Deviation 0.37
|
0.19 units on a scale
Standard Deviation 0.40
|
|
Biomicroscopy Findings - Corneal Staining Extent
Inferior
|
0.34 units on a scale
Standard Deviation 0.58
|
0.51 units on a scale
Standard Deviation 0.74
|
SECONDARY outcome
Timeframe: 1 weekPatient subjective scoring using 0-100 continuous scale:0=Intolerable;100=Not noticable
Outcome measures
| Measure |
Phenacite Test Lens
n=44 Participants
Participants were randomized to wear Phenacite test lens for one week
Phenacite: contact lens
|
Comfilcon A Control Lens
n=44 Participants
Participants were randomized to wear comfilcon A control lens for one week
comfilcon A: contact lens
|
|---|---|---|
|
Ghosting - Distance Vision
|
93 units on a scale
Standard Deviation 12
|
93 units on a scale
Standard Deviation 12
|
SECONDARY outcome
Timeframe: 1 weekPatient subjective scoring using 0-100 continuous scale:0=Intolerable;100=Not noticable
Outcome measures
| Measure |
Phenacite Test Lens
n=44 Participants
Participants were randomized to wear Phenacite test lens for one week
Phenacite: contact lens
|
Comfilcon A Control Lens
n=44 Participants
Participants were randomized to wear comfilcon A control lens for one week
comfilcon A: contact lens
|
|---|---|---|
|
Ghosting - Near Vision
|
93 units on a scale
Standard Deviation 10
|
93 units on a scale
Standard Deviation 10
|
SECONDARY outcome
Timeframe: Baseline (After 10 minutes of lens dispense)Patient subjective scoring using 0-100 continuous scale, 0= cannot be worn, 100= cannot be felt ever.
Outcome measures
| Measure |
Phenacite Test Lens
n=44 Participants
Participants were randomized to wear Phenacite test lens for one week
Phenacite: contact lens
|
Comfilcon A Control Lens
n=44 Participants
Participants were randomized to wear comfilcon A control lens for one week
comfilcon A: contact lens
|
|---|---|---|
|
Overall Comfort
|
91 units on a scale
Standard Deviation 8
|
89 units on a scale
Standard Deviation 12
|
SECONDARY outcome
Timeframe: 1 weekPatient subjective scoring for overall comfort using 0-100 continuous scale, 0= cannot be worn, 100= cannot be felt ever.
Outcome measures
| Measure |
Phenacite Test Lens
n=44 Participants
Participants were randomized to wear Phenacite test lens for one week
Phenacite: contact lens
|
Comfilcon A Control Lens
n=44 Participants
Participants were randomized to wear comfilcon A control lens for one week
comfilcon A: contact lens
|
|---|---|---|
|
Overall Comfort
|
78 units on a scale
Standard Deviation 23
|
79 units on a scale
Standard Deviation 19
|
SECONDARY outcome
Timeframe: Baseline (after 10 minutes of lens dispense)Patient subjective scoring for overall dryness using 0-100 continuous scale, 0=cannot be worn, 100=no dryness experienced at any time.
Outcome measures
| Measure |
Phenacite Test Lens
n=44 Participants
Participants were randomized to wear Phenacite test lens for one week
Phenacite: contact lens
|
Comfilcon A Control Lens
n=44 Participants
Participants were randomized to wear comfilcon A control lens for one week
comfilcon A: contact lens
|
|---|---|---|
|
Overall Dryness
|
92 units on a scale
Standard Deviation 12
|
92 units on a scale
Standard Deviation 12
|
SECONDARY outcome
Timeframe: 1 weekPatient subjective scoring for overall dryness using 0-100 continuous scale, 0=cannot be worn, 100=no dryness experienced at any time.
