Trial Outcomes & Findings for A Comparison of Two Daily Disposable Contact Lenses (NCT NCT00634101)
NCT ID: NCT00634101
Last Updated: 2021-01-06
Results Overview
Comfort at the end of the day was assessed by the individual questionnaire item "Comfort at the end of the day" with the response cateogries 1=Poor, 2=Fair, 3=Good, 4=Very good and 5=Excellent. EOD Comfort was also assessed by the individual item "How comfortable did your eyes feel at the end of the day when wearing the contact lenses you were provided?" with the respopnse categories of 1=Extremely Uncomfortable, 2=Very Uncomfortable, 3=Slightly Uncomfortable, 4=Comfortable and 5= Very Comfortable. The number of participants that responsed in each cateogry for each item was reported.
TERMINATED
NA
129 participants
1-Week Follow-up
2021-01-06
Participant Flow
A total of 129 subject were enrolled into this study. Of those enrolled, all were assigned to a study lens, however, only 125 eligble to be dispensed. Of those dispensed, 117 subjects completed the study. However, this study was utlimately terminated.
Participant milestones
| Measure |
Test (Narafilcon A)
Subjects randomized to receive the Test lens throughout the study
|
Control (Nelfilcon A)
Subjects randomized to receive the Control lens throughout the study
|
|---|---|---|
|
Overall Study
STARTED
|
66
|
59
|
|
Overall Study
COMPLETED
|
61
|
56
|
|
Overall Study
NOT COMPLETED
|
5
|
3
|
Reasons for withdrawal
| Measure |
Test (Narafilcon A)
Subjects randomized to receive the Test lens throughout the study
|
Control (Nelfilcon A)
Subjects randomized to receive the Control lens throughout the study
|
|---|---|---|
|
Overall Study
Study Terminated
|
3
|
3
|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
Baseline Characteristics
A Comparison of Two Daily Disposable Contact Lenses
Baseline characteristics by cohort
| Measure |
Test (Narafilcon A)
n=67 Participants
Subjects randomized to receive the Test lens throughout the study
|
Control (Nelfilcon A)
n=62 Participants
Subjects randomized to receive the Control lens throughout the study
|
Total
n=129 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
34.5 Years
STANDARD_DEVIATION 10.4 • n=5 Participants
|
33.9 Years
STANDARD_DEVIATION 9.8 • n=7 Participants
|
34.2 Years
STANDARD_DEVIATION 10.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
41 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
89 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
67 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
129 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1-Week Follow-upPopulation: All available data at the 1-Week follow-up.
Comfort at the end of the day was assessed by the individual questionnaire item "Comfort at the end of the day" with the response cateogries 1=Poor, 2=Fair, 3=Good, 4=Very good and 5=Excellent. EOD Comfort was also assessed by the individual item "How comfortable did your eyes feel at the end of the day when wearing the contact lenses you were provided?" with the respopnse categories of 1=Extremely Uncomfortable, 2=Very Uncomfortable, 3=Slightly Uncomfortable, 4=Comfortable and 5= Very Comfortable. The number of participants that responsed in each cateogry for each item was reported.
Outcome measures
| Measure |
Test (Narafilcon A)
n=53 Participants
Subject that wore the Test lens throughout the study.
|
Control (Nelfilcon A)
n=49 Participants
Subject that wore the Control lens throughout the study.
