Trial Outcomes & Findings for Evaluating Soft Contact Lens Prototypes for Myopia Control (NCT NCT03408444)
NCT ID: NCT03408444
Last Updated: 2022-06-08
Results Overview
Axial length (in the unit of mm) was measured by a commercially available device based on the interferometry technique.
Recruitment status
COMPLETED
Target enrollment
240 participants
Primary outcome timeframe
6-month follow-up
Results posted on
2022-06-08
Participant Flow
A total of 240 subjects were enrolled into this study. Of those enrolled, 199 subjects were randomized and dispensed one of the four study lenses while 41 subjects failed too meet all eligibility criteria. Of those dispensed, 14 subjects discontinued and 185 subjects completed all required study visits.
Participant milestones
| Measure |
Test 1
Subjects randomized to receive senofilcon A (Test 1) lens throughout the entire duration of the study
|
Test 2
Subjects randomized to receive senofilcon A (Test 2) throughout the entire duration of the study
|
Test 3
Subjects randomized to receive senofilcon A (Test 3) throughout the entire duration of the study
|
Control
Subjects randomized to receive the senofilcon A (Control) Lens throughout the entire duration of the study
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
50
|
48
|
50
|
51
|
|
Overall Study
COMPLETED
|
49
|
45
|
44
|
47
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
6
|
4
|
Reasons for withdrawal
| Measure |
Test 1
Subjects randomized to receive senofilcon A (Test 1) lens throughout the entire duration of the study
|
Test 2
Subjects randomized to receive senofilcon A (Test 2) throughout the entire duration of the study
|
Test 3
Subjects randomized to receive senofilcon A (Test 3) throughout the entire duration of the study
|
Control
Subjects randomized to receive the senofilcon A (Control) Lens throughout the entire duration of the study
|
|---|---|---|---|---|
|
Overall Study
Subject No Longer Meets Eligibility Criteria
|
1
|
0
|
0
|
0
|
|
Overall Study
Lens Discomfort
|
0
|
1
|
0
|
0
|
|
Overall Study
Unsatisfactory Visual Response due to Test Article
|
0
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
3
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
0
|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
1
|
|
Overall Study
Lens Handling Difficulties
|
0
|
0
|
1
|
0
|
|
Overall Study
Subject Decided to Not Wear Contact Lenses
|
0
|
0
|
0
|
3
|
Baseline Characteristics
Evaluating Soft Contact Lens Prototypes for Myopia Control
Baseline characteristics by cohort
| Measure |
Test 1
n=50 Participants
Subjects randomized to receive senofilcon A (Test 1) throughout the entire duration of the study
|
Test 2
n=48 Participants
Subjects randomized to receive senofilcon A (Test 2) throughout the entire duration of the study
|
Test 3
n=50 Participants
Subjects randomized to receive senofilcon A (Test 3) throughout the entire duration of the study
|
Control
n=51 Participants
Subjects randomized to receive the senofilcon A (Control) Lens throughout the entire duration of the study
|
Total
n=199 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
10.1 years
STANDARD_DEVIATION 1.38 • n=5 Participants
|
10.2 years
STANDARD_DEVIATION 1.51 • n=7 Participants
|
10.0 years
STANDARD_DEVIATION 1.58 • n=5 Participants
|
9.9 years
STANDARD_DEVIATION 1.59 • n=4 Participants
|
10.0 years
STANDARD_DEVIATION 1.51 • n=21 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
106 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
93 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian
|
26 Count of Participants
n=5 Participants
|
25 Count of Participants
n=7 Participants
|
27 Count of Participants
n=5 Participants
|
24 Count of Participants
n=4 Participants
|
102 Count of Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Count of Participants
n=5 Participants
|
1 Count of Participants
n=7 Participants
|
2 Count of Participants
n=5 Participants
|
2 Count of Participants
n=4 Participants
|
5 Count of Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White
|
22 Count of Participants
n=5 Participants
|
20 Count of Participants
n=7 Participants
|
19 Count of Participants
n=5 Participants
|
25 Count of Participants
n=4 Participants
|
86 Count of Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Count of Participants
n=5 Participants
|
2 Count of Participants
n=7 Participants
|
2 Count of Participants
n=5 Participants
|
0 Count of Participants
n=4 Participants
|
6 Count of Participants
n=21 Participants
|
|
Region of Enrollment
Canada
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
|
Region of Enrollment
China
|
25 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
97 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
20 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
85 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 6-month follow-upPopulation: All randomized subjects regardless of actual treatment and subsequent withdrawal from study or deviation from protocol. At least one observation was recorded.
Axial length (in the unit of mm) was measured by a commercially available device based on the interferometry technique.
