Trial Outcomes & Findings for Evaluation of a Daily Disposable Novel Multifocal Contact Lens in a Myopic Population (NCT NCT04310566)
NCT ID: NCT04310566
Last Updated: 2022-01-19
Results Overview
Subjective 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- xperience 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
67 participants
1-Week Follow-up
2022-01-19
Participant Flow
A total of 67 subjects were enrolled into this study. Of those enrolled, 65 were dispensed at least one study lens, while 2 subjects failed to meet all eligibility criteria. Of those dispensed a study lens, 17 subjects completed the study prior to the study being terminated, while 45 subjects were discontinued. This study was terminated due to the COVID-19 Pandemic.
Participant milestones
| Measure |
Test/Control
Subjects randomized to this sequence received the Test lens during the first period and then received the Control lens during the second period
|
Control/Test
Subjects randomized to this sequence received the Control lens during the first period and then received the Test lens during the second period
|
|---|---|---|
|
Period 1
STARTED
|
31
|
34
|
|
Period 1
COMPLETED
|
15
|
14
|
|
Period 1
NOT COMPLETED
|
16
|
20
|
|
Period 2
STARTED
|
15
|
14
|
|
Period 2
COMPLETED
|
8
|
9
|
|
Period 2
NOT COMPLETED
|
7
|
5
|
Reasons for withdrawal
| Measure |
Test/Control
Subjects randomized to this sequence received the Test lens during the first period and then received the Control lens during the second period
|
Control/Test
Subjects randomized to this sequence received the Control lens during the first period and then received the Test lens during the second period
|
|---|---|---|
|
Period 1
Study Termination due to COVID-19
|
15
|
17
|
|
Period 1
Protocol Violation
|
0
|
1
|
|
Period 1
Subject no longer meets eligbility criteria
|
0
|
1
|
|
Period 1
Lost to Follow-up
|
1
|
0
|
|
Period 1
Withdrawal by Subject
|
0
|
1
|
|
Period 2
Study Termination
|
7
|
5
|
Baseline Characteristics
Evaluation of a Daily Disposable Novel Multifocal Contact Lens in a Myopic Population
Baseline characteristics by cohort
| Measure |
All Dispensed Subjects
n=65 Participants
All subjects dispensed a study lens.
|
|---|---|
|
Age, Continuous
|
50.3 Years
STANDARD_DEVIATION 6.60 • n=5 Participants
|
|
Sex: Female, Male
Female
|
49 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
8 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
56 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
65 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1-Week Follow-upPopulation: All available data
Subjective 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- xperience 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=28 Participants
All subjects that wore the Test lens during either the first or second period fo the study
|
Control
n=31 Participants
All subjects that wore the Control lens during either the first or second period of the study.
|
|---|---|---|
|
Subjective Vision Scores
|
61.41 Units on a Scale
Standard Deviation 19.917
|
55.03 Units on a Scale
Standard Deviation 18.199
|
PRIMARY outcome
Timeframe: 1-Week Follow-upPopulation: All avaiable data.
High contrast bright illumination binocular logMAR (Logarithm of the Minimum Angle of Resolution) visual acuity was assessed at distance (4 meters) using ETDRS Charts, near (40 cm) and intermediate (64 cm) using reduced Guillon-Poling charts. A value of 0.0 logMAR indicated a Snellen vision of 20/20. Lower logMAR visual acuity values indicates better vision. The average logMAR visual acuity for each lens was reported. Note: The room illuminance was required to be between 7.3 and 7.9 EV (394-597 lux). Acceptable Luminance Range for Distance (4M): 10.5-10.7 EV (181-208 cd/m2). Acceptable Luminance Range for Near (40cm) and Intermediate Guillon-Poling :10.8- 11.1 EV (223-274 cd/m2).
Outcome measures
| Measure |
Test
n=28 Participants
All subjects that wore the Test lens during either the first or second period fo the study
|
Control
n=31 Participants
All subjects that wore the Control lens during either the first or second period of the study.
|
|---|---|---|
|
Visual Acuity (logMAR)
Distance (4 meters)
|
-0.11 logMAR
Standard Deviation 0.116
|
-0.11 logMAR
Standard Deviation 0.112
|
|
Visual Acuity (logMAR)
Intermediate (64 centimeters)
|
-0.09 logMAR
Standard Deviation 0.092
|
-0.06 logMAR
Standard Deviation 0.093
|
|
Visual Acuity (logMAR)
Near ( 40 centimeters)
|
0.01 logMAR
Standard Deviation 0.135
|
0.05 logMAR
Standard Deviation 0.129
|
Adverse Events
Test
Control
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Thomas Karkkainen - Sr.Principal Research Optometrist
Johnson & Johnson Vision Care
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60