|
|---|---|---|
|
Comfort at the End of the Day
Comfort EOD · 5
|
8 Participants
|
7 Participants
|
|
Comfort at the End of the Day
Comfort EOD · 4
|
17 Participants
|
12 Participants
|
|
Comfort at the End of the Day
Comfort EOD · 1
|
13 Participants
|
7 Participants
|
|
Comfort at the End of the Day
Comfort EOD · Intentionally Left Blank
|
0 Participants
|
0 Participants
|
|
Comfort at the End of the Day
Eye Comfort EOD · 5
|
14 Participants
|
7 Participants
|
|
Comfort at the End of the Day
Eye Comfort EOD · 4
|
13 Participants
|
16 Participants
|
|
Comfort at the End of the Day
Eye Comfort EOD · 3
|
14 Participants
|
18 Participants
|
|
Comfort at the End of the Day
Eye Comfort EOD · 2
|
6 Participants
|
4 Participants
|
|
Comfort at the End of the Day
Eye Comfort EOD · 1
|
6 Participants
|
3 Participants
|
|
Comfort at the End of the Day
Comfort EOD · 3
|
10 Participants
|
15 Participants
|
|
Comfort at the End of the Day
Comfort EOD · 2
|
5 Participants
|
8 Participants
|
|
Comfort at the End of the Day
Eye Comfort EOD · Intentionally Left Blank
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: 1-Week Follow-upPopulation: All available data at the 1-Week follow-up.
Limbal Hyperaemia was measured using Efron Grading Scale ranges from 0 to 4 with 0.5 units increments (0 = Normal, 1 = Trace, 2 = Mild, 3 = Moderate, 4 = Severe).
Outcome measures
| Measure |
Test (Narafilcon A)
n=122 eyes
Subject that wore the Test lens throughout the study.
|
Control (Nelfilcon A)
n=112 eyes
Subject that wore the Control lens throughout the study.
|
|---|---|---|
|
Limbal Hyperaemia
Grade 3.5
|
0 eyes
|
0 eyes
|
|
Limbal Hyperaemia
Grade 4
|
0 eyes
|
0 eyes
|
|
Limbal Hyperaemia
Grade 0
|
72 eyes
|
54 eyes
|
|
Limbal Hyperaemia
Grade 0.5
|
26 eyes
|
34 eyes
|
|
Limbal Hyperaemia
Grade 1
|
15 eyes
|
8 eyes
|
|
Limbal Hyperaemia
Grade 1.5
|
0 eyes
|
8 eyes
|
|
Limbal Hyperaemia
Grade 2
|
4 eyes
|
5 eyes
|
|
Limbal Hyperaemia
Grade 2.5
|
4 eyes
|
3 eyes
|
|
Limbal Hyperaemia
Grade 3
|
1 eyes
|
0 eyes
|
PRIMARY outcome
Timeframe: 1-Week Follow-upPopulation: All available data at the 1-Week follow-up.
Comfort immediately when you first put them on was assessed by the individual questionnaire item "Comfort immediately when you first put them on" with the response cateogries 1=Poor, 2=Fair, 3=Good, 4=Very good and 5=Excellent. The number of participants that responsed in each cateogry was reported.
Outcome measures
| Measure |
Test (Narafilcon A)
n=53 Participants
Subject that wore the Test lens throughout the study.
|
Control (Nelfilcon A)
n=49 Participants
Subject that wore the Control lens throughout the study.
|
|---|---|---|
|
Comfort Immediately When You First Put Them on
Excellent (5)
|
13 Participants
|
19 Participants
|
|
Comfort Immediately When You First Put Them on
Very Good (4)
|
22 Participants
|
13 Participants
|
|
Comfort Immediately When You First Put Them on
Good (3)
|
8 Participants
|
8 Participants
|
|
Comfort Immediately When You First Put Them on
Fair (2)
|
6 Participants
|
7 Participants
|
|
Comfort Immediately When You First Put Them on
Poor (1)
|
4 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: 1-Week Follow-upPopulation: All available data at the 1-Week follow-up.
Comfort throughout the day was assessed by the individual questionnaire item "Comfort throughout the day" with the response cateogries 1=Poor, 2=Fair, 3=Good, 4=Very good and 5=Excellent. The number of participants that responsed in each cateogry was reported.
