Trial Outcomes & Findings for Myopia Assessment of Two Manufacturing Processes (NCT NCT04126057)
NCT ID: NCT04126057
Last Updated: 2022-01-25
Results Overview
Change in axial length progression over time between DOT spectacle lenses manufactured by method A versus method B Axial length progression is defined as an axial length elongation that is attributable to myopia.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
50 participants
Primary outcome timeframe
6 months
Results posted on
2022-01-25
Participant Flow
Unit of analysis: Eyes
Participant milestones
| Measure |
DOT Spectacle Lenses Test
Single vision, impact-resistant spectacles using SightGlass Vision DOT spectacle lenses, manufacturing method A
SightGlass Vision DOT Spectacle Lenses: Subjects randomized to test vs control, left eyes and right eyes
|
DOT Spectacle Lenses Control
Single vision, impact-resistant spectacles using SightGlass Vision DOT spectacle lenses, manufacturing method B
SightGlass Vision DOT Spectacle Lenses: Subjects randomized to test vs control, left eyes and right eyes
|
|---|---|---|
|
Overall Study
STARTED
|
50 50
|
50 50
|
|
Overall Study
COMPLETED
|
47 47
|
46 46
|
|
Overall Study
NOT COMPLETED
|
3 3
|
4 4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Myopia Assessment of Two Manufacturing Processes
Baseline characteristics by cohort
| Measure |
DOT Spectacle Lenses Test
n=43 Eyes
Single vision, impact-resistant spectacles using SightGlass Vision DOT spectacle lenses, manufacturing method A
SightGlass Vision DOT Spectacle Lenses: Subjects randomized to test vs control, left eyes and right eyes
|
DOT Spectacle Lenses Control
n=43 Eyes
Single vision, impact-resistant spectacles using SightGlass Vision DOT spectacle lenses, manufacturing method B
SightGlass Vision DOT Spectacle Lenses: Subjects randomized to test vs control, left eyes and right eyes
|
Total
n=86 Eyes
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
43 Eyes
n=14 Eyes
|
43 Eyes
n=23 Eyes
|
86 Eyes
n=50 Eyes
|
|
Age, Categorical
Between 18 and 65 years
|
0 Eyes
n=14 Eyes
|
0 Eyes
n=23 Eyes
|
0 Eyes
n=50 Eyes
|
|
Age, Categorical
>=65 years
|
0 Eyes
n=14 Eyes
|
0 Eyes
n=23 Eyes
|
0 Eyes
n=50 Eyes
|
|
Age, Continuous
|
11.67 years
STANDARD_DEVIATION 2.073 • n=5 Participants
|
11.67 years
STANDARD_DEVIATION 2.073 • n=7 Participants
|
11.67 years
STANDARD_DEVIATION 2.073 • n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Eyes
n=14 Eyes
|
21 Eyes
n=23 Eyes
|
42 Eyes
n=50 Eyes
|
|
Sex: Female, Male
Male
|
22 Eyes
n=14 Eyes
|
22 Eyes
n=23 Eyes
|
44 Eyes
n=50 Eyes
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Eyes
n=14 Eyes
|
6 Eyes
n=23 Eyes
|
12 Eyes
n=50 Eyes
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
37 Eyes
n=14 Eyes
|
37 Eyes
n=23 Eyes
|
74 Eyes
n=50 Eyes
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Eyes
n=14 Eyes
|
0 Eyes
n=23 Eyes
|
0 Eyes
n=50 Eyes
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
5 Eyes
n=14 Eyes
|
5 Eyes
n=23 Eyes
|
10 Eyes
n=50 Eyes
|
|
Race (NIH/OMB)
Asian
|
2 Eyes
n=14 Eyes
|
2 Eyes
n=23 Eyes
|
4 Eyes
n=50 Eyes
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Eyes
n=14 Eyes
|
0 Eyes
n=23 Eyes
|
0 Eyes
n=50 Eyes
|
|
Race (NIH/OMB)
Black or African American
|
9 Eyes
n=14 Eyes
|
9 Eyes
n=23 Eyes
|
18 Eyes
n=50 Eyes
|
|
Race (NIH/OMB)
White
|
27 Eyes
n=14 Eyes
|
27 Eyes
n=23 Eyes
|
54 Eyes
n=50 Eyes
|
|
Race (NIH/OMB)
More than one race
|
0 Eyes
n=14 Eyes
|
0 Eyes
n=23 Eyes
|
0 Eyes
n=50 Eyes
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Eyes
n=14 Eyes
|
0 Eyes
n=23 Eyes
|
0 Eyes
n=50 Eyes
|
|
Region of Enrollment
United States
|
43 Eyes
n=14 Eyes
|
43 Eyes
n=23 Eyes
|
86 Eyes
n=50 Eyes
|
PRIMARY outcome
Timeframe: 6 monthsChange in axial length progression over time between DOT spectacle lenses manufactured by method A versus method B Axial length progression is defined as an axial length elongation that is attributable to myopia.
Outcome measures
| Measure |
DOT Spectacle Lenses Using Test
n=43 Eyes
Single vision, impact-resistant spectacles using SightGlass Vision DOT spectacle lenses, manufacturing method A
SightGlass Vision DOT Spectacle Lenses: Subjects randomized to test vs control, left eyes and right eyes
|
DOT Spectacle Lenses Using Control
n=43 Eyes
Single vision, impact-resistant spectacles using SightGlass Vision DOT spectacle lenses, manufacturing method B
SightGlass Vision DOT Spectacle Lenses: Subjects randomized to test vs control, left eyes and right eyes
|
|---|---|---|
|
Change in Axial Length Progression From Baseline
|
0.046 mm
Standard Deviation 0.139
|
0.047 mm
Standard Deviation 0.128
|
Adverse Events
DOT Spectacle Lenses Using Test
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
DOT Spectacle Lenses Using Control
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
Restriction type: OTHER