Outcome measures
| Measure |
Phenacite Test Lens
n=44 Participants
Participants were randomized to wear Phenacite test lens for one week
Phenacite: contact lens
|
Comfilcon A Control Lens
n=44 Participants
Participants were randomized to wear comfilcon A control lens for one week
comfilcon A: contact lens
|
|---|---|---|
|
Overall Dryness
|
76 units on a scale
Standard Deviation 23
|
77 units on a scale
Standard Deviation 21
|
SECONDARY outcome
Timeframe: 1 weekSubjective rating of lens preference for overall vision preference (Phenacite, comfilcon A, No preference)
Outcome measures
| Measure |
Phenacite Test Lens
n=44 Participants
Participants were randomized to wear Phenacite test lens for one week
Phenacite: contact lens
|
Comfilcon A Control Lens
Participants were randomized to wear comfilcon A control lens for one week
comfilcon A: contact lens
|
|---|---|---|
|
Lens Preference - Overall Vision Preference
Phenacite
|
14 Participants
|
—
|
|
Lens Preference - Overall Vision Preference
comfilcon A
|
25 Participants
|
—
|
|
Lens Preference - Overall Vision Preference
No Preference
|
5 Participants
|
—
|
SECONDARY outcome
Timeframe: 1 weekSubjective rating of change in eye fatigue frequency of tiredness assessed using Eye fatigue Experience Questionnaire (EFEG)
Outcome measures
| Measure |
Phenacite Test Lens
n=44 Participants
Participants were randomized to wear Phenacite test lens for one week
Phenacite: contact lens
|
Comfilcon A Control Lens
n=44 Participants
Participants were randomized to wear comfilcon A control lens for one week
comfilcon A: contact lens
|
|---|---|---|
|
Subjective Ratings of Change in Frequency of Tiredness
Much Better
|
11 percentage of participants
|
18 percentage of participants
|
|
Subjective Ratings of Change in Frequency of Tiredness
Better
|
50 percentage of participants
|
39 percentage of participants
|
|
Subjective Ratings of Change in Frequency of Tiredness
No Difference
|
36 percentage of participants
|
39 percentage of participants
|
|
Subjective Ratings of Change in Frequency of Tiredness
Worse
|
0 percentage of participants
|
4 percentage of participants
|
|
Subjective Ratings of Change in Frequency of Tiredness
Much Worse
|
4 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: 1 weekSubjective rating of change in eye fatigue severity of tiredness assessed using Eye fatigue Experience Questionnaire (EFEG)
Outcome measures
| Measure |
Phenacite Test Lens
n=44 Participants
Participants were randomized to wear Phenacite test lens for one week
Phenacite: contact lens
|
Comfilcon A Control Lens
n=44 Participants
Participants were randomized to wear comfilcon A control lens for one week
comfilcon A: contact lens
|
|---|---|---|
|
Subjective Ratings of Change in Severity of Tiredness
Much Better
|
17 percentage of participants
|
17 percentage of participants
|
|
Subjective Ratings of Change in Severity of Tiredness
Better
|
48 percentage of participants
|
39 percentage of participants
|
|
Subjective Ratings of Change in Severity of Tiredness
No Difference
|
26 percentage of participants
|
35 percentage of participants
|
|
Subjective Ratings of Change in Severity of Tiredness
Worse
|
4 percentage of participants
|
9 percentage of participants
|
|
Subjective Ratings of Change in Severity of Tiredness
Much Worse
|
4 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: 1 weekSubjective rating of change in eye fatigue bothersome rating for tiredness assessed using Eye fatigue Experience Questionnaire (EFEG)
Outcome measures
| Measure |
Phenacite Test Lens
n=44 Participants
Participants were randomized to wear Phenacite test lens for one week
Phenacite: contact lens
|
Comfilcon A Control Lens
n=44 Participants
Participants were randomized to wear comfilcon A control lens for one week
comfilcon A: contact lens
|
|---|---|---|
|
Subjective Ratings of Change in Bothersome Rating for Tiredness
