Trial Outcomes & Findings for Clinical Evaluation of a Daily Wear Frequent Replacement Silicone Hydrogel Lens (NCT NCT03920280)
NCT ID: NCT03920280
Last Updated: 2022-07-28
Results Overview
Visual acuity (VA) was assessed for each eye individually with study lenses in place at a distance of 6 meters using a letter chart. VA was collected in Snellen and converted to logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with lower logMAR values indicating better visual acuity. No formal hypothesis testing was planned.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
120 participants
Primary outcome timeframe
Day 1 Dispense; Week 1 Follow-up; Week 2 Follow-up; Month 1 Follow-up; Month 2 Follow-up; Month 3 Follow-up/Exit (at least 4 hours after lens insertion at each follow-up assessment visit)
Results posted on
2022-07-28
Participant Flow
Subjects were recruited from 8 investigative sites located in the United States.
Of the 120 subjects enrolled, 1 was exited from the study prior to randomization as a screen failure. This reporting group includes all enrolled and dispensed subjects (119).
Unit of analysis: eyes
Participant milestones
| Measure |
Biofinity
Comfilcon A contact lenses worn in both eyes during waking hours only for at least 8 hours per day and 5 days per week over a 3-month exposure period. Lenses were removed nightly for cleaning with CLEAR CARE.
|
LID015385
LID015385 contact lenses worn in both eyes during waking hours only for at least 8 hours per day and 5 days per week over a 3-month exposure period. Lenses were removed nightly for cleaning with CLEAR CARE.
|
|---|---|---|
|
Overall Study
STARTED
|
41 82
|
78 156
|
|
Overall Study
COMPLETED
|
38 76
|
72 144
|
|
Overall Study
NOT COMPLETED
|
3 6
|
6 12
|
Reasons for withdrawal
| Measure |
Biofinity
Comfilcon A contact lenses worn in both eyes during waking hours only for at least 8 hours per day and 5 days per week over a 3-month exposure period. Lenses were removed nightly for cleaning with CLEAR CARE.
|
LID015385
LID015385 contact lenses worn in both eyes during waking hours only for at least 8 hours per day and 5 days per week over a 3-month exposure period. Lenses were removed nightly for cleaning with CLEAR CARE.
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
3
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
|
Overall Study
Corneal cylinder greater than 1.00 diopter
|
0
|
1
|
Baseline Characteristics
Clinical Evaluation of a Daily Wear Frequent Replacement Silicone Hydrogel Lens
Baseline characteristics by cohort
| Measure |
Biofinity
n=41 Participants
Comfilcon A contact lenses worn in both eyes during waking hours only for at least 8 hours per day and 5 days per week over a 3-month exposure period. Lenses were removed nightly for cleaning with CLEAR CARE.
|
LID015385
n=78 Participants
LID015385 contact lenses worn in both eyes during waking hours only for at least 8 hours per day and 5 days per week over a 3-month exposure period. Lenses were removed nightly for cleaning with CLEAR CARE.
|
Total
n=119 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
31.3 years
STANDARD_DEVIATION 7.7 • n=5 Participants
|
32.9 years
STANDARD_DEVIATION 7.7 • n=7 Participants
|
32.4 years
STANDARD_DEVIATION 7.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
91 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
40 Participants
n=5 Participants
|
74 Participants
n=7 Participants
|
114 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 (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
39 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
106 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
41 participants
n=5 Participants
|
78 participants
n=7 Participants
|
119 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1 Dispense; Week 1 Follow-up; Week 2 Follow-up; Month 1 Follow-up; Month 2 Follow-up; Month 3 Follow-up/Exit (at least 4 hours after lens insertion at each follow-up assessment visit)Population: This analysis population includes all enrolled and dispensed subjects/eyes that completed the study.
Visual acuity (VA) was assessed for each eye individually with study lenses in place at a distance of 6 meters using a letter chart. VA was collected in Snellen and converted to logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with lower logMAR values indicating better visual acuity. No formal hypothesis testing was planned.
Outcome measures
| Measure |
Biofinity
n=76 eyes
Comfilcon A contact lenses worn in both eyes during waking hours only for at least 8 hours per day and 5 days per week over a 3-month exposure period. Lenses were removed nightly for cleaning with CLEAR CARE.
|
LID015385
n=144 eyes
LID015385 contact lenses worn in both eyes during waking hours only for at least 8 hours per day and 5 days per week over a 3-month exposure period. Lenses were removed nightly for cleaning with CLEAR CARE.
