Trial Outcomes & Findings for Clinical Evaluation of the Safety and Efficacy of a New Multifocal Contact Lens (NCT NCT01797783)
NCT ID: NCT01797783
Last Updated: 2014-05-23
Results Overview
The participant was instructed to, "Please rate the aggregate of distance, intermediate, and near vision quality. Fill in the circle below the number that indicates your selection. Rate eyes together, marking only 1 circle for both eyes. Higher numbers mean better vision." The response was recorded on a continuous scale from 1-10 (1=poor, 10=excellent).
COMPLETED
NA
83 participants
Up to Day 30
2014-05-23
Participant Flow
Participants were recruited from 9 study centers located in the United States.
Of the 83 consented participants, 2 were exited as screen failures prior to randomization, and 2 were exited after randomization but prior to product dispense. This reporting group includes all randomized participants who were dispensed study product (79).
Participant milestones
| Measure |
DAILIES® AquaComfort Plus® Multifocal
Nelfilcon A multifocal contact lens with comfort additive worn for 30 days on a daily wear, daily disposable basis
|
Focus® DAILIES® Progressives
Nelfilcon A multifocal contact lens worn for 30 days on a daily wear, daily disposable basis
|
|---|---|---|
|
Overall Study
STARTED
|
52
|
27
|
|
Overall Study
COMPLETED
|
50
|
26
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
DAILIES® AquaComfort Plus® Multifocal
Nelfilcon A multifocal contact lens with comfort additive worn for 30 days on a daily wear, daily disposable basis
|
Focus® DAILIES® Progressives
Nelfilcon A multifocal contact lens worn for 30 days on a daily wear, daily disposable basis
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Clinical Evaluation of the Safety and Efficacy of a New Multifocal Contact Lens
Baseline characteristics by cohort
| Measure |
DAILIES® AquaComfort Plus® Multifocal
n=52 Participants
Nelfilcon A multifocal contact lens with comfort additive worn for 30 days on a daily wear, daily disposable basis
|
Focus® DAILIES® Progressives
n=27 Participants
Nelfilcon A multifocal contact lens worn for 30 days on a daily wear, daily disposable basis
|
Total
n=79 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49.9 years
STANDARD_DEVIATION 5.19 • n=5 Participants
|
49.7 years
STANDARD_DEVIATION 5.21 • n=7 Participants
|
49.8 years
STANDARD_DEVIATION 5.16 • n=5 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to Day 30Population: This analysis population includes all randomized and dispensed participants who completed the study. No imputation was used for missing values. Here, "n" is the number of participants with non-missing values at the specific time point for each arm. group,
The participant was instructed to, "Please rate the aggregate of distance, intermediate, and near vision quality. Fill in the circle below the number that indicates your selection. Rate eyes together, marking only 1 circle for both eyes. Higher numbers mean better vision." The response was recorded on a continuous scale from 1-10 (1=poor, 10=excellent).
Outcome measures
| Measure |
DAILIES® AquaComfort Plus® Multifocal
n=50 Participants
Nelfilcon A multifocal contact lens with comfort additive worn for 30 days on a daily wear, daily disposable basis
|
Focus® DAILIES® Progressives
n=26 Participants
Nelfilcon A multifocal contact lens worn for 30 days on a daily wear, daily disposable basis
|
DACP MF @ Day 14
Nelfilcon A multifocal contact lens with comfort additive worn for 30 days on a daily wear, daily disposable basis
|
DACP MF @ Day 30
Nelfilcon A multifocal contact lens with comfort additive worn for 30 days on a daily wear, daily disposable basis
|
FDP @ Dispense
Nelfilcon A multifocal contact lens worn for 30 days on a daily wear, daily disposable basis
|
FDP @ Day 3
Nelfilcon A multifocal contact lens worn for 30 days on a daily wear, daily disposable basis
|
FDP @ Day 14
Nelfilcon A multifocal contact lens worn for 30 days on a daily wear, daily disposable basis
|
FDP @ Day 30
Nelfilcon A multifocal contact lens worn for 30 days on a daily wear, daily disposable basis
|
|---|---|---|---|---|---|---|---|---|
|
Subjective Overall Vision
Dispense (Day 0) (n=49,26)
|
8.7 Units on a scale
Standard Deviation 1.1
|
8.4 Units on a scale
Standard Deviation 1.2
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Subjective Overall Vision
Day 3 (n=49,26)
|
8.4 Units on a scale
Standard Deviation 1.3
|
7.5 Units on a scale
Standard Deviation 1.7
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Subjective Overall Vision
Day 14 (n=50,26)
|
8.6 Units on a scale
Standard Deviation 1.2
|
7.7 Units on a scale
Standard Deviation 1.9
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Subjective Overall Vision
Day 30 (n=50,26)
|
8.5 Units on a scale
Standard Deviation 1.1
|
7.6 Units on a scale
Standard Deviation 1.9
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Day 30Population: This analysis population includes all randomized and dispensed participants who completed the study.
Visual Acuity was tested while reading a chart at 20-foot equivalent distance from the participant with both eyes together. The Snellen fraction compares the participant's result to the result expected from the 'normal' visual system. The numerator represents the distance between the participant and the chart, and the denominator represents the distance at which a person with 'normal' vision would be able to discern the same letter size. 20/20 is considered to be 'normal' vision, whereas visual acuity of 20/40 means the participant is able to read a certain size letter 20 feet away that a person with 'normal' vision would be able to read from 40 feet away. A larger denominator, therefore, indicates a lower visual acuity.