Much Better
|
20 percentage of participants
|
10 percentage of participants
|
|
Subjective Ratings of Change in Bothersome Rating for Tiredness
Better
|
45 percentage of participants
|
45 percentage of participants
|
|
Subjective Ratings of Change in Bothersome Rating for Tiredness
No Difference
|
35 percentage of participants
|
40 percentage of participants
|
|
Subjective Ratings of Change in Bothersome Rating for Tiredness
Worse
|
0 percentage of participants
|
5 percentage of participants
|
|
Subjective Ratings of Change in Bothersome Rating for Tiredness
Much Worse
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: 1 weekSubjective rating of change in eye fatigue frequency of dryness assessed using Eye fatigue Experience Questionnaire (EFEG)
Outcome measures
| Measure |
Phenacite Test Lens
n=44 Participants
Participants were randomized to wear Phenacite test lens for one week
Phenacite: contact lens
|
Comfilcon A Control Lens
n=44 Participants
Participants were randomized to wear comfilcon A control lens for one week
comfilcon A: contact lens
|
|---|---|---|
|
Subjective Ratings of Change in Frequency of Dryness
Much Better
|
15 percentage of participants
|
20 percentage of participants
|
|
Subjective Ratings of Change in Frequency of Dryness
Better
|
35 percentage of participants
|
15 percentage of participants
|
|
Subjective Ratings of Change in Frequency of Dryness
No Difference
|
25 percentage of participants
|
35 percentage of participants
|
|
Subjective Ratings of Change in Frequency of Dryness
Worse
|
15 percentage of participants
|
25 percentage of participants
|
|
Subjective Ratings of Change in Frequency of Dryness
Much Worse
|
10 percentage of participants
|
5 percentage of participants
|
SECONDARY outcome
Timeframe: 1 weekSubjective rating of change in eye fatigue severity of dryness assessed using Eye fatigue Experience Questionnaire (EFEG)
Outcome measures
| Measure |
Phenacite Test Lens
n=44 Participants
Participants were randomized to wear Phenacite test lens for one week
Phenacite: contact lens
|
Comfilcon A Control Lens
n=44 Participants
Participants were randomized to wear comfilcon A control lens for one week
comfilcon A: contact lens
|
|---|---|---|
|
Subjective Ratings of Change in Severity of Dryness
Much Better
|
9 percentage of participants
|
5 percentage of participants
|
|
Subjective Ratings of Change in Severity of Dryness
Better
|
41 percentage of participants
|
41 percentage of participants
|
|
Subjective Ratings of Change in Severity of Dryness
No Difference
|
32 percentage of participants
|
27 percentage of participants
|
|
Subjective Ratings of Change in Severity of Dryness
Worse
|
9 percentage of participants
|
23 percentage of participants
|
|
Subjective Ratings of Change in Severity of Dryness
Much Worse
|
9 percentage of participants
|
5 percentage of participants
|
SECONDARY outcome
Timeframe: 1 weekSubjective rating of change in eye fatigue bothersome rating for dryness assessed using Eye fatigue Experience Questionnaire (EFEG)
Outcome measures
| Measure |
Phenacite Test Lens
n=44 Participants
Participants were randomized to wear Phenacite test lens for one week
Phenacite: contact lens
|
Comfilcon A Control Lens
n=44 Participants
Participants were randomized to wear comfilcon A control lens for one week
comfilcon A: contact lens
|
|---|---|---|
|
Subjective Ratings of Change in Bothersome Rating of Dryness
Much Better
|
15 percentage of participants
|
10 percentage of participants
|
|
Subjective Ratings of Change in Bothersome Rating of Dryness
Better
|
40 percentage of participants
|
40 percentage of participants
|
|
Subjective Ratings of Change in Bothersome Rating of Dryness
No Difference
|
25 percentage of participants
|
25 percentage of participants
|
|
Subjective Ratings of Change in Bothersome Rating of Dryness
Worse
|
15 percentage of participants
|
