Trial Outcomes & Findings for Comparison of New Contact Lens With Current Marketed Lens (NCT NCT03360110)
NCT ID: NCT03360110
Last Updated: 2020-09-02
Results Overview
Measurement of extent of corneal staining using Fluorescein, blue light, yellow filter, full beam, medium magnification on a scale 0-4 (0=no staining, 1 = 1-15% of area, 2= 16-30% of area, 3=31-45% of area, 4=\>45% of area).
COMPLETED
NA
53 participants
Baseline
2020-09-02
Participant Flow
Participant milestones
| Measure |
Test Lens, Then Control Lens
Subjects randomized to wear pair of test lens, then control lens. Each lens type was worn for three days using a daily wear / daily replacement schedule.
Phoebe test lens: Daily disposable contact lens
stenfilcon A lens (control): Daily disposable contact lens
|
Control Lens, Then Test Lens
Subjects randomized to wear pair of control lens, then test lens. Each lens type was worn for three days using a daily wear / daily replacement schedule.
Phoebe test lens: Daily disposable contact lens
stenfilcon A lens (control): Daily disposable contact lens
|
|---|---|---|
|
First Intervention
STARTED
|
27
|
26
|
|
First Intervention
COMPLETED
|
27
|
26
|
|
First Intervention
NOT COMPLETED
|
0
|
0
|
|
Second Intervention
STARTED
|
27
|
26
|
|
Second Intervention
COMPLETED
|
27
|
26
|
|
Second Intervention
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparison of New Contact Lens With Current Marketed Lens
Baseline characteristics by cohort
| Measure |
Overall Study
n=47 Participants
Subjects randomized to wear pair of test/control lens either first or second, then wear other lens.
Phoebe test lens: Daily disposable contact lens
stenfilcon A lens (control): Daily disposable contact lens
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
47 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
23 years
STANDARD_DEVIATION 3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
47 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
47 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: BaselinePopulation: There were 6 protocol deviations reported in this study and data from the 6 subjects were not used for data analyses.
Measurement of extent of corneal staining using Fluorescein, blue light, yellow filter, full beam, medium magnification on a scale 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 |
Phoebe Test Lens
n=94 Eyes
Subjects randomized to wear pair of test lens, then control lens. Each lens type was worn for three days using a daily wear / daily replacement schedule.
Phoebe test lens: Daily disposable contact lens
stenfilcon A lens (control): Daily disposable contact lens
|
Stenfilcon A Control Lens
n=94 Eyes
Subjects randomized to wear pair of control lens, then test lens. Each lens type was worn for three days using a daily wear / daily replacement schedule.
Phoebe test lens: Daily disposable contact lens
stenfilcon A lens (control): Daily disposable contact lens
|
|---|---|---|
|
Corneal Staining Extent
|
0.04 units on a scale
Standard Deviation 0.09
|
0.04 units on a scale
Standard Deviation 0.09
|
PRIMARY outcome
Timeframe: Day 3Population: There were 6 protocol deviations reported in this study and data from the 6 subjects were not used for data analyses.
Measurement of extent of corneal staining using Fluorescein, blue light, yellow filter, full beam, medium magnification on a scale 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 |
Phoebe Test Lens
n=94 Eyes
Subjects randomized to wear pair of test lens, then control lens. Each lens type was worn for three days using a daily wear / daily replacement schedule.
Phoebe test lens: Daily disposable contact lens
stenfilcon A lens (control): Daily disposable contact lens
|
Stenfilcon A Control Lens
n=94 Eyes
Subjects randomized to wear pair of control lens, then test lens. Each lens type was worn for three days using a daily wear / daily replacement schedule.
Phoebe test lens: Daily disposable contact lens
stenfilcon A lens (control): Daily disposable contact lens
|
|---|---|---|
|
Corneal Staining Extent
|
0.07 units on a scale
Standard Deviation 0.13
|
0.07 units on a scale
Standard Deviation 0.12
|
PRIMARY outcome
Timeframe: BaselinePopulation: There were 6 protocol deviations reported in this study and data from the 6 subjects were not used for data analyses.
Amount of staining observed on the conjunctiva scored 0-4 (0=none, 4=Deep Confluent, in 0.50 steps
Outcome measures
| Measure |
Phoebe Test Lens
n=94 Eyes
Subjects randomized to wear pair of test lens, then control lens. Each lens type was worn for three days using a daily wear / daily replacement schedule.
