Trial Outcomes & Findings for Multifocal Lens Design Evaluation (NCT NCT01997216)
NCT ID: NCT01997216
Last Updated: 2014-02-04
Results Overview
The participant read a Snellen chart at 40 centimeters with both eyes together while wearing study lenses. The Snellen acuity was converted into logMAR units (logarithm of the minimum angle of resolution). A 20/20 Snellen acuity equates to a logMAR acuity of 0.0 and is considered normal near eyesight. A negative logMAR value denotes better visual acuity.
COMPLETED
NA
42 participants
Up to Hour 9
2014-02-04
Participant Flow
Participants were recruited from 1 study center located in the United States.
Of the 42 participants enrolled, 1 participant was exited as a screen failure and 1 participant was discontinued due to product unavailability prior to study product exposure. This reporting group includes all enrolled participants exposed to study product (40).
Participant milestones
| Measure |
Delefilcon A MF, Then AOAMF
Delefilcon A multifocal contact lenses, followed by lotrafilcon B multifocal contact lenses, as randomized. Each product was worn bilaterally (in both eyes) for 9 hours. The wear periods were separated by 2 ± 1 days.
|
AOAMF, Then Delefilcon A MF
Lotrafilcon B multifocal contact lenses, followed by delefilcon A multifocal contact lenses, as randomized. Each product was worn bilaterally (in both eyes) for 9 hours. The wear periods were separated by 2 ± 1 days.
|
|---|---|---|
|
First 9 Hours
STARTED
|
18
|
21
|
|
First 9 Hours
COMPLETED
|
18
|
21
|
|
First 9 Hours
NOT COMPLETED
|
0
|
0
|
|
Second 9 Hours
STARTED
|
19
|
21
|
|
Second 9 Hours
COMPLETED
|
19
|
21
|
|
Second 9 Hours
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Multifocal Lens Design Evaluation
Baseline characteristics by cohort
| Measure |
Overall
n=40 Participants
Delefilcon A multifocal contact lenses and lotrafilcon B multifocal contact lenses, worn as randomized for 9 hours each.
|
|---|---|
|
Age, Continuous
|
52.1 years
STANDARD_DEVIATION 6.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to Hour 9Population: All enrolled participants exposed to study product. 1 participant was not exposed to Delefilcon A MF due to product unavailability.
The participant read a Snellen chart at 40 centimeters with both eyes together while wearing study lenses. The Snellen acuity was converted into logMAR units (logarithm of the minimum angle of resolution). A 20/20 Snellen acuity equates to a logMAR acuity of 0.0 and is considered normal near eyesight. A negative logMAR value denotes better visual acuity.
Outcome measures
| Measure |
Delefilcon A MF
n=39 Participants
Delefilcon A multifocal contact lenses worn bilaterally (in both eyes) for 9 hours
|
AOAMF
n=40 Participants
Lotrafilcon B multifocal contact lenses worn bilaterally (in both eyes) for 9 hours
|
|---|---|---|
|
Mean Binocular HC/HI Visual Acuity at Near (40 cm)
Dispense (Hour 0)
|
0.08 logMAR
Standard Deviation 0.10
|
0.06 logMAR
Standard Deviation 0.09
|
|
Mean Binocular HC/HI Visual Acuity at Near (40 cm)
Hour 9
|
0.05 logMAR
Standard Deviation 0.08
|
0.05 logMAR
Standard Deviation 0.10
|
SECONDARY outcome
Timeframe: Up to Hour 9Population: All enrolled participants exposed to study product. 1 participant was not exposed to Delefilcon A MF due to product unavailability.
The participant read a Snellen chart at a 20-foot equivalent distance with both eyes together while wearing study lenses. The Snellen acuity was converted into logMAR units (logarithm of the minimum angle of resolution). A 20/20 Snellen acuity equates to a logMAR acuity of 0.0 and is considered normal distance eyesight. A negative logMAR value denotes better visual acuity.
Outcome measures
| Measure |
Delefilcon A MF
n=39 Participants
Delefilcon A multifocal contact lenses worn bilaterally (in both eyes) for 9 hours
|
AOAMF
n=40 Participants
Lotrafilcon B multifocal contact lenses worn bilaterally (in both eyes) for 9 hours
|
|---|---|---|
|
Mean Binocular HC/HI Visual Acuity at Distance
Dispense (Hour 0)
|
-0.06 logMAR
Standard Deviation 0.04
|
-0.06 logMAR
Standard Deviation 0.04
|
|
Mean Binocular HC/HI Visual Acuity at Distance
Hour 9
|
-0.05 logMAR
Standard Deviation 0.08
|
-0.05 logMAR
Standard Deviation 0.05
|
SECONDARY outcome
Timeframe: Up to Hour 9Population: All enrolled participants exposed to study product. OR data is included for the 1 participant not exposed to Delefilcon A MF due to product unavailability.
OR is the amount of additional correction needed to improve visual acuity (VA). The OR at dispense was conducted with non-study product to determine lens power for the 9-hour wear. Dispensing of the study product (Pair 1 and Pair 2) was dependent upon lens power as determined by OR and resultant product availability. The OR at 9 hours was conducted with study product. All OR data is reported regardless whether study product was dispensed. Each eye contributed to the mean.
Outcome measures
| Measure |
Delefilcon A MF
n=40 Participants
Delefilcon A multifocal contact lenses worn bilaterally (in both eyes) for 9 hours
|
AOAMF
n=40 Participants
Lotrafilcon B multifocal contact lenses worn bilaterally (in both eyes) for 9 hours
|
|---|---|---|
|
Mean Monocular Over-refraction (OR) at Distance
Dispense (Hour 0)
|
0.08 diopter
Standard Deviation 0.14
|
0.06 diopter
Standard Deviation 0.13
|
|
Mean Monocular Over-refraction (OR) at Distance
Hour 9
|
0.06 diopter
Standard Deviation 0.13
|
0.03 diopter
Standard Deviation 0.12
|
Adverse Events
Delefilcon A MF
AOAMF
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Joachim Nick, Dipl.-Ing. (FH), Clinical Lead
Alcon Research, Ltd.
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place