Outcome measures
| Measure |
DAILIES® AquaComfort Plus® Multifocal
n=50 Participants
Nelfilcon A multifocal contact lens with comfort additive worn for 30 days on a daily wear, daily disposable basis
|
Focus® DAILIES® Progressives
n=50 Participants
Nelfilcon A multifocal contact lens worn for 30 days on a daily wear, daily disposable basis
|
DACP MF @ Day 14
n=50 Participants
Nelfilcon A multifocal contact lens with comfort additive worn for 30 days on a daily wear, daily disposable basis
|
DACP MF @ Day 30
n=50 Participants
Nelfilcon A multifocal contact lens with comfort additive worn for 30 days on a daily wear, daily disposable basis
|
FDP @ Dispense
n=26 Participants
Nelfilcon A multifocal contact lens worn for 30 days on a daily wear, daily disposable basis
|
FDP @ Day 3
n=26 Participants
Nelfilcon A multifocal contact lens worn for 30 days on a daily wear, daily disposable basis
|
FDP @ Day 14
n=26 Participants
Nelfilcon A multifocal contact lens worn for 30 days on a daily wear, daily disposable basis
|
FDP @ Day 30
n=26 Participants
Nelfilcon A multifocal contact lens worn for 30 days on a daily wear, daily disposable basis
|
|---|---|---|---|---|---|---|---|---|
|
Binocular Snellen Visual Acuity (VA) at Distance With Study Lenses
20/25
|
5 participants
|
8 participants
|
6 participants
|
6 participants
|
4 participants
|
1 participants
|
4 participants
|
5 participants
|
|
Binocular Snellen Visual Acuity (VA) at Distance With Study Lenses
20/15
|
5 participants
|
4 participants
|
4 participants
|
2 participants
|
0 participants
|
0 participants
|
1 participants
|
2 participants
|
|
Binocular Snellen Visual Acuity (VA) at Distance With Study Lenses
20/20
|
40 participants
|
38 participants
|
40 participants
|
42 participants
|
22 participants
|
24 participants
|
21 participants
|
19 participants
|
|
Binocular Snellen Visual Acuity (VA) at Distance With Study Lenses
20/30
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Up to Day 30Population: This reporting group includes all randomized and dispensed participants who completed the study.
Visual Acuity was tested while reading charts at a distance of 40 cm from the participant with both eyes together. The Snellen fraction 20/20 represents 'normal' near vision. A larger denominator indicates a lower visual acuity.
Outcome measures
| Measure |
DAILIES® AquaComfort Plus® Multifocal
n=50 Participants
Nelfilcon A multifocal contact lens with comfort additive worn for 30 days on a daily wear, daily disposable basis
|
Focus® DAILIES® Progressives
n=50 Participants
Nelfilcon A multifocal contact lens worn for 30 days on a daily wear, daily disposable basis
|
DACP MF @ Day 14
n=50 Participants
Nelfilcon A multifocal contact lens with comfort additive worn for 30 days on a daily wear, daily disposable basis
|
DACP MF @ Day 30
n=50 Participants
Nelfilcon A multifocal contact lens with comfort additive worn for 30 days on a daily wear, daily disposable basis
|
FDP @ Dispense
n=26 Participants
Nelfilcon A multifocal contact lens worn for 30 days on a daily wear, daily disposable basis
|
FDP @ Day 3
n=26 Participants
Nelfilcon A multifocal contact lens worn for 30 days on a daily wear, daily disposable basis
|
FDP @ Day 14
n=26 Participants
Nelfilcon A multifocal contact lens worn for 30 days on a daily wear, daily disposable basis
|
FDP @ Day 30
n=26 Participants
Nelfilcon A multifocal contact lens worn for 30 days on a daily wear, daily disposable basis
|
|---|---|---|---|---|---|---|---|---|
|
Binocular Snellen Visual Acuity (VA) at Near (40cm) With Study Lenses
20/10
|
0 participants
|
1 participants
|
1 participants
|
0 participants
|
1 participants
|
1 participants
|
1 participants
|
0 participants
|
|
Binocular Snellen Visual Acuity (VA) at Near (40cm) With Study Lenses
20/16
|
2 participants
|
0 participants
|
2 participants
|
0 participants
|
0 participants
|
0 participants
|
2 participants
|
0 participants
|
|
Binocular Snellen Visual Acuity (VA) at Near (40cm) With Study Lenses
20/25
|
21 participants
|
24 participants
|
25 participants
|
20 participants
|
14 participants
|
10 participants
|
10 participants
|
14 participants
|
|
Binocular Snellen Visual Acuity (VA) at Near (40cm) With Study Lenses
20/40
|
0 participants
|
1 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Binocular Snellen Visual Acuity (VA) at Near (40cm) With Study Lenses
20/12.5
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
2 participants
|
0 participants
|
|
Binocular Snellen Visual Acuity (VA) at Near (40cm) With Study Lenses
20/20
|
19 participants
|
18 participants
|
15 participants
|
23 participants
|
3 participants
|
5 participants
|
5 participants
|
8 participants
|
|
Binocular Snellen Visual Acuity (VA) at Near (40cm) With Study Lenses
20/30
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Binocular Snellen Visual Acuity (VA) at Near (40cm) With Study Lenses
20/32
|
6 participants
|
6 participants
|
6 participants
|
7 participants
|
7 participants
|
8 participants
|
5 participants
|
4 participants
|
|
Binocular Snellen Visual Acuity (VA) at Near (40cm) With Study Lenses
20/50
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
Adverse Events
DAILIES® AquaComfort Plus® Multifocal
Focus® DAILIES® Progressives
Serious adverse events
Adverse event data not reported
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