Trial Outcomes & Findings for Initial Evaluation of Investigational Lenses Manufactured on a New Production Line (NCT NCT03679741)
NCT ID: NCT03679741
Last Updated: 2019-12-26
Results Overview
Overall comfort 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.
COMPLETED
NA
126 participants
2-Week Follow-up
2019-12-26
Participant Flow
A total of 126 subjects were enrolled into this study. Of those enrolled, 120 subjects were randomized and dispensed at least one study lens. Of the dispensed subjects, 110 completed the study, while 10 subjects were discontinued.
Participant milestones
| Measure |
Test/Control/Control
Subjects that were randomized to receive the test lens during the first period and the control lens during both the second and third periods.
|
Control/Test/Test
Subjects that were randomized to receive the control lens during the first period and the test lens during both the second and third periods.
|
|---|---|---|
|
Period 1
STARTED
|
59
|
61
|
|
Period 1
COMPLETED
|
57
|
58
|
|
Period 1
NOT COMPLETED
|
2
|
3
|
|
Period 2
STARTED
|
57
|
58
|
|
Period 2
COMPLETED
|
54
|
56
|
|
Period 2
NOT COMPLETED
|
3
|
2
|
|
Period 3
STARTED
|
54
|
56
|
|
Period 3
COMPLETED
|
54
|
56
|
|
Period 3
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Test/Control/Control
Subjects that were randomized to receive the test lens during the first period and the control lens during both the second and third periods.
|
Control/Test/Test
Subjects that were randomized to receive the control lens during the first period and the test lens during both the second and third periods.
|
|---|---|---|
|
Period 1
No longer meet eligibility criteria
|
1
|
0
|
|
Period 1
Lost to Follow-up
|
0
|
1
|
|
Period 1
Adverse Event
|
1
|
1
|
|
Period 1
Withdrawal by Subject
|
0
|
1
|
|
Period 2
Adverse Event
|
2
|
1
|
|
Period 2
Withdrawal by Subject
|
1
|
1
|
Baseline Characteristics
Initial Evaluation of Investigational Lenses Manufactured on a New Production Line
Baseline characteristics by cohort
| Measure |
All Dispensed Subjects
n=120 Participants
All subjects dispensed at least one study lens regardless of randomization.
|
|---|---|
|
Age, Continuous
|
33.3 Years
STANDARD_DEVIATION 8.02 • n=5 Participants
|
|
Sex: Female, Male
Female
|
91 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
11 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
102 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
120 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2-Week Follow-upPopulation: Subjects that completed all study visits without a major protocol deviation.
Overall comfort 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.
Outcome measures
| Measure |
Test
n=109 Participants
Subjects that wore the Test lens during any of the three periods during the study.
|
Control
n=109 Participants
Subjects that wore the Control lens during any of the three periods during the study.
|
|---|---|---|
|
Overall Comfort Score
|
59.30 Units on a Scale
Standard Deviation 23.779
|
58.54 Units on a Scale
Standard Deviation 22.303
|
PRIMARY outcome
Timeframe: 2-Week Follow-upPopulation: subjects that completed all study visits without a major protocol deviation.
Vision satisfaction in bright light was assessed using the individual item" I was satisfied with the quality of my vision in bright lighting" from the CLUE™ questionnaire. This item used the response scale, 1: Strongly Disagree, 2: Disagree, 3: Neither Agree nor Disagree, 4: Agree and 5: Strongly Agree. CLUE is the Contact Lens User Experience™ 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 Proportion of responses in each category were reported for each lens type.
Outcome measures
| Measure |
Test
n=109 Participants
Subjects that wore the Test lens during any of the three periods during the study.
|
Control
n=109 Participants
Subjects that wore the Control lens during any of the three periods during the study.
|
|---|---|---|
|
Vision Satisfaction in Bright Lighting
Strongly Agree
|
0.22 Proportion of participants
|
0.11 Proportion of participants
|
|
Vision Satisfaction in Bright Lighting
Agree
|
0.622 Proportion of participants
|
0.583 Proportion of participants
|
|
Vision Satisfaction in Bright Lighting
Neither Agree Nor Agree
|
0.098 Proportion of participants
|
0.141 Proportion of participants
|
|
Vision Satisfaction in Bright Lighting
Disagree
|
0.061 Proportion of participants
|
0.135 Proportion of participants
|
|
Vision Satisfaction in Bright Lighting
Strongly Disagree
|
0.00 Proportion of participants
|
0.031 Proportion of participants
|
PRIMARY outcome
Timeframe: 2-Week Follow-upPopulation: subjects that completed all study visits without a major protocol deviation.
Distance Monocular LogMAR visual acuity was assessed at 4 meters using an ETDRS chart under high illumination low contrast (room illumination \> 400 lux and chart luminance 120-200 cd/m2) and low illumination high contrast (room illumination \<2.5 lux and chart luminance 2.0 - 5.0 cd/m2 at the 2-week follow-up for each subject eye. The average visual acuity for each lens was reported.
