Trial Outcomes & Findings for Characterizing Successful Myopic Multifocal Contact Lens Wearers (NCT NCT04178772)
NCT ID: NCT04178772
Last Updated: 2022-03-23
Results Overview
Subjects are classified into 1 of 4 mutually exclusive groups based on their responses to 6 individual items. 5 items were assessed using the 7-point like-rt scale. A composite score "Life Satisfaction" was calculated for each subject by summing their responses, the final score ranges 0-35 points. Where higher scores indicate higher satisfaction with life. The final item was assessed using a 5 point like-rt scale. If a subject scored 26 or higher for the composite score and responded positively (4 or 5) to the final item, then a subject was classified as "Content \& Driven". If a subject scored 26 or higher but did not respond positively, then "Content \& Indifferent". If a subject scored lower than 26 and responded positively, then "Discontented \& Driven". Lastly, if a subject scored lower than 26 but did not respond positively, then "Discontented \& Indifferent". The percentage of subjects for each group was reported.
TERMINATED
NA
29 participants
Baseline
2022-03-23
Participant Flow
A total of 29 subjects were enrolled into this study. Of those enrolled, 27 were dispensed study lenses, while 2 subjects failed to meet all eligibility criteria. Of those dispensed, 19 completed the study while 8 subjects were discontinued. This study was terminated early due to COVID-19.
Participant milestones
| Measure |
Etafilcon A Multifocal Lens
Subjects that wore the etafilcon A lens during any point of the study.
|
|---|---|
|
Overall Study
STARTED
|
27
|
|
Overall Study
COMPLETED
|
19
|
|
Overall Study
NOT COMPLETED
|
8
|
Reasons for withdrawal
| Measure |
Etafilcon A Multifocal Lens
Subjects that wore the etafilcon A lens during any point of the study.
|
|---|---|
|
Overall Study
Unsatisfacotry VIsual Response
|
1
|
|
Overall Study
study terminated early due to COVID-19
|
7
|
Baseline Characteristics
Characterizing Successful Myopic Multifocal Contact Lens Wearers
Baseline characteristics by cohort
| Measure |
Dispensed Subject
n=27 Participants
All subjects dispensed a study lens.
|
|---|---|
|
Age, Continuous
|
46.8 years
STANDARD_DEVIATION 3.95 • n=93 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
2 participants
n=93 Participants
|
|
Race/Ethnicity, Customized
White
|
24 participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 participants
n=93 Participants
|
|
Region of Enrollment
Canada
|
27 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: BaselinePopulation: All subjects dispensed a study lens.
Subjects are classified into 1 of 4 mutually exclusive groups based on their responses to 6 individual items. 5 items were assessed using the 7-point like-rt scale. A composite score "Life Satisfaction" was calculated for each subject by summing their responses, the final score ranges 0-35 points. Where higher scores indicate higher satisfaction with life. The final item was assessed using a 5 point like-rt scale. If a subject scored 26 or higher for the composite score and responded positively (4 or 5) to the final item, then a subject was classified as "Content \& Driven". If a subject scored 26 or higher but did not respond positively, then "Content \& Indifferent". If a subject scored lower than 26 and responded positively, then "Discontented \& Driven". Lastly, if a subject scored lower than 26 but did not respond positively, then "Discontented \& Indifferent". The percentage of subjects for each group was reported.
Outcome measures
| Measure |
Etafilcon A Multifocal Lens
n=27 Participants
Subjects that wore the etafilcon A lens during any point of the study.
|
|---|---|
|
Quest Questionnaire Classification Summary
Discontented & Driven
|
22.2 Percentage of Participants
|
|
Quest Questionnaire Classification Summary
Content & Driven
|
33.3 Percentage of Participants
|
|
Quest Questionnaire Classification Summary
Discontented & Indifferent
|
11.2 Percentage of Participants
|
|
Quest Questionnaire Classification Summary
Content & Indifferent
|
33.3 Percentage of Participants
|
PRIMARY outcome
Timeframe: 12-Week Follow-upPopulation: All subjects dispensed a study lens.
