Trial Outcomes & Findings for Evaluation of a Daily Disposable Silicone Hydrogel Multifocal Contact Lens in Myopes and Hyperopes (NCT NCT05222880)
NCT ID: NCT05222880
Last Updated: 2023-04-13
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
140 participants
1-Week Follow-up
2023-04-13
Participant Flow
A total of 140 subjects were enrolled in this study. Of those enrolled, 139 subjects were dispensed at least one study lens, while 1 subject failed to meet all eligibility criteria. Of those dispensed, 136 subjects completed the study while 3 subjects were discontinued.
Participant milestones
| Measure |
Test (Senofilcon A C3)
Subjects randomized to receive the Test lens during the study
|
|---|---|
|
Overall Study
STARTED
|
139
|
|
Overall Study
COMPLETED
|
136
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Test (Senofilcon A C3)
Subjects randomized to receive the Test lens during the study
|
|---|---|
|
Overall Study
Unsatisfactory Visual Response due to Test Article
|
1
|
|
Overall Study
Withdrew Consent during Study
|
1
|
|
Overall Study
COVID-19 Related
|
1
|
Baseline Characteristics
Evaluation of a Daily Disposable Silicone Hydrogel Multifocal Contact Lens in Myopes and Hyperopes
Baseline characteristics by cohort
| Measure |
Hyperopes
n=50 Participants
Subjects were classified as Hyperopic if the distance spherical equivalent refraction was in the range of +0.75 D to +3.25 D.
|
Myopes
n=89 Participants
Subjects were classified as Myopic if the distance spherical equivalent refraction was in the range of -5.75 D to -1.25 D.
|
Total
n=139 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.1 Years
STANDARD_DEVIATION 7.20 • n=5 Participants
|
50.4 Years
STANDARD_DEVIATION 6.14 • n=7 Participants
|
51.7 Years
STANDARD_DEVIATION 6.76 • n=5 Participants
|
|
Sex: Female, Male
Female
|
45 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
111 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
2 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
44 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
119 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
50 Participants
n=5 Participants
|
89 Participants
n=7 Participants
|
139 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1-Week Follow-upPopulation: All dispensed subjects regardless of deviation from protocol with data collected at the 1-week follow-up.
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=136 Participants
Subjects that wore the Test lens during the study.
|
|---|---|
|
Binocular logMAR Visual Acuity
Distance(4m)
|
-0.098 LogMAR
Standard Deviation 0.0854
|
|
Binocular logMAR Visual Acuity
Intermediate (64cm)
|
-0.043 LogMAR
Standard Deviation 0.0797
|
|
Binocular logMAR Visual Acuity
Near (40cm)
|
0.0797 LogMAR
Standard Deviation 0.1077
|
PRIMARY outcome
Timeframe: 1-Week Follow-upPopulation: All dispensed subjects regardless of deviation from protocol with data collected at the 1-week follow-up.
Subjective 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. The average CLUE vision score for each sphere stratum (Hyperope and Myope) was reported.
Outcome measures
| Measure |
Test (Senofilcon A C3)
n=136 Participants
Subjects that wore the Test lens during the study.
|
|---|---|
|
CLUE Vision Score
Hyperopes
|
52.30 Units on a scale
Standard Deviation 19.121
|
|
CLUE Vision Score
Myopes
|
63.27 Units on a scale
Standard Deviation 19.031
|
PRIMARY outcome
Timeframe: Up to 1-Week Follow-upPopulation: All dispensed subjects regardless of subsequent withdrawal from study or deviation from protocol.
Contact lens fitting acceptance was assessed for each subject eye using a biomicroscope post lens insertion, the 1-week follow-up and any unscheduled visits. 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.
Outcome measures
| Measure |
Test (Senofilcon A C3)
n=278 Eyes
Subjects that wore the Test lens during the study.
|
|---|---|
|
Proportion of Eyes With Unacceptable Lens Fitting
|
0 Proportion of eyes
|
PRIMARY outcome
Timeframe: Up to 1-Week Follow-upPopulation: All dispensed subjects regardless of subsequent withdrawal from study or deviation from protocol.
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 1-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.
Outcome measures
| Measure |
Test (Senofilcon A C3)
n=278 Eyes
Subjects that wore the Test lens during the study.
|
|---|---|
|
Proportion of Eyes With Grade 3 or Higher Slit Lamp Findings
|
0 Porportion of eyes
|
SECONDARY outcome
Timeframe: 1-Week Follow-upPopulation: All dispensed subjects regardless of deviation from protocol with data collected at the 1-week follow-up.
Subjective 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. The average CLUE vision score for each sphere stratum (Hyperope and Myope) was reported.
Outcome measures
| Measure |
Test (Senofilcon A C3)
n=136 Participants
Subjects that wore the Test lens during the study.
|
|---|---|
|
CLUE Vision Score
Hyperopes
|
52.30 Units on a scale
Standard Deviation 19.121
|
|
CLUE Vision Score
Myopes
|
63.27 Units on a scale
Standard Deviation 19.031
|
SECONDARY outcome
Timeframe: 1-Week Follow-upPopulation: All dispensed subjects regardless of deviation from protocol with data collected at the 1-week follow-up.
Subjective comfort 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. The average CLUE comfort score was reported. The pre-specified aim was not to compare comfort between the hyperope and myope subgroups, therefore, comfort scores were reported for both groups combined.
Outcome measures
| Measure |
Test (Senofilcon A C3)
n=136 Participants
Subjects that wore the Test lens during the study.
|
|---|---|
|
CLUE Comfort Score
|
72.60 Units on a scale
Standard Deviation 20.696
|
SECONDARY outcome
Timeframe: 1-Week Follow-upPopulation: All dispensed subjects regardless of deviation from protocol with data collected at the 1-week follow-up.
Subjective Handling 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. The average CLUE handling score was reported. The pre-specified aim was not to compare comfort between the hyperope and myope subgroups, therefore, comfort scores were reported for both groups combined.
Outcome measures
| Measure |
Test (Senofilcon A C3)
n=136 Participants
Subjects that wore the Test lens during the study.
|
|---|---|
|
CLUE Handling Score
|
67.56 Units on a scale
Standard Deviation 20.619
|
SECONDARY outcome
Timeframe: Up to 1-Week Follow-upPopulation: All dispensed subjects regardless of subsequent withdrawal from study or deviation from protocol.
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 10. 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.
Outcome measures
| Measure |
Test (Senofilcon A C3)
n=139 Participants
Subjects that wore the Test lens during the study.
|
|---|---|
|
Proportion of Subject Achieving Optimal Lens Pair in 4 Lenses or Less
|
1 Proportion of subjects
|
Adverse Events
Test (Senofilcon A C3)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Thomas R. Karkkainen
Johnson & Johnson Vision Care, Inc. (JJVC)
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60