Trial Outcomes & Findings for Novel Multifocal Soft Contact Lens Study (NCT NCT06172881)
NCT ID: NCT06172881
Last Updated: 2024-05-01
Results Overview
LogMAR typically ranges from -0.3 (20/10 vision on the Snellen chart) to 1 (20/200 vision). Lower scores indicate better vision.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
10 participants
Primary outcome timeframe
1 day (This is a single visit study)
Results posted on
2024-05-01
Participant Flow
Participant milestones
| Measure |
Distance Visual Acuity
Visual acuity will be measured while participant's wear study lenses.
Investigational Contact Lens: A soft contact lens that will be worn only at the study visit.
|
|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Novel Multifocal Soft Contact Lens Study
Baseline characteristics by cohort
| Measure |
Distance Visual Acuity
n=10 Participants
Visual acuity will be measured while participant's wear study lenses.
Investigational Contact Lens: A soft contact lens that will be worn only at the study visit.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
|
Age, Continuous
Age
|
29.3 years
STANDARD_DEVIATION 5.9 • n=93 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 1 day (This is a single visit study)LogMAR typically ranges from -0.3 (20/10 vision on the Snellen chart) to 1 (20/200 vision). Lower scores indicate better vision.
Outcome measures
| Measure |
Distance Visual Acuity
n=10 Participants
Visual acuity will be measured while participant's wear study lenses.
Investigational Contact Lens: A soft contact lens that will be worn only at the study visit.
|
|---|---|
|
Distance Visual Acuity
High Contrast Distance Visual Acuity OD
|
-0.13 logMAR
Standard Deviation 0.08
|
|
Distance Visual Acuity
High Contrast Distance Visual Acuity OS
|
-0.12 logMAR
Standard Deviation 0.09
|
Adverse Events
Distance Visual Acuity
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
Dr. Jennifer Fogt, OD, MS
The Ohio State University College of Optometry
Phone: 614-292-0882
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place