Trial Outcomes & Findings for An Evaluation of the Effectiveness of Dual Focus Soft Contact Lenses in Slowing Mypoia Progression (NCT NCT01729208)
NCT ID: NCT01729208
Last Updated: 2020-02-24
Results Overview
Mean change in refractive error, measured with cycloplegic auto-refraction in Diopters at 12 months, relative to baseline.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
144 participants
Primary outcome timeframe
12 months
Results posted on
2020-02-24
Participant Flow
Participant milestones
| Measure |
Dual Focus Soft Contact Lens
Dual Focus Soft Contact Lens
Dual Focus Soft Contact Lens
|
Single Vision Soft Contact Lens
Single Vision Soft Contact Lens
Single Vision Soft Contact Lens
|
|---|---|---|
|
Baseline
STARTED
|
70
|
74
|
|
Baseline
COMPLETED
|
65
|
70
|
|
Baseline
NOT COMPLETED
|
5
|
4
|
|
12 Months Follow-up
STARTED
|
65
|
70
|
|
12 Months Follow-up
COMPLETED
|
58
|
60
|
|
12 Months Follow-up
NOT COMPLETED
|
7
|
10
|
|
24 Months Follow-up
STARTED
|
58
|
60
|
|
24 Months Follow-up
COMPLETED
|
55
|
60
|
|
24 Months Follow-up
NOT COMPLETED
|
3
|
0
|
|
36 Months Follow-up
STARTED
|
55
|
60
|
|
36 Months Follow-up
COMPLETED
|
52
|
56
|
|
36 Months Follow-up
NOT COMPLETED
|
3
|
4
|
Reasons for withdrawal
| Measure |
Dual Focus Soft Contact Lens
Dual Focus Soft Contact Lens
Dual Focus Soft Contact Lens
|
Single Vision Soft Contact Lens
Single Vision Soft Contact Lens
Single Vision Soft Contact Lens
|
|---|---|---|
|
Baseline
Physician Decision
|
5
|
4
|
|
12 Months Follow-up
Withdrawal by Subject
|
4
|
7
|
|
12 Months Follow-up
Lost to Follow-up
|
3
|
3
|
|
24 Months Follow-up
Lost to Follow-up
|
3
|
0
|
|
36 Months Follow-up
Physician Decision
|
1
|
0
|
|
36 Months Follow-up
Withdrawal by Subject
|
2
|
4
|
Baseline Characteristics
An Evaluation of the Effectiveness of Dual Focus Soft Contact Lenses in Slowing Mypoia Progression
Baseline characteristics by cohort
| Measure |
Dual Focus Soft Contact Lens
n=70 Participants
Dual Focus Soft Contact Lens
Dual Focus Soft Contact Lens
|
Single Vision Soft Contact Lens
n=74 Participants
Single Vision Soft Contact Lens
Single Vision Soft Contact Lens
|
Total
n=144 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
70 Participants
n=5 Participants
|
74 Participants
n=7 Participants
|
144 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
10.1 years
STANDARD_DEVIATION 1.3 • n=5 Participants
|
10.1 years
STANDARD_DEVIATION 1.4 • n=7 Participants
|
10.1 years
STANDARD_DEVIATION 1.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
38 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
39 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
East Asian
|
16 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Indian/Pakistani/Sri Lankan
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Mixed
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
32 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
|
Region of Enrollment
Singapore
|
15 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
13 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Region of Enrollment
Portugal
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 monthsMean change in refractive error, measured with cycloplegic auto-refraction in Diopters at 12 months, relative to baseline.
Outcome measures
| Measure |
Dual Focus Soft Contact Lens
n=116 Eyes
Dual Focus Soft Contact Lens
Dual Focus Soft Contact Lens
|
Single Vision Soft Contact Lens
n=120 Eyes
Single Vision Soft Contact Lens
Single Vision Soft Contact Lens
|
|---|---|---|
|
Change in Refractive Error Relative to Baseline
|
-0.18 Diopters
Standard Deviation 0.39
|
-0.58 Diopters
Standard Deviation 0.41
|
PRIMARY outcome
Timeframe: 24 monthsMean change in refractive error, measured with cycloplegic auto-refraction in Diopters at 24 months, relative to baseline.
