Trial Outcomes & Findings for Clinical Comparison of Two Daily Wear Frequent Replacement Silicone Hydrogel Soft Contact Lenses (NCT NCT04532099)
NCT ID: NCT04532099
Last Updated: 2022-05-03
Results Overview
Distance VA was assessed with study lenses in place. VA was 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. No formal hypothesis testing was predefined for the primary endpoint. The primary endpoint was prespecified for Part A only.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
132 participants
Primary outcome timeframe
Day 30, each study lens type
Results posted on
2022-05-03
Participant Flow
Subjects were recruited from 4 investigative sites located in the United States.
Participant milestones
| Measure |
LID018869, Then AOHP (Part A)
Lehfilcon A contact lenses worn first, followed by senofilcon A contact lenses, as randomized. Each product was worn bilaterally (in both eyes) for approximately 30 days, with a scheduled visit at approximately Day 15 of each wear period. Lenses were removed nightly for cleaning and disinfection with CLEAR CARE contact lens solution.
|
AOHP, Then LID018869 (Part A)
Senofilcon A contact lenses worn first, followed by lehfilcon A contact lenses, as randomized. Each product was worn bilaterally (in both eyes) for approximately 30 days, with a scheduled visit at approximately Day 15 of each wear period. Lenses were removed nightly for cleaning and disinfection with CLEAR CARE contact lens solution.
|
Biofinity (Part B)
Comfilcon A contact lenses worn bilaterally (in both eyes) for approximately 30 days, with a scheduled visit at approximately Day 15 of the wear period. Lenses were removed nightly for cleaning and disinfection with CLEAR CARE contact lens solution.
|
|---|---|---|---|
|
First Wear Period (30 Days)
STARTED
|
33
|
33
|
66
|
|
First Wear Period (30 Days)
COMPLETED
|
32
|
33
|
66
|
|
First Wear Period (30 Days)
NOT COMPLETED
|
1
|
0
|
0
|
|
Second Wear Period (30 Days)
STARTED
|
32
|
33
|
0
|
|
Second Wear Period (30 Days)
COMPLETED
|
32
|
33
|
0
|
|
Second Wear Period (30 Days)
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
LID018869, Then AOHP (Part A)
Lehfilcon A contact lenses worn first, followed by senofilcon A contact lenses, as randomized. Each product was worn bilaterally (in both eyes) for approximately 30 days, with a scheduled visit at approximately Day 15 of each wear period. Lenses were removed nightly for cleaning and disinfection with CLEAR CARE contact lens solution.
|
AOHP, Then LID018869 (Part A)
Senofilcon A contact lenses worn first, followed by lehfilcon A contact lenses, as randomized. Each product was worn bilaterally (in both eyes) for approximately 30 days, with a scheduled visit at approximately Day 15 of each wear period. Lenses were removed nightly for cleaning and disinfection with CLEAR CARE contact lens solution.
|
Biofinity (Part B)
Comfilcon A contact lenses worn bilaterally (in both eyes) for approximately 30 days, with a scheduled visit at approximately Day 15 of the wear period. Lenses were removed nightly for cleaning and disinfection with CLEAR CARE contact lens solution.
|
|---|---|---|---|
|
First Wear Period (30 Days)
Withdrawal by Subject
|
1
|
0
|
0
|
Baseline Characteristics
Clinical Comparison of Two Daily Wear Frequent Replacement Silicone Hydrogel Soft Contact Lenses
Baseline characteristics by cohort
| Measure |
LID018869, Then AOHP (Part A)
n=33 Participants
Lehfilcon A contact lenses worn first, followed by senofilcon A contact lenses, as randomized. Each product was worn bilaterally (in both eyes) for approximately 30 days, with a scheduled visit at approximately Day 15 of each wear period. Lenses were removed nightly for cleaning and disinfection with CLEAR CARE contact lens solution.
|
AOHP, Then LID018869 (Part A)
n=33 Participants
Senofilcon A contact lenses worn first, followed by lehfilcon A contact lenses, as randomized. Each product was worn bilaterally (in both eyes) for approximately 30 days, with a scheduled visit at approximately Day 15 of each wear period. Lenses were removed nightly for cleaning and disinfection with CLEAR CARE contact lens solution.
|
Biofinity (Part B)
n=66 Participants
Comfilcon A contact lenses worn bilaterally (in both eyes) for approximately 30 days, with a scheduled visit at approximately Day 15 of the wear period. Lenses were removed nightly for cleaning and disinfection with CLEAR CARE contact lens solution.
|
Total
n=132 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
18-64 years
|
33 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
132 Participants
n=4 Participants
|
|
Age, Customized
Equal to or greater than 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
95 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
37 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
32 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
125 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
31 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
125 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Day 30, each study lens typePopulation: Safety Analysis Set
Distance VA was assessed with study lenses in place. VA was 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. No formal hypothesis testing was predefined for the primary endpoint. The primary endpoint was prespecified for Part A only.
Outcome measures
| Measure |
LID018869 (Part A)
n=132 eyes
Lehfilcon A contact lenses worn during Period 1 or Period 2, as randomized, for approximately 30 days. Lenses were removed nightly for cleaning and disinfection with CLEAR CARE contact lens solution.
|
AOHP (Part A)
n=130 eyes
Senofilcon A contact lenses worn during Period 1 or Period 2, as randomized, for approximately 30 days. Lenses were removed nightly for cleaning and disinfection with CLEAR CARE contact lens solution.
|
|---|---|---|
|
Distance Visual Acuity (VA) (Part A)
|
-0.12 logMAR
Standard Deviation 0.09
|
-0.12 logMAR
Standard Deviation 0.09
|
Adverse Events
Pretreatment Part A
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
LID018869 Ocular (Part A)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
LID018869 Nonocular
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
AOHP Ocular
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
AOHP Nonocular
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Pretreatment Part B
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Biofinity Ocular
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Biofinity 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