Trial Outcomes & Findings for Clinical Evaluation of a Reusable Multifocal Optical Design in a Presbyopic Population Phase 2 (NCT NCT03586648)
NCT ID: NCT03586648
Last Updated: 2020-05-13
Results Overview
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.
COMPLETED
NA
71 participants
2-Week Follow-up
2020-05-13
Participant Flow
In total, 71 subjects were enrolled in this study of which, 70 subjects were dispensed at least 1 study lens, 1subject failed to meet all eligibility criteria. Of those dispensed a study lens, 61 subjects completed the study while, 9 were discontinued from the study.
Participant milestones
| Measure |
Test/Control
Subjects that were randomized to receive the Test lens in both eyes during the first period and the Control lens in both eyes during the second period.
|
Control/Test
Subjects that were randomized to receive the Control lens in both eyes during the first period and the Test lens in both eyes during the second period.
|
|---|---|---|
|
Period 1
STARTED
|
36
|
34
|
|
Period 1
COMPLETED
|
32
|
30
|
|
Period 1
NOT COMPLETED
|
4
|
4
|
|
Period 2
STARTED
|
32
|
30
|
|
Period 2
COMPLETED
|
31
|
30
|
|
Period 2
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Test/Control
Subjects that were randomized to receive the Test lens in both eyes during the first period and the Control lens in both eyes during the second period.
|
Control/Test
Subjects that were randomized to receive the Control lens in both eyes during the first period and the Test lens in both eyes during the second period.
|
|---|---|---|
|
Period 1
Withdrawal by Subject
|
0
|
1
|
|
Period 1
Lost to Follow-up
|
1
|
1
|
|
Period 1
Adverse Event
|
1
|
0
|
|
Period 1
Study related symptoms or complaints
|
2
|
1
|
|
Period 1
Physician Decision
|
0
|
1
|
|
Period 2
Adverse Event
|
1
|
0
|
Baseline Characteristics
Clinical Evaluation of a Reusable Multifocal Optical Design in a Presbyopic Population Phase 2
Baseline characteristics by cohort
| Measure |
Dispensed Subjects
n=70 Participants
All subjects dispensed at least one study lens.
|
|---|---|
|
Age, Continuous
|
56.1 Years
STANDARD_DEVIATION 6.87 • n=5 Participants
|
|
Sex: Female, Male
Female
|
59 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
2 Count of Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
67 Count of Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Count of Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
70 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2-Week Follow-upPopulation: All subjects that completed the study 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=59 Participants
Subjects that wore the Test lens in the study.
|
Control
n=59 Participants
Subjects that wore the Control lens in the study.
|
|---|---|---|
|
Vision Scores
Period 1
|
42.2 units on a scale
Standard Deviation 13.68
|
55.3 units on a scale
Standard Deviation 22.99
|
|
Vision Scores
Period 2
|
52.4 units on a scale
Standard Deviation 22.77
|
41.8 units on a scale
Standard Deviation 14.92
|
PRIMARY outcome
Timeframe: 2-Week Follow-upPopulation: All subjects that completed the study 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=59 Participants
Subjects that wore the Test lens in the study.
|
Control
n=59 Participants
Subjects that wore the Control lens in the study.
|
|---|---|---|
|
Vision Scores Comparison Between Test and Control
Period 1
|
42.2 units on a scale
Standard Deviation 13.68
|
55.3 units on a scale
Standard Deviation 22.99
|
|
Vision Scores Comparison Between Test and Control
Period 2
|
52.4 units on a scale
Standard Deviation 22.77
|
41.8 units on a scale
Standard Deviation 14.92
|
Adverse Events
Test
Control
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Thomas Karkkainen, OD, MS, FAAO- 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