Successful lens wearers were defined as subjects that fit the following criteria: 1.Completed all required study visits, 2. responded Excellent or Very Good to both the individual questionnaire items (Overall quality of vision and Overall Comfort) and 3. the investigator would recommend the study lenses. Overall quality of Vision and Overall Comfort are individual questionnaire items with the response set of 0: Not Applicable, 1: Excellent, 2: Very Good, 3: Good, 4: Fair and 5: Poor. Investigator recommendation was determined by the individual item "In your opinion, is it suitable to prescribe contact lenses for this subject? (Yes/No)". The proportion of successful lens wearers was reported.
Outcome measures
| Measure |
Etafilcon A Multifocal Lens
n=27 Participants
Subjects that wore the etafilcon A lens during any point of the study.
|
|---|---|
|
Proportion of Successful Lens Wearers
|
0.593 Proportion of Participants
|
SECONDARY outcome
Timeframe: Baseline, Post Lens Fitting, 2-Week Follow-up, 12-Week Follow-upPopulation: All subjects dispensed a study lens.
Monocular Contrast threshold was measured at Distance (4 meter) for both the left and right eyes using the M\&S clinical trial suit (CTS) under standard room illumination. Contrast threshold was collected at Baseline, post lens fitting, 2-week follow-up evaluation and the 12-week evaluation. Contrast threshold at baseline was measured while wearing a spherical-cylinder refraction in a trial frame. The M\&S system displayed the contrast threshold score in log units. The average contrast threshold was reported for each timepoint.
Outcome measures
| Measure |
Etafilcon A Multifocal Lens
n=54 eyes
Subjects that wore the etafilcon A lens during any point of the study.
|
|---|---|
|
Monocular Contrast Threshold
Baseline
|
-1.32 log CS
Standard Deviation 0.174
|
|
Monocular Contrast Threshold
Post Lens Fitting
|
-1.15 log CS
Standard Deviation 0.244
|
|
Monocular Contrast Threshold
2-Week Follow-up
|
-1.24 log CS
Standard Deviation 0.196
|
|
Monocular Contrast Threshold
12-Week Follow-up
|
-1.16 log CS
Standard Deviation 0.226
|
SECONDARY outcome
Timeframe: Baseline, Post Lens Fitting, 2-Week Follow-up, 12-Week Follow-upPopulation: All subjects dispensed a study lens.
Binocular Contrast threshold was measured at Distance (4 meter) using the M\&S clinical trial suit (CTS) under standard room illumination. Contrast threshold was collected at Baseline, post lens fitting, 2-week follow-up evaluation and the 12-week evaluation. Contrast threshold at baseline was measured while wearing a spherical-cylinder refraction in a trial frame. The M\&S system displayed the contrast threshold score in log units.
Outcome measures
| Measure |
Etafilcon A Multifocal Lens
n=27 Participants
Subjects that wore the etafilcon A lens during any point of the study.
|
|---|---|
|
Binocular Contrast Threshold
Baseline
|
-1.46 log CS
Standard Deviation 0.178
|
|
Binocular Contrast Threshold
Post Lens Fitting
|
-1.32 log CS
Standard Deviation 0.228
|
|
Binocular Contrast Threshold
2-Week Follow-up
|
-1.43 log CS
Standard Deviation 0.196
|
|
Binocular Contrast Threshold
12-Week Follow-up
|
-1.35 log CS
Standard Deviation 0.209
|
SECONDARY outcome
Timeframe: Baseline, 1-Week Follow-upPopulation: All subjects dispensed a study lens.
Pupillometry was measured for both the left and right eyes at baseline and the 1-week follow-up evaluation . Pupil size was measured at distance, intermediate and near positions under photopic (500 lux) conditions using the NeurOptic VIP-300 pupilometer. The average pupil size across both eyes was reported for each distance and timepoint.
