Trial Outcomes & Findings for Clinical Evaluation of Fitting Investigational Contact Lenses (NCT NCT03150485)
NCT ID: NCT03150485
Last Updated: 2018-06-29
Results Overview
The eye care practitioner (ECP) followed the fitting guides to assess the vision provided by the study lenses and determined if a lens change (modification) was needed. The ECP modified the lenses based upon the subject's responses in accordance with the fitting guide. Up to two modifications per subject was allowed. The number of modifications required by the ECP to optimize vision was reported.
COMPLETED
NA
23 participants
15 minutes post lens insertion
2018-06-29
Participant Flow
A total of 23 subjects were enrolled into this study. Of the enrolled subjects all 23 were dispensed a study lens. Of the dispensed subjects 22 completed the study while 1 subjects was discontinued.
This was a non-randomized study. The JJVC fitting guide, subjects responses and eye care practitioner opinions dictated which study lens the subject was to be fit with. Lens type and lens sequence are not experimental design factors.
Participant milestones
| Measure |
Multifocal
Subjects that wore the etafilcon A multifocal lens in both eyes for the entire duration of the study.
|
Toric Multifocal
Subjects that wore the etafilcon A Toric multifocal lens in both eyes for the entire duration of the study.
|
Toric Multifocal/Multifocal
Subjects that wore the etafilcon A toric multifocal lens in their right eye and the etafilcon A multifocal lens in their left eye for the entire duration of the study.
|
Multifocal/Toric Multifocal
Subjects that wore the etafilcon A multifocal lens in their right eye and the etafilcon A toric multifocal lens in their left eye for the entire duration of the study.
|
Multifocal/Toric Multifocal -Toric Multifocal
Subjects that first wore the etafilcon A multifocal lens in their right eye and the etafilcon A toric multifocal lens in their left eye and then wore the etafilcon A toric multifocal lens in both eyes for the remainder of the study.
|
Multifocal/Toric Multifocal - Multifocal -Toric Multifocal
Subjects that first wore the etafilcon A multifocal lens in their right eye and the etafilcon A toric multifocal lens in their left eye. Then wore the etafilcon A multifocal lens in both eyes secondary and lastly wore then etafilcon A toric multifocal lens in both eyes for the remainder of the study.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
2
|
9
|
4
|
5
|
2
|
1
|
|
Overall Study
COMPLETED
|
2
|
8
|
4
|
5
|
2
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Multifocal
Subjects that wore the etafilcon A multifocal lens in both eyes for the entire duration of the study.
|
Toric Multifocal
Subjects that wore the etafilcon A Toric multifocal lens in both eyes for the entire duration of the study.
|
Toric Multifocal/Multifocal
Subjects that wore the etafilcon A toric multifocal lens in their right eye and the etafilcon A multifocal lens in their left eye for the entire duration of the study.
|
Multifocal/Toric Multifocal
Subjects that wore the etafilcon A multifocal lens in their right eye and the etafilcon A toric multifocal lens in their left eye for the entire duration of the study.
|
Multifocal/Toric Multifocal -Toric Multifocal
Subjects that first wore the etafilcon A multifocal lens in their right eye and the etafilcon A toric multifocal lens in their left eye and then wore the etafilcon A toric multifocal lens in both eyes for the remainder of the study.
|
Multifocal/Toric Multifocal - Multifocal -Toric Multifocal
Subjects that first wore the etafilcon A multifocal lens in their right eye and the etafilcon A toric multifocal lens in their left eye. Then wore the etafilcon A multifocal lens in both eyes secondary and lastly wore then etafilcon A toric multifocal lens in both eyes for the remainder of the study.
|
|---|---|---|---|---|---|---|
|
Overall Study
Unsatisfactory Lens Fitting
|
0
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Clinical Evaluation of Fitting Investigational Contact Lenses
Baseline characteristics by cohort
| Measure |
Dispensed Subjects
n=23 Participants
All subjects dispensed at least one study lens.
|
|---|---|
|
Age, Continuous
|
55.7 Years
STANDARD_DEVIATION 5.08 • n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
23 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 15 minutes post lens insertionPopulation: Subjects that completed all study visits without a major protocol deviation.
