Trial Outcomes & Findings for Visual Performance of Soft Contact Lenses With Myopia Control Optics (NCT NCT05141448)
NCT ID: NCT05141448
Last Updated: 2025-04-27
Results Overview
Visual performance was calculated as binocular contact lens-corrected distance visual acuity using a Logarithm of Minimal Angle of Resolution (logMAR) visual acuity scale. This was evaluated under high luminance and high contrast conditions (HLHC) at 4 meters from Early Treatment Diabetic Retinopathy Study (ETDRS) charts at the 2-week follow-up visit. Lower visual performance values indicate better vision. A value of 0.0 logMAR is equivalent to 20/20 Snellen Visual Acuity. The average visual performance was reported for each lens type. Binocular visual performance for Run-in lens was measured at 1-week follow-up visit.
COMPLETED
79 participants
Up to 2-Week Follow-up
2025-04-27
Participant Flow
A total of 79 subjects were enrolled in this study. Of those enrolled, 75 subjects were randomized and dispensed at least one study lens, while 4 subjects failed to meet all eligibility criteria. Of those dispensed, 65 subjects completed the study while, 10 subjects were discontinued from the study.
Participant milestones
| Measure |
Run-in Lens/Test 2/Test 1/Control
All subjects wore the Run-in lens during Period 1. Subjects randomized to this arm wore senofilcon A C3 (EMO-114) \[Test 2\] during Period 2, senofilcon A C3 (EMO-118) \[Test 1\] during Period 3 and omafilcon A \[Control\] during Period 4.
|
Run-in Lens/Test 2/Control/Test 1
All subjects wore the Run-in lens during Period 1. Subjects randomized to this arm wore senofilcon A C3 (EMO-114) \[Test 2\] during Period 2, omafilcon A \[Control\] during Period 3 and senofilcon A C3 (EMO-118) \[Test 1\] during Period 4.
|
Run-in Lens/Test 1/Test 2/Control
All subjects wore the Run-in lens during Period 1. Subjects randomized to this arm wore senofilcon A C3 (EMO-118) \[Test 1\] during Period 2, senofilcon A C3 (EMO-114) \[Test 2\] during Period 3 and omafilcon A \[Control\] during Period 4.
|
Run-in Lens/Test 1/Control/Test 2
All subjects wore the Run-in lens during Period 1. Subjects randomized to this arm wore senofilcon A C3 (EMO-118) \[Test 1\] during Period 2, omafilcon A \[Control\] during Period 3 and senofilcon A C3 (EMO-114) \[Test 2\] during Period 4.
|
Run-in Lens/Control/Test 2/Test 1
All subjects wore the Run-in lens during Period 1. Subjects randomized to this arm wore omafilcon A \[Control\] during Period 2, senofilcon A C3 (EMO-114) \[Test 2\] during Period 3 and senofilcon A C3 (EMO-118) \[Test 1\] during Period 4.
|
Run-in Lens/Control/Test1/Test2
All subjects wore the Run-in lens during Period 1. Subjects randomized to this arm wore omafilcon A \[Control\] during Period 2, senofilcon A C3 (EMO-118) \[Test 1\] during Period 3 and senofilcon A C3 (EMO-114) \[Test 2\] during Period 4.
|
|---|---|---|---|---|---|---|
|
Period 1
STARTED
|
13
|
13
|
15
|
12
|
11
|
11
|
|
Period 1
COMPLETED
|
13
|
12
|
15
|
12
|
10
|
11
|
|
Period 1
NOT COMPLETED
|
0
|
1
|
0
|
0
|
1
|
0
|
|
Period 2
STARTED
|
13
|
12
|
15
|
12
|
10
|
11
|
|
Period 2
COMPLETED
|
13
|
11
|
15
|
11
|
10
|
9
|
|
Period 2
NOT COMPLETED
|
0
|
1
|
0
|
1
|
0
|
2
|
|
3
STARTED
|
13
|
11
|
15
|
11
|
10
|
9
|
|
3
COMPLETED
|
11
|
11
|
15
|
11
|
10
|
8
|
|
3
NOT COMPLETED
|
2
|
0
|
0
|
0
|
0
|
1
|
|
4
STARTED
|
11
|
11
|
15
|
11
|
10
|
8
|
|
4
COMPLETED
|
10
|
11
|
15
|
11
|
10
|
8
|
|
4
NOT COMPLETED
|
1
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Run-in Lens/Test 2/Test 1/Control
All subjects wore the Run-in lens during Period 1. Subjects randomized to this arm wore senofilcon A C3 (EMO-114) \[Test 2\] during Period 2, senofilcon A C3 (EMO-118) \[Test 1\] during Period 3 and omafilcon A \[Control\] during Period 4.
|
Run-in Lens/Test 2/Control/Test 1
All subjects wore the Run-in lens during Period 1. Subjects randomized to this arm wore senofilcon A C3 (EMO-114) \[Test 2\] during Period 2, omafilcon A \[Control\] during Period 3 and senofilcon A C3 (EMO-118) \[Test 1\] during Period 4.