Phoebe test lens: Daily disposable contact lens
stenfilcon A lens (control): Daily disposable contact lens
|
Stenfilcon A Control Lens
n=94 Eyes
Subjects randomized to wear pair of control lens, then test lens. Each lens type was worn for three days using a daily wear / daily replacement schedule.
Phoebe test lens: Daily disposable contact lens
stenfilcon A lens (control): Daily disposable contact lens
|
|---|---|---|
|
Conjunctival Staining Score
|
0.18 score on a scale
Standard Deviation 0.21
|
0.18 score on a scale
Standard Deviation 0.21
|
PRIMARY outcome
Timeframe: Day 3Population: There were 6 protocol deviations reported in this study and data from the 6 subjects were not used for data analyses.
Amount of staining observed on the conjunctiva scored 0-4 (0=none, 4=Deep Confluent, in 0.50 steps
Outcome measures
| Measure |
Phoebe Test Lens
n=94 Eyes
Subjects randomized to wear pair of test lens, then control lens. Each lens type was worn for three days using a daily wear / daily replacement schedule.
Phoebe test lens: Daily disposable contact lens
stenfilcon A lens (control): Daily disposable contact lens
|
Stenfilcon A Control Lens
n=94 Eyes
Subjects randomized to wear pair of control lens, then test lens. Each lens type was worn for three days using a daily wear / daily replacement schedule.
Phoebe test lens: Daily disposable contact lens
stenfilcon A lens (control): Daily disposable contact lens
|
|---|---|---|
|
Conjunctival Staining Score
|
0.26 score on a scale
Standard Deviation 0.26
|
0.29 score on a scale
Standard Deviation 0.28
|
PRIMARY outcome
Timeframe: BaselinePopulation: There were 6 protocol deviations reported in this study and data from the 6 subjects were not used for data analyses.
Measurement of hyperemia of the palpebral conjunctiva; graded 0-4 (0=none, 4=severe) in 0.25 steps
Outcome measures
| Measure |
Phoebe Test Lens
n=94 Eyes
Subjects randomized to wear pair of test lens, then control lens. Each lens type was worn for three days using a daily wear / daily replacement schedule.
Phoebe test lens: Daily disposable contact lens
stenfilcon A lens (control): Daily disposable contact lens
|
Stenfilcon A Control Lens
n=94 Eyes
Subjects randomized to wear pair of control lens, then test lens. Each lens type was worn for three days using a daily wear / daily replacement schedule.
Phoebe test lens: Daily disposable contact lens
stenfilcon A lens (control): Daily disposable contact lens
|
|---|---|---|
|
Palpebral Hyperemia on Upper Lid
|
0.96 units on a scale
Standard Deviation 0.39
|
0.96 units on a scale
Standard Deviation 0.39
|
PRIMARY outcome
Timeframe: Day 3Population: There were 6 protocol deviations reported in this study and data from the 6 subjects were not used for data analyses.
Measurement of hyperemia of the palpebral conjunctiva; graded 0-4 (0=none, 4=severe) in 0.25 steps
Outcome measures
| Measure |
Phoebe Test Lens
n=94 Eyes
Subjects randomized to wear pair of test lens, then control lens. Each lens type was worn for three days using a daily wear / daily replacement schedule.
Phoebe test lens: Daily disposable contact lens
stenfilcon A lens (control): Daily disposable contact lens
|
Stenfilcon A Control Lens
n=94 Eyes
Subjects randomized to wear pair of control lens, then test lens. Each lens type was worn for three days using a daily wear / daily replacement schedule.
Phoebe test lens: Daily disposable contact lens
stenfilcon A lens (control): Daily disposable contact lens
|
|---|---|---|
|
Palpebral Hyperemia on Upper Lid
|
1.05 units on a scale
Standard Deviation 0.40
|
1.06 units on a scale
Standard Deviation 0.38
|
PRIMARY outcome
Timeframe: BaselinePopulation: There were 6 protocol deviations reported in this study and data from the 6 subjects were not used for data analyses.
Measurement of hyperemia of the palpebral conjunctiva; graded 0-4 (0=none, 4=severe) in 0.25 steps
Outcome measures
| Measure |
Phoebe Test Lens
n=94 Eyes
Subjects randomized to wear pair of test lens, then control lens. Each lens type was worn for three days using a daily wear / daily replacement schedule.