Outcome measures
| Measure |
Test
n=218 Eyes
Subjects that wore the Test lens during any of the three periods during the study.
|
Control
n=218 Eyes
Subjects that wore the Control lens during any of the three periods during the study.
|
|---|---|---|
|
Distance Monocular LogMAR Visual Acuity
High Illumination low contrast
|
0.10 logMAR
Standard Deviation 0.086
|
0.14 logMAR
Standard Deviation 0.089
|
|
Distance Monocular LogMAR Visual Acuity
Low illumination high contrast
|
0.06 logMAR
Standard Deviation 0.082
|
0.08 logMAR
Standard Deviation 0.085
|
PRIMARY outcome
Timeframe: Up to 2-Week Follow-upPopulation: Subjects that completed all study visits without a major protocol deviation.
Contact lens fitting acceptance was assessed for each subject eye using a biomicroscope at all study visits. Lens fit was a binary variable where acceptable lens fit=1 and unacceptable lens fit=0. The percentage of eyes with acceptable lens fit was reported for each lens.
Outcome measures
| Measure |
Test
n=218 eyes
Subjects that wore the Test lens during any of the three periods during the study.
|
Control
n=218 eyes
Subjects that wore the Control lens during any of the three periods during the study.
|
|---|---|---|
|
Contact Lens Fitting Acceptance Rate
|
100 percentage of eyes
|
100 percentage of eyes
|
PRIMARY outcome
Timeframe: Up to 2-Week Follow-upPopulation: All subjects dispensed a 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). This was performed on each subject eye at every study visit (baseline, unscheduled visits and 2-week follow-up). The data was then dichotomized into two groups. Those with grade 3 or higher and those with grade 2 or lower. The proportion of eyes with SLF with grade 3 or higher by lens was reported.
Outcome measures
| Measure |
Test
n=218 eyes
Subjects that wore the Test lens during any of the three periods during the study.
|
Control
n=218 eyes
Subjects that wore the Control lens during any of the three periods during the study.
|
|---|---|---|
|
Number of Grade 3 or Higher Slit Lamp Findings
|
0.005 proportion of eyes
|
0.000 proportion of eyes
|
SECONDARY outcome
Timeframe: 2-Week Follow-upPopulation: Subjects that completed all study visits without a major protocol deviation.
Overall quality of vision 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.
Outcome measures
| Measure |
Test
n=109 Participants
Subjects that wore the Test lens during any of the three periods during the study.
|
Control
n=109 Participants
Subjects that wore the Control lens during any of the three periods during the study.
|
|---|---|---|
|
Overall Quality of Vision Score
|
62.25 Units on a Scale
Standard Deviation 18.460
|
58.47 Units on a Scale
Standard Deviation 18.707
|
SECONDARY outcome
Timeframe: 2-Week Follow-upPopulation: Subjects that completed all study visits without a major protocol deviation.
Overall handling 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.
Outcome measures
| Measure |
Test
n=109 Participants
Subjects that wore the Test lens during any of the three periods during the study.
|
Control
n=109 Participants
Subjects that wore the Control lens during any of the three periods during the study.
|
|---|---|---|
|
Overall Handling Scores
|
66.24 Units on a Scale
Standard Deviation 19.185
|
64.66 Units on a Scale
Standard Deviation 20.460
|
SECONDARY outcome
Timeframe: 2-Week Follow-upPopulation: subjects that completed all study visits without a major protocol deviation.
Overall Quality of Vision Indoors was assessed using the individual item" Overall Quality of Vision Indoors" from questionnaire assessing contact lens performance. This item used the response scale, 0: Not Applicable, 1: Excellent, 2: Very Good, 3: Good, 4: Fair and 5: Poor. The Proportion of responses in each category were reported for each lens type.
Outcome measures
| Measure |
Test
n=109 Participants
Subjects that wore the Test lens during any of the three periods during the study.
|
Control
n=109 Participants
Subjects that wore the Control lens during any of the three periods during the study.
|
|---|---|---|
|
Overall Quality of Vision Indoors
Excellent
|
0.433 Proportion of participants
|
0.374 Proportion of participants
|
|
Overall Quality of Vision Indoors
Very Good
|
0.396 Proportion of participants
|
0.393 Proportion of participants
|
|
Overall Quality of Vision Indoors
Good
|
0.128 Proportion of participants
|
0.184 Proportion of participants
|
|
Overall Quality of Vision Indoors
Fair
|
0.043 Proportion of participants
|
0.049 Proportion of participants
|
|
Overall Quality of Vision Indoors
Poor
|
0 Proportion of participants
|
0 Proportion of participants
|
|
Overall Quality of Vision Indoors
Not Applicable
|
0 Proportion of participants
|
0 Proportion of participants
|
Adverse Events
Test
Control
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
John Buch, O.D., M.S. Sr. Prinicpal Research Optometrist
Johnson & Johnson Vision Care
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60