Trial Outcomes & Findings for Evaluation of a Daily Disposable Novel Multifocal Contact Lens in a Hyperopic Population (NCT NCT04567186)
NCT ID: NCT04567186
Last Updated: 2022-01-21
Results Overview
Binocular visual acuity was measured on a logMAR (Logarithm of Minimal Angle of Resolution) scale and was evaluated at distance (4 meters), intermediate (64 cm) and near (40 cm) under high lumiance high contrast lighting conditions using ETDRS (Early Treatment Diabetic Retinopathy Study) charts. The room illuminance was required to be beetween 7.3 and 7.9 EV (394-597 lux). For Distance (4 meters), the acceptable range for the chart luminance was 10.5-10.7 EV (181-208 cd/m2). For Intermediate (64 cm) and Near (40cm), the acceptable range for the chart luminance 10.8-11.1 EV (223-274 cd/m2). 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.
COMPLETED
NA
81 participants
1-Week Follow-up
2022-01-21
Participant Flow
A total of 81 subject were enrolled into this study. Of those enrolled, 78 were dispensed at least one study lens while 3 subjects failed to meet all eligibility criteria. Of those dispensed, 70 completed the study while 8 subjects were discontinued.
Participant milestones
| Measure |
Test/Control/Control
Subjects that wore the Test lens in a bilateral fashion during period 1 and the Control lens in an bilateral fashion during both the second and third study periods.
|
Control/Test/Test
Subjects that wore the Control lens in a bilateral fashion during period 1 and the Test lens in an bilateral fashion during both the second and third study periods
|
|---|---|---|
|
Period 1
STARTED
|
38
|
40
|
|
Period 1
COMPLETED
|
37
|
37
|
|
Period 1
NOT COMPLETED
|
1
|
3
|
|
Period 2
STARTED
|
37
|
37
|
|
Period 2
COMPLETED
|
37
|
34
|
|
Period 2
NOT COMPLETED
|
0
|
3
|
|
Period 3
STARTED
|
37
|
34
|
|
Period 3
COMPLETED
|
36
|
34
|
|
Period 3
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Test/Control/Control
Subjects that wore the Test lens in a bilateral fashion during period 1 and the Control lens in an bilateral fashion during both the second and third study periods.
|
Control/Test/Test
Subjects that wore the Control lens in a bilateral fashion during period 1 and the Test lens in an bilateral fashion during both the second and third study periods
|
|---|---|---|
|
Period 1
COVID-19 related
|
1
|
0
|
|
Period 1
Protocol Violation
|
0
|
1
|
|
Period 1
Adverse Event
|
0
|
2
|
|
Period 2
COVID-19 Related
|
0
|
1
|
|
Period 2
Protocol Violation
|
0
|
1
|
|
Period 2
Lost to Follow-up
|
0
|
1
|
|
Period 3
Subject no longer meets eligibilty criteria
|
1
|
0
|
Baseline Characteristics
Evaluation of a Daily Disposable Novel Multifocal Contact Lens in a Hyperopic Population
Baseline characteristics by cohort
| Measure |
All Dispensed Subjects
n=78 Participants
All subjects dispensed at least one study lens
|
|---|---|
|
Age, Continuous
|
56.6 Years
STANDARD_DEVIATION 6.84 • n=99 Participants
|
|
Sex: Female, Male
Female
|
61 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Asian
|
5 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
7 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
White
|
63 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
78 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 1-Week Follow-upPopulation: Subjects that completed all study visits without a major protocol deviation impacting a primary or secondary endpoint.
Binocular visual acuity was measured on a logMAR (Logarithm of Minimal Angle of Resolution) scale and was evaluated at distance (4 meters), intermediate (64 cm) and near (40 cm) under high lumiance high contrast lighting conditions using ETDRS (Early Treatment Diabetic Retinopathy Study) charts. The room illuminance was required to be beetween 7.3 and 7.9 EV (394-597 lux). For Distance (4 meters), the acceptable range for the chart luminance was 10.5-10.7 EV (181-208 cd/m2). For Intermediate (64 cm) and Near (40cm), the acceptable range for the chart luminance 10.8-11.1 EV (223-274 cd/m2). 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 |
Test
n=99 Participants
Subjects that wore the Test lens during any of the three study periods
|
Control
n=102 Participants
Subjects that wore the Control lens during any of the three study periods.
|
|---|---|---|
|
Binocular Visual Acuity (logMAR)
Distance
|
-0.07 logMAR
Standard Deviation 0.083
|
-0.05 logMAR
Standard Deviation 0.084
|
|
Binocular Visual Acuity (logMAR)
Intermediate
|
-0.05 logMAR
Standard Deviation 0.087
|
-0.04 logMAR
Standard Deviation 0.080
|
|
Binocular Visual Acuity (logMAR)
Near
|
0.07 logMAR
Standard Deviation 0.102
|
0.08 logMAR
Standard Deviation 0.095
|
SECONDARY outcome
Timeframe: 1- Week Follow-upPopulation: Subjects that completed all study visits without a major protocol deviation impacting a primary or secondary endpoint.
Overall vision scores were assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patientexperience 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 |
Test
n=99 Participants
Subjects that wore the Test lens during any of the three study periods
|
Control
n=102 Participants
Subjects that wore the Control lens during any of the three study periods.
|
|---|---|---|
|
Subjective Overall Vision Scores
|
53.1 units on a scale
Standard Deviation 20.09
|
55.2 units on a scale
Standard Deviation 18.90
|
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, 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