Phoebe test lens: Daily disposable contact lens
stenfilcon A lens (control): Daily disposable contact lens
|
Stenfilcon A Control Lens
n=94 Eyes
Subjects randomized to wear pair of control lens, then test lens. Each lens type was worn for three days using a daily wear / daily replacement schedule.
Phoebe test lens: Daily disposable contact lens
stenfilcon A lens (control): Daily disposable contact lens
|
|---|---|---|
|
Palpebral Hyperemia on Lower Lid
|
0.96 units on a scale
Standard Deviation 0.39
|
0.96 units on a scale
Standard Deviation 0.39
|
PRIMARY outcome
Timeframe: Day 3Population: There were 6 protocol deviations reported in this study and data from the 6 subjects were not used for data analyses.
Measurement of hyperemia of the palpebral conjunctiva; graded 0-4 (0=none, 4=severe) in 0.25 steps
Outcome measures
| Measure |
Phoebe Test Lens
n=47 Participants
Subjects randomized to wear pair of test lens, then control lens. Each lens type was worn for three days using a daily wear / daily replacement schedule.
Phoebe test lens: Daily disposable contact lens
stenfilcon A lens (control): Daily disposable contact lens
|
Stenfilcon A Control Lens
n=47 Participants
Subjects randomized to wear pair of control lens, then test lens. Each lens type was worn for three days using a daily wear / daily replacement schedule.
Phoebe test lens: Daily disposable contact lens
stenfilcon A lens (control): Daily disposable contact lens
|
|---|---|---|
|
Palpebral Hyperemia on Lower Lid
|
1.05 units on a scale
Standard Deviation 0.40
|
1.06 units on a scale
Standard Deviation 0.38
|
PRIMARY outcome
Timeframe: BaselinePopulation: There were 6 protocol deviations reported in this study and data from the 6 subjects were not used for data analyses.
Measurement of smoothness of palpebral conjunctiva; graded 0-4 (0=smooth, 4=severe) in 0.25 steps
Outcome measures
| Measure |
Phoebe Test Lens
n=94 Eyes
Subjects randomized to wear pair of test lens, then control lens. Each lens type was worn for three days using a daily wear / daily replacement schedule.
Phoebe test lens: Daily disposable contact lens
stenfilcon A lens (control): Daily disposable contact lens
|
Stenfilcon A Control Lens
n=94 Eyes
Subjects randomized to wear pair of control lens, then test lens. Each lens type was worn for three days using a daily wear / daily replacement schedule.
Phoebe test lens: Daily disposable contact lens
stenfilcon A lens (control): Daily disposable contact lens
|
|---|---|---|
|
Palpebral Roughness Grade - Upper Lid
|
1.09 units on a scale
Standard Deviation 0.51
|
1.09 units on a scale
Standard Deviation 0.51
|
PRIMARY outcome
Timeframe: Day 3Population: There were 6 protocol deviations reported in this study and data from the 6 subjects were not used for data analyses.
Measurement of smoothness of palpebral conjunctiva; graded 0-4 (0=smooth, 4=severe) in 0.25 steps
Outcome measures
| Measure |
Phoebe Test Lens
n=94 Eyes
Subjects randomized to wear pair of test lens, then control lens. Each lens type was worn for three days using a daily wear / daily replacement schedule.
Phoebe test lens: Daily disposable contact lens
stenfilcon A lens (control): Daily disposable contact lens
|
Stenfilcon A Control Lens
n=94 Eyes
Subjects randomized to wear pair of control lens, then test lens. Each lens type was worn for three days using a daily wear / daily replacement schedule.
Phoebe test lens: Daily disposable contact lens
stenfilcon A lens (control): Daily disposable contact lens
|
|---|---|---|
|
Palpebral Roughness Grade - Upper Lid
|
1.26 units on a scale
Standard Deviation 0.53
|
1.20 units on a scale
Standard Deviation 0.46
|
PRIMARY outcome
Timeframe: BaselinePopulation: There were 6 protocol deviations reported in this study and data from the 6 subjects were not used for data analyses.
Measurement of smoothness of palpebral conjunctiva; graded 0-4 (0=smooth, 4=severe) in 0.25 steps
Outcome measures
| Measure |
Phoebe Test Lens
n=94 Eyes
Subjects randomized to wear pair of test lens, then control lens. Each lens type was worn for three days using a daily wear / daily replacement schedule.
