Trial Outcomes & Findings for Clinical Assessment of Two Daily Wear Monthly Replacement Soft Silicone Hydrogel Contact Lenses (NCT NCT04980456)
NCT ID: NCT04980456
Last Updated: 2023-01-06
Results Overview
Distance visual acuity (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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
257 participants
Primary outcome timeframe
Day 30, each study product
Results posted on
2023-01-06
Participant Flow
This study was conducted at 14 investigative sites located in the United States.
Of the 257 enrolled, 8 subjects were exited prior to randomization as screen failures. This reporting group includes all subjects exposed to the study lenses, as treated (249). Note: One subject randomized to TOTAL30, then Biofinity was exposed to the incorrect study lenses in the sequence (Biofinity, then TOTAL30).
Unit of analysis: eyes
Participant milestones
| Measure |
TOTAL30, Then Biofinity
Lehfilcon A contact lenses worn first, followed by comfilcon A contact lenses as randomized. Each study product was worn bilaterally (in both eyes) for approximately 30 days for at least 10 hours per day during waking hours only. CLEAR CARE was used for daily cleaning and disinfection.
|
Biofinity, Then TOTAL30
Comfilcon A contact lenses worn first, followed by lehfilcon A contact lenses, as randomized. Each study product was worn bilaterally (in both eyes) for approximately 30 days for at least 10 hours per day during waking hours only. CLEAR CARE was used for daily cleaning and disinfection.
|
|---|---|---|
|
Period 1 (Approximately 30 Days)
STARTED
|
122 244
|
127 254
|
|
Period 1 (Approximately 30 Days)
COMPLETED
|
119 238
|
124 248
|
|
Period 1 (Approximately 30 Days)
NOT COMPLETED
|
3 6
|
3 6
|
|
Period 2 (Approximately 30 Days)
STARTED
|
119 238
|
123 246
|
|
Period 2 (Approximately 30 Days)
COMPLETED
|
119 238
|
122 244
|
|
Period 2 (Approximately 30 Days)
NOT COMPLETED
|
0 0
|
1 2
|
Reasons for withdrawal
| Measure |
TOTAL30, Then Biofinity
Lehfilcon A contact lenses worn first, followed by comfilcon A contact lenses as randomized. Each study product was worn bilaterally (in both eyes) for approximately 30 days for at least 10 hours per day during waking hours only. CLEAR CARE was used for daily cleaning and disinfection.
|
Biofinity, Then TOTAL30
Comfilcon A contact lenses worn first, followed by lehfilcon A contact lenses, as randomized. Each study product was worn bilaterally (in both eyes) for approximately 30 days for at least 10 hours per day during waking hours only. CLEAR CARE was used for daily cleaning and disinfection.
|
|---|---|---|
|
Period 1 (Approximately 30 Days)
Adverse Event
|
2
|
0
|
|
Period 1 (Approximately 30 Days)
Lost to Follow-up
|
0
|
1
|
|
Period 1 (Approximately 30 Days)
Withdrawal by Subject
|
1
|
2
|
|
Period 2 (Approximately 30 Days)
Adverse Event
|
0
|
1
|
Baseline Characteristics
Clinical Assessment of Two Daily Wear Monthly Replacement Soft Silicone Hydrogel Contact Lenses
Baseline characteristics by cohort
| Measure |
TOTAL30, Then Biofinity
n=123 Participants
Lehfilcon A contact lenses worn first, followed by comfilcon A contact lenses, as randomized. Comfilcon A contact lenses worn first, followed by lehfilcon A contact lenses, as randomized. Each study product was worn bilaterally (in both eyes) for approximately 30 days for at least 10 hours per day during waking hours only. CLEAR CARE was used for daily cleaning and disinfection.
|
Biofinity, Then TOTAL30
n=126 Participants
Comfilcon A contact lenses worn first, followed by lehfilcon A contact lenses, as randomized. Comfilcon A contact lenses worn first, followed by lehfilcon A contact lenses, as randomized. Each study product was worn bilaterally (in both eyes) for approximately 30 days for at least 10 hours per day during waking hours only. CLEAR CARE was used for daily cleaning and disinfection.
|
Total
n=249 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
32.1 years
STANDARD_DEVIATION 7.7 • n=5 Participants
|
33.1 years
STANDARD_DEVIATION 8.7 • n=7 Participants
|
32.6 years
STANDARD_DEVIATION 8.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
91 Participants
n=5 Participants
|
87 Participants
n=7 Participants
|
178 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
114 Participants
n=5 Participants
|
118 Participants
n=7 Participants
|
232 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
|
80 Participants
n=5 Participants
|
79 Participants
n=7 Participants
|
159 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 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
|
37 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Multi-racial
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
123 participants
n=5 Participants
|
126 participants
n=7 Participants
|
249 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 30, each study productPopulation: All subjects exposed to any study lenses evaluated in this study, as randomized, with non-missing response (eye)
Distance visual acuity (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.
