Trial Outcomes & Findings for Evaluation of Wear Experience With a Weekly Replacement Soft Contact Lens in Neophyte Lens Wearers With Astigmatism (NCT NCT06751225)
NCT ID: NCT06751225
Last Updated: 2026-06-04
Results Overview
VAS assessment of overall vision. (0-100 scale; 0=unacceptable 100=excellent)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
40 participants
Primary outcome timeframe
After 3 weeks of lens wear
Results posted on
2026-06-04
Participant Flow
Participant milestones
| Measure |
Contact Lens Wear Experience
One week replacement soft contact lenses will be worn for 3 weeks.
|
|---|---|
|
Overall Study
STARTED
|
40
|
|
Overall Study
COMPLETED
|
38
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of Wear Experience With a Weekly Replacement Soft Contact Lens in Neophyte Lens Wearers With Astigmatism
Baseline characteristics by cohort
| Measure |
Contact Lens Wear Experience
n=40 Participants
One week replacement soft contact lenses will be worn for 3 weeks.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=9 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
40 Participants
n=9 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=9 Participants
|
|
Age, Continuous
|
27.25 years
STANDARD_DEVIATION 5.90 • n=9 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
34 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Asian
|
14 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=9 Participants
|
|
Race (NIH/OMB)
White
|
24 Participants
n=9 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
|
Region of Enrollment
United States
|
40 participants
n=9 Participants
|
PRIMARY outcome
Timeframe: After 3 weeks of lens wearVAS assessment of overall vision. (0-100 scale; 0=unacceptable 100=excellent)
Outcome measures
| Measure |
Contact Lens Wear Experience
n=38 Participants
One week replacement soft contact lenses will be worn for 3 weeks.
|
|---|---|
|
Subjective Assessment of Lens Wear Experience
</= 50
|
2 Participants
|
|
Subjective Assessment of Lens Wear Experience
51-60
|
0 Participants
|
|
Subjective Assessment of Lens Wear Experience
61-70
|
5 Participants
|
|
Subjective Assessment of Lens Wear Experience
71-80
|
8 Participants
|
|
Subjective Assessment of Lens Wear Experience
81-90
|
11 Participants
|
|
Subjective Assessment of Lens Wear Experience
91-100
|
12 Participants
|
Adverse Events
Contact Lens Wear Experience
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Contact Lens Wear Experience
n=40 participants at risk
One week replacement soft contact lenses will be worn for 3 weeks.
|
|---|---|
|
General disorders
Cold
|
7.5%
3/40 • Number of events 3 • Adverse events were collected for each participant's study duration (~1 month).
The Sub-I or PI conducting each study visit asked participants at the beginning of each visit about any changes to health or medications.
|
Additional Information
Jennifer Fogt
The Ohio State University - Innovation in Eye Care
Phone: 6142928858
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place