20 percentage of participants
|
|
Subjective Ratings of Change in Bothersome Rating of Dryness
Much Worse
|
5 percentage of participants
|
5 percentage of participants
|
SECONDARY outcome
Timeframe: 1 weekSubjective questionnaire response for " My eyes don't feel strained while wearing these lenses" - Agree, Disagree
Outcome measures
| Measure |
Phenacite Test Lens
n=44 Participants
Participants were randomized to wear Phenacite test lens for one week
Phenacite: contact lens
|
Comfilcon A Control Lens
n=44 Participants
Participants were randomized to wear comfilcon A control lens for one week
comfilcon A: contact lens
|
|---|---|---|
|
Subjective Questionnaire Response - Eye Strain
Agree
|
75 percentage of participants
|
75 percentage of participants
|
|
Subjective Questionnaire Response - Eye Strain
Disagree
|
25 percentage of participants
|
25 percentage of participants
|
SECONDARY outcome
Timeframe: 1 weekSubjective questionnaire response for " These lenses make my eyes feel good" - Agree, Disagree
Outcome measures
| Measure |
Phenacite Test Lens
n=44 Participants
Participants were randomized to wear Phenacite test lens for one week
Phenacite: contact lens
|
Comfilcon A Control Lens
n=44 Participants
Participants were randomized to wear comfilcon A control lens for one week
comfilcon A: contact lens
|
|---|---|---|
|
Subjective Questionnaire Response - Eye Feel Good
Agree
|
86 percentage of participants
|
71 percentage of participants
|
|
Subjective Questionnaire Response - Eye Feel Good
Disagree
|
14 percentage of participants
|
29 percentage of participants
|
SECONDARY outcome
Timeframe: 1 weekSubjective questionnaire response for " These lenses make my eyes feel relaxed" - Agree, Disagree
Outcome measures
| Measure |
Phenacite Test Lens
n=44 Participants
Participants were randomized to wear Phenacite test lens for one week
Phenacite: contact lens
|
Comfilcon A Control Lens
n=44 Participants
Participants were randomized to wear comfilcon A control lens for one week
comfilcon A: contact lens
|
|---|---|---|
|
Subjective Questionnaire Response - Eye Feel Relaxed
Agree
|
79 percentage of participants
|
79 percentage of participants
|
|
Subjective Questionnaire Response - Eye Feel Relaxed
Disagree
|
21 percentage of participants
|
21 percentage of participants
|
SECONDARY outcome
Timeframe: 1 weekSubjective questionnaire response for " These lenses help my vision" - Agree, Disagree
Outcome measures
| Measure |
Phenacite Test Lens
n=44 Participants
Participants were randomized to wear Phenacite test lens for one week
Phenacite: contact lens
|
Comfilcon A Control Lens
n=44 Participants
Participants were randomized to wear comfilcon A control lens for one week
comfilcon A: contact lens
|
|---|---|---|
|
Subjective Questionnaire Response - Vision
Agree
|
96 percentage of participants
|
96 percentage of participants
|
|
Subjective Questionnaire Response - Vision
Disagree
|
4 percentage of participants
|
4 percentage of participants
|
SECONDARY outcome
Timeframe: 1 weekSubjective questionnaire response for " These lenses make my eyes feel less tired" - Agree, Disagree
Outcome measures
| Measure |
Phenacite Test Lens
n=44 Participants
Participants were randomized to wear Phenacite test lens for one week
Phenacite: contact lens
|
Comfilcon A Control Lens
n=44 Participants
Participants were randomized to wear comfilcon A control lens for one week
comfilcon A: contact lens
|
|---|---|---|
|
Subjective Questionnaire Response - Eye Tired
Agree
|
82 percentage of participants
|
75 percentage of participants
|
|
Subjective Questionnaire Response - Eye Tired
Disagree
|
18 percentage of participants
|
25 percentage of participants
|
Adverse Events
Phenacite Test Lens
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Comfilcon A Control 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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place