Trial Outcomes & Findings for Clinical Performance of a Silicone Hydrogel Contact Lens Following One Night of Extended Wear (NCT NCT03560141)
NCT ID: NCT03560141
Last Updated: 2021-07-28
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 a lower logMAR value indicating better visual acuity. No formal hypothesis testing was planned.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
12 participants
Primary outcome timeframe
Day 1 Dispense; Day 1 Follow-up Prior to Sleeping; Day 2 Follow-up Upon Eye Opening; Day 2 Follow-up Approximately 1 Hour after Awakening/Exit
Results posted on
2021-07-28
Participant Flow
Subjects were recruited from 1 investigative site located in the United States.
Of the 12 subjects enrolled, 1 was exited from the study prior to randomization as a screen failure. This reporting group includes all randomized subjects (11).
Unit of analysis: eyes
Participant milestones
| Measure |
LID011121 (OD) / Biofinity (OS)
LID011121 contact lens worn in the right eye, with comfilcon A contact lens worn in the left eye, as randomized, for one night of extended (overnight) wear
|
Biofinity (OD) / LID011121 (OS)
Comfilcon A contact lens worn in the right eye, with LID011121 contact lens worn in the left eye, as randomized, for one night of extended (overnight) wear
|
|---|---|---|
|
Overall Study
STARTED
|
6 12
|
5 10
|
|
Overall Study
COMPLETED
|
6 12
|
5 10
|
|
Overall Study
NOT COMPLETED
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Clinical Performance of a Silicone Hydrogel Contact Lens Following One Night of Extended Wear
Baseline characteristics by cohort
| Measure |
LID011121 (OD) / Biofinity (OS)
n=6 Participants
LID011121 contact lens in the right eye, with comfilcon A contact lens in the left eye, as randomized, for one night of extended (overnight) wear
|
Biofinity (OD) / LID011121 (OS)
n=5 Participants
Comfilcon A contact lens in the right eye, with LID011121 contact lens in the left eye, as randomized, for one night of extended (overnight) wear
|
Total
n=11 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
33.2 years
STANDARD_DEVIATION 11.0 • n=5 Participants
|
23.4 years
STANDARD_DEVIATION 4.6 • n=7 Participants
|
28.7 years
STANDARD_DEVIATION 9.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 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
|
1 Participants
n=5 Participants
|
0 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
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
5 participants
n=7 Participants
|
11 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1 Dispense; Day 1 Follow-up Prior to Sleeping; Day 2 Follow-up Upon Eye Opening; Day 2 Follow-up Approximately 1 Hour after Awakening/ExitPopulation: Safety Analysis Set
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 a lower logMAR value indicating better visual acuity. No formal hypothesis testing was planned.
Outcome measures
| Measure |
LID011121
n=11 Participants
LID011121 contact lens worn in the right eye or left eye, as randomized, for one night of extended (overnight) wear
|
Biofinity
n=11 eyes
Comfilcon A contact lens worn in the right eye or left eye, as randomized, for one night of extended (overnight) wear
|
|---|---|---|
|
Visual Acuity (VA) With Study Lenses, Collected by Eye
Day 1 Dispense
|
-0.10 logMAR
Standard Deviation 0.05
|
-0.11 logMAR
Standard Deviation 0.04
|
|
Visual Acuity (VA) With Study Lenses, Collected by Eye
Day 1 Follow-up Prior to Sleeping
|
-0.09 logMAR
Standard Deviation 0.06
|
-0.12 logMAR
Standard Deviation 0.00
|
|
Visual Acuity (VA) With Study Lenses, Collected by Eye
Day 2 Follow-up Upon Eye Opening
|
0.02 logMAR
Standard Deviation 0.11
|
-0.01 logMAR
Standard Deviation 0.11
|
|
Visual Acuity (VA) With Study Lenses, Collected by Eye
Day 2 Follow-up Approximately 1 Hour after Awakening/Exit
|
-0.10 logMAR
Standard Deviation 0.05
|
-0.11 logMAR
Standard Deviation 0.04
|
Adverse Events
Pretreatment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
LID011121 - Ocular
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Biofinity - Ocular
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Nonocular/Systemic
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Pretreatment
n=11 participants at risk
Events reported in this group occurred prior to exposure to the study contact lenses
|
LID011121 - Ocular
n=11 participants at risk
Events reported in this group occurred while exposed to LID011121 contact lenses
|
Biofinity - Ocular
n=11 participants at risk
Events reported in this group occurred while exposed to comfilcon A contact lenses
|
Nonocular/Systemic
n=11 participants at risk
Events reported in this group occurred during exposure to the study contact lenses
|
|---|---|---|---|---|
|
Eye disorders
Punctate keratitis
|
0.00%
0/11 • Adverse events (AE's) were collected from time of consent to study exit, approximately 2 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 participants. The safety analysis set includes all eyes exposed to a study lens evaluated in this study.
|
0.00%
0/11 • Adverse events (AE's) were collected from time of consent to study exit, approximately 2 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 participants. The safety analysis set includes all eyes exposed to a study lens evaluated in this study.
|
18.2%
2/11 • Adverse events (AE's) were collected from time of consent to study exit, approximately 2 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 participants. The safety analysis set includes all eyes exposed to a study lens evaluated in this study.
|
0.00%
0/11 • Adverse events (AE's) were collected from time of consent to study exit, approximately 2 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 participants. The safety analysis set includes all eyes exposed to a study lens evaluated in this study.
|
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