Outcome measures
| Measure |
Test 1
n=94 eyes
Subjects randomized to receive senofilcon A (Test 1) throughout the entire duration of the study
|
Test 2
n=92 eyes
Subjects randomized to receive senofilcon A (Test 2) throughout the entire duration of the study
|
Test 3
n=88 eyes
Subjects randomized to receive senofilcon A (Test 3) throughout the entire duration of the study
|
Control
n=94 eyes
Subjects randomized to receive the senofilcon A (Control) Lens throughout the entire duration of the study
|
|---|---|---|---|---|
|
Axial Length
|
0.119 mm
Standard Deviation 0.1008
|
0.135 mm
Standard Deviation 0.1165
|
0.079 mm
Standard Deviation 0.1251
|
0.189 mm
Standard Deviation 0.1206
|
PRIMARY outcome
Timeframe: 6-month follow-upPopulation: All randomized subjects regardless of actual treatment and subsequent withdrawal from study or deviation from protocol. At least one observation was recorded.
SECAR (in the unit of D) was computed from the spherocylindrical refraction measured by a commercially available autorefractor.
Outcome measures
| Measure |
Test 1
n=94 eye
Subjects randomized to receive senofilcon A (Test 1) throughout the entire duration of the study
|
Test 2
n=92 eye
Subjects randomized to receive senofilcon A (Test 2) throughout the entire duration of the study
|
Test 3
n=88 eye
Subjects randomized to receive senofilcon A (Test 3) throughout the entire duration of the study
|
Control
n=94 eye
Subjects randomized to receive the senofilcon A (Control) Lens throughout the entire duration of the study
|
|---|---|---|---|---|
|
Spherical Equivalent of Cycloplegic Autorefraction (SECAR)
|
-0.26 D
Standard Deviation 0.32
|
-0.25 D
Standard Deviation 0.35
|
-0.12 D
Standard Deviation 0.27
|
-0.35 D
Standard Deviation 0.33
|
Adverse Events
Test 1
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Test 2
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Test 3
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Test 1
n=50 participants at risk
Subjects randomized to receive senofilcon A (Test 1) throughout the entire duration of the study
|
Test 2
n=48 participants at risk
Subjects randomized to receive senofilcon A (Test 2) throughout the entire duration of the study
|
Test 3
n=50 participants at risk
Subjects randomized to receive senofilcon A (Test 3) throughout the entire duration of the study
|
Control
n=51 participants at risk
Subjects randomized to receive the senofilcon A (Control) Lens throughout the entire duration of the study
|
|---|---|---|---|---|
|
Infections and infestations
Cellulitis of Left Elbow and Upper Arm
|
0.00%
0/50 • Throughout the duration of the study, 6-month up to 1 year.
|
2.1%
1/48 • Number of events 1 • Throughout the duration of the study, 6-month up to 1 year.
|
0.00%
0/50 • Throughout the duration of the study, 6-month up to 1 year.
|
0.00%
0/51 • Throughout the duration of the study, 6-month up to 1 year.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia Mycoplasma Acute Bronchitis , Leukopenia
|
0.00%
0/50 • Throughout the duration of the study, 6-month up to 1 year.
|
0.00%
0/48 • Throughout the duration of the study, 6-month up to 1 year.
|
2.0%
1/50 • Number of events 1 • Throughout the duration of the study, 6-month up to 1 year.
|
0.00%
0/51 • Throughout the duration of the study, 6-month up to 1 year.
|
Other adverse events
| Measure |
Test 1
n=50 participants at risk
Subjects randomized to receive senofilcon A (Test 1) throughout the entire duration of the study
|
Test 2
n=48 participants at risk
Subjects randomized to receive senofilcon A (Test 2) throughout the entire duration of the study
|
Test 3
n=50 participants at risk
Subjects randomized to receive senofilcon A (Test 3) throughout the entire duration of the study
|
Control
n=51 participants at risk
Subjects randomized to receive the senofilcon A (Control) Lens throughout the entire duration of the study
|
|---|---|---|---|---|
|
General disorders
Cold
|
18.0%
9/50 • Number of events 10 • Throughout the duration of the study, 6-month up to 1 year.
|
8.3%
4/48 • Number of events 5 • Throughout the duration of the study, 6-month up to 1 year.
|
4.0%
2/50 • Number of events 3 • Throughout the duration of the study, 6-month up to 1 year.
|
2.0%
1/51 • Number of events 1 • Throughout the duration of the study, 6-month up to 1 year.
|
Additional Information
Xu Cheng - Sr. Principal Clinical Scientist
Johnson & Johnson Vision Care, Inc.
Phone: 1-800-843-2020
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60