Trial Outcomes & Findings for Evaluation of a Toric Multifocal Contact Lens Manufactured in Etafilcon Material in a Low ADD Hyperopic Population (NCT NCT03713281)
NCT ID: NCT03713281
Last Updated: 2025-04-25
Results Overview
High Luminance, high contrast distance (4 meters) binocular visual acuity was recorded with the test contact lenses using ETDRS visual acuity charts. The logMAR visual acuity was measured as follows: 0.02 logMAR=1 letter. Where lower logMAR scores represent better vision. A value of 0.0 logMAR is equivalent to 20/20 Snellen visual acuity.
COMPLETED
30 participants
2-Week Follow-up
2025-04-25
Participant Flow
In total, 30 subjects were enrolled in this study of which, 28 subjects were assigned and dispensed a study lens, while 2 subjects failed to meet all eligibility criteria. Of the total dispensed subjects, 25 completed the study and 3 subjects were discontinued.
Participant milestones
| Measure |
Toric Multifocal Etafilcon A With PVP
All subjects that were disepnsed the sudy lens.
|
|---|---|
|
Overall Study
STARTED
|
28
|
|
Overall Study
COMPLETED
|
25
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Toric Multifocal Etafilcon A With PVP
All subjects that were disepnsed the sudy lens.
|
|---|---|
|
Overall Study
Lens handling difficuluties
|
2
|
|
Overall Study
Subject was not dispensed enough lenses
|
1
|
Baseline Characteristics
Evaluation of a Toric Multifocal Contact Lens Manufactured in Etafilcon Material in a Low ADD Hyperopic Population
Baseline characteristics by cohort
| Measure |
Toric Multifocal Etafilcon A With PVP
n=28 Participants
All subjects dispensed a study lens.
|
|---|---|
|
Age, Continuous
|
51.8 Years
STANDARD_DEVIATION 4.98 • n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
24 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
28 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2-Week Follow-upPopulation: All sub jects that completed all planned study visits without a major protocol deviation impacting a primary endpoint.
High Luminance, high contrast distance (4 meters) binocular visual acuity was recorded with the test contact lenses using ETDRS visual acuity charts. The logMAR visual acuity was measured as follows: 0.02 logMAR=1 letter. Where lower logMAR scores represent better vision. A value of 0.0 logMAR is equivalent to 20/20 Snellen visual acuity.
Outcome measures
| Measure |
Toric Multifocal Etafilcon A With PVP
n=23 Participants
All subjects that were dispensed the study lens.
|
|---|---|
|
Distance Visual Acuity (logMAR)
|
-0.13 logMAR
Standard Deviation 0.095
|
PRIMARY outcome
Timeframe: 2-Week Follow-upPopulation: All subjects that completed all planned study visits without a major protocol deviation impacting a primary endpoint.
High Luminance, high contrast near (40 centimeters) binocular visual acuity was recorded with the test contact lenses using ETDRS visual acuity charts. The logMAR visual acuity was measured as follows:0.02 logMAR=1 letter. Where lower logMAR scores represent better vision. A value of 0.0 logMAR is equivalent to 20/20 Snellen visual acuity.
Outcome measures
| Measure |
Toric Multifocal Etafilcon A With PVP
n=23 Participants
All subjects that were dispensed the study lens.
|
|---|---|
|
Near Visual Acuity (logMAR)
|
0.06 logMAR
Standard Deviation 0.080
|
Adverse Events
Toric Multifocal Etafilcon A With PVP
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Thomas R. 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