Trial Outcomes & Findings for Controlling Myopia Progression With Soft Contact Lenses (NCT NCT01787760)
NCT ID: NCT01787760
Last Updated: 2018-06-19
Results Overview
Axial Length was measured with the IOLMaster at baseline, and then every 6 months throughout the course of the study. Five measurements were collected for each eye at each visit and the average of the 5 measurements were used for the analysis. Higher values of axial elongation indicate worse vision.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
221 participants
Primary outcome timeframe
Baseline and every 6 months post-baseline up to 3 years
Results posted on
2018-06-19
Participant Flow
Of those 221 screened subjects, 56 were ineligible to participate in the study and 13 were eligible but not randomized to the study lens groups.
Participant milestones
| Measure |
Test Soft Contact Lens B
Lenses will be worn in a daily disposable modality
|
Test Soft Contact Lens C
Lenses will be worn in a daily disposable modality
|
Spectacle Lenses
Control spectacle lenses worn daily.
|
|---|---|---|---|
|
Overall Study
STARTED
|
51
|
50
|
51
|
|
Overall Study
COMPLETED
|
25
|
34
|
46
|
|
Overall Study
NOT COMPLETED
|
26
|
16
|
5
|
Reasons for withdrawal
| Measure |
Test Soft Contact Lens B
Lenses will be worn in a daily disposable modality
|
Test Soft Contact Lens C
Lenses will be worn in a daily disposable modality
|
Spectacle Lenses
Control spectacle lenses worn daily.
|
|---|---|---|---|
|
Overall Study
Anisometropia > -1.00D in spherical equi
|
1
|
0
|
0
|
|
Overall Study
Decompensated on left exotropia
|
0
|
0
|
1
|
|
Overall Study
Dryness
|
0
|
1
|
0
|
|
Overall Study
Relocation
|
1
|
1
|
0
|
|
Overall Study
Lens discomfort
|
3
|
0
|
0
|
|
Overall Study
Lens handling difficulty
|
1
|
2
|
0
|
|
Overall Study
Protocol Violation
|
6
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
5
|
1
|
2
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
1
|
|
Overall Study
Stroke
|
1
|
0
|
0
|
|
Overall Study
Unsatisfactory lens fitting performance
|
3
|
6
|
0
|
|
Overall Study
Unsatisfactory physiological response
|
2
|
4
|
0
|
|
Overall Study
Unsatisfactory visual response
|
1
|
1
|
0
|
|
Overall Study
Near vision blur
|
1
|
0
|
0
|
Baseline Characteristics
Controlling Myopia Progression With Soft Contact Lenses
Baseline characteristics by cohort
| Measure |
Test Soft Contact Lens B
n=51 Participants
Lenses will be worn in a daily disposable modality
|
Test Soft Contact Lens C
n=50 Participants
Lenses will be worn in a daily disposable modality
|
Spectacle Lenses
n=51 Participants
Control spectacle lenses worn daily.
|
Total
n=152 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
51 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
152 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Continuous
|
9.5 years
STANDARD_DEVIATION 1.1 • n=5 Participants
|
9.6 years
STANDARD_DEVIATION 1.1 • n=7 Participants
|
9.5 years
STANDARD_DEVIATION 1.1 • n=5 Participants
|
9.5 years
STANDARD_DEVIATION 1.1 • n=4 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
72 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
80 Participants
n=4 Participants
|
|
Region of Enrollment
United States · Hong Kong
|
51 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
152 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline and every 6 months post-baseline up to 3 yearsPopulation: Analysis was conducted on all randomized subjects who have at least one data point.
Axial Length was measured with the IOLMaster at baseline, and then every 6 months throughout the course of the study. Five measurements were collected for each eye at each visit and the average of the 5 measurements were used for the analysis. Higher values of axial elongation indicate worse vision.
Outcome measures
| Measure |
Spectacle Lenses
n=96 eyes
Control spectacle lenses worn daily.
|
Test Soft Contact Lens B
n=70 eyes
Lenses will be worn in a daily disposable modality.
|
Test Soft Contact Lens C
n=74 eyes
Lenses will be worn in a daily disposable modality.