The eye care practitioner (ECP) followed the fitting guides to assess the vision provided by the study lenses and determined if a lens change (modification) was needed. The ECP modified the lenses based upon the subject's responses in accordance with the fitting guide. Up to two modifications per subject was allowed. The number of modifications required by the ECP to optimize vision was reported.
Outcome measures
| Measure |
JJVC Fitting Guides
n=44 Eyes
ECPs used JJCV Fitting guides to fit subjects with etafilcon A Toric Multifocal and etafilcon A Multifocal.
|
|---|---|
|
The Average Number of Fitting Modifications to Optimize Vision
|
0.30 Lens
Standard Deviation 0.553
|
SECONDARY outcome
Timeframe: 15 Minuted Post Lens InsertionPopulation: All subjects that completed the study without a major protocol deviation.
Subjects responses to individual item "Considering Your Experience With The Study Contact Lenses, Which Statement Best Describes Your Overall Satisfaction Of These Contact Lenses?". This item had a response set of extremely satisfied, very satisfied, moderately satisfied, slightly satisfied and not at all satisfied. The percentage of subject's in each response category was reported.
Outcome measures
| Measure |
JJVC Fitting Guides
n=22 Participants
ECPs used JJCV Fitting guides to fit subjects with etafilcon A Toric Multifocal and etafilcon A Multifocal.
|
|---|---|
|
Subject's Responses to Individual Item 1
Extremely Satisfied
|
63.6 percentage of participants
|
|
Subject's Responses to Individual Item 1
Very Satisfied
|
31.8 percentage of participants
|
|
Subject's Responses to Individual Item 1
Moderately Satisfied
|
4.6 percentage of participants
|
|
Subject's Responses to Individual Item 1
Slightly Satisfied
|
0 percentage of participants
|
|
Subject's Responses to Individual Item 1
Not at all Satisfied
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: 15 Minuted Post Lens InsertionPopulation: All subjects that completed the study without a major protocol deviation.
Subjects responses to individual item "Based On Your Experience Today, How Likely Are You To Purchase This Contact Lens?". This item had a response set of extremely likely, very likely, somewhat likely, slightly likely and not at all likely. The percentage of subject's in each response category was reported.
Outcome measures
| Measure |
JJVC Fitting Guides
n=22 Participants
ECPs used JJCV Fitting guides to fit subjects with etafilcon A Toric Multifocal and etafilcon A Multifocal.
|
|---|---|
|
Subject's Responses to Individual Item 2
Extremely likely
|
59.1 percentage of participants
|
|
Subject's Responses to Individual Item 2
Very likely
|
36.4 percentage of participants
|
|
Subject's Responses to Individual Item 2
Somewhat likely
|
4.6 percentage of participants
|
|
Subject's Responses to Individual Item 2
Slightly likely
|
0 percentage of participants
|
|
Subject's Responses to Individual Item 2
Not at all likely
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: 15 Minuted Post Lens InsertionPopulation: All subjects that completed the study without a major protocol deviation.
Subjects responses to individual item "Please Think About Your Experience Today With The Study Contact Lenses. Please Indicate How You Satisfied You Are With The Overall Contact Lens Fitting Process?". This item had a response set of very satisfied, satisfied, unsure, dissatisfied and very dissatisfied. The percentage of subject's in each response category was reported.
Outcome measures
| Measure |
JJVC Fitting Guides
n=22 Participants
ECPs used JJCV Fitting guides to fit subjects with etafilcon A Toric Multifocal and etafilcon A Multifocal.
|
|---|---|
|
Subject's Responses to Individual Item 3
Very Satisfied
|
86.4 percentage of participants
|
|
Subject's Responses to Individual Item 3
Satisfied
|
13.6 percentage of participants
|
|
Subject's Responses to Individual Item 3
Unsure
|
0 percentage of participants
|
|
Subject's Responses to Individual Item 3
Dissatisfied
|
0 percentage of participants
|
|
Subject's Responses to Individual Item 3
Very Dissatisfied
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: 15 Minuted Post Lens InsertionPopulation: All subjects that completed the study without a major protocol deviation.
