Trial Outcomes & Findings for Clinical Comparison of DDT2 Contact Lens and a Daily Disposable Contact Lens - Study 2 (NCT NCT03888482)
NCT ID: NCT03888482
Last Updated: 2020-07-13
Results Overview
Visual acuity was assessed and collected for each eye separately using logarithmic of the Minimum Angle of Resolution (logMAR) charts. A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity (normal visual acuity), with a negative value denoting better than 20/20 visual acuity.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
154 participants
Primary outcome timeframe
Day 8, each product
Results posted on
2020-07-13
Participant Flow
This study was performed at 8 study centers in the United States (US).
Of the 154 enrolled, 2 were exited from the study as screen failures and 1 subject was randomized but not exposed. This reporting group includes all exposed subjects (151).
Participant milestones
| Measure |
DDT2, Then Clariti
Verofilcon A contact lenses worn first, with somofilcon A contact lenses worn second, as randomized. Each product was worn bilaterally (in both eyes) for 8 -1/+2 days in a daily disposable modality.
|
Clariti, Then DDT2
Somofilcon A contact lenses worn first, with verofilcon A contact lenses worn second, as randomized. Each product was worn bilaterally (in both eyes) for 8 -1/+2 days in a daily disposable modality.
|
|---|---|---|
|
First Wear Period (8 -1/+2 Days)
STARTED
|
76
|
75
|
|
First Wear Period (8 -1/+2 Days)
COMPLETED
|
76
|
75
|
|
First Wear Period (8 -1/+2 Days)
NOT COMPLETED
|
0
|
0
|
|
Second Wear (8 -1/+2 Days)
STARTED
|
74
|
75
|
|
Second Wear (8 -1/+2 Days)
COMPLETED
|
73
|
74
|
|
Second Wear (8 -1/+2 Days)
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
DDT2, Then Clariti
Verofilcon A contact lenses worn first, with somofilcon A contact lenses worn second, as randomized. Each product was worn bilaterally (in both eyes) for 8 -1/+2 days in a daily disposable modality.
|
Clariti, Then DDT2
Somofilcon A contact lenses worn first, with verofilcon A contact lenses worn second, as randomized. Each product was worn bilaterally (in both eyes) for 8 -1/+2 days in a daily disposable modality.
|
|---|---|---|
|
Second Wear (8 -1/+2 Days)
Adverse Event
|
0
|
1
|
|
Second Wear (8 -1/+2 Days)
Other
|
1
|
0
|
Baseline Characteristics
Clinical Comparison of DDT2 Contact Lens and a Daily Disposable Contact Lens - Study 2
Baseline characteristics by cohort
| Measure |
DDT2, Then Clariti
n=76 Participants
Verofilcon A contact lenses worn first, with somofilcon A contact lenses worn second, as randomized. Each product was worn bilaterally (in both eyes) for 8 -1/+2 days in a daily disposable modality.
Verofilcon A contact lenses: Investigational daily disposable soft contact lenses
Somofilcon A contact lenses: Commercially available daily disposable soft contact lenses
|
Clariti, Then DDT2
n=75 Participants
Somofilcon A contact lenses worn first, with verofilcon A contact lenses worn second, as randomized. Each product was worn bilaterally (in both eyes) for 8 -1/+2 days in a daily disposable modality.
Verofilcon A contact lenses: Investigational daily disposable soft contact lenses
Somofilcon A contact lenses: Commercially available daily disposable soft contact lenses
|
Total
n=151 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
35.1 years
STANDARD_DEVIATION 7.9 • n=5 Participants
|
31.8 years
STANDARD_DEVIATION 7.9 • n=7 Participants
|
33.5 years
STANDARD_DEVIATION 8.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
56 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
103 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
73 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
142 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
65 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
132 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Multi-racial
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
76 participants
n=5 Participants
|
75 participants
n=7 Participants
|
151 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 8, each productPopulation: Full analysis set (FAS): All randomized subjects/eyes with non-missing responses, who were exposed to any study lenses evaluated in this study, with the exception of the lenses used at Visit 1 for optimization and fitting.
Visual acuity was assessed and collected for each eye separately using logarithmic of the Minimum Angle of Resolution (logMAR) charts. A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity (normal visual acuity), with a negative value denoting better than 20/20 visual acuity.
Outcome measures
| Measure |
DDT2
n=294 eyes
Verofilcon A contact lenses worn bilaterally (in both eyes) during Period 1 or Period 2, as randomized, for 8 -1/+2 days in a daily disposable modality.
|
Clariti
n=296 eyes
Somofilcon A contact lenses worn bilaterally (in both eyes) during Period 1 or Period 2, as randomized, for 8 -1/+2 days in a daily disposable modality.
|
|---|---|---|
|
Least Squares Mean Distance Visual Acuity With Study Lenses
|
-0.08 logMAR
Standard Error 0.006
|
-0.08 logMAR
Standard Error 0.006
|
Adverse Events
DDT2 - Ocular
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
DDT2 - Systemic / Nonocular
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Clariti - Ocular
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Clariti - Systemic / Nonocular
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 Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
- Publication restrictions are in place
Restriction type: OTHER