Outcome measures
| Measure |
Dual Focus Soft Contact Lens
n=110 Eyes
Dual Focus Soft Contact Lens
Dual Focus Soft Contact Lens
|
Single Vision Soft Contact Lens
n=120 Eyes
Single Vision Soft Contact Lens
Single Vision Soft Contact Lens
|
|---|---|---|
|
Change in Refractive Error Relative to Baseline
|
-0.38 Diopters
Standard Deviation 0.52
|
-0.92 Diopters
Standard Deviation 0.53
|
PRIMARY outcome
Timeframe: 36 monthsMean change in refractive error, measured with cycloplegic auto-refraction in Diopters at 36 months, relative to baseline.
Outcome measures
| Measure |
Dual Focus Soft Contact Lens
n=104 Eyes
Dual Focus Soft Contact Lens
Dual Focus Soft Contact Lens
|
Single Vision Soft Contact Lens
n=112 Eyes
Single Vision Soft Contact Lens
Single Vision Soft Contact Lens
|
|---|---|---|
|
Change in Refractive Error Relative to Baseline
|
-0.51 Diopters
Standard Deviation 0.64
|
-1.24 Diopters
Standard Deviation 0.61
|
PRIMARY outcome
Timeframe: 12 monthsMean change in axial length measurement, in millimeters at 12 months, relative to baseline.
Outcome measures
| Measure |
Dual Focus Soft Contact Lens
n=116 Eyes
Dual Focus Soft Contact Lens
Dual Focus Soft Contact Lens
|
Single Vision Soft Contact Lens
n=120 Eyes
Single Vision Soft Contact Lens
Single Vision Soft Contact Lens
|
|---|---|---|
|
Change in Axial Length Relative to Baseline
|
0.09 mm
Standard Deviation 0.13
|
0.24 mm
Standard Deviation 0.15
|
PRIMARY outcome
Timeframe: 24 monthsMean change in axial length measurement, in millimeters at 24 months, relative to baseline.
Outcome measures
| Measure |
Dual Focus Soft Contact Lens
n=110 Eyes
Dual Focus Soft Contact Lens
Dual Focus Soft Contact Lens
|
Single Vision Soft Contact Lens
n=120 Eyes
Single Vision Soft Contact Lens
Single Vision Soft Contact Lens
|
|---|---|---|
|
Change in Axial Length Relative to Baseline
|
0.21 mm
Standard Deviation 0.22
|
0.45 mm
Standard Deviation 0.23
|
PRIMARY outcome
Timeframe: 36 monthsMean change in axial length measurement, in millimeters at 36 months, relative to baseline.
Outcome measures
| Measure |
Dual Focus Soft Contact Lens
n=104 Eyes
Dual Focus Soft Contact Lens
Dual Focus Soft Contact Lens
|
Single Vision Soft Contact Lens
n=112 Eyes
Single Vision Soft Contact Lens
Single Vision Soft Contact Lens
|
|---|---|---|
|
Change in Axial Length Relative to Baseline
|
0.30 mm
Standard Deviation 0.28
|
0.62 mm
Standard Deviation 0.30
|
SECONDARY outcome
Timeframe: BaselineCumulative incidence of biomicroscopic findings. Slit lamp severity greater than Grade 2 (based on a 0-4 scale, where 0=none and 4=severe).
Outcome measures
| Measure |
Dual Focus Soft Contact Lens
n=70 Participants
Dual Focus Soft Contact Lens
Dual Focus Soft Contact Lens
|
Single Vision Soft Contact Lens
n=74 Participants
Single Vision Soft Contact Lens
Single Vision Soft Contact Lens
|
|---|---|---|
|
Number of Participants With Biomicroscopic Findings Greater Than Grade 2
Corneal Staining
|
0 participants
|
0 participants
|
|
Number of Participants With Biomicroscopic Findings Greater Than Grade 2
Conjuctival Staining
|
0 participants
|
0 participants
|
|
Number of Participants With Biomicroscopic Findings Greater Than Grade 2
Bulbar Hyperemia
|
0 participants
|
0 participants
|
|
Number of Participants With Biomicroscopic Findings Greater Than Grade 2
Limbal Hyperemia
|
0 participants
|
0 participants
|
|
Number of Participants With Biomicroscopic Findings Greater Than Grade 2
Palpebral Hyperemia
|
0 participants
|
0 participants
|
|
Number of Participants With Biomicroscopic Findings Greater Than Grade 2
Palpebral Roughness
|
0 participants
|
0 participants
|
|
Number of Participants With Biomicroscopic Findings Greater Than Grade 2
Vascularization
|
0 participants
|
0 participants
|
|
Number of Participants With Biomicroscopic Findings Greater Than Grade 2
"Other" Findings
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 12 monthsCumulative incidence of biomicroscopic findings. Slit lamp severity greater than Grade 2 (based on a 0-4 scale, where 0=none and 4=severe).