Outcome measures
| Measure |
Etafilcon A Multifocal Lens
n=27 Participants
Subjects that wore the etafilcon A lens during any point of the study.
|
|---|---|
|
Photopic Pupillometry
Baseline: Distance (4 meter)
|
3.85 mm
Standard Deviation 0.578
|
|
Photopic Pupillometry
Baseline: Intermediate (1 meter)
|
3.73 mm
Standard Deviation 0.568
|
|
Photopic Pupillometry
Baseline: Near (40 cm)
|
3.70 mm
Standard Deviation 0.608
|
|
Photopic Pupillometry
1-Week Follow-up: Distance (4 meter)
|
3.87 mm
Standard Deviation 0.502
|
|
Photopic Pupillometry
1-Week Follow-up: Intermediate (1 meter)
|
3.64 mm
Standard Deviation 0.428
|
|
Photopic Pupillometry
1-Week Follow-up: Near (40 cm)
|
3.44 mm
Standard Deviation 0.463
|
SECONDARY outcome
Timeframe: Baseline, 1-Week Follow-upPopulation: All subjects dispensed a study lens.
Pupillometry was measured for both the left and right eyes at baseline and the 1-week follow-up evaluation . Pupil size was measured at distance, intermediate and near positions under scotopic (0 lux) conditions using the NeurOptic VIP-300 pupilometer. The average pupil size across both eyes was reported for each distance and timepoint.
Outcome measures
| Measure |
Etafilcon A Multifocal Lens
n=27 Participants
Subjects that wore the etafilcon A lens during any point of the study.
|
|---|---|
|
Scotopic Pupillometry
Baseline: Distance (4 meter)
|
5.92 mm
Standard Deviation 0.804
|
|
Scotopic Pupillometry
Baseline: Intermediate (1 meter)
|
5.75 mm
Standard Deviation 0.786
|
|
Scotopic Pupillometry
Baseline: Near (40 cm)
|
5.33 mm
Standard Deviation 0.816
|
|
Scotopic Pupillometry
1-Week Follow-up: Distance (4 meter)
|
5.79 mm
Standard Deviation 0.872
|
|
Scotopic Pupillometry
1-Week Follow-up: Intermediate (1 meter)
|
5.65 mm
Standard Deviation 0.769
|
|
Scotopic Pupillometry
1-Week Follow-up: Near (40 cm)
|
5.19 mm
Standard Deviation 0.839
|
SECONDARY outcome
Timeframe: Baseline, 10-mintue Post Lens Fitting, 2-Week Follow-up, 12-Week Follow-upPopulation: All subjects enrolled the study.
Near Stereopsis threshold was collected binocularly using a Randot Stereopsis book at near (40cm) at baseline (over bare eyes), and at 10-minutes post lens fitting, 2-Week and 12-week follow-up evaluations over the study contact lenses. The average stereopsis threshold for each timepoint was reported.
Outcome measures
| Measure |
Etafilcon A Multifocal Lens
n=28 Participants
Subjects that wore the etafilcon A lens during any point of the study.
|
|---|---|
|
Near Stereopsis Threshold
Baseline
|
43.04 seconds of arc
Standard Deviation 17.968
|
|
Near Stereopsis Threshold
10-minutes Post Lens Fitting
|
58.54 seconds of arc
Standard Deviation 51.213
|
|
Near Stereopsis Threshold
2-Week Follow-up
|
43.48 seconds of arc
Standard Deviation 16.544
|
|
Near Stereopsis Threshold
12-Week Follow-up
|
41.67 seconds of arc
Standard Deviation 14.577
|
SECONDARY outcome
Timeframe: BaselinePopulation: All subjects dispensed a study lens.