Phoebe test lens: Daily disposable contact lens
stenfilcon A lens (control): Daily disposable contact lens
|
Stenfilcon A Control Lens
n=94 Eyes
Subjects randomized to wear pair of control lens, then test lens. Each lens type was worn for three days using a daily wear / daily replacement schedule.
Phoebe test lens: Daily disposable contact lens
stenfilcon A lens (control): Daily disposable contact lens
|
|---|---|---|
|
Palpebral Roughness Grade - Lower Lid
|
1.07 units on a scale
Standard Deviation 0.50
|
1.07 units on a scale
Standard Deviation 0.50
|
PRIMARY outcome
Timeframe: Day 3Population: There were 6 protocol deviations reported in this study and data from the 6 subjects were not used for data analyses.
Measurement of smoothness of palpebral conjunctiva; graded 0-4 (0=smooth, 4=severe) in 0.25 steps
Outcome measures
| Measure |
Phoebe Test Lens
n=94 Eyes
Subjects randomized to wear pair of test lens, then control lens. Each lens type was worn for three days using a daily wear / daily replacement schedule.
Phoebe test lens: Daily disposable contact lens
stenfilcon A lens (control): Daily disposable contact lens
|
Stenfilcon A Control Lens
n=94 Eyes
Subjects randomized to wear pair of control lens, then test lens. Each lens type was worn for three days using a daily wear / daily replacement schedule.
Phoebe test lens: Daily disposable contact lens
stenfilcon A lens (control): Daily disposable contact lens
|
|---|---|---|
|
Palpebral Roughness Grade - Lower Lid
|
1.23 units on a scale
Standard Deviation 0.52
|
1.20 units on a scale
Standard Deviation 0.46
|
SECONDARY outcome
Timeframe: Baseline (at lens dispense)Population: There were 6 protocol deviations reported in this study and data from the 6 subjects were not used for data analyses.
Distance visual acuity recorded in logMAR.
Outcome measures
| Measure |
Phoebe Test Lens
n=47 Participants
Subjects randomized to wear pair of test lens, then control lens. Each lens type was worn for three days using a daily wear / daily replacement schedule.
Phoebe test lens: Daily disposable contact lens
stenfilcon A lens (control): Daily disposable contact lens
|
Stenfilcon A Control Lens
n=47 Participants
Subjects randomized to wear pair of control lens, then test lens. Each lens type was worn for three days using a daily wear / daily replacement schedule.
Phoebe test lens: Daily disposable contact lens
stenfilcon A lens (control): Daily disposable contact lens
|
|---|---|---|
|
Distance Visual Acuity
High Illumination High Contrast, Binocular
|
-0.23 Log(MAR)
Standard Deviation 0.06
|
-0.22 Log(MAR)
Standard Deviation 0.06
|
|
Distance Visual Acuity
Low Illumination High Contrast, Binocular
|
-0.03 Log(MAR)
Standard Deviation 0.08
|
-0.03 Log(MAR)
Standard Deviation 0.07
|
SECONDARY outcome
Timeframe: Day 3Population: There were 6 protocol deviations reported in this study and data from the 6 subjects were not used for data analyses.
Distance visual acuity recorded in logMAR.
Outcome measures
| Measure |
Phoebe Test Lens
n=47 Participants
Subjects randomized to wear pair of test lens, then control lens. Each lens type was worn for three days using a daily wear / daily replacement schedule.
Phoebe test lens: Daily disposable contact lens
stenfilcon A lens (control): Daily disposable contact lens
|
Stenfilcon A Control Lens
n=47 Participants
Subjects randomized to wear pair of control lens, then test lens. Each lens type was worn for three days using a daily wear / daily replacement schedule.
Phoebe test lens: Daily disposable contact lens
stenfilcon A lens (control): Daily disposable contact lens
|
|---|---|---|
|
Distance Visual Acuity
High Illumination High Contrast, Binocular
|
-0.23 Log(MAR)
Standard Deviation 0.06
|
-0.22 Log(MAR)
Standard Deviation 0.06
|
|
Distance Visual Acuity
Low Illumination High Contrast, Binocular
|
-0.04 Log(MAR)
Standard Deviation 0.06
|
-0.04 Log(MAR)
Standard Deviation 0.07
|
SECONDARY outcome
Timeframe: Baseline (at dispense)Population: There were 6 protocol deviations reported in this study and data from the 6 subjects were not used for data analyses.
Near visual acuity recorded in logMAR
Outcome measures
| Measure |
Phoebe Test Lens
n=47 Participants
Subjects randomized to wear pair of test lens, then control lens. Each lens type was worn for three days using a daily wear / daily replacement schedule.
