Trial Outcomes & Findings for Validation of Senofilcon A With New UV / HEV Filter (NCT NCT05099380)
NCT ID: NCT05099380
Last Updated: 2023-02-06
Results Overview
Overall quality of vision score was 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, ages 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. The average CLUE vision score for each lens type was reported.
COMPLETED
NA
296 participants
2-Week Follow-up
2023-02-06
Participant Flow
A total of 296 subjects were enrolled in this study. Of those enrolled, 295 subjects were dispensed at least one study lens, while 1 subject failed to meet all eligibility criteria. Of those dispensed, 289 subjects completed the study while 6 subjects were discontinued.
Participant milestones
| Measure |
Control (Senofilcon A)
Subjects that wore the Control (senofilcon A) lens during the study.
|
Test (Senofilcon A C3)
Subjects that wore the Test lens during the study.
|
|---|---|---|
|
Overall Study
STARTED
|
150
|
145
|
|
Overall Study
COMPLETED
|
145
|
144
|
|
Overall Study
NOT COMPLETED
|
5
|
1
|
Reasons for withdrawal
| Measure |
Control (Senofilcon A)
Subjects that wore the Control (senofilcon A) lens during the study.
|
Test (Senofilcon A C3)
Subjects that wore the Test lens during the study.
|
|---|---|---|
|
Overall Study
Subject enrolled in error
|
1
|
0
|
|
Overall Study
Study Procedure
|
1
|
0
|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Adverse Event
|
1
|
1
|
|
Overall Study
Subject no longer meets eligibility criteria
|
1
|
0
|
Baseline Characteristics
Validation of Senofilcon A With New UV / HEV Filter
Baseline characteristics by cohort
| Measure |
Control (Senofilcon A)
n=150 Participants
Subjects that wore the Control (senofilcon A) lens during the study.
|
Test (Senofilcon A C3)
n=145 Participants
Subjects that wore the Test lens during the study.
|
Total
n=295 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Sex: Female, Male
Gender · Female
|
102 Participants
n=5 Participants
|
100 Participants
n=7 Participants
|
202 Participants
n=5 Participants
|
|
Sex: Female, Male
Gender · Male
|
48 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
93 Participants
n=5 Participants
|
|
Age, Continuous
Age
|
30.0 years
STANDARD_DEVIATION 5.86 • n=5 Participants
|
29.0 years
STANDARD_DEVIATION 5.70 • n=7 Participants
|
29.5 years
STANDARD_DEVIATION 5.80 • n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
10 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
131 Participants
n=5 Participants
|
122 Participants
n=7 Participants
|
253 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
150 Participants
n=5 Participants
|
145 Participants
n=7 Participants
|
295 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2-Week Follow-upPopulation: All subjects that completed all study visits without a major protocol deviation.
Overall quality of vision score was 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, ages 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. The average CLUE vision score for each lens type was reported.
Outcome measures
| Measure |
Control (Senofilcon A)
n=145 Participants
Subjects that wore the Control (senofilcon A) lens during the study.
|
Test (Senofilcon A C3)
n=144 Participants
Subjects that wore the Test lens during the study.
|
|---|---|---|
|
Overall Quality of Vision Score
|
67.0 Units on a scale
Standard Deviation 20.02
|
70.4 Units on a scale
Standard Deviation 19.73
|
PRIMARY outcome
Timeframe: 2-Week Follow-upPopulation: All subjects that completed all study visits without a major protocol deviation.
Monocular visual acuity was measured on a logMAR (Logarithm of Minimal Angle of Resolution) scale and was evaluated at distance (4 meter) under high luminance high contrast lighting condition using ETDRS (Early Treatment Diabetic Retinopathy Study) charts. Letter-by-letter results calculated the visual performance score for each chart read. LogMAR scores closer to zero, or below zero, indicate a better visual acuity. A logMAR visual performance score of 0.0 is equivalent to Snellen visual acuity of 20/20.
Outcome measures
| Measure |
Control (Senofilcon A)
n=290 eyes
Subjects that wore the Control (senofilcon A) lens during the study.
|
Test (Senofilcon A C3)
n=288 eyes
Subjects that wore the Test lens during the study.
|
|---|---|---|
|
Distance Monocular logMAR Visual Acuity
|
-0.12 logMAR
Standard Deviation 0.093
|
-0.11 logMAR
Standard Deviation 0.080
|
PRIMARY outcome
Timeframe: up to 2-week follow-upPopulation: All subjects were dispensed at least one study lens. Subjects were summarized by actual treatment received.
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). This was performed on each subject eye at every study visit (baseline, unscheduled visits, 2-week follow-up and final evaluation). The data was then dichotomized into two groups. Those with Grade 3 or higher SLF and those with Grade 2 or lower. The proportion of eyes with Grade 3 or higher SLF was reported.
Outcome measures
| Measure |
Control (Senofilcon A)
n=300 eyes
Subjects that wore the Control (senofilcon A) lens during the study.
|
Test (Senofilcon A C3)
n=290 eyes
Subjects that wore the Test lens during the study.
|
|---|---|---|
|
Proportion of Eyes With Grade 3 or Higher Slit Lamp Findings
|
0 proportion of eyes
|
0 proportion of eyes
|
PRIMARY outcome
Timeframe: Up to 2-Week Follow-upPopulation: All subjects were dispensed at least one study lens. Subjects were summarized by actual treatment received.