Outcome measures
| Measure |
Test (Narafilcon A)
n=53 Participants
Subject that wore the Test lens throughout the study.
|
Control (Nelfilcon A)
n=49 Participants
Subject that wore the Control lens throughout the study.
|
|---|---|---|
|
Comfort Throughout the Day
Excellent (5)
|
13 Participants
|
19 Participants
|
|
Comfort Throughout the Day
Very Good (4)
|
22 Participants
|
13 Participants
|
|
Comfort Throughout the Day
Good (3)
|
8 Participants
|
8 Participants
|
|
Comfort Throughout the Day
Fair (2)
|
6 Participants
|
7 Participants
|
|
Comfort Throughout the Day
Poor (1)
|
4 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: 1-Week Follow-upPopulation: All available data at the 1-Week follow-up.
Lack of dryness at the end of the day was assessed by the individual questionnaire item "Not making your eyes feel dry even at the end of the day" with the response cateogries 1=Poor, 2=Fair, 3=Good, 4=Very good and 5=Excellent. The number of participants that responsed in each cateogry was reported.
Outcome measures
| Measure |
Test (Narafilcon A)
n=53 Participants
Subject that wore the Test lens throughout the study.
|
Control (Nelfilcon A)
n=49 Participants
Subject that wore the Control lens throughout the study.
|
|---|---|---|
|
Lack of Dryness at the End of the Day
Very Good (4)
|
11 Participants
|
12 Participants
|
|
Lack of Dryness at the End of the Day
Good (3)
|
9 Participants
|
8 Participants
|
|
Lack of Dryness at the End of the Day
Fair (2)
|
8 Participants
|
9 Participants
|
|
Lack of Dryness at the End of the Day
Poor (1)
|
13 Participants
|
9 Participants
|
|
Lack of Dryness at the End of the Day
Intentionally left Blank
|
0 Participants
|
2 Participants
|
|
Lack of Dryness at the End of the Day
Excellent (5)
|
12 Participants
|
9 Participants
|
PRIMARY outcome
Timeframe: 1-Week Follow-upPopulation: All available data at the 1-Week follow-up.
Overall opinion was assessed by the individual questionnaire item "Considering your experience with the contact lenses you were provided, which statement best describes your overall opinion of these contact lenses? " with the response cateogries 1=Poor, 2=Fair, 3=Good, 4=Very good and 5=Excellent. The number of participants that responsed in each cateogry was reported.
Outcome measures
| Measure |
Test (Narafilcon A)
n=53 Participants
Subject that wore the Test lens throughout the study.
|
Control (Nelfilcon A)
n=49 Participants
Subject that wore the Control lens throughout the study.
|
|---|---|---|
|
Overall Opinion
Excellent (5)
|
12 Participants
|
12 Participants
|
|
Overall Opinion
Very Good (4)
|
17 Participants
|
19 Participants
|
|
Overall Opinion
Good (3)
|
10 Participants
|
9 Participants
|
|
Overall Opinion
Fair (2)
|
9 Participants
|
8 Participants
|
|
Overall Opinion
Poor (1)
|
5 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: 1-Week Follow-upPopulation: All available data at the 1-Week follow-up.
Overall comfort was assessed by the individual questionnaire item "Overall Comfort" with the response cateogries 1=Poor, 2=Fair, 3=Good, 4=Very good and 5=Excellent. The number of participants that responsed in each cateogry was reported.
Outcome measures
| Measure |
Test (Narafilcon A)
n=53 Participants
Subject that wore the Test lens throughout the study.
|
Control (Nelfilcon A)
n=49 Participants
Subject that wore the Control lens throughout the study.
|
|---|---|---|
|
Overall Comfort
Excellent (5)
|
12 Participants
|
14 Participants
|
|
Overall Comfort
Very Good (4)
|
20 Participants
|
17 Participants
|
|
Overall Comfort
Good (3)
|
8 Participants
|
8 Participants
|
|
Overall Comfort
Fair (2)
|
6 Participants
|
7 Participants
|
|
Overall Comfort
Poor (1)
|
7 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: 1-Week Follow-upPopulation: All available data at the 1-Week follow-up.