Phoebe test lens: Daily disposable contact lens
stenfilcon A lens (control): Daily disposable contact lens
|
Stenfilcon A Control Lens
n=47 Participants
Subjects randomized to wear pair of control lens, then test lens. Each lens type was worn for three days using a daily wear / daily replacement schedule.
Phoebe test lens: Daily disposable contact lens
stenfilcon A lens (control): Daily disposable contact lens
|
|---|---|---|
|
Near Visual Acuity
High Illumination High Contrast, Binocular
|
-0.16 Log(MAR)
Standard Deviation 0.07
|
-0.16 Log(MAR)
Standard Deviation 0.06
|
|
Near Visual Acuity
Low Illumination High Contrast, Binocular
|
0.09 Log(MAR)
Standard Deviation 0.10
|
0.06 Log(MAR)
Standard Deviation 0.09
|
SECONDARY outcome
Timeframe: Day 3Population: There were 6 protocol deviations reported in this study and data from the 6 subjects were not used for data analyses.
Near visual acuity recorded in logMAR
Outcome measures
| Measure |
Phoebe Test Lens
n=47 Participants
Subjects randomized to wear pair of test lens, then control lens. Each lens type was worn for three days using a daily wear / daily replacement schedule.
Phoebe test lens: Daily disposable contact lens
stenfilcon A lens (control): Daily disposable contact lens
|
Stenfilcon A Control Lens
n=47 Participants
Subjects randomized to wear pair of control lens, then test lens. Each lens type was worn for three days using a daily wear / daily replacement schedule.
Phoebe test lens: Daily disposable contact lens
stenfilcon A lens (control): Daily disposable contact lens
|
|---|---|---|
|
Near Visual Acuity
High Illumination High Contrast, Binocular
|
-0.17 Log(MAR)
Standard Deviation 0.07
|
-0.19 Log(MAR)
Standard Deviation 0.07
|
|
Near Visual Acuity
Low Illumination High Contrast, Binocular
|
0.06 Log(MAR)
Standard Deviation 0.09
|
0.04 Log(MAR)
Standard Deviation 0.09
|
SECONDARY outcome
Timeframe: Baseline (at dispense)Population: There were 6 protocol deviations reported in this study and data from the 6 subjects were not used for data analyses.
Subjective vision quality rated on a 0-10 scale (0=extremely poor, 10=excellent)
Outcome measures
| Measure |
Phoebe Test Lens
n=47 Participants
Subjects randomized to wear pair of test lens, then control lens. Each lens type was worn for three days using a daily wear / daily replacement schedule.
Phoebe test lens: Daily disposable contact lens
stenfilcon A lens (control): Daily disposable contact lens
|
Stenfilcon A Control Lens
n=47 Participants
Subjects randomized to wear pair of control lens, then test lens. Each lens type was worn for three days using a daily wear / daily replacement schedule.
Phoebe test lens: Daily disposable contact lens
stenfilcon A lens (control): Daily disposable contact lens
|
|---|---|---|
|
Vision Quality Rating
|
9.2 units on a scale
Standard Deviation 1.0
|
9.3 units on a scale
Standard Deviation 0.07
|
SECONDARY outcome
Timeframe: Day 3Population: There were 6 protocol deviations reported in this study and data from the 6 subjects were not used for data analyses.
Subjective vision quality rated on a 0-10 scale (0=extremely poor, 10=excellent)
Outcome measures
| Measure |
Phoebe Test Lens
n=47 Participants
Subjects randomized to wear pair of test lens, then control lens. Each lens type was worn for three days using a daily wear / daily replacement schedule.
Phoebe test lens: Daily disposable contact lens
stenfilcon A lens (control): Daily disposable contact lens
|
Stenfilcon A Control Lens
n=47 Participants
Subjects randomized to wear pair of control lens, then test lens. Each lens type was worn for three days using a daily wear / daily replacement schedule.
Phoebe test lens: Daily disposable contact lens
stenfilcon A lens (control): Daily disposable contact lens
|
|---|---|---|
|
Vision Quality Rating
|
9.3 units on a scale
Standard Deviation 0.9
|
9.2 units on a scale
Standard Deviation 1.0
|
Adverse Events
Test Lens
Stenfilcon A Lens (Control)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Myhanh Nguyen, OD, Manager of Clinical Research
CooperVision
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER