Trial Outcomes & Findings for Short-Term Clinical Comparison of Two Silicone Hydrogel Daily Disposable Contact Lenses (NCT NCT03139578)
NCT ID: NCT03139578
Last Updated: 2019-02-01
Results Overview
Overall lens fit acceptance was assessed by the investigator based on lens fitting characteristics and graded on a scale of 0 to 5, where 0=should not be worn and 5=perfect fit. The score ranges from 0 to 5, where higher scores indicate better fitting. The number of eye for each Grade was reported.
COMPLETED
NA
51 participants
30-45 minutes after lens settling
2019-02-01
Participant Flow
A total of 51 subjects were enrolled in the study from two sites. Of those enrolled, 50 subjects were randomized and 50 subjects were dispensed a study lens. All 50 subjects completed the study, while no one discontinued from the study.
Participant milestones
| Measure |
C 8.5\C 9.0\T 8.5\T 9.0
Subjects randomized to this sequence received Control lens (base curve 8.5 on the left eye and 9.0 on the right eye) during the first period and then received Test lens (base curve 8.5 on the left eye and 9.0 on the right eye) during the second period.
|
C 9.0\C 8.5\T 9.0\T 8.5
Subjects randomized to this sequence received Control lens (base curve 9.0 on the left eye and 8.5 on the right eye) during the first period and then received Test lens (base curve 9.0 on the left eye and 8.5 on the right eye) during the second period.
|
T 8.5\T 9.0\C 8.5\C 9.0
Subjects randomized to this sequence received Test lens (base curve 8.5 on the left eye and 9.0 on the right eye) during the first period and then received Control lens (base curve 8.5 on the left eye and 9.0 on the right eye) during the second period.
|
T 9.0\T 8.5\C 9.0\C 8.5
Subjects randomized to this sequence received Test lens (base curve 9.0 on the left eye and 8.5 on the right eye) during the first period and then received Control lens (base curve 9.0 on the left eye and 8.5 on the right eye) during the second period.
|
|---|---|---|---|---|
|
Period 1
STARTED
|
12
|
13
|
12
|
13
|
|
Period 1
Discontinued
|
0
|
0
|
0
|
0
|
|
Period 1
COMPLETED
|
12
|
13
|
12
|
13
|
|
Period 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Period 2
STARTED
|
12
|
13
|
12
|
13
|
|
Period 2
Discontinued
|
0
|
0
|
0
|
0
|
|
Period 2
COMPLETED
|
12
|
13
|
12
|
13
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Short-Term Clinical Comparison of Two Silicone Hydrogel Daily Disposable Contact Lenses
Baseline characteristics by cohort
| Measure |
Total
n=50 Participants
All subjects who were administered any test article excluding subjects who drop out prior to administering any test article
|
|---|---|
|
Age, Continuous
|
30.3 years
STANDARD_DEVIATION 13.61 • n=5 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
47 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
14 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
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
50 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 30-45 minutes after lens settlingPopulation: All subjects who had successfully completed all required assessments visits without any a major protocol deviations.
Overall lens fit acceptance was assessed by the investigator based on lens fitting characteristics and graded on a scale of 0 to 5, where 0=should not be worn and 5=perfect fit. The score ranges from 0 to 5, where higher scores indicate better fitting. The number of eye for each Grade was reported.
Outcome measures
| Measure |
Test 8.5BC
n=48 Eyes
Subjects randomized to receive senofilcon A lens 8.5 base curve in either the right or left eye and successfully completed all assessments without a major protocol deviation.
|
Test 9.0BC
n=48 Participants
Subjects randomized to receive senofilcon A lens 9.0 base curve in either the right or left eye and successfully completed all assessments without a major protocol deviation.
|
Control 8.5BC
n=48 Eyes
Subjects randomized to receive narafilcon A lens 8.5 base curve in either the right or left eye and successfully completed all assessments without a major protocol deviation.
|
Control 9.0BC
n=48 Eyes
Subjects randomized to receive narafilcon A lens 9.0 base curve in either the right or left eye and successfully completed all assessments without a major protocol deviation.
|
|---|---|---|---|---|
|
Overall Fit Acceptance
0
|
0 Eyes
|
0 Eyes
|
0 Eyes
|
0 Eyes
|
|
Overall Fit Acceptance
1
|
0 Eyes
|
0 Eyes
|
0 Eyes
|
0 Eyes
|
|
Overall Fit Acceptance
2
|
1 Eyes
|
2 Eyes
|
1 Eyes
|
5 Eyes
|
|
Overall Fit Acceptance
3
|
5 Eyes
|
8 Eyes
|
5 Eyes
|
7 Eyes
|
|
Overall Fit Acceptance
4
|
17 Eyes
|
24 Eyes
|
19 Eyes
|
17 Eyes
|
|
Overall Fit Acceptance
5
|
25 Eyes
|
14 Eyes
|
23 Eyes
|
19 Eyes
|
PRIMARY outcome
Timeframe: 30-45 minutes after lens settlingPopulation: All subjects who had successfully completed all required assessments without a major protocol deviation.
The lens power requirements (aka sphere requirements) for each lens type was calculated by summing the lens power and the spherical over-refraction. Then the difference of lens power requirement between the Test and Control lenses was calculated (Test-Control).
Outcome measures
| Measure |
Test 8.5BC
n=48 Eyes
Subjects randomized to receive senofilcon A lens 8.5 base curve in either the right or left eye and successfully completed all assessments without a major protocol deviation.
|
Test 9.0BC
n=48 Eyes
Subjects randomized to receive senofilcon A lens 9.0 base curve in either the right or left eye and successfully completed all assessments without a major protocol deviation.
|
Control 8.5BC
n=48 Eyes
Subjects randomized to receive narafilcon A lens 8.5 base curve in either the right or left eye and successfully completed all assessments without a major protocol deviation.
|
Control 9.0BC
n=48 Eyes
Subjects randomized to receive narafilcon A lens 9.0 base curve in either the right or left eye and successfully completed all assessments without a major protocol deviation.
|
|---|---|---|---|---|
|
Lens Power Requirement
<= -3.75
|
10 Eyes
|
9 Eyes
|
10 Eyes
|
8 Eyes
|
|
Lens Power Requirement
-3.50 to -3.00
|
7 Eyes
|
9 Eyes
|
7 Eyes
|
10 Eyes
|
|
Lens Power Requirement
-2.75 to -2.25
|
17 Eyes
|
15 Eyes
|
16 Eyes
|
15 Eyes
|
|
Lens Power Requirement
-2.00 t -1.50
|
9 Eyes
|
10 Eyes
|
10 Eyes
|
10 Eyes
|
|
Lens Power Requirement
-1.25 to -0.75
|
2 Eyes
|
2 Eyes
|
3 Eyes
|
2 Eyes
|
|
Lens Power Requirement
>= -0.50
|
3 Eyes
|
3 Eyes
|
2 Eyes
|
3 Eyes
|
SECONDARY outcome
Timeframe: Immediately upon lens insertionPopulation: All subjects who had successfully completed all required assessments without a major protocol deviation.
Subjective comfort on insertion was assessed by the subject on an 11-point scale (0 to 10) where 0=painful and 10=can't be felt. The score ranges from 0 to 10, where higher scores indicate better comfort. The average comfort score for each lens was reported.
Outcome measures
| Measure |
Test 8.5BC
n=48 Eyes
Subjects randomized to receive senofilcon A lens 8.5 base curve in either the right or left eye and successfully completed all assessments without a major protocol deviation.
|
Test 9.0BC
n=48 Eyes
Subjects randomized to receive senofilcon A lens 9.0 base curve in either the right or left eye and successfully completed all assessments without a major protocol deviation.
|
Control 8.5BC
n=48 Eyes
Subjects randomized to receive narafilcon A lens 8.5 base curve in either the right or left eye and successfully completed all assessments without a major protocol deviation.
|
Control 9.0BC
n=48 Eyes
Subjects randomized to receive narafilcon A lens 9.0 base curve in either the right or left eye and successfully completed all assessments without a major protocol deviation.
|
|---|---|---|---|---|
|
Subjective Comfort at Lens Insertion
|
9.15 Graded Scale 0-10
Standard Deviation 1.353
|
9.04 Graded Scale 0-10
Standard Deviation 1.220
|
8.92 Graded Scale 0-10
Standard Deviation 1.302
|
9.02 Graded Scale 0-10
Standard Deviation 1.176
|
SECONDARY outcome
Timeframe: 30-45 minutes after lens settlingPopulation: All subjects who had successfully completed all required assessments without a major protocol deviation.
Subjective comfort on setting was assessed by the subject on an 11-point scale (0 to 10) where 0=painful and 10=can't be felt. The score ranges from 0 to 10, where higher scores indicate better comfort. The average comfort score for each lens was reported.
Outcome measures
| Measure |
Test 8.5BC
n=48 Eyes
Subjects randomized to receive senofilcon A lens 8.5 base curve in either the right or left eye and successfully completed all assessments without a major protocol deviation.
|
Test 9.0BC
n=48 Eyes
Subjects randomized to receive senofilcon A lens 9.0 base curve in either the right or left eye and successfully completed all assessments without a major protocol deviation.
|
Control 8.5BC
n=48 Eyes
Subjects randomized to receive narafilcon A lens 8.5 base curve in either the right or left eye and successfully completed all assessments without a major protocol deviation.
|
Control 9.0BC
n=48 Eyes
Subjects randomized to receive narafilcon A lens 9.0 base curve in either the right or left eye and successfully completed all assessments without a major protocol deviation.
|
|---|---|---|---|---|
|
Subjective Comfort After Lens Settling
|
9.50 Graded scale 0-10
Standard Deviation 0.715
|
9.27 Graded scale 0-10
Standard Deviation 1.005
|
9.56 Graded scale 0-10
Standard Deviation 0.769
|
9.13 Graded scale 0-10
Standard Deviation 1.214
|
SECONDARY outcome
Timeframe: 30-45 minutes after lens settlingPopulation: All subjects who had successfully completed all required assessments without a major protocol deviation.
Subjective vision quality was assessed by the subject on an 11-point scale (0 to 10) where 0=extremely blurred and 10=perfect. The score ranges from 0 to 10, where higher scores indicate better vision quality. The average vision quality score for each lens was reported.
Outcome measures
| Measure |
Test 8.5BC
n=48 Eyes
Subjects randomized to receive senofilcon A lens 8.5 base curve in either the right or left eye and successfully completed all assessments without a major protocol deviation.
|
Test 9.0BC
n=48 Eyes
Subjects randomized to receive senofilcon A lens 9.0 base curve in either the right or left eye and successfully completed all assessments without a major protocol deviation.
|
Control 8.5BC
n=48 Eyes
Subjects randomized to receive narafilcon A lens 8.5 base curve in either the right or left eye and successfully completed all assessments without a major protocol deviation.
|
Control 9.0BC
n=48 Eyes
Subjects randomized to receive narafilcon A lens 9.0 base curve in either the right or left eye and successfully completed all assessments without a major protocol deviation.
|
|---|---|---|---|---|
|
Subjective Vision Quality
|
9.33 Graded scale 0-10
Standard Deviation 0.753
|
9.25 Graded scale 0-10
Standard Deviation 0.911
|
9.19 Graded scale 0-10
Standard Deviation 1.104
|
9.19 Graded scale 0-10
Standard Deviation 1.065
|
SECONDARY outcome
Timeframe: Immediately upon lens insertionPopulation: All subjects who had successfully completed all required assessments without a major protocol deviation.
Subjective handling was assessed by the subject on an 11-point scale (0 to 10) where 0=extremely difficult and 10=very easy. The score ranges from 0 to 10, where higher scores indicate better handling. The average handling score for each lens was reported.
Outcome measures
| Measure |
Test 8.5BC
n=48 Eyes
Subjects randomized to receive senofilcon A lens 8.5 base curve in either the right or left eye and successfully completed all assessments without a major protocol deviation.
|
Test 9.0BC
n=48 Eyes
Subjects randomized to receive senofilcon A lens 9.0 base curve in either the right or left eye and successfully completed all assessments without a major protocol deviation.
|
Control 8.5BC
n=48 Eyes
Subjects randomized to receive narafilcon A lens 8.5 base curve in either the right or left eye and successfully completed all assessments without a major protocol deviation.
|
Control 9.0BC
n=48 Eyes
Subjects randomized to receive narafilcon A lens 9.0 base curve in either the right or left eye and successfully completed all assessments without a major protocol deviation.
|
|---|---|---|---|---|
|
Subjective Handling
|
9.17 Graded scale 0-10
Standard Deviation 1.243
|
9.10 Graded scale 0-10
Standard Deviation 1.242
|
9.13 Graded scale 0-10
Standard Deviation 1.248
|
9.25 Graded scale 0-10
Standard Deviation 1.139
|
SECONDARY outcome
Timeframe: 30-45 minutes after lens settlingPopulation: All subjects who had successfully completed all required assessments without a major protocol deviation.
Monocular high contrast distance VA with the study lenses was collected to the nearest letter using computer generated logMAR charts. 0.02 logMAR is equivalent to 1 letter. Negative logMAR values indicate better lens performance. The average visual acuity was reported for each lens type.
Outcome measures
| Measure |
Test 8.5BC
n=48 Eyes
Subjects randomized to receive senofilcon A lens 8.5 base curve in either the right or left eye and successfully completed all assessments without a major protocol deviation.
|
Test 9.0BC
n=48 Eyes
Subjects randomized to receive senofilcon A lens 9.0 base curve in either the right or left eye and successfully completed all assessments without a major protocol deviation.
|
Control 8.5BC
n=48 Eyes
Subjects randomized to receive narafilcon A lens 8.5 base curve in either the right or left eye and successfully completed all assessments without a major protocol deviation.
|
Control 9.0BC
n=48 Eyes
Subjects randomized to receive narafilcon A lens 9.0 base curve in either the right or left eye and successfully completed all assessments without a major protocol deviation.
|
|---|---|---|---|---|
|
Monocular High Contrast Visual Acuity (VA)
|
-0.02 logMAR
Standard Deviation 0.068
|
-0.02 logMAR
Standard Deviation 0.083
|
-0.02 logMAR
Standard Deviation 0.064
|
-0.02 logMAR
Standard Deviation 0.061
|
Adverse Events
Test 8.5BC
Test 9.0BC
Control 8.5BC
Control 9.0BC
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Anna Sulley BSc MCOptom FAAO
Johnson & Johnson Vision
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60