My Lenses Stayed Moist was assessed by the individual questionnaire item "They stayed moist and smooth, even after long hours at the computer" with the response cateogries 1=Disagree Strongly, 2=Disagree Somewhat, 3=Neither Agree Nor Disagree, 4=Very Somewhat and 5=Agree Strongly. The number of participants that responsed in each cateogry was reported.
Outcome measures
| Measure |
Test (Narafilcon A)
n=53 Participants
Subject that wore the Test lens throughout the study.
|
Control (Nelfilcon A)
n=49 Participants
Subject that wore the Control lens throughout the study.
|
|---|---|---|
|
My Lenses Stayed Moist
Disagree Strongly (1)
|
11 Participants
|
9 Participants
|
|
My Lenses Stayed Moist
Agree Strongly (5)
|
8 Participants
|
11 Participants
|
|
My Lenses Stayed Moist
Agree Somewhat (4)
|
18 Participants
|
11 Participants
|
|
My Lenses Stayed Moist
Neither Agree Nor Disagree (3)
|
8 Participants
|
10 Participants
|
|
My Lenses Stayed Moist
Disagree Somewhat (2)
|
8 Participants
|
8 Participants
|
PRIMARY outcome
Timeframe: 1-Week Follow-upPopulation: All available data at the 1-Week follow-up.
I forgot i was wearing lenses was assessed by the individual questionnaire item "They made me forget that I was wearing contact lenses" with the response cateogries 1=Disagree Strongly, 2=Disagree Somewhat, 3=Neither Agree Nor Disagree, 4=Very Somewhat and 5=Agree Strongly. The number of participants that responsed in each cateogry was reported.
Outcome measures
| Measure |
Test (Narafilcon A)
n=53 Participants
Subject that wore the Test lens throughout the study.
|
Control (Nelfilcon A)
n=49 Participants
Subject that wore the Control lens throughout the study.
|
|---|---|---|
|
I Forgot i Was Wearing Lenses Was
Agree Strongly (5)
|
12 Participants
|
16 Participants
|
|
I Forgot i Was Wearing Lenses Was
Agree Somewhat (4)
|
16 Participants
|
15 Participants
|
|
I Forgot i Was Wearing Lenses Was
Neither Agree Nor Disagree (3)
|
6 Participants
|
4 Participants
|
|
I Forgot i Was Wearing Lenses Was
Disagree Somewhat (2)
|
13 Participants
|
8 Participants
|
|
I Forgot i Was Wearing Lenses Was
Disagree Strongly (1)
|
6 Participants
|
6 Participants
|
PRIMARY outcome
Timeframe: 1-Week Follow-upPopulation: All available data at the 1-Week follow-up.
Mainted natural moisture was assessed by the individual questionnaire item "They maintained my eyes' own natural moisture" with the response cateogries 1=Disagree Strongly, 2=Disagree Somewhat, 3=Neither Agree Nor Disagree, 4=Very Somewhat and 5=Agree Strongly. The number of participants that responsed in each cateogry was reported.
Outcome measures
| Measure |
Test (Narafilcon A)
n=53 Participants
Subject that wore the Test lens throughout the study.
|
Control (Nelfilcon A)
n=49 Participants
Subject that wore the Control lens throughout the study.
|
|---|---|---|
|
Mainted Natural Moisture
Agree Strongly (5)
|
14 Participants
|
10 Participants
|
|
Mainted Natural Moisture
Agree Somewhat (4)
|
17 Participants
|
16 Participants
|
|
Mainted Natural Moisture
Neither Agree Nor Disagree (3)
|
7 Participants
|
10 Participants
|
|
Mainted Natural Moisture
Disagree Somewhat (2)
|
10 Participants
|
6 Participants
|
|
Mainted Natural Moisture
Disagree Strongly (1)
|
5 Participants
|
7 Participants
|
PRIMARY outcome
Timeframe: 1-Week Follow-upPopulation: All available data at the 1-Week follow-up.