Subjects responses to individual item "Where Would You Expect To Go Looking For Information About This Contact Lens? Please Select All That Apply.". The percentage of subject's in each response category was reported.
Outcome measures
| Measure |
JJVC Fitting Guides
n=22 Participants
ECPs used JJCV Fitting guides to fit subjects with etafilcon A Toric Multifocal and etafilcon A Multifocal.
|
|---|---|
|
Subject's Responses to Individual Item 4
On a website for particular brand of contacts
|
63.3 percentage of participants
|
|
Subject's Responses to Individual Item 4
On a general healthcare website such as WebMD
|
9.1 percentage of participants
|
|
Subject's Responses to Individual Item 4
In a Magazine
|
22.7 percentage of participants
|
|
Subject's Responses to Individual Item 4
In a Newspaper
|
4.6 percentage of participants
|
|
Subject's Responses to Individual Item 4
On a search engine (ex: Google)
|
45.5 percentage of participants
|
|
Subject's Responses to Individual Item 4
On a Blog
|
0 percentage of participants
|
|
Subject's Responses to Individual Item 4
On Social Media Networks
|
9.1 percentage of participants
|
|
Subject's Responses to Individual Item 4
On YouTube
|
9.1 percentage of participants
|
|
Subject's Responses to Individual Item 4
In an Online Forum
|
0 percentage of participants
|
|
Subject's Responses to Individual Item 4
On your Vision Care Insurance Website
|
22.7 percentage of participants
|
|
Subject's Responses to Individual Item 4
Talking with friends family or colleagues
|
36.4 percentage of participants
|
|
Subject's Responses to Individual Item 4
Talking with an eye doctor
|
95.5 percentage of participants
|
|
Subject's Responses to Individual Item 4
Online, but not through an advertisement
|
27.3 percentage of participants
|
|
Subject's Responses to Individual Item 4
Other
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: 15 Minuted Post Lens InsertionPopulation: All subjects that completed the study without a major protocol deviation.
Subjects responses to individual item "If You Were To Purchase The Study Contact Lenses, With What Frequency Would You Expect To Wear Them?". This item had a response set of All of the time, Usually, Frequently, Sometimes, Rarely and never. The percentage of subject's in each response category was reported.
Outcome measures
| Measure |
JJVC Fitting Guides
n=22 Participants
ECPs used JJCV Fitting guides to fit subjects with etafilcon A Toric Multifocal and etafilcon A Multifocal.
|
|---|---|
|
Subject's Responses to Individual Item 5
All of the time
|
86.4 percentage of participants
|
|
Subject's Responses to Individual Item 5
Usually
|
13.6 percentage of participants
|
|
Subject's Responses to Individual Item 5
Frequently
|
0 percentage of participants
|
|
Subject's Responses to Individual Item 5
Sometimes
|
0 percentage of participants
|
|
Subject's Responses to Individual Item 5
Rarely
|
0 percentage of participants
|
|
Subject's Responses to Individual Item 5
Never
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: 15 Minuted Post Lens InsertionPopulation: All subjects that completed the study without a major protocol deviation.
Subjects responses to individual item "What Are Your Current Vision Correction Solutions?". The percentage of subject's in each response category was reported.
Outcome measures
| Measure |
JJVC Fitting Guides
n=22 Participants
ECPs used JJCV Fitting guides to fit subjects with etafilcon A Toric Multifocal and etafilcon A Multifocal.
|
|---|---|
|
Subject's Responses to Individual Item 6
Other
|
13.6 percentage of participants
|
|
Subject's Responses to Individual Item 6
Toric Contact lenses
|
27.3 percentage of participants
|
|
Subject's Responses to Individual Item 6
Multifocal Contact lenses
|
40.9 percentage of participants
|
|
Subject's Responses to Individual Item 6
Monovision
|
36.4 percentage of participants
|
|
Subject's Responses to Individual Item 6
Readers
|
36.4 percentage of participants
|
|
Subject's Responses to Individual Item 6
Progressive lenses
|
9.1 percentage of participants
|
SECONDARY outcome
Timeframe: 15 Minuted Post Lens InsertionPopulation: All subjects that completed the study without a major protocol deviation.
