Trial Outcomes & Findings for Extended Depth of Focus Contact Lenses for Presbyopia (NCT NCT05495971)
NCT ID: NCT05495971
Last Updated: 2024-12-16
Results Overview
High contrast/high illumination distant (6M) logMAR vision
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
24 participants
Primary outcome timeframe
4 hours
Results posted on
2024-12-16
Participant Flow
Participant milestones
| Measure |
Presbyopia
Subject's baseline vision will be compared with vision wearing treatment product
NaturalVue Multifocal: EDOF
|
|---|---|
|
Overall Study
STARTED
|
24
|
|
Overall Study
COMPLETED
|
24
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Presbyopia
n=24 Participants
Subject's baseline vision will be compared with vision wearing treatment product
NaturalVue Multifocal: EDOF
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=24 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
23 Participants
n=24 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=24 Participants
|
|
Age, Continuous
|
59.2 years
n=24 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=24 Participants
|
|
Region of Enrollment
United States
|
24 participants
n=24 Participants
|
|
Visual acuity
|
-0.07 logMAR
STANDARD_DEVIATION 0.07 • n=24 Participants
|
PRIMARY outcome
Timeframe: 4 hoursHigh contrast/high illumination distant (6M) logMAR vision
Outcome measures
| Measure |
Presbyopia
n=24 Participants
Subject's baseline vision will be compared with vision wearing treatment product
NaturalVue Multifocal: EDOF
|
|---|---|
|
LogMAR Visual Acuity
|
-0.07 logMAR
Standard Deviation 0.07
|
Adverse Events
Presbyopia
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