|
Run-in Lens/Test 1/Test 2/Control
All subjects wore the Run-in lens during Period 1. Subjects randomized to this arm wore senofilcon A C3 (EMO-118) \[Test 1\] during Period 2, senofilcon A C3 (EMO-114) \[Test 2\] during Period 3 and omafilcon A \[Control\] during Period 4.
|
Run-in Lens/Test 1/Control/Test 2
All subjects wore the Run-in lens during Period 1. Subjects randomized to this arm wore senofilcon A C3 (EMO-118) \[Test 1\] during Period 2, omafilcon A \[Control\] during Period 3 and senofilcon A C3 (EMO-114) \[Test 2\] during Period 4.
|
Run-in Lens/Control/Test 2/Test 1
All subjects wore the Run-in lens during Period 1. Subjects randomized to this arm wore omafilcon A \[Control\] during Period 2, senofilcon A C3 (EMO-114) \[Test 2\] during Period 3 and senofilcon A C3 (EMO-118) \[Test 1\] during Period 4.
|
Run-in Lens/Control/Test1/Test2
All subjects wore the Run-in lens during Period 1. Subjects randomized to this arm wore omafilcon A \[Control\] during Period 2, senofilcon A C3 (EMO-118) \[Test 1\] during Period 3 and senofilcon A C3 (EMO-114) \[Test 2\] during Period 4.
|
|---|---|---|---|---|---|---|
|
Period 1
Unsatisfactory Visual Response due to Test Article
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Period 1
Subject No Longer Meets Eligibility Criteria
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Period 2
Unsatisfactory Visual Response due to Test Article
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Period 2
Subject Withdrawn by PI due to Non Compliance to Protocol
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Period 2
COVID-19 Related
|
0
|
0
|
0
|
1
|
0
|
1
|
|
3
Covid-19 related
|
2
|
0
|
0
|
0
|
0
|
1
|
|
4
Unsatisfactory Visual Response due to Test Article
|
1
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
All subjects dispensed a study lens.
Baseline characteristics by cohort
| Measure |
Total
n=75 Participants
All subjects dispensed a study lens.
|
|---|---|
|
Age, Continuous
|
12.6 Years
STANDARD_DEVIATION 2.36 • n=5 Participants • All subjects dispensed a study lens.
|
|
Sex: Female, Male
Female
|
50 Participants
n=5 Participants • All subjects dispensed a study lens.
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants • All subjects dispensed a study lens.
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants • All subjects dispensed a study lens.
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=5 Participants • All subjects dispensed a study lens.
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants • All subjects dispensed a study lens.
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants • All subjects dispensed a study lens.
|
|
Race (NIH/OMB)
White
|
60 Participants
n=5 Participants • All subjects dispensed a study lens.
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=5 Participants • All subjects dispensed a study lens.
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants • All subjects dispensed a study lens.
|
|
Region of Enrollment
United States
|
75 Participants
n=5 Participants • All subjects dispensed a study lens.
|
PRIMARY outcome
Timeframe: Up to 2-Week Follow-upPopulation: All subjects who successfully completed all study visits without a major protocol deviation.
Visual performance was calculated as binocular contact lens-corrected distance visual acuity using a Logarithm of Minimal Angle of Resolution (logMAR) visual acuity scale. This was evaluated under high luminance and high contrast conditions (HLHC) at 4 meters from Early Treatment Diabetic Retinopathy Study (ETDRS) charts at the 2-week follow-up visit. Lower visual performance values indicate better vision. A value of 0.0 logMAR is equivalent to 20/20 Snellen Visual Acuity. The average visual performance was reported for each lens type. Binocular visual performance for Run-in lens was measured at 1-week follow-up visit.
Outcome measures
| Measure |
Run-in: Etafilcon A
n=49 Participants
Run-in: etafilcon A (1-Week Follow-up)
|
Senofilcon A C3 (EMO-114) [Test 2]
n=49 Participants
Subjects that wore senofilcon A C3 (EMO-114) \[Test 2\] during any point of the study.
|
Senofilcon A C3 (EMO-118) [Test 1]
n=49 Participants
Subjects that wore senofilcon A C3 (EMO-118) \[Test 1\] during any point of the study.
|
Omafilcon A (MS1D) [Control]
n=49 Participants
Subjects that wore omafilcon A \[Control\] during any point of the study.
|
|---|---|---|---|---|
|
Binocular Visual Performance (LogMAR)
|
-0.10 logMAR
Standard Deviation 0.057
|
-0.10 logMAR
Standard Deviation 0.063
|
-0.07 logMAR
Standard Deviation 0.064
|
-0.11 logMAR
Standard Deviation 0.059
|
Adverse Events
Run-in: Etafilcon A
Senofilcon A C3 (EMO-114)
Senofilcon A C3 (EMO-118)
Omafilcon A
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Principal Research Optometrist
Johnson & Johnson Vision Care, Inc. (JJVC)
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60