Trial Outcomes & Findings for Clinical Evaluation of a Daily Wear Reusable Multifocal Optical Design in a Presbyopic Population (NCT NCT04534517)
NCT ID: NCT04534517
Last Updated: 2022-01-13
Results Overview
Overall vision scores were 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 CLUE vision score for each sphere stratum (Hyperope and Myope) was reported.
COMPLETED
NA
119 participants
2-Week Follow-up
2022-01-13
Participant Flow
A total of 119 subjects were enrolled into this study. Of those enrolled, 114 subjects were dispensed a study lens while 4 subjects failed to meet all eligibility criteria. Of those dispensed, 110 completed the study while 4 subjects were discontinued.
Participant milestones
| Measure |
Senofilcon A (Investigational Multifocal Lens)
All subjects that wore the investigational multifocal lens made from senofilcon A material during the entire duration of the study.
|
|---|---|
|
Overall Study
STARTED
|
114
|
|
Overall Study
COMPLETED
|
110
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
Senofilcon A (Investigational Multifocal Lens)
All subjects that wore the investigational multifocal lens made from senofilcon A material during the entire duration of the study.
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Unsatisfactory Visual Response due to Test Article
|
1
|
|
Overall Study
COVID-19 Related
|
1
|
Baseline Characteristics
Clinical Evaluation of a Daily Wear Reusable Multifocal Optical Design in a Presbyopic Population
Baseline characteristics by cohort
| Measure |
Hyperopes
n=55 Participants
All subjects dispensed a study lens.
|
Myopes
n=59 Participants
All subjects dispensed a study lens.
|
Total
n=114 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.8 years
STANDARD_DEVIATION 6.78 • n=5 Participants
|
50.5 years
STANDARD_DEVIATION 6.21 • n=7 Participants
|
53.5 years
STANDARD_DEVIATION 7.21 • n=5 Participants
|
|
Sex: Female, Male
Female
|
49 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
97 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
50 participants
n=5 Participants
|
56 participants
n=7 Participants
|
106 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
55 participants
n=5 Participants
|
59 participants
n=7 Participants
|
114 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2-Week Follow-upPopulation: All subjects that completed all study visits without a major protocol deviation impacting a primary 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 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 CLUE vision score for each sphere stratum (Hyperope and Myope) was reported.
Outcome measures
| Measure |
Senofilcon A (Investigational Multifocal Lens)
n=105 Participants
All subjects that wore the investigational multifocal lens made from senofilcon A material during the entire duration of the study.
|
|---|---|
|
Vision Scores
Hyperopes
|
57.48 CLUE points
Standard Deviation 21.175
|
|
Vision Scores
Myopes
|
61.97 CLUE points
Standard Deviation 20.671
|
PRIMARY outcome
Timeframe: 2-Week Follow-upPopulation: All subjects that completed all study visits without a major protocol deviation impacting a primary endpoint. Hyperopes and myopes were combined based on historical data for subjects in this study with regard to visual performance logMAR.
Binocular visual performance on logMAR (Logarithm of Minimal Angle of Resolution) scale was evaluated at distance (4m), intermediate (64cm) and near (40cm) under high luminance high contrast lighting condition using ETDRS (Early Treatment Diabetic Retinopathy Study) charts. The room illuminance was required to be between 7.3 to 7.9 EV (394-597 lux). For Distance (4m), the acceptable range for the chart luminance was 10.5-10.7 EV (181 208 cd/m2). For Intermediate (64cm) 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. A logMAR score closer to zero, or below zero, indicates a better visual acuity. A logMAR visual performance score of 0.0 is equivalent to Snellen visual acuity of 20/20. Data from hyperopes and myopes were combined for this outcome since logMAR scores between the two populations are similar.
Outcome measures
| Measure |
Senofilcon A (Investigational Multifocal Lens)
n=105 Participants
All subjects that wore the investigational multifocal lens made from senofilcon A material during the entire duration of the study.
|
|---|---|
|
Visual Performance LogMAR
Distance (4M)
|
-0.09 logMAR
Standard Deviation 0.105
|
|
Visual Performance LogMAR
Intermediate (64 cm)
|
-0.06 logMAR
Standard Deviation 0.084
|
|
Visual Performance LogMAR
Near (40 cm)
|
0.06 logMAR
Standard Deviation 0.086
|
PRIMARY outcome
Timeframe: Up to 2-Week Follow-upPopulation: All subjects were dispensed at least one study lens.
Contact lens fitting acceptance was assessed for each subject eye using a biomicroscope 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 unacceptable lens fit was reported. Data from the hyperope and myopes group were combined for this outcome since lens fitting characteristerics are similar for these two populations.
Outcome measures
| Measure |
Senofilcon A (Investigational Multifocal Lens)
n=228 Eyes
All subjects that wore the investigational multifocal lens made from senofilcon A material during the entire duration of the study.
|
|---|---|
|
Proportion of Eyes With Unacceptable Lens Fitting
|
0 proportion of eyes
|
PRIMARY outcome
Timeframe: Up to 2-Week Follow-upPopulation: All subjects 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 proportion of eyes with SLF with grade 3 or higher was reported. Data from the hyperope and myopes group were combined for this outcome since the rate of SLFs grade 3 + is similar for both populations.
Outcome measures
| Measure |
Senofilcon A (Investigational Multifocal Lens)
n=228 Eyes
All subjects that wore the investigational multifocal lens made from senofilcon A material during the entire duration of the study.
|
|---|---|
|
Proportion of Eyes With Grade 3 or Higher Slit Lamp Findings
|
0 proportion of eyes
|
SECONDARY outcome
Timeframe: Up to 2-Week Follow-upPopulation: All subjects were dispensed at least one study lens.
The number of lenses to achieve the optimal pair for each subject was calculated as the original pair (2) plus all the required modifications to reach the optimal pair. In this study the minimum number of lenses per subject used was 2 where the maximum possible number of lenses used was 12. The data was dichotomized as Y=1 if the subject was able to achieve optimal lens pair in 4 lenses or lenses or less and 0 otherwise. A lens modification was performed if the subject reports unsatisfactory vision or was unable to obtain 20/30 distance visual acuity in both eyes. If the subject reported satisfactory vision with the lenses a modification was not required. However, based upon the investigator's findings on the measured visual acuity and/or over-refraction a modification may have been performed. Data for the hyperope and myope groups were combined for this endpoint since the number of lenses needed to optimize vision is indpendent of which group a subject belongs to.
Outcome measures
| Measure |
Senofilcon A (Investigational Multifocal Lens)
n=228 Eyes
All subjects that wore the investigational multifocal lens made from senofilcon A material during the entire duration of the study.
|
|---|---|
|
Proportion of Eyes That Achieved Optimal Lens Pair in 4 Lenses or Less
|
0.4 proportion of eyes
|
Adverse Events
Senofilcon A (Investigational Multifocal Lens)
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