Trial Outcomes & Findings for Evaluation of Approved and Investigational Contact Lenses (NCT NCT03228212)
NCT ID: NCT03228212
Last Updated: 2018-12-13
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. The average comfort score from the 3 study periods was reported.
COMPLETED
NA
133 participants
2-Week Follow-up
2018-12-13
Participant Flow
A total of 133 subjects were enrolled into this study. Of the enrolled subjects, 130 were dispensed at least one study lens and 3 subjects failed to meet all eligibility criteria. Of the dispensed subjects 127 completed the study while 3 subjects were discontinued.
Participant milestones
| Measure |
Test/Control/Control
Subjects that wore the Test lens during the first period, and the control lens during the second and third period of the study.
|
Control/Test/Test
Subjects that wore the Control lens during the first period and the Test lens during the second and third period.
|
|---|---|---|
|
Period 1
STARTED
|
65
|
65
|
|
Period 1
COMPLETED
|
64
|
64
|
|
Period 1
NOT COMPLETED
|
1
|
1
|
|
Period 2
STARTED
|
64
|
64
|
|
Period 2
COMPLETED
|
63
|
64
|
|
Period 2
NOT COMPLETED
|
1
|
0
|
|
Period 3
STARTED
|
63
|
64
|
|
Period 3
COMPLETED
|
63
|
64
|
|
Period 3
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Test/Control/Control
Subjects that wore the Test lens during the first period, and the control lens during the second and third period of the study.
|
Control/Test/Test
Subjects that wore the Control lens during the first period and the Test lens during the second and third period.
|
|---|---|---|
|
Period 1
Adverse Event
|
1
|
0
|
|
Period 1
no longer meets eligibility criteria
|
0
|
1
|
|
Period 2
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
Evaluation of Approved and Investigational Contact Lenses
Baseline characteristics by cohort
| Measure |
Dispensed Subjects
n=130 Participants
All subjects that were dispensed at least one study lens.
|
|---|---|
|
Age, Continuous
|
31.6 Years
STANDARD_DEVIATION 7.69 • n=5 Participants
|
|
Sex: Female, Male
Female
|
88 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
42 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
12 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
111 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2-Week Follow-upPopulation: All 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. The average comfort score from the 3 study periods was reported.
Outcome measures
| Measure |
Test
n=121 Participants
Subjects that wore the Test lens during any of the 3 periods of the study.
|
Control
n=121 Participants
Subjects that wore the Control lens during any of the 3 periods of the study.
|
|---|---|---|
|
Overall Comfort
|
67.509 Units on a Scale
Standard Deviation 23.8724
|
61.185 Units on a Scale
Standard Deviation 24.2024
|
PRIMARY outcome
Timeframe: 2-Week Follow-upPopulation: All 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 at the 2-week follow-up for each subject eye during each of the three study periods. The average visual acuity for each lens type from the 3 study periods was reported.
Outcome measures
| Measure |
Test
n=130 Eyes
Subjects that wore the Test lens during any of the 3 periods of the study.
|
Control
n=130 Eyes
Subjects that wore the Control lens during any of the 3 periods of the study.
|
|---|---|---|
|
Distance Monocular LogMAR Visual Acuity
|
-0.095 logMAR
Standard Deviation 0.0831
|
-0.075 logMAR
Standard Deviation 0.0806
|
PRIMARY outcome
Timeframe: Up to 2-Week Follow-upPopulation: Subjects that completed all study visits.
Contact lens fitting acceptance was assessed for each subject eye using a biomicroscope at 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 acceptable lens fit was reported for each lens. The lens fit acceptance rate for both post lens fitting at the 2-week follow-up was reported for each lens type.
Outcome measures
| Measure |
Test
n=130 eyes
Subjects that wore the Test lens during any of the 3 periods of the study.
|
Control
n=130 eyes
Subjects that wore the Control lens during any of the 3 periods of the study.
|
|---|---|---|
|
Contact Lens Fitting Acceptance Rate
|
1 proportion of eyes
|
1 proportion of eyes
|
PRIMARY outcome
Timeframe: Up to 2-Week Follow-upPopulation: Subjects that were dispensed at least one 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 number of SLF with grade 3 or higher by lens was reported.
Outcome measures
| Measure |
Test
n=130 Eyes
Subjects that wore the Test lens during any of the 3 periods of the study.
|
Control
n=130 Eyes
Subjects that wore the Control lens during any of the 3 periods of the study.
|
|---|---|---|
|
Number of Grade 3 or Higher Slit Lamp Findings
|
0 Slit Lamp Finding
|
1 Slit Lamp Finding
|
SECONDARY outcome
Timeframe: 2-Week Follow-upPopulation: All 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. The average vision score from the 3 study periods was reported.
Outcome measures
| Measure |
Test
n=121 Participants
Subjects that wore the Test lens during any of the 3 periods of the study.
|
Control
n=121 Participants
Subjects that wore the Control lens during any of the 3 periods of the study.
|
|---|---|---|
|
Overall Quality of Vision
|
69.16 Units on a Scale
Standard Deviation 20.362
|
60.329 Units on a Scale
Standard Deviation 22.289
|
SECONDARY outcome
Timeframe: 2-Week Follow-upPopulation: All 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. The average handling score from the 3 study periods was reported.
Outcome measures
| Measure |
Test
n=121 Participants
Subjects that wore the Test lens during any of the 3 periods of the study.
|
Control
n=121 Participants
Subjects that wore the Control lens during any of the 3 periods of the study.
|
|---|---|---|
|
Overall Handling
|
72.11 Units on a Scale
Standard Deviation 20.046
|
66.79 Units on a Scale
Standard Deviation 20.007
|
Adverse Events
Test
Control
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
John Buch -SENIOR 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