Trial Outcomes & Findings for Evaluation of a Reusable Silicone Hydrogel Multifocal Contact Lens (NCT NCT04189224)
NCT ID: NCT04189224
Last Updated: 2025-04-27
Results Overview
The contact lens-corrected visual performance on logMAR scale was evaluated binocularly under high luminance high contrast, dim luminance high contrast and high luminance low contrast conditions at 4 meters (distance), 64 cm (intermediate) and 40 cm (near) using ETDRS/reduced Guillon-Poling charts. A value of 0.0 logMAR equates to 20/20 vision on a Snellen Scale. Lower values indicate better visual performance. The average visual performance was reported for each lens type and distance.
COMPLETED
NA
46 participants
2-Week Follow-up
2025-04-27
Participant Flow
A total of 46 subjects were enrolled in this study. Of those enrolled, 44 (95.7%) subjects randomized and dispensed at least 1 study lens while, 2 (4.3%) subjects failed to meet all eligibility criteria. Of those dispensed, 43 (93.5%) subjects completed the study while, 1 (2.2%) subject was discontinued from the study.
Participant milestones
| Measure |
Test/Control
Subjects randomized to this sequence received the Test lens during the first period and then received the Control lens during the second period.
|
Control/Test
Subjects randomized to this sequence received the Control lens during the first period and then received the Test lens during the second period.
|
|---|---|---|
|
Period 1
STARTED
|
23
|
21
|
|
Period 1
COMPLETED
|
23
|
21
|
|
Period 1
NOT COMPLETED
|
0
|
0
|
|
Period 2
STARTED
|
23
|
21
|
|
Period 2
COMPLETED
|
23
|
20
|
|
Period 2
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Test/Control
Subjects randomized to this sequence received the Test lens during the first period and then received the Control lens during the second period.
|
Control/Test
Subjects randomized to this sequence received the Control lens during the first period and then received the Test lens during the second period.
|
|---|---|---|
|
Period 2
Adverse Event
|
0
|
1
|
Baseline Characteristics
Evaluation of a Reusable Silicone Hydrogel Multifocal Contact Lens
Baseline characteristics by cohort
| Measure |
All Participants
n=44 Participants
Subjects that wore either Test or Control lens in either first or second period of the study.
|
|---|---|
|
Age, Continuous
|
55.3 years
STANDARD_DEVIATION 6.86 • n=5 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 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
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
43 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
44 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2-Week Follow-upPopulation: Analysis population consisted of all subjects who had successfully completed the study and did not substantially deviate from the protocol.
The contact lens-corrected visual performance on logMAR scale was evaluated binocularly under high luminance high contrast, dim luminance high contrast and high luminance low contrast conditions at 4 meters (distance), 64 cm (intermediate) and 40 cm (near) using ETDRS/reduced Guillon-Poling charts. A value of 0.0 logMAR equates to 20/20 vision on a Snellen Scale. Lower values indicate better visual performance. The average visual performance was reported for each lens type and distance.
Outcome measures
| Measure |
Test (Senofilcon A)
n=40 Participants
Subjects that wore the Test lens in either the first or second period of the study.
|
Control (Etafilcon A)
n=40 Participants
Subjects that wore the Control lens in either the first or second period of the study.
|
|---|---|---|
|
Binocular Contact Lens-Corrected Visual Performance Under Standard High Contrast Bright
Standard High Contrast Bright: Near
|
0.07 logMAR
Standard Deviation 0.097
|
0.08 logMAR
Standard Deviation 0.106
|
|
Binocular Contact Lens-Corrected Visual Performance Under Standard High Contrast Bright
Standard High Contrast Bright: Distance
|
-0.12 logMAR
Standard Deviation 0.073
|
-0.12 logMAR
Standard Deviation 0.067
|
|
Binocular Contact Lens-Corrected Visual Performance Under Standard High Contrast Bright
Standard High Contrast Bright: Intermediate
|
-0.06 logMAR
Standard Deviation 0.070
|
-0.06 logMAR
Standard Deviation 0.072
|
PRIMARY outcome
Timeframe: 2-Week Follow-upPopulation: Analysis population consisted of all subjects who had successfully completed the study and did not substantially deviate from the protocol.
The contact lens-corrected visual performance on logMAR scale was evaluated binocularly under high luminance high contrast, dim luminance high contrast and high luminance low contrast conditions at 4 meters (distance), 64 cm (intermediate) and 40 cm (near) using ETDRS/reduced Guillon-Poling charts. A value of 0.0 logMAR equates to 20/20 vision on a Snellen Scale. Lower values indicate better visual performance. The average visual performance was reported for each lens type and distance.
Outcome measures
| Measure |
Test (Senofilcon A)
n=40 Participants
Subjects that wore the Test lens in either the first or second period of the study.
|
Control (Etafilcon A)
n=40 Participants
Subjects that wore the Control lens in either the first or second period of the study.
|
|---|---|---|
|
Binocular Contact Lens-Corrected Visual Performance Under Standard High Contrast Dim With Goggles
Standard High Contrast Dim with Goggles: Distance
|
0.14 logMAR
Standard Deviation 0.109
|
0.13 logMAR
Standard Deviation 0.085
|
|
Binocular Contact Lens-Corrected Visual Performance Under Standard High Contrast Dim With Goggles
Standard High Contrast Dim with Goggles: Intermediate
|
0.02 logMAR
Standard Deviation 0.095
|
0.00 logMAR
Standard Deviation 0.091
|
|
Binocular Contact Lens-Corrected Visual Performance Under Standard High Contrast Dim With Goggles
Standard High Contrast Dim with Goggles: Near
|
0.18 logMAR
Standard Deviation 0.098
|
0.16 logMAR
Standard Deviation 0.101
|
PRIMARY outcome
Timeframe: 2-Week Follow-upPopulation: Analysis population consisted of all subjects who had successfully completed the study and did not substantially deviate from the protocol.