Blur tolerance was assessed by subjects being presented with a series on images on a screen. Two aspects of blur were evaluated, noticeable blur and objectionable blur; where, noticeable blur was defined as the threshold in diopters at which point the subject indicated a "just noticeable blur", while objectional blur was defined as the point which the subject indicated the blur of the image to be "absolutely intolerable". Blur tolerance was measured binocularly at 1-meter at baseline only.
Outcome measures
| Measure |
Etafilcon A Multifocal Lens
n=27 Participants
Subjects that wore the etafilcon A lens during any point of the study.
|
|---|---|
|
Blur Tolerance
Noticeable blur
|
0.2 diopters
Standard Deviation 0.06
|
|
Blur Tolerance
Objectionable blur
|
0.3 diopters
Standard Deviation 0.07
|
SECONDARY outcome
Timeframe: BaselinePopulation: All subjects dispensed a study lens.
Fixation disparity with Refraction was measured at baseline with a Mallet Unit for both distance (4 meter) and near (40 cm). This test measures small misalignments between eyes when the eyes are in a fused state. The average amount of base (prism diopters) was reported. The Amount of base can range from 0.00 to 4.00.
Outcome measures
| Measure |
Etafilcon A Multifocal Lens
n=27 Participants
Subjects that wore the etafilcon A lens during any point of the study.
|
|---|---|
|
Fixation Disparity With Refraction
Distance
|
0.74 prism diopters
Standard Deviation 1.130
|
|
Fixation Disparity With Refraction
Near
|
0.63 prism diopters
Standard Deviation 1.079
|
SECONDARY outcome
Timeframe: Baseline, 10-minute Post Lens Fitting, 2-Week Follow-upPopulation: All subjects dispensed a study lens.
Measurement of non-invasive tear break up time (NITBUT) was conducted using a Placido disc topographer in both the left and right eyes on a bare eye at baseline and over the study contact lens 10 minutes post-lens insertion and at the 2-Week follow-up evaluation. Subjects were instructed to blink three times and then hold their eyes open. At the hold time was started, time was stopped once the first area of distortion or break in the tear film was observed. Three replicates were taken on each eye. The average NITBUT across eyes and replicate at each time point was provided. Larger values of NITBUT indicates better tear film.
Outcome measures
| Measure |
Etafilcon A Multifocal Lens
n=27 Participants
Subjects that wore the etafilcon A lens during any point of the study.
|
|---|---|
|
Non-invasive Tear Break-up Time
Baseline
|
5.99 seconds
Standard Deviation 3.839
|
|
Non-invasive Tear Break-up Time
10 minutes Post-Lens Insertion
|
3.75 seconds
Standard Deviation 1.241
|
|
Non-invasive Tear Break-up Time
2-Week Follow-up
|
3.88 seconds
Standard Deviation 1.667
|
SECONDARY outcome
Timeframe: Baseline, 10-minute Post Lens Fitting, 2-Week Follow-up, 12-Week Follow-upPopulation: All subjects dispensed a study lens.
Coma was measured over 2 seconds after blink in both the left and right eyes at baseline (over bare eye) and at 10-minutes post-lens fitting, 2-week, and 12-week follow-up evaluations over the study contact lenses using the COAS wavefront sensor. Both vertical and horizontal Coma was collected in each eye. The average vertical and horizontal coma at each timepoint was reported.
Outcome measures
| Measure |
Etafilcon A Multifocal Lens
n=54 eyes
Subjects that wore the etafilcon A lens during any point of the study.