Outcome measures
| Measure |
TOTAL30
n=480 eyes
Lehfilcon A contact lenses worn bilaterally (in both eyes) during Period 1 or Period 2, as randomized, for approximately 30 days at least 10 hours per day during waking hours only. CLEAR CARE was used for daily cleaning and disinfection.
|
Biofinity
n=486 eyes
Comfilcon A contact lenses worn bilaterally (in both eyes) during Period 1 or Period 2, as randomized, for approximately 30 days at least 10 hours per day during waking hours only. CLEAR CARE was used for daily cleaning and disinfection.
|
|---|---|---|
|
Least Squares Mean Distance VA (logMAR) With Study Lenses
|
-0.07 logMAR
Standard Error 0.005
|
-0.08 logMAR
Standard Error 0.005
|
Adverse Events
Pretreatment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
TOTAL30 Ocular
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
TOTAL30 Nonocular
Serious events: 2 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
| Measure |
Pretreatment
n=249 participants at risk
Events reported in this group occurred prior to exposure to the study contact lenses
|
TOTAL30 Ocular
n=490 participants at risk
Events reported in this group occurred while exposed to the lehfilcon A contact lenses
|
TOTAL30 Nonocular
n=245 participants at risk
Events reported in this group occurred while exposed to the lehfilcon A contact lenses
|
Biofinity Ocular
n=492 participants at risk
Events reported in this group occurred while exposed to the comfilcon A contact lenses
|
Biofinity Nonocular
n=246 participants at risk
Events reported in this group occurred while exposed to the comfilcon A contact lenses
|
|---|---|---|---|---|---|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/249 • Adverse events (AE's) were collected from time of consent to study exit, approximately 65 days.
AE's were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is reported in units of eyes; all other populations are reported in units of subjects. This analysis population includes all subjects/eyes exposed to any study lenses evaluated in this study
|
0.00%
0/490 • Adverse events (AE's) were collected from time of consent to study exit, approximately 65 days.
AE's were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is reported in units of eyes; all other populations are reported in units of subjects. This analysis population includes all subjects/eyes exposed to any study lenses evaluated in this study
|
0.41%
1/245 • Adverse events (AE's) were collected from time of consent to study exit, approximately 65 days.
AE's were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is reported in units of eyes; all other populations are reported in units of subjects. This analysis population includes all subjects/eyes exposed to any study lenses evaluated in this study
|
0.00%
0/492 • Adverse events (AE's) were collected from time of consent to study exit, approximately 65 days.
AE's were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is reported in units of eyes; all other populations are reported in units of subjects. This analysis population includes all subjects/eyes exposed to any study lenses evaluated in this study
|
0.00%
0/246 • Adverse events (AE's) were collected from time of consent to study exit, approximately 65 days.
AE's were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is reported in units of eyes; all other populations are reported in units of subjects. This analysis population includes all subjects/eyes exposed to any study lenses evaluated in this study
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/249 • Adverse events (AE's) were collected from time of consent to study exit, approximately 65 days.
AE's were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is reported in units of eyes; all other populations are reported in units of subjects. This analysis population includes all subjects/eyes exposed to any study lenses evaluated in this study
|
0.00%
0/490 • Adverse events (AE's) were collected from time of consent to study exit, approximately 65 days.
AE's were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is reported in units of eyes; all other populations are reported in units of subjects. This analysis population includes all subjects/eyes exposed to any study lenses evaluated in this study
|
0.41%
1/245 • Adverse events (AE's) were collected from time of consent to study exit, approximately 65 days.
AE's were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is reported in units of eyes; all other populations are reported in units of subjects. This analysis population includes all subjects/eyes exposed to any study lenses evaluated in this study
|
0.00%
0/492 • Adverse events (AE's) were collected from time of consent to study exit, approximately 65 days.
AE's were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is reported in units of eyes; all other populations are reported in units of subjects. This analysis population includes all subjects/eyes exposed to any study lenses evaluated in this study
|
0.00%
0/246 • Adverse events (AE's) were collected from time of consent to study exit, approximately 65 days.
AE's were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is reported in units of eyes; all other populations are reported in units of subjects. This analysis population includes all subjects/eyes exposed to any study lenses evaluated in this study
|
|
Vascular disorders
Hypotension
|
0.00%
0/249 • Adverse events (AE's) were collected from time of consent to study exit, approximately 65 days.
AE's were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is reported in units of eyes; all other populations are reported in units of subjects. This analysis population includes all subjects/eyes exposed to any study lenses evaluated in this study
|
0.00%
0/490 • Adverse events (AE's) were collected from time of consent to study exit, approximately 65 days.
AE's were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is reported in units of eyes; all other populations are reported in units of subjects. This analysis population includes all subjects/eyes exposed to any study lenses evaluated in this study
|
0.41%
1/245 • Adverse events (AE's) were collected from time of consent to study exit, approximately 65 days.
AE's were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is reported in units of eyes; all other populations are reported in units of subjects. This analysis population includes all subjects/eyes exposed to any study lenses evaluated in this study
|
0.00%
0/492 • Adverse events (AE's) were collected from time of consent to study exit, approximately 65 days.
AE's were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is reported in units of eyes; all other populations are reported in units of subjects. This analysis population includes all subjects/eyes exposed to any study lenses evaluated in this study
|
0.00%
0/246 • Adverse events (AE's) were collected from time of consent to study exit, approximately 65 days.
AE's were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is reported in units of eyes; all other populations are reported in units of subjects. This analysis population includes all subjects/eyes exposed to any study lenses evaluated in this study
|
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