The contact lens-corrected visual performance on logMAR scale was evaluated binocularly under high luminance high contrast, dim luminance high contrast and high luminance low contrast conditions at 4 meters (distance), 64 cm (intermediate) and 40 cm (near) using ETDRS/reduced Guillon-Poling charts. A value of 0.0 logMAR equates to 20/20 vision on a Snellen Scale. Lower values indicate better visual performance. The average visual performance was reported for each lens type and distance.
Outcome measures
| Measure |
Test (Senofilcon A)
n=40 Participants
Subjects that wore the Test lens in either the first or second period of the study.
|
Control (Etafilcon A)
n=40 Participants
Subjects that wore the Control lens in either the first or second period of the study.
|
|---|---|---|
|
Binocular Contact Lens-Corrected Visual Performance Under Standard Low Contrast Bright
Standard Low Contrast Bright: Distance
|
0.08 logMAR
Standard Deviation 0.093
|
0.07 logMAR
Standard Deviation 0.075
|
|
Binocular Contact Lens-Corrected Visual Performance Under Standard Low Contrast Bright
Standard Low Contrast Bright: Intermediate
|
0.12 logMAR
Standard Deviation 0.075
|
0.10 logMAR
Standard Deviation 0.094
|
|
Binocular Contact Lens-Corrected Visual Performance Under Standard Low Contrast Bright
Standard Low Contrast Bright: Near
|
0.25 logMAR
Standard Deviation 0.113
|
0.27 logMAR
Standard Deviation 0.119
|
SECONDARY outcome
Timeframe: 2-Week Follow-upPopulation: Analysis population consisted of all subjects who had successfully completed the study and did not substantially deviate from the protocol.
Overall vision scores were assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, aged 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120.
Outcome measures
| Measure |
Test (Senofilcon A)
n=40 Participants
Subjects that wore the Test lens in either the first or second period of the study.
|
Control (Etafilcon A)
n=40 Participants
Subjects that wore the Control lens in either the first or second period of the study.
|
|---|---|---|
|
Overall Vision Scores
|
52.24 CLUE points
Standard Deviation 22.035
|
50.24 CLUE points
Standard Deviation 23.282
|
SECONDARY outcome
Timeframe: 2-Week Follow-upPopulation: Analysis population consisted of all subjects who had successfully completed the study and did not substantially deviate from the protocol.
Overall comfort scores were assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, aged 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120.
Outcome measures
| Measure |
Test (Senofilcon A)
n=40 Participants
Subjects that wore the Test lens in either the first or second period of the study.
|
Control (Etafilcon A)
n=40 Participants
Subjects that wore the Control lens in either the first or second period of the study.
|
|---|---|---|
|
Overall Comfort Scores
|
64.51 CLUE points
Standard Deviation 26.630
|
62.71 CLUE points
Standard Deviation 24.006
|
SECONDARY outcome
Timeframe: 2-Week Follow-upPopulation: Analysis population consisted of all subjects who were dispensed at least 1 study lens.
Slit Lamp Findings (SLF) were assessed using a biomicroscope and was graded using the FDA grading scale (Grade: 0, 1,2, 3 and 4) with grade 0 represents the absence of findings and 1 to 4 representing successively worse findings (i.e. Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). Slit Lamp Findings were assessed at the 2-Week Follow-up. SLF is a binary response where Y=1 for at least one Grade 3 or 4 slit lamp finding. The number of eyes with SLF with grade 3 or higher by lens was reported.
Outcome measures
| Measure |
Test (Senofilcon A)
n=88 number of eyes
Subjects that wore the Test lens in either the first or second period of the study.
|
Control (Etafilcon A)
n=44 Participants
Subjects that wore the Control lens in either the first or second period of the study.
|
|---|---|---|
|
Number of Grade 3 or Higher Slit Lamp Findings
|
0 number of eyes
|
0 number of eyes
|
SECONDARY outcome
Timeframe: 2-Week Follow-upPopulation: Analysis population consisted of all subjects who were dispensed at least 1 study lens.
Subject reported ocular symptoms were assessed using a questionnaire at the 2-week follow-up. Subjects were asked if they experienced any of the following symptoms: Burning/Stinging, Itchiness/Scratchiness, Dryness, Lens Awareness, Grittiness/Foreign Body Sensation, Redness, Irritation/Discomfort, Cloudy/Blurry/Hazy, Variable Vision and Other; using the scale of: None, Mild, Moderate and Severe. The proportion of subjects that reported symptoms (Mild, Moderate and Severe) was reported for each lens type.
Outcome measures
| Measure |
Test (Senofilcon A)
n=88 number of eyes
Subjects that wore the Test lens in either the first or second period of the study.
|
Control (Etafilcon A)
n=88 number of eyes
Subjects that wore the Control lens in either the first or second period of the study.
|
|---|---|---|
|
Proportion of Subjects That Reported Ocular Symptoms
|
0.837 proportion
|
0.813 proportion
|
Adverse Events
Test
Control
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Thomas R Karkkainen.
Johnson & Johnson Vision Care, Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60