|
|---|---|
|
Coma
Horizontal: Baseline
|
0.02 microns
Standard Deviation 0.045
|
|
Coma
Horizontal: 10 minutes Post-Lens Insertion
|
0.03 microns
Standard Deviation 0.062
|
|
Coma
Horizontal: 2-Week Follow-up
|
0.03 microns
Standard Deviation 0.066
|
|
Coma
Horizontal: 12-Week Follow-up
|
0.03 microns
Standard Deviation 0.076
|
|
Coma
Vertical: Baseline
|
0.02 microns
Standard Deviation 0.047
|
|
Coma
Vertical: 10 minutes Post-Lens Insertion
|
0.03 microns
Standard Deviation 0.054
|
|
Coma
Vertical: 2-Week Follow-up
|
0.02 microns
Standard Deviation 0.054
|
|
Coma
Vertical: 12-Week Follow-up
|
0.01 microns
Standard Deviation 0.080
|
SECONDARY outcome
Timeframe: Baseline, 10-minute Post Lens Fitting, 2-Week Follow-up, 12-Week Follow-upPopulation: All subjects dispensed a study lens.
Higher Order Aberration (HOA) was measured over 2 seconds after blink in both the left and right eyes at baseline (over bare eye) and at 10-minutes post-lens fitting, 2-week, and 12-week follow-up evaluations over the study contact lenses using the COAS wavefront sensor. The average HOA at each timepoint was reported.
Outcome measures
| Measure |
Etafilcon A Multifocal Lens
n=54 eyes
Subjects that wore the etafilcon A lens during any point of the study.
|
|---|---|
|
Higher Order Aberration
Baseline
|
0.17 microns
Standard Deviation 0.044
|
|
Higher Order Aberration
10 minutes Post-Lens Insertion
|
0.21 microns
Standard Deviation 0.146
|
|
Higher Order Aberration
2-Week Follow-up
|
0.23 microns
Standard Deviation 0.207
|
|
Higher Order Aberration
12-Week Follow-up
|
0.21 microns
Standard Deviation 0.060
|
SECONDARY outcome
Timeframe: BaselinePopulation: All subjects dispensed a study lens.
Keratometry (corneal curvature) collected at baseline for each eye (left and right) using an autokeratometer. The measurement was recorded in diopters (DK) of major keratometric meridians. The average of each measurement was reported.
Outcome measures
| Measure |
Etafilcon A Multifocal Lens
n=54 eyes
Subjects that wore the etafilcon A lens during any point of the study.
|
|---|---|
|
Keratometry (Diopters)
Steep
|
44.46 diopters
Standard Deviation 1.628
|
|
Keratometry (Diopters)
Flat
|
43.72 diopters
Standard Deviation 1.735
|
SECONDARY outcome
Timeframe: BaselinePopulation: All subjects dispensed a study lens.
Keratometry (corneal curvature) collected at baseline for each eye (left and right) using an autokeratometer. The measurement was recorded for locations (degrees) of major keratometric meridians. The average of each measurement was reported.
Outcome measures
| Measure |
Etafilcon A Multifocal Lens
n=54 eyes
Subjects that wore the etafilcon A lens during any point of the study.
|
|---|---|
|
Keratometry (Degrees)
Steep
|
86.43 degrees
Standard Deviation 21.576
|
|
Keratometry (Degrees)
Flat
|
106.43 degrees
Standard Deviation 74.425
|
SECONDARY outcome
Timeframe: Baseline, 10-minute Post Lens Fitting, 2-Week Follow-up, 12-Week Follow-upPopulation: All subjects dispensed a study lens.
Objective accommodation with sphero-cylindrical distance refraction was collected using the WAM-5500 auto-refractor at distance (4-meter), Intermediate (1-meter) and Near (40cm) in both the left and right eyes at baseline, 10-minutes post lens fitting, 2-week and 12-week follow-up evaluations. Measurements at baseline were collected on bare eyes and over the study contact lens at the follow-up evaluations. The average sphere power (diopters) across eyes was report for each distance and timepoint.
