Trial Outcomes & Findings for A Randomized, Active-Controlled, Double-Masked, Crossover Study to Evaluate the Clinical Performance of Deseyne (Vifilcon C) Daily Disposable Soft Contact Lens for Presbyopia Extended Depth of Focus (EDOF) (NCT NCT06698731)
NCT ID: NCT06698731
Last Updated: 2026-03-17
Results Overview
The primary effectiveness endpoint for the study is monocular (study \[right\] eye only) photopic negative lens-induced distance-corrected depth of focus (DOF) at the 0.2 logMAR VA threshold.. This is accomplished by adding small incremental negative lens power over the distance best corrected vision correction until blurred vision is determined (study eye only).
COMPLETED
NA
78 participants
Day 1
2026-03-17
Participant Flow
The same 78 participants wore both test and control lenses in the same (study) eye. Randomization was done to determine sequence (test group is test lens first, and control group is control lens first).
Unit of analysis: Eyes
Participant milestones
| Measure |
Control Lens First
The 1-Day Acuvue Moist Daily Disposable single vision contact lens (control lens) was used first, followed by crossover to the test lens.
|
Test Lens First
The Deseyne Daily Disposable contact lens (test lens) was used first, followed by crossover to the control lens.
|
|---|---|---|
|
Overall Study
STARTED
|
38 38
|
40 40
|
|
Overall Study
COMPLETED
|
37 37
|
40 40
|
|
Overall Study
NOT COMPLETED
|
1 1
|
0 0
|
Reasons for withdrawal
| Measure |
Control Lens First
The 1-Day Acuvue Moist Daily Disposable single vision contact lens (control lens) was used first, followed by crossover to the test lens.
|
Test Lens First
The Deseyne Daily Disposable contact lens (test lens) was used first, followed by crossover to the control lens.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
A Randomized, Active-Controlled, Double-Masked, Crossover Study to Evaluate the Clinical Performance of Deseyne (Vifilcon C) Daily Disposable Soft Contact Lens for Presbyopia Extended Depth of Focus (EDOF)
Baseline characteristics by cohort
| Measure |
Test Lens First
n=40 Participants
The Deseyne Daily Disposable contact lens (test lens) was used first, followed by crossover to the control lens.
|
Control Lens First
n=38 Participants
The 1-Day Acuvue Moist Daily Disposable single vision contact lens (control lens) was used first, followed by crossover to the test lens.
|
Total
n=78 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Mean (SD) age
|
54.9 years
STANDARD_DEVIATION 6.32 • n=10 Participants
|
52.9 years
STANDARD_DEVIATION 5.75 • n=50 Participants
|
53.9 years
STANDARD_DEVIATION 6.09 • n=108 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=10 Participants
|
29 Participants
n=50 Participants
|
60 Participants
n=108 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=10 Participants
|
9 Participants
n=50 Participants
|
18 Participants
n=108 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=10 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=108 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=10 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=108 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=10 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=108 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=10 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=108 Participants
|
|
Race (NIH/OMB)
White
|
40 Participants
n=10 Participants
|
38 Participants
n=50 Participants
|
78 Participants
n=108 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=10 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=108 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=10 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=108 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=10 Participants
|
2 Participants
n=50 Participants
|
3 Participants
n=108 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
39 Participants
n=10 Participants
|
36 Participants
n=50 Participants
|
75 Participants
n=108 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=10 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=108 Participants
|
|
Pupil diameter OD
|
4.24 mm
STANDARD_DEVIATION 0.751 • n=10 Participants
|
4.56 mm
STANDARD_DEVIATION 0.867 • n=50 Participants
|
4.39 mm
STANDARD_DEVIATION 0.820 • n=108 Participants
|
|
BCDVA without lenses OD
|
57.4 letters read
STANDARD_DEVIATION 3.78 • n=10 Participants
|
58.3 letters read
STANDARD_DEVIATION 3.35 • n=50 Participants
|
57.9 letters read
STANDARD_DEVIATION 3.58 • n=108 Participants
|
PRIMARY outcome
Timeframe: Day 1Population: All 77 eyes were analyzed for both Test and Control lenses
The primary effectiveness endpoint for the study is monocular (study \[right\] eye only) photopic negative lens-induced distance-corrected depth of focus (DOF) at the 0.2 logMAR VA threshold.. This is accomplished by adding small incremental negative lens power over the distance best corrected vision correction until blurred vision is determined (study eye only).
Outcome measures
| Measure |
Test
n=77 Eyes
The Deseyne Daily Disposable contact lens is a lens used for single use up to 8 hours daily and disposed after use.
|
Control
n=77 Eyes
The 1-Day Acuvue Moist Daily Disposable single vision contact lens is used as single use only and disposed of after use. Lens may be worn during waking hours.
|
|---|---|---|
|
The Primary Effectiveness Endpoint for the Study is Monocular (Study [Right] Eye Only) Photopic Negative Lens-induced Distance-corrected Depth of Focus (DOF) at the 0.2 logMAR VA Threshold.
|
-2.22 D
Standard Deviation 0.774
|
-1.44 D
Standard Deviation 0.672
|
SECONDARY outcome
Timeframe: Day 1Population: All 77 eyes were analyzed for both Test and Control lenses
Method defines measurement of visual acuity through the distance correction contact lens measured at a distance of 66 cm from the patient.
Outcome measures
| Measure |
Test
n=77 Eyes
The Deseyne Daily Disposable contact lens is a lens used for single use up to 8 hours daily and disposed after use.
|
Control
n=77 Eyes
The 1-Day Acuvue Moist Daily Disposable single vision contact lens is used as single use only and disposed of after use. Lens may be worn during waking hours.
|
|---|---|---|
|
Mean Monocular (Study Eye Only) Photopic Distance-corrected Intermediate Visual Acuity (DCIVA) at 66 cm
|
0.015 logMAR
Standard Deviation 0.1135
|
0.158 logMAR
Standard Deviation 0.1360
|
SECONDARY outcome
Timeframe: Day 1Population: All 77 eyes were analyzed for both Test and Control lenses
Method is to test visual acuity through the distance contact lens correction at 40cm from the patient.
Outcome measures
| Measure |
Test
n=77 Eyes
The Deseyne Daily Disposable contact lens is a lens used for single use up to 8 hours daily and disposed after use.
|
Control
n=77 Eyes
The 1-Day Acuvue Moist Daily Disposable single vision contact lens is used as single use only and disposed of after use. Lens may be worn during waking hours.
|
|---|---|---|
|
Mean Monocular (Study Eye Only) Photopic Distance-corrected Near Visual Acuity (DCNVA) at 40 cm
|
0.196 logMAR
Standard Error 0.1145
|
0.353 logMAR
Standard Error 0.1707
|
Adverse Events
Test Lens
Control Lens
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