Trial Outcomes & Findings for Evaluating Contact Lens Optics (NCT NCT05028790)
NCT ID: NCT05028790
Last Updated: 2024-02-06
Results Overview
Low contrast visual acuity was measured for each participant while wearing each of the two lenses
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
16 participants
Primary outcome timeframe
Through completion of study visit, an average of 2.5 hours
Results posted on
2024-02-06
Participant Flow
Participant milestones
| Measure |
Single Vision Soft Contact Lens First, Then Multifocal Soft Contact Lens
Participants wore the single vision soft contact lens first, then the multifocal soft contact lens
|
Multifocal Soft Contact Lens First, Then Single Vision Soft Contact Lens
Participants wore the multifocal soft contact lens first, then the single vision soft contact lens
|
|---|---|---|
|
First Intervention (40 Mins)
STARTED
|
9
|
7
|
|
First Intervention (40 Mins)
COMPLETED
|
9
|
7
|
|
First Intervention (40 Mins)
NOT COMPLETED
|
0
|
0
|
|
Washout (5 Mins)
STARTED
|
9
|
7
|
|
Washout (5 Mins)
COMPLETED
|
9
|
7
|
|
Washout (5 Mins)
NOT COMPLETED
|
0
|
0
|
|
Second Intervention (40 Mins)
STARTED
|
9
|
7
|
|
Second Intervention (40 Mins)
COMPLETED
|
9
|
7
|
|
Second Intervention (40 Mins)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluating Contact Lens Optics
Baseline characteristics by cohort
| Measure |
Single Vision Soft Contact Lens First, Then Multifocal Soft Contact Lens
n=9 Participants
Participants wore the single vision soft contact lens first, then the multifocal soft contact lens
|
Multifocal Soft Contact Lens First, Then Single Vision Soft Contact Lens
n=7 Participants
Participants wore the multifocal soft contact lens first, then the single vision soft contact lens
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
25.11 years
STANDARD_DEVIATION 1.83 • n=99 Participants
|
24 years
STANDARD_DEVIATION 1.15 • n=107 Participants
|
24.63 years
STANDARD_DEVIATION 1.63 • n=206 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
9 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Through completion of study visit, an average of 2.5 hoursLow contrast visual acuity was measured for each participant while wearing each of the two lenses
Outcome measures
| Measure |
Single Vision Contact Lens
n=9 Participants
Low contrast visual acuity measured while participants were wearing the single vision soft contact lens
|
Multifocal Contact Lens
n=7 Participants
Spherical equivalent refractive error measured while participants were wearing the multifocal soft contact lens
|
|---|---|---|
|
Visual Performance
|
0.23 logMAR
Standard Deviation 0.08
|
0.38 logMAR
Standard Deviation 0.12
|
SECONDARY outcome
Timeframe: Through completion of study visit, an average of 2.5 hoursRefraction was measured after cycloplegia with two drops of 1% tropicamide hydrochloride. Spherical equivalent refractive error was then measured 3 times with an aberrometer and averaged.
Outcome measures
| Measure |
Single Vision Contact Lens
n=16 Participants
Low contrast visual acuity measured while participants were wearing the single vision soft contact lens
|
Multifocal Contact Lens
n=16 Participants
Spherical equivalent refractive error measured while participants were wearing the multifocal soft contact lens
|
|---|---|---|
|
Spherical Equivalent Refractive Error On-axis
|
0.61 D
Standard Deviation 0.46
|
0.17 D
Standard Deviation 0.44
|
SECONDARY outcome
Timeframe: Through completion of study visit, an average of 2.5 hoursCycloplegic spherical equivalent refractive error was measured 3 times with an aberrometer and averaged.
Outcome measures
| Measure |
Single Vision Contact Lens
n=16 Participants
Low contrast visual acuity measured while participants were wearing the single vision soft contact lens
|
Multifocal Contact Lens
n=16 Participants
Spherical equivalent refractive error measured while participants were wearing the multifocal soft contact lens
|
|---|---|---|
|
Spherical Equivalent Refractive Error at 30 Degrees Temporal Retina
|
0.68 D
Standard Deviation 1.03
|
-1.20 D
Standard Deviation 1
|
SECONDARY outcome
Timeframe: Through completion of study visit, an average of 2.5 hoursCycloplegic spherical equivalent refractive error was measured 3 times with an aberrometer and averaged.
Outcome measures
| Measure |
Single Vision Contact Lens
n=16 Participants
Low contrast visual acuity measured while participants were wearing the single vision soft contact lens
|
Multifocal Contact Lens
n=16 Participants
Spherical equivalent refractive error measured while participants were wearing the multifocal soft contact lens
|
|---|---|---|
|
Spherical Equivalent Refractive Error at 20 Degrees Temporal Retina
|
0.52 D
Standard Deviation 0.68
|
-1.30 D
Standard Deviation 0.44
|
SECONDARY outcome
Timeframe: Through completion of study visit, an average of 2.5 hoursCycloplegic spherical equivalent refractive error was measured 3 times with an aberrometer and averaged.
Outcome measures
| Measure |
Single Vision Contact Lens
n=16 Participants
Low contrast visual acuity measured while participants were wearing the single vision soft contact lens
|
Multifocal Contact Lens
n=16 Participants
Spherical equivalent refractive error measured while participants were wearing the multifocal soft contact lens
|
|---|---|---|
|
Spherical Equivalent Refractive Error at 20 Degrees Nasal Retina
|
0.67 D
Standard Deviation 0.58
|
-0.17 D
Standard Deviation 0.57
|
SECONDARY outcome
Timeframe: Through completion of study visit, an average of 2.5 hoursCycloplegic spherical equivalent refractive error was measured 3 times with an aberrometer and averaged.
Outcome measures
| Measure |
Single Vision Contact Lens
n=16 Participants
Low contrast visual acuity measured while participants were wearing the single vision soft contact lens
|
Multifocal Contact Lens
n=16 Participants
Spherical equivalent refractive error measured while participants were wearing the multifocal soft contact lens
|
|---|---|---|
|
Spherical Equivalent Refractive Error at 30 Degrees Nasal Retina
|
0.77 D
Standard Deviation 0.70
|
-0.75 D
Standard Deviation 0.60
|
Adverse Events
Single Vision Contact Lens
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Multifocal 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