Comfort while wearing lenses in heat/air conditioned environments was assessed by the individual questionnaire item "How often are you comfortable while sitting under or near an air conditioning vent or heating vent " with the response cateogries 0=Not Applicable, 1=Always, 2=Frequently, 3=Occasionally, 4=Rarely and 5=never. The number of participants that responsed in each cateogry was reported.
Outcome measures
| Measure |
Test (Narafilcon A)
n=53 Participants
Subject that wore the Test lens throughout the study.
|
Control (Nelfilcon A)
n=49 Participants
Subject that wore the Control lens throughout the study.
|
|---|---|---|
|
Comfort While Wearing Lenses in Heat/Air Conditioned Environments
Not Applicable (0)
|
7 Participants
|
8 Participants
|
|
Comfort While Wearing Lenses in Heat/Air Conditioned Environments
Always (1)
|
15 Participants
|
11 Participants
|
|
Comfort While Wearing Lenses in Heat/Air Conditioned Environments
Frequently (2)
|
16 Participants
|
12 Participants
|
|
Comfort While Wearing Lenses in Heat/Air Conditioned Environments
Occasionally (3)
|
10 Participants
|
10 Participants
|
|
Comfort While Wearing Lenses in Heat/Air Conditioned Environments
Rarely (4)
|
4 Participants
|
6 Participants
|
|
Comfort While Wearing Lenses in Heat/Air Conditioned Environments
Never (5)
|
1 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: 1-Week Follow-upPopulation: All available data at the 1-Week follow-up.
Dryness at the end of the day was assessed by the individual questionnaire item "How dry did your eyes feel at the end of the day when wearing the contact lenses you were provided" with the response cateogries 1=Extremely Dry, 2=Very Dry, 3=Moderately Dry, 4=Slightly Dry and 5=Not Dry at All. The number of participants that responsed in each cateogry was reported.
Outcome measures
| Measure |
Test (Narafilcon A)
n=53 Participants
Subject that wore the Test lens throughout the study.
|
Control (Nelfilcon A)
n=49 Participants
Subject that wore the Control lens throughout the study.
|
|---|---|---|
|
Dryness at the End of the Day
Not Dry at all (5)
|
22 Participants
|
11 Participants
|
|
Dryness at the End of the Day
Slightly Dry (4)
|
19 Participants
|
18 Participants
|
|
Dryness at the End of the Day
Moderately Dry (3)
|
2 Participants
|
11 Participants
|
|
Dryness at the End of the Day
Very Dry (2)
|
6 Participants
|
6 Participants
|
|
Dryness at the End of the Day
Extremely Dry(1)
|
4 Participants
|
2 Participants
|
|
Dryness at the End of the Day
Intentionally Left Blank
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 1-Week Follow-upPopulation: All available data at the 1-Week follow-up.
Handling was assessed through opinion of handling in the final questionnaire. There were 5 categories Excellent (5), Very Good (4), Good (3), Fair (2) and Poor (1).
Outcome measures
| Measure |
Test (Narafilcon A)
n=61 Participants
Subject that wore the Test lens throughout the study.
|
Control (Nelfilcon A)
n=56 Participants
Subject that wore the Control lens throughout the study.
|
|---|---|---|
|
Overall Handling
Excellent (5)
|
23 Participants
|
8 Participants
|
|
Overall Handling
Very Good (4)
|
27 Participants
|
23 Participants
|
|
Overall Handling
Good (3)
|
8 Participants
|
18 Participants
|
|
Overall Handling
Fair (2)
|
3 Participants
|
6 Participants
|
|
Overall Handling
Poor (1)
|
0 Participants
|
1 Participants
|
Adverse Events
Test (Narafilcon A)
Control (Nelfilcon A)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
DIR CLINICAL NEW PRODUCT DEVELOPMENT
Johnson & Johnson Vision
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60