Outcome measures
| Measure |
Dual Focus Soft Contact Lens
n=58 Participants
Dual Focus Soft Contact Lens
Dual Focus Soft Contact Lens
|
Single Vision Soft Contact Lens
n=60 Participants
Single Vision Soft Contact Lens
Single Vision Soft Contact Lens
|
|---|---|---|
|
Number of Participants With Biomicroscopic Findings Greater Than Grade 2
Corneal Staining
|
0 participants
|
0 participants
|
|
Number of Participants With Biomicroscopic Findings Greater Than Grade 2
Conjuctival Staining
|
0 participants
|
0 participants
|
|
Number of Participants With Biomicroscopic Findings Greater Than Grade 2
Bulbar Hyperemia
|
0 participants
|
0 participants
|
|
Number of Participants With Biomicroscopic Findings Greater Than Grade 2
Limbal Hyperemia
|
0 participants
|
0 participants
|
|
Number of Participants With Biomicroscopic Findings Greater Than Grade 2
Palpebral Hyperemia
|
0 participants
|
0 participants
|
|
Number of Participants With Biomicroscopic Findings Greater Than Grade 2
Palpebral Roughness
|
1 participants
|
0 participants
|
|
Number of Participants With Biomicroscopic Findings Greater Than Grade 2
Vascularization
|
0 participants
|
0 participants
|
|
Number of Participants With Biomicroscopic Findings Greater Than Grade 2
"Other" Findings
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 24 monthsCumulative incidence of biomicroscopic findings. Slit lamp severity greater than Grade 2 (based on a 0-4 scale, where 0=none and 4=severe).
Outcome measures
| Measure |
Dual Focus Soft Contact Lens
n=55 Participants
Dual Focus Soft Contact Lens
Dual Focus Soft Contact Lens
|
Single Vision Soft Contact Lens
n=60 Participants
Single Vision Soft Contact Lens
Single Vision Soft Contact Lens
|
|---|---|---|
|
Number of Participants With Biomicroscopic Findings
Corneal Staining
|
0 participants
|
0 participants
|
|
Number of Participants With Biomicroscopic Findings
Conjuctival Staining
|
0 participants
|
0 participants
|
|
Number of Participants With Biomicroscopic Findings
Bulbar Hyperemia
|
0 participants
|
0 participants
|
|
Number of Participants With Biomicroscopic Findings
Limbal Hyperemia
|
0 participants
|
0 participants
|
|
Number of Participants With Biomicroscopic Findings
Palpebral Hyperemia
|
0 participants
|
0 participants
|
|
Number of Participants With Biomicroscopic Findings
Palpebral Roughness
|
0 participants
|
0 participants
|
|
Number of Participants With Biomicroscopic Findings
Vascularization
|
0 participants
|
0 participants
|
|
Number of Participants With Biomicroscopic Findings
"Other" Findings
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 36 monthsCumulative incidence of biomicroscopic findings. Slit lamp severity greater than Grade 2 (based on a 0-4 scale, where 0=none and 4=severe).
Outcome measures
| Measure |
Dual Focus Soft Contact Lens
n=52 Participants
Dual Focus Soft Contact Lens
Dual Focus Soft Contact Lens
|
Single Vision Soft Contact Lens
n=56 Participants
Single Vision Soft Contact Lens
Single Vision Soft Contact Lens
|
|---|---|---|
|
Number of Participants With Biomicroscopic Findings Greater Than Grade 2.
Corneal Staining
|
0 participants
|
0 participants
|
|
Number of Participants With Biomicroscopic Findings Greater Than Grade 2.
Conjuctival Staining
|
0 participants
|
0 participants
|
|
Number of Participants With Biomicroscopic Findings Greater Than Grade 2.
Bulbar Hyperemia
|
0 participants
|
0 participants
|
|
Number of Participants With Biomicroscopic Findings Greater Than Grade 2.
Limbal Hyperemia
|
0 participants
|
0 participants
|
|
Number of Participants With Biomicroscopic Findings Greater Than Grade 2.
Palpebral Hyperemia
|
0 participants
|
0 participants
|
|
Number of Participants With Biomicroscopic Findings Greater Than Grade 2.
Palpebral Roughness
|
0 participants
|
0 participants
|
|
Number of Participants With Biomicroscopic Findings Greater Than Grade 2.
Vascularization
|
0 participants
|
0 participants
|
|
Number of Participants With Biomicroscopic Findings Greater Than Grade 2.
"Other" Findings
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 12 monthsCumulative incidence of adverse events.
Outcome measures
| Measure |
Dual Focus Soft Contact Lens
n=58 Participants
Dual Focus Soft Contact Lens
Dual Focus Soft Contact Lens
|
Single Vision Soft Contact Lens
n=60 Participants
Single Vision Soft Contact Lens
Single Vision Soft Contact Lens
|
|---|---|---|
|
Incidence of Adverse Events
Significant adverse events
|
0 participants
|
0 participants
|
|
Incidence of Adverse Events
Non-significant infiltrative event- device related
|
0 participants
|
2 participants
|
|
Incidence of Adverse Events
Blepharitis - not device related
|
2 participants
|
0 participants
|
|
Incidence of Adverse Events
Localized allergic reaction - device related
|
0 participants
|
1 participants
|
|
Incidence of Adverse Events
Localized allergic reaction-not device related
|
0 participants
|
1 participants
|
|
Incidence of Adverse Events
Non-significant-Other-Device related
|
2 participants
|
0 participants
|
|
Incidence of Adverse Events
Non-significant-Other- Not device related
|
3 participants
|
0 participants
|
|
Incidence of Adverse Events
Foreign Body -Device related
|
1 participants
|
0 participants
|
|
Incidence of Adverse Events
Corneal event -Device related
|
3 participants
|
0 participants
|
|
Incidence of Adverse Events
Corneal event- Not device related
|
1 participants
|
0 participants
|
|
Incidence of Adverse Events
Meibomianitis - Not device related
|
2 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 24 monthsCumulative incidence of adverse events.
Outcome measures
| Measure |
Dual Focus Soft Contact Lens
n=55 Participants
Dual Focus Soft Contact Lens
Dual Focus Soft Contact Lens
|
Single Vision Soft Contact Lens
n=60 Participants
Single Vision Soft Contact Lens
Single Vision Soft Contact Lens
|
|---|---|---|
|
Incidence of Adverse Events
Conjuctivitis - Not device related
|
2 participants
|
0 participants
|
|
Incidence of Adverse Events
Non-significant Other - Device related
|
1 participants
|
0 participants
|
|
Incidence of Adverse Events
Non-significant Other - Not device related
|
0 participants
|
3 participants
|
|
Incidence of Adverse Events
Non-significant infiltrative event Device related
|
0 participants
|
1 participants
|
|
Incidence of Adverse Events
Significant Adverse Events
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 36 monthsCumulative incidence of adverse events.
Outcome measures
| Measure |
Dual Focus Soft Contact Lens
n=52 Participants
Dual Focus Soft Contact Lens
Dual Focus Soft Contact Lens
|
Single Vision Soft Contact Lens
n=56 Participants
Single Vision Soft Contact Lens
Single Vision Soft Contact Lens
|
|---|---|---|
|
Incidence of Adverse Events
Conjuctivitis - Not device related
|
0 participants
|
1 participants
|
|
Incidence of Adverse Events
Non-significant Other - Device related
|
0 participants
|
1 participants
|
|
Incidence of Adverse Events
Non-significant Other - Not device related
|
0 participants
|
1 participants
|
|
Incidence of Adverse Events
Non-significant infiltrative event-no device relat
|
1 participants
|
0 participants
|
|
Incidence of Adverse Events
Corneal event- device related
|
0 participants
|
1 participants
|
|
Incidence of Adverse Events
Significant Adverse Events
|
0 participants
|
0 participants
|
Adverse Events
Dual Focus Soft Contact Lens
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Single Vision Soft Contact Lens
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place