Subjects responses to individual item "Study Compare To Your Current Vision Correction Solutions?". This item had a response set of Much better, somewhat better, about the same, somewhat worse and much worse. The percentage of subject's in each response category was reported.
Outcome measures
| Measure |
JJVC Fitting Guides
n=22 Participants
ECPs used JJCV Fitting guides to fit subjects with etafilcon A Toric Multifocal and etafilcon A Multifocal.
|
|---|---|
|
Subject's Responses to Individual Item 7
Much Better
|
50.0 percentage of participants
|
|
Subject's Responses to Individual Item 7
Somewhat Better
|
31.8 percentage of participants
|
|
Subject's Responses to Individual Item 7
About the Same
|
13.6 percentage of participants
|
|
Subject's Responses to Individual Item 7
Somewhat Worse
|
4.6 percentage of participants
|
|
Subject's Responses to Individual Item 7
Much Worse
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: 15 Minuted Post Lens InsertionPopulation: All subjects that completed the study without a major protocol deviation.
Subjects responses to individual item "Considering your experience with the study contact lens, how excited are you about this lens being available to purchase?". This item had a response set of Very Excited, Excited, Unsure, Unexcited and Very Unexcited. The percentage of subject's in each response category was reported.
Outcome measures
| Measure |
JJVC Fitting Guides
n=22 Participants
ECPs used JJCV Fitting guides to fit subjects with etafilcon A Toric Multifocal and etafilcon A Multifocal.
|
|---|---|
|
Subject's Responses to Individual Item 8
Very Excited
|
59.1 percentage of participants
|
|
Subject's Responses to Individual Item 8
Excited
|
27.3 percentage of participants
|
|
Subject's Responses to Individual Item 8
Unsure
|
13.6 percentage of participants
|
|
Subject's Responses to Individual Item 8
Unexcited
|
0 percentage of participants
|
|
Subject's Responses to Individual Item 8
Very Unexcited
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: 15 Minuted Post Lens InsertionPopulation: All subjects that completed the study without a major protocol deviation.
Subjects responses to individual item "How would you rate your overall visual performance with the study contact lens?". This item had a response set of Excellent, Very Good, Good, Fair and Poor. The percentage of subject's in each response category was reported.
Outcome measures
| Measure |
JJVC Fitting Guides
n=22 Participants
ECPs used JJCV Fitting guides to fit subjects with etafilcon A Toric Multifocal and etafilcon A Multifocal.
|
|---|---|
|
Subject's Responses to Individual Item 9
Excellent
|
63.6 percentage of participants
|
|
Subject's Responses to Individual Item 9
Very Good
|
31.8 percentage of participants
|
|
Subject's Responses to Individual Item 9
Good
|
4.6 percentage of participants
|
|
Subject's Responses to Individual Item 9
Fair
|
0 percentage of participants
|
|
Subject's Responses to Individual Item 9
Poor
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: 15 Minuted Post Lens InsertionPopulation: All subjects that completed the study without a major protocol deviation.
Subjects responses to individual item "Considering Your Experience With The Study Contact Lenses, Which Statement Best Describes Your Overall Opinion Of These Contact Lenses?". This item had a response set of Excellent, Very Good, Good, Fair and Poor. The percentage of subject's in each response category was reported.
Outcome measures
| Measure |
JJVC Fitting Guides
n=22 Participants
ECPs used JJCV Fitting guides to fit subjects with etafilcon A Toric Multifocal and etafilcon A Multifocal.
|
|---|---|
|
Subject's Responses to Individual Item 10
Excellent
|
77.3 percentage of participants
|
|
Subject's Responses to Individual Item 10
Very Good
|
18.2 percentage of participants
|
|
Subject's Responses to Individual Item 10
Good
|
4.6 percentage of participants
|
|
Subject's Responses to Individual Item 10
Fair
|
0 percentage of participants
|
|
Subject's Responses to Individual Item 10
Poor
|
0 percentage of participants
|
Adverse Events
Multifocal
Toric Multifocal
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Thomas Karkkainen - SR PRINCIPAL RESEARCH OPTOMETRIST
Johnson & Johnson Vision
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60