|
|---|---|---|---|
|
Axial Length (Axial Elongation)
Change from baseline 6 months
|
0.158 millimeter (mm)
Standard Deviation 0.0981
|
0.144 millimeter (mm)
Standard Deviation 0.0834
|
0.121 millimeter (mm)
Standard Deviation 0.0749
|
|
Axial Length (Axial Elongation)
Change from baseline 12 months
|
0.242 millimeter (mm)
Standard Deviation 0.1448
|
0.236 millimeter (mm)
Standard Deviation 0.1267
|
0.222 millimeter (mm)
Standard Deviation 0.1288
|
|
Axial Length (Axial Elongation)
Change from baseline 18 months; N=92, N=54, N=72
|
0.348 millimeter (mm)
Standard Deviation 0.2129
|
0.355 millimeter (mm)
Standard Deviation 0.1837
|
0.344 millimeter (mm)
Standard Deviation 0.1676
|
|
Axial Length (Axial Elongation)
Change from baseline 24 months; N=92, N=54, N=72
|
0.455 millimeter (mm)
Standard Deviation 0.2520
|
0.409 millimeter (mm)
Standard Deviation 0.2247
|
0.445 millimeter (mm)
Standard Deviation 0.2444
|
|
Axial Length (Axial Elongation)
Change from baseline 30 months
|
0.565 millimeter (mm)
Standard Deviation 0.2941
|
0.512 millimeter (mm)
Standard Deviation 0.2634
|
0.511 millimeter (mm)
Standard Deviation 0.2564
|
|
Axial Length (Axial Elongation)
Change from baseline 36 months
|
0.640 millimeter (mm)
Standard Deviation 0.3199
|
0.634 millimeter (mm)
Standard Deviation 0.3249
|
0.512 millimeter (mm)
Standard Deviation 0.3072
|
PRIMARY outcome
Timeframe: Baseline and every 6 months post-baseline up to 3 yearsPopulation: Analysis was conducted on all randomized subjects who have at least one data point.
Spherical Equivalent Refraction was computed from the sphero-cylindrical refraction measured with an open-field auto refractor. The median of 3 repeated measurements, each of which was the average of 3 consecutive readings, was used for the analysis. Higher values of spherical refraction indicate progression in Myopia.
Outcome measures
| Measure |
Spectacle Lenses
n=96 eyes
Control spectacle lenses worn daily.
|
Test Soft Contact Lens B
n=70 eyes
Lenses will be worn in a daily disposable modality.
|
Test Soft Contact Lens C
n=72 eyes
Lenses will be worn in a daily disposable modality.
|
|---|---|---|---|
|
Spherical Equivalent Refraction
Change from baseline 6 months
|
-0.238 diopter (D)
Standard Deviation 0.3443
|
-0.327 diopter (D)
Standard Deviation 0.3038
|
-0.230 diopter (D)
Standard Deviation 0.3436
|
|
Spherical Equivalent Refraction
Change from baseline 12 months
|
-0.417 diopter (D)
Standard Deviation 0.4557
|
-0.456 diopter (D)
Standard Deviation 0.3733
|
-0.429 diopter (D)
Standard Deviation 0.4199
|
|
Spherical Equivalent Refraction
Change from baseline 18 months
|
-0.562 diopter (D)
Standard Deviation 0.5841
|
-0.692 diopter (D)
Standard Deviation 0.3965
|
-0.720 diopter (D)
Standard Deviation 0.4988
|
|
Spherical Equivalent Refraction
Change from baseline 24 months
|
-0.776 diopter (D)
Standard Deviation 0.6185
|
-0.781 diopter (D)
Standard Deviation 0.4447
|
-0.861 diopter (D)
Standard Deviation 0.5504
|
|
Spherical Equivalent Refraction
Change from baseline 30 months
|
-0.966 diopter (D)
Standard Deviation 0.7592
|
-1.000 diopter (D)
Standard Deviation 0.5485
|
-1.003 diopter (D)
Standard Deviation 0.6829
|
|
Spherical Equivalent Refraction
Change from baseline 36 months
|
-1.073 diopter (D)
Standard Deviation 0.9922
|
-1.266 diopter (D)
Standard Deviation 0.3193
|
-0.824 diopter (D)
Standard Deviation 0.8244
|
Adverse Events
Spectacle Lenses
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Test Soft Contact Lens B
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Test Soft Contact Lens C
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Not Randomized
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Spectacle Lenses
n=51 participants at risk
Control spectacle lenses worn daily.
|
Test Soft Contact Lens B
n=51 participants at risk
Lenses will be worn in a daily disposable modality.
|
Test Soft Contact Lens C
n=50 participants at risk
Lenses will be worn in a daily disposable modality.
|
Not Randomized
n=13 participants at risk
Subjects who met the all study eligible criteria but did not randomize to the study arm.
|
|---|---|---|---|---|
|
Eye disorders
Slit-lamp finding
|
0.00%
0/51
|
13.7%
7/51 • Number of events 10
|
8.0%
4/50 • Number of events 5
|
0.00%
0/13
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place