Trial Outcomes & Findings for Evaluation of a New Daily Disposable Multifocal Contact Lens Design (NCT NCT01951573)
NCT ID: NCT01951573
Last Updated: 2014-12-02
Results Overview
Near VA was assessed binocularly (both eyes together) at 40 centimeters, with over-refraction (OR), if necessary, and measured in logMAR units (logarithm of the minimum angle of resolution). A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity, with a negative value denoting better than 20/20 visual acuity.
COMPLETED
NA
36 participants
Dispense (Day 1), Hour 9
2014-12-02
Participant Flow
Subjects were recruited from 1 study center located in the US.
Of the 36 enrolled, 2 subjects were exited as screen failures prior to randomization. This reporting group includes all randomized subjects (34).
Participant milestones
| Measure |
Delefilcon A MF, Then AOAMF
Each product worn bilaterally (ie, in both eyes), as randomized, for 9-12 hours, with a 1-8 day washout separating the 2 wear periods.
|
AOAMF, Then Delefilcon A MF
Each product worn bilaterally (ie, in both eyes), as randomized, for 9-12 hours, with a 1-8 day washout separating the 2 wear periods.
|
|---|---|---|
|
Period 1, First 9 Hours of Wear
STARTED
|
17
|
17
|
|
Period 1, First 9 Hours of Wear
COMPLETED
|
17
|
17
|
|
Period 1, First 9 Hours of Wear
NOT COMPLETED
|
0
|
0
|
|
Washout Period
STARTED
|
17
|
17
|
|
Washout Period
COMPLETED
|
17
|
16
|
|
Washout Period
NOT COMPLETED
|
0
|
1
|
|
Period 2, Second 9 Hours of Wear
STARTED
|
17
|
16
|
|
Period 2, Second 9 Hours of Wear
COMPLETED
|
17
|
16
|
|
Period 2, Second 9 Hours of Wear
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Delefilcon A MF, Then AOAMF
Each product worn bilaterally (ie, in both eyes), as randomized, for 9-12 hours, with a 1-8 day washout separating the 2 wear periods.
|
AOAMF, Then Delefilcon A MF
Each product worn bilaterally (ie, in both eyes), as randomized, for 9-12 hours, with a 1-8 day washout separating the 2 wear periods.
|
|---|---|---|
|
Washout Period
Adverse Event
|
0
|
1
|
Baseline Characteristics
Evaluation of a New Daily Disposable Multifocal Contact Lens Design
Baseline characteristics by cohort
| Measure |
Overall
n=34 Participants
Delefilcon A MF and AOAMF contact lenses worn during Period 1 and Period 2 in a crossover assignment.
|
|---|---|
|
Age, Continuous
|
59.9 years
STANDARD_DEVIATION 8.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Dispense (Day 1), Hour 9Population: This analysis population includes all randomized subjects excluding those who met any of the specified deviation criteria.
Near VA was assessed binocularly (both eyes together) at 40 centimeters, with over-refraction (OR), if necessary, and measured in logMAR units (logarithm of the minimum angle of resolution). A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity, with a negative value denoting better than 20/20 visual acuity.
Outcome measures
| Measure |
Delefilcon A MF
n=33 Participants
Contact lenses worn during Period 1 or Period 2 for 9-12 hours
|
AOAMF
n=34 Participants
Contact lenses worn during Period 1 or Period 2 for 9-12 hours
|
|---|---|---|
|
High Contrast/High Illumination (HC/HI) Binocular Visual Acuity (VA) at Near
Dispense
|
0.10 logMAR
Standard Deviation 0.09
|
0.12 logMAR
Standard Deviation 0.06
|
|
High Contrast/High Illumination (HC/HI) Binocular Visual Acuity (VA) at Near
Hour 9
|
0.08 logMAR
Standard Deviation 0.09
|
0.09 logMAR
Standard Deviation 0.07
|
SECONDARY outcome
Timeframe: Dispense (Day 1), Hour 9Population: This analysis population includes all randomized subjects excluding those who met any of the specified deviation criteria.
Distance VA was assessed binocularly (both eyes together) at 6 meters, with over-refraction (OR), if necessary, and measured in logMAR units (logarithm of the minimum angle of resolution). A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity, with a negative value denoting better than 20/20 visual acuity.
Outcome measures
| Measure |
Delefilcon A MF
n=33 Participants
Contact lenses worn during Period 1 or Period 2 for 9-12 hours
|
AOAMF
n=34 Participants
Contact lenses worn during Period 1 or Period 2 for 9-12 hours
|
|---|---|---|
|
HC/HI Binocular VA at Distance
Dispense
|
-0.02 logMAR
Standard Deviation 0.06
|
-0.03 logMAR
Standard Deviation 0.06
|
|
HC/HI Binocular VA at Distance
Hour 9
|
0.00 logMAR
Standard Deviation 0.07
|
-0.01 logMAR
Standard Deviation 0.07
|
SECONDARY outcome
Timeframe: Dispense (Day 1), Hour 9Population: This analysis population includes all randomized subjects excluding those who met any of the specified deviation criteria.
OR (the amount of additional correction needed to improve VA) at distance (equivalent to 6 meters) was assessed monocularly (for each eye separately) in diopters (D). Both eyes contributed to the mean.
Outcome measures
| Measure |
Delefilcon A MF
n=66 eyes
Contact lenses worn during Period 1 or Period 2 for 9-12 hours
|
AOAMF
n=68 eyes
Contact lenses worn during Period 1 or Period 2 for 9-12 hours
|
|---|---|---|
|
Over-refraction (OR) Monocular at Distance
Dispense
|
0.00 Diopters
Standard Deviation 0.00
|
0.00 Diopters
Standard Deviation 0.00
|
|
Over-refraction (OR) Monocular at Distance
Hour 9
|
0.11 Diopters
Standard Deviation 0.16
|
0.09 Diopters
Standard Deviation 0.14
|
Adverse Events
Delefilcon A MF
AOAMF
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Mary Fahmy, Head, Clinical Development, Vision Care
Alcon Research, Ltd.
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place