Contact lens fitting acceptance was assessed for each subject eye using a biomicroscope post lens insertion and the 2-week follow-up. Lens fit was a binary variable where acceptable lens fit=1 and unacceptable lens fit=0. The proportion of eyes with unacceptable lens fit was reported. Summaries presented in the Participant flow are summarized by planned arm, where as summaries for this measure are summarized by actual arm. One subject was dispensed the incorrect study lens, there for, the number of subjects that were randomized to the Control were 149 but 150 subjects were actually dispensed the control.
Outcome measures
| Measure |
Control (Senofilcon A)
n=300 eyes
Subjects that wore the Control (senofilcon A) lens during the study.
|
Test (Senofilcon A C3)
n=290 eyes
Subjects that wore the Test lens during the study.
|
|---|---|---|
|
Proportion of Eyes With Unacceptable Lens Fitting
|
0 proportion of eyes
|
0 proportion of eyes
|
SECONDARY outcome
Timeframe: 2-Week Follow-upPopulation: All subjects that completed all study visits without a major protocol deviation.
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, ages 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. The average CLUE comfort score for each lens type was reported.
Outcome measures
| Measure |
Control (Senofilcon A)
n=145 Participants
Subjects that wore the Control (senofilcon A) lens during the study.
|
Test (Senofilcon A C3)
n=144 Participants
Subjects that wore the Test lens during the study.
|
|---|---|---|
|
Overall Comfort Scores
|
70.5 Units on a scale
Standard Deviation 22.83
|
70.4 Units on a scale
Standard Deviation 22.66
|
SECONDARY outcome
Timeframe: 2-Week Follow-upPopulation: All subjects that completed all study visits without a major protocol deviation.
Overall handling 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, ages 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. The average CLUE handling score for each lens type was reported.
Outcome measures
| Measure |
Control (Senofilcon A)
n=145 Participants
Subjects that wore the Control (senofilcon A) lens during the study.
|
Test (Senofilcon A C3)
n=144 Participants
Subjects that wore the Test lens during the study.
|
|---|---|---|
|
Overall Handling Scores
|
69.2 Units on a scale
Standard Deviation 20.13
|
67.8 Units on a scale
Standard Deviation 20.44
|
SECONDARY outcome
Timeframe: 2-Week Follow-upPopulation: All subjects that completed all study visits without a major protocol deviation.
Indoor performance was assessed using the individual questionnaire item "Clarity of Vision indoors in bright light" with a 5-point Likert scale (1: Excellent, 2: Very Good, 3: Good, 4: Fair and 5: Poor) and a Not Applicable response option. Subject responses were reported by lens using frequencies.
Outcome measures
| Measure |
Control (Senofilcon A)
n=145 Participants
Subjects that wore the Control (senofilcon A) lens during the study.
|
Test (Senofilcon A C3)
n=144 Participants
Subjects that wore the Test lens during the study.
|
|---|---|---|
|
Situational Visual Performance - Indoors
Poor
|
1 number of responses
|
0 number of responses
|
|
Situational Visual Performance - Indoors
Very Good
|
51 number of responses
|
48 number of responses
|
|
Situational Visual Performance - Indoors
Good
|
17 number of responses
|
11 number of responses
|
|
Situational Visual Performance - Indoors
Fair
|
1 number of responses
|
0 number of responses
|
|
Situational Visual Performance - Indoors
Not Applicable
|
0 number of responses
|
0 number of responses
|
|
Situational Visual Performance - Indoors
Excellent
|
75 number of responses
|
85 number of responses
|
SECONDARY outcome
Timeframe: 2-Week Follow-upPopulation: All randomized subjects regardless of actual treatment and subsequent withdrawal from study or deviation from protocol.
Situational visual performance related to digital device use was assessed using the individual preference item "Overall preference while using computer screens \& digital devices". The response set include: Strongly prefer my habitual lenses, Slightly prefer my habitual lenses, No Preference, Slightly prefer the study lenses and Strongly prefer the study lenses. Responses were collapsed into three categories for analysis purpose: Prefer Study Lens, No Preference, Prefer Habitual Lens. Subject responses were reported by lens using frequencies.
Outcome measures
| Measure |
Control (Senofilcon A)
n=146 Participants
Subjects that wore the Control (senofilcon A) lens during the study.
|
Test (Senofilcon A C3)
n=144 Participants
Subjects that wore the Test lens during the study.
|
|---|---|---|
|
Situational Visual Performance - Digital Devices
Strongly prefer my habitual lenses
|
17 number of responses
|
12 number of responses
|
|
Situational Visual Performance - Digital Devices
Slightly prefer my habitual lenses
|
16 number of responses
|
16 number of responses
|
|
Situational Visual Performance - Digital Devices
No Preference
|
61 number of responses
|
48 number of responses
|
|
Situational Visual Performance - Digital Devices
Slightly prefer the study lenses
|
36 number of responses
|
42 number of responses
|
|
Situational Visual Performance - Digital Devices
Strongly prefer the study lenses
|
16 number of responses
|
26 number of responses
|
Adverse Events
Control (Senofilcon A)
Test (Senofilcon A C3)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
John R. Buch-Sr. Principal Research Optometrist
Johnson & Johnson Vision Care, Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60