Trial Outcomes & Findings for Comparison of a Daily Disposable Multifocal Contact Lens to a Marketed Product (NCT NCT05101252)
NCT ID: NCT05101252
Last Updated: 2023-01-10
Results Overview
Binocular visual acuity was measured on a logMAR (Logarithm of Minimal Angle of Resolution) scale under high luminance high contrast condition. At distance (4 meters), VA is assessed using ETDRS (Early Treatment Diabetic Retinopathy Study) charts; while near (40 cm) and intermediate (64 cm) assessments were made using reduced Guillon-Poling charts. 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
77 participants
1-Week Follow-up
2023-01-10
Participant Flow
A total of 77 subjects were enrolled in this study. Of those enrolled, 74 subjects were dispensed at least one study lens, while 3 subject failed to meet all eligibility criteria. Of those dispensed, 69 subjects completed the study while 5 subjects were discontinued.
Participant milestones
| Measure |
Test (Senofilcon A C3)
Subjects that wore the Test lens during the study.
|
Control (Delefilcon A)
Subjects that wore the Control lens during the study.
|
|---|---|---|
|
Overall Study
STARTED
|
37
|
37
|
|
Overall Study
COMPLETED
|
35
|
34
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
Reasons for withdrawal
| Measure |
Test (Senofilcon A C3)
Subjects that wore the Test lens during the study.
|
Control (Delefilcon A)
Subjects that wore the Control lens during the study.
|
|---|---|---|
|
Overall Study
Unsatisfactory Test Article
|
1
|
0
|
|
Overall Study
Subject Withdrawn by PI due to Non Compliance to Protocol
|
0
|
1
|
|
Overall Study
Withdrew Consent during study
|
0
|
1
|
|
Overall Study
Subject dispensed incorrect lens in 1 eye
|
1
|
1
|
Baseline Characteristics
Comparison of a Daily Disposable Multifocal Contact Lens to a Marketed Product
Baseline characteristics by cohort
| Measure |
Test (Senofilcon A C3)
n=36 Participants
Subjects that wore the Test lens during the study.
|
Control (Delefilcon A)
n=34 Participants
Subjects that wore the Control lens during the study.
|
Total
n=70 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.0 Years
STANDARD_DEVIATION 5.95 • n=5 Participants
|
55.4 Years
STANDARD_DEVIATION 5.48 • n=7 Participants
|
56.7 Years
STANDARD_DEVIATION 5.84 • n=5 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 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
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
32 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
36 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1-Week Follow-upPopulation: All randomized subjects regardless of actual treatment and subsequent withdrawal from study or deviation from protocol, with data at the 1-Week Follow-up Evaluation.
Binocular visual acuity was measured on a logMAR (Logarithm of Minimal Angle of Resolution) scale under high luminance high contrast condition. At distance (4 meters), VA is assessed using ETDRS (Early Treatment Diabetic Retinopathy Study) charts; while near (40 cm) and intermediate (64 cm) assessments were made using reduced Guillon-Poling charts. 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 (Senofilcon A C3)
n=36 Participants
Subjects that wore the Test lens during the study.
|
Control (Delefilcon A)
n=34 Participants
Subjects that wore the Control lens during the study.
|
|---|---|---|
|
Binocular logMAR Visual Acuity
Distance (4m)
|
-0.076 LogMAR
Standard Deviation 0.0915
|
-0.081 LogMAR
Standard Deviation 0.1052
|
|
Binocular logMAR Visual Acuity
Intermediate (64cm)
|
0.006 LogMAR
Standard Deviation 0.0876
|
-0.013 LogMAR
Standard Deviation 0.0934
|
|
Binocular logMAR Visual Acuity
Near (40cm)
|
0.090 LogMAR
Standard Deviation 0.0924
|
0.084 LogMAR
Standard Deviation 0.0904
|
PRIMARY outcome
Timeframe: 1-Week Follow-upPopulation: All randomized subjects regardless of actual treatment and subsequent withdrawal from study or deviation from protocol, with data at the 1-Week Follow-up Evaluation.
Subjective vision was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patientreported 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 lens type was reported.
Outcome measures
| Measure |
Test (Senofilcon A C3)
n=36 Participants
Subjects that wore the Test lens during the study.
|
Control (Delefilcon A)
n=34 Participants
Subjects that wore the Control lens during the study.
|
|---|---|---|
|
CLUE Vision Score
|
49.80 Units on a scale
Standard Deviation 19.662
|
52.35 Units on a scale
Standard Deviation 19.212
|
SECONDARY outcome
Timeframe: 1-Week Follow-upPopulation: All subjects that completed all study visits without a major protocol deviation.
Binocular visual acuity was measured on a logMAR (Logarithm of Minimal Angle of Resolution) scale at distance (4m) under high luminance high contrast condition assessed using ETDRS (Early Treatment Diabetic Retinopathy Study) charts. 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 (Senofilcon A C3)
n=33 Participants
Subjects that wore the Test lens during the study.
|
Control (Delefilcon A)
n=32 Participants
Subjects that wore the Control lens during the study.
|
|---|---|---|
|
Binocular Distance logMAR Visual Acuity
|
-0.078 LogMAR
Standard Deviation 0.0942
|
-0.083 LogMAR
Standard Deviation 0.1080
|
Adverse Events
Test (Senofilcon A C3)
Control (Delefilcon A)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Thomas R. Karkkainen, OD, MS, FAAO
Johnson & Johnson Vision Care, Inc. (JJVC)
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60