Outcome measures
| Measure |
Etafilcon A Multifocal Lens
n=54 eyes
Subjects that wore the etafilcon A lens during any point of the study.
|
|---|---|
|
Objective Accommodation With Distance Refraction
Distance: Baseline
|
0.61 diopters
Standard Deviation 0.400
|
|
Objective Accommodation With Distance Refraction
Distance: 10-Minutes Post Lens Fitting
|
0.17 diopters
Standard Deviation 0.347
|
|
Objective Accommodation With Distance Refraction
Distance: 2-Week Follow-up
|
0.15 diopters
Standard Deviation 0.296
|
|
Objective Accommodation With Distance Refraction
Distance: 12-Week Follow-up
|
0.11 diopters
Standard Deviation 0.296
|
|
Objective Accommodation With Distance Refraction
Intermediate: Baseline
|
0.35 diopters
Standard Deviation 0.450
|
|
Objective Accommodation With Distance Refraction
Intermediate: 10-Minutes Post Lens Fitting
|
-0.09 diopters
Standard Deviation 0.343
|
|
Objective Accommodation With Distance Refraction
Intermediate: 2-Week Follow-up
|
-0.06 diopters
Standard Deviation 0.366
|
|
Objective Accommodation With Distance Refraction
Intermediate: 12-Week Follow-up
|
-0.11 diopters
Standard Deviation 0.335
|
|
Objective Accommodation With Distance Refraction
Near: Baseline
|
-0.24 diopters
Standard Deviation 0.684
|
|
Objective Accommodation With Distance Refraction
Near: 10-Minutes Post Lens Fitting
|
-0.57 diopters
Standard Deviation 0.509
|
|
Objective Accommodation With Distance Refraction
Near: 2-Week Follow-up
|
-0.60 diopters
Standard Deviation 0.596
|
|
Objective Accommodation With Distance Refraction
Near: 12-Week Follow-up
|
-0.61 diopters
Standard Deviation 0.407
|
SECONDARY outcome
Timeframe: 10-minute Post Lens Fitting, 1-Week Follow-up, 2-Week Follow-up, 6-Week Follow-up, 12-Week Follow-upPopulation: All subjects dispensed a study lens.
Binocular Visual Acuity (logMAR) was collected using logMAR visual acuity chart under standard room illumination at distance (4 meter), intermediate (64cm) and near (40cm) at 10 minutes-post lens fitting, and the 1-, 2-, 6- and 12-week follow-up evaluations. However, intermediate was not collected post fitting and at the 1-week follow-up evaluation. A value of 0.0 logMAR is approximate to 20/20 Snellen Visual Acuity. Lower values of visual acuity (logMAR) indicate better vision. The average visual acuity was reported for each distance and timepoint.
Outcome measures
| Measure |
Etafilcon A Multifocal Lens
n=27 Participants
Subjects that wore the etafilcon A lens during any point of the study.
|
|---|---|
|
Binocular Visual Acuity (logMAR)
Distance: 10-Minutes Post Lens Fitting
|
-0.076 logMAR
Standard Deviation 0.0719
|
|
Binocular Visual Acuity (logMAR)
Distance: 1-Week Follow-up
|
-0.104 logMAR
Standard Deviation 0.0646
|
|
Binocular Visual Acuity (logMAR)
Distance: 2-Week Follow-up
|
-0.102 logMAR
Standard Deviation 0.0741
|
|
Binocular Visual Acuity (logMAR)
Distance: 6-Week Follow-up
|
-0.107 logMAR
Standard Deviation 0.0681
|
|
Binocular Visual Acuity (logMAR)
Distance: 12-Week Follow-up
|
-0.098 logMAR
Standard Deviation 0.0570
|
|
Binocular Visual Acuity (logMAR)
Near: 10-Minutes Post Lens Fitting
|
-0.012 logMAR
Standard Deviation 0.1013
|
|
Binocular Visual Acuity (logMAR)
Near: 1-Week Follow-up
|
-0.024 logMAR
Standard Deviation 0.1091
|
|
Binocular Visual Acuity (logMAR)
Near: 2-Week Follow-up
|
-0.051 logMAR
Standard Deviation 0.1019
|
|
Binocular Visual Acuity (logMAR)
Near: 6-Week Follow-up
|
-0.077 logMAR
Standard Deviation 0.0922
|
|
Binocular Visual Acuity (logMAR)
Near: 12-Week Follow-up
|
-0.027 logMAR
Standard Deviation 0.1196
|
|
Binocular Visual Acuity (logMAR)
Intermediate: 2-Week Follow-up
|
-0.152 logMAR
Standard Deviation 0.0725
|
|
Binocular Visual Acuity (logMAR)
Intermediate: 6-Week Follow-up
|
-0.166 logMAR
Standard Deviation 0.0476
|
|
Binocular Visual Acuity (logMAR)
Intermediate: 12-Week Follow-up
|
-0.131 logMAR
Standard Deviation 0.0549
|
SECONDARY outcome
Timeframe: 10-minute Post Lens Fitting, 1-Week Follow-up, 2-Week Follow-up, 6-Week Follow-up, 12-Week Follow-upPopulation: All subjects dispensed a study lens.