|
|---|---|---|
|
Distance Visual Acuity (VA) With Study Lenses - Completed Eyes
Day 1 Dispense
|
-0.06 logMAR
Standard Deviation 0.06
|
-0.06 logMAR
Standard Deviation 0.06
|
|
Distance Visual Acuity (VA) With Study Lenses - Completed Eyes
Week 1 Follow-up
|
-0.06 logMAR
Standard Deviation 0.06
|
-0.05 logMAR
Standard Deviation 0.06
|
|
Distance Visual Acuity (VA) With Study Lenses - Completed Eyes
Week 2 Follow-up
|
-0.06 logMAR
Standard Deviation 0.06
|
-0.06 logMAR
Standard Deviation 0.06
|
|
Distance Visual Acuity (VA) With Study Lenses - Completed Eyes
Month 1 Follow-up
|
-0.06 logMAR
Standard Deviation 0.06
|
-0.05 logMAR
Standard Deviation 0.06
|
|
Distance Visual Acuity (VA) With Study Lenses - Completed Eyes
Month 2 Follow-up
|
-0.05 logMAR
Standard Deviation 0.06
|
-0.04 logMAR
Standard Deviation 0.06
|
|
Distance Visual Acuity (VA) With Study Lenses - Completed Eyes
Month 3 Follow-up/Exit
|
-0.05 logMAR
Standard Deviation 0.06
|
-0.05 logMAR
Standard Deviation 0.06
|
PRIMARY outcome
Timeframe: Day 1 Dispense; Week 1 Follow-up; Week 2 Follow-up; Month 1 Follow-up; Month 2 Follow-up (at least 4 hours after lens insertion at each follow-up assessment visit)Population: This analysis population includes all enrolled and dispensed subjects/eyes that discontinued the study early.
Visual acuity (VA) was assessed for each eye individually with study lenses in place at a distance of 6 meters using a letter chart. VA was collected in Snellen and converted to the logarithm minimum angle of resolution (logMAR) scale. A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with lower logMAR values indicating better visual acuity. No formal hypothesis testing was planned.
Outcome measures
| Measure |
Biofinity
n=6 eyes
Comfilcon A contact lenses worn in both eyes during waking hours only for at least 8 hours per day and 5 days per week over a 3-month exposure period. Lenses were removed nightly for cleaning with CLEAR CARE.
|
LID015385
n=12 eyes
LID015385 contact lenses worn in both eyes during waking hours only for at least 8 hours per day and 5 days per week over a 3-month exposure period. Lenses were removed nightly for cleaning with CLEAR CARE.
|
|---|---|---|
|
Distance Visual Acuity (VA) With Study Lenses - Discontinued Eyes
Day 1 Dispense
|
-0.04 logMAR
Standard Deviation 0.06
|
-0.06 logMAR
Standard Deviation 0.07
|
|
Distance Visual Acuity (VA) With Study Lenses - Discontinued Eyes
Week 1 Follow-up
|
-0.02 logMAR
Standard Deviation 0.05
|
-0.06 logMAR
Standard Deviation 0.07
|
|
Distance Visual Acuity (VA) With Study Lenses - Discontinued Eyes
Week 2 Follow-up
|
-0.04 logMAR
Standard Deviation 0.06
|
-0.05 logMAR
Standard Deviation 0.06
|
|
Distance Visual Acuity (VA) With Study Lenses - Discontinued Eyes
Month 1 Follow-up
|
0.00 logMAR
Standard Deviation 0.00
|
-0.12 logMAR
Standard Deviation 0.00
|
|
Distance Visual Acuity (VA) With Study Lenses - Discontinued Eyes
Month 2 Follow-up
|
—
|
-0.12 logMAR
Standard Deviation 0.00
|
Adverse Events
Pretreatment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Biofinity - Ocular
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Biofinity - Nonocular/Systemic
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
LID015385 - Ocular
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
LID015385 - Nonocular/Systemic
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pretreatment
n=119 participants at risk
Events reported in this group occurred prior to exposure to the study contact lenses
|
Biofinity - Ocular
n=82 participants at risk
Events reported in this group occurred while exposed to the comfilcon A contact lenses
|
Biofinity - Nonocular/Systemic
n=41 participants at risk
Events reported in this group occurred while exposed to the comfilcon A contact lenses
|
LID015385 - Ocular
n=156 participants at risk
Events reported in this group occurred while exposed to the LID015385 contact lenses
|
LID015385 - Nonocular/Systemic
n=78 participants at risk
Events reported in this group occurred while exposed to the LID015385 contact lenses
|
|---|---|---|---|---|---|
|
Eye disorders
Ulcerative keratitis
|
0.00%
0/119 • Adverse events (AE's) were collected from time of consent to study exit, approximately 3 months.
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 participants. This analysis population includes all enrolled and dispensed subjects.
|
1.2%
1/82 • Adverse events (AE's) were collected from time of consent to study exit, approximately 3 months.
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 participants. This analysis population includes all enrolled and dispensed subjects.
|
0.00%
0/41 • Adverse events (AE's) were collected from time of consent to study exit, approximately 3 months.
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 participants. This analysis population includes all enrolled and dispensed subjects.
|
0.00%
0/156 • Adverse events (AE's) were collected from time of consent to study exit, approximately 3 months.
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 participants. This analysis population includes all enrolled and dispensed subjects.
|
0.00%
0/78 • Adverse events (AE's) were collected from time of consent to study exit, approximately 3 months.
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 participants. This analysis population includes all enrolled and dispensed subjects.
|
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