Trial Outcomes & Findings for Total30 Sphere Contact Lenses (NCT NCT05183022)
NCT ID: NCT05183022
Last Updated: 2022-12-16
Results Overview
A visual analog scale (VAS) was used to compare end of day ocular comfort at 16 hours of contact lens wear over the 1 month study (0 to 100 scale with 100 being best).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
48 participants
Primary outcome timeframe
1 month
Results posted on
2022-12-16
Participant Flow
Participant milestones
| Measure |
Total30 Sphere Contact Lenses
All qualified participants will be refit into Total30 Sphere contact lenses.
Total30 Sphere Contact Lenses: Participants will be refit into Total30 Sphere contact lenses and followed for 1 month.
|
|---|---|
|
Overall Study
STARTED
|
48
|
|
Overall Study
COMPLETED
|
48
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Total30 Sphere Contact Lenses
Baseline characteristics by cohort
| Measure |
Total30 Sphere Contact Lenses
n=48 Participants
All qualified participants will be refit into Total30 Sphere contact lenses.
Total30 Sphere Contact Lenses: Participants will be refit into Total30 Sphere contact lenses and followed for 1 month.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
48 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
Total30 Participants
|
26.2 Years
STANDARD_DEVIATION 5.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
46 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
31 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
48 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 monthPopulation: Total30 Contact Lens Wearing Participants
A visual analog scale (VAS) was used to compare end of day ocular comfort at 16 hours of contact lens wear over the 1 month study (0 to 100 scale with 100 being best).
Outcome measures
| Measure |
Total30 Sphere Contact Lenses
n=48 Participants
All qualified participants will be refit into Total30 Sphere contact lenses.
Total30 Sphere Contact Lenses: Participants will be refit into Total30 Sphere contact lenses and followed for 1 month.
|
|---|---|
|
Visual Analog Scale (VAS) Ocular Comfort
Day 1: Comfort at Hour 16
|
36.66 units on a scale
Standard Deviation 19.11
|
|
Visual Analog Scale (VAS) Ocular Comfort
Day 2: Comfort at Hour 16
|
38.06 units on a scale
Standard Deviation 14.71
|
|
Visual Analog Scale (VAS) Ocular Comfort
Day 3: Comfort at hour 16
|
33.68 units on a scale
Standard Deviation 22.49
|
|
Visual Analog Scale (VAS) Ocular Comfort
Day 4: Comfort at hour 16
|
39.36 units on a scale
Standard Deviation 13.95
|
|
Visual Analog Scale (VAS) Ocular Comfort
Day 5: Comfort at hour 16
|
31.26 units on a scale
Standard Deviation 24.73
|
|
Visual Analog Scale (VAS) Ocular Comfort
2 weeks: Comfort at hour 16
|
33.84 units on a scale
Standard Deviation 23.15
|
|
Visual Analog Scale (VAS) Ocular Comfort
1 month: Comfort at hour 16
|
33.21 units on a scale
Standard Deviation 22.39
|
Adverse Events
Total30 Sphere Contact Lenses
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
Andrew D. Pucker, OD, PhD
University of Alabama at Birmingham
Phone: 1-920-579-2900
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place