Monocular Visual Acuity (logMAR) was collected in both the left and right eyes using logMAR visual acuity chart under standard room illumination at distance (4 meter), intermediate (64cm) and near (40cm) at 10 minutes-post lens fitting, and the 1-, 2-, 6- and 12-week follow-up evaluations. However, intermediate was not collected post fitting and at the 1-week follow-up evaluation. A value of 0.0 logMAR is approximate to 20/20 Snellen Visual Acuity. Lower values of visual acuity (logMAR) indicate better vision. The average visual acuity was reported for each distance and timepoint.
Outcome measures
| Measure |
Etafilcon A Multifocal Lens
n=54 eyes
Subjects that wore the etafilcon A lens during any point of the study.
|
|---|---|
|
Monocular Visual Acuity (logMAR)
Distance: 10-Minutes Post Lens Fitting
|
-0.013 logMAR
Standard Deviation 0.0828
|
|
Monocular Visual Acuity (logMAR)
Distance: 1-Week Follow-up
|
-0.034 logMAR
Standard Deviation 0.0808
|
|
Monocular Visual Acuity (logMAR)
Distance: 2-Week Follow-up
|
-0.038 logMAR
Standard Deviation 0.0774
|
|
Monocular Visual Acuity (logMAR)
Distance: 6-Week Follow-up
|
-0.040 logMAR
Standard Deviation 0.0790
|
|
Monocular Visual Acuity (logMAR)
Distance: 12-Week Follow-up
|
-0.024 logMAR
Standard Deviation 0.0708
|
|
Monocular Visual Acuity (logMAR)
Near: 10-Minutes Post Lens Fitting
|
0.082 logMAR
Standard Deviation 0.1060
|
|
Monocular Visual Acuity (logMAR)
Near: 1-Week Follow-up
|
0.063 logMAR
Standard Deviation 0.1185
|
|
Monocular Visual Acuity (logMAR)
Near: 2-Week Follow-up
|
0.019 logMAR
Standard Deviation 0.0975
|
|
Monocular Visual Acuity (logMAR)
Near: 6-Week Follow-up
|
0.021 logMAR
Standard Deviation 0.0899
|
|
Monocular Visual Acuity (logMAR)
Near: 12-Week Follow-up
|
0.029 logMAR
Standard Deviation 0.1039
|
|
Monocular Visual Acuity (logMAR)
Intermediate: 2-Week Follow-up
|
-0.074 logMAR
Standard Deviation 0.0826
|
|
Monocular Visual Acuity (logMAR)
Intermediate: 12-Week Follow-up
|
-0.064 logMAR
Standard Deviation 0.0721
|
|
Monocular Visual Acuity (logMAR)
Intermediate: 6-Week Follow-up
|
-0.095 logMAR
Standard Deviation 0.0657
|
Adverse Events
Etafilcon A Multifocal Lens
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Thomas Karkkanien - 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