Trial Outcomes & Findings for Clinical Characterization of an Investigational Frequent Replacement Daily Wear Silicone Hydrogel Sphere Contact Lens (NCT NCT04702984)
NCT ID: NCT04702984
Last Updated: 2022-03-16
Results Overview
Front surface wettability (i.e., assessment of the disruption of the front surface wettability of the contact lens) was assessed by the investigator for each eye individually. Front surface wettability was collected on a 5-point scale, where where Grade 0 = a smooth uniformly reflecting surface, Grade 1 = a coarse hazy surface which seems resolved momentarily with each blink and becomes exacerbated with staring, Grade 2 = one stable dry (non-wetting) area of some magnitude, Grade 3 = more than one stable dry (non-wetting) area of some magnitude, and Grade 4 = non-wettable lens surface. No formal hypothesis was predefined for the primary endpoint. No inferential testing was performed.
COMPLETED
NA
39 participants
Dispense; Week 1 Follow-up
2022-03-16
Participant Flow
Subjects were recruited at 3 investigative sites located in the United States.
This reporting group includes all subjects/eyes exposed to any study lenses evaluated in this study, except for the lenses used with the purpose of power optimization (Safety Analysis Set).
Unit of analysis: eyes
Participant milestones
| Measure |
LID021201
LID021201 contact lenses worn in both eyes for 7 days. Lenses were removed nightly for cleaning and disinfection with OPTI-FREE multipurpose solution.
|
|---|---|
|
Overall Study
STARTED
|
39 78
|
|
Overall Study
COMPLETED
|
38 76
|
|
Overall Study
NOT COMPLETED
|
1 2
|
Reasons for withdrawal
| Measure |
LID021201
LID021201 contact lenses worn in both eyes for 7 days. Lenses were removed nightly for cleaning and disinfection with OPTI-FREE multipurpose solution.
|
|---|---|
|
Overall Study
Adverse Event Unrelated to the Study Device
|
1
|
Baseline Characteristics
Clinical Characterization of an Investigational Frequent Replacement Daily Wear Silicone Hydrogel Sphere Contact Lens
Baseline characteristics by cohort
| Measure |
LID021201
n=39 Participants
LID021201 contact lenses worn in both eyes for 7 days. Lenses were removed nightly for cleaning and disinfection with OPTI-FREE multipurpose solution.
|
|---|---|
|
Age, Continuous
|
35.1 years
STANDARD_DEVIATION 7.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
36 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
|
3 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
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
35 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
39 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Dispense; Week 1 Follow-upPopulation: Safety Analysis Set
Front surface wettability (i.e., assessment of the disruption of the front surface wettability of the contact lens) was assessed by the investigator for each eye individually. Front surface wettability was collected on a 5-point scale, where where Grade 0 = a smooth uniformly reflecting surface, Grade 1 = a coarse hazy surface which seems resolved momentarily with each blink and becomes exacerbated with staring, Grade 2 = one stable dry (non-wetting) area of some magnitude, Grade 3 = more than one stable dry (non-wetting) area of some magnitude, and Grade 4 = non-wettable lens surface. No formal hypothesis was predefined for the primary endpoint. No inferential testing was performed.
Outcome measures
| Measure |
LID021201
n=78 eyes
LID021201 contact lenses worn in both eyes for 7 days. Lenses were removed nightly for cleaning and disinfection with OPTI-FREE multipurpose solution.
|
|---|---|
|
Front Surface Wettability, by Category
Dispense, Grade 0
|
78 eyes
|
|
Front Surface Wettability, by Category
Dispense, Grade 1
|
0 eyes
|
|
Front Surface Wettability, by Category
Dispense, Grade 2
|
0 eyes
|
|
Front Surface Wettability, by Category
Dispense, Grade 3
|
0 eyes
|
|
Front Surface Wettability, by Category
Dispense, Grade 4
|
0 eyes
|
|
Front Surface Wettability, by Category
Week 1 Follow-up, Grade 0
|
56 eyes
|
|
Front Surface Wettability, by Category
Week 1 Follow-up, Grade 1
|
19 eyes
|
|
Front Surface Wettability, by Category
Week 1 Follow-up, Grade 2
|
1 eyes
|
|
Front Surface Wettability, by Category
Week 1 Follow-up, Grade 3
|
0 eyes
|
|
Front Surface Wettability, by Category
Week 1 Follow-up, Grade 4
|
0 eyes
|
Adverse Events
Pretreatment
LID021201 Ocular
LID021201 Nonocular
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