Trial Outcomes & Findings for Lens Wear Schedules and End-of-Day Comfort (NCT NCT01433549)
NCT ID: NCT01433549
Last Updated: 2013-05-06
Results Overview
As assessed by the participant using a visual analog scale ranging from 0 (extremely uncomfortable) to 100 (very comfortable and fresh) at the end of each 12-hour (approximate) cycle. During each cycle, contact lenses were worn for 2-hour intervals, separated by lens-free (recovery) intervals of either 0, 30, 60, or 80 minutes. A new pair of contact lenses was dispensed for each 2-hour interval of lens wear.
COMPLETED
NA
44 participants
Hour 12
2013-05-06
Participant Flow
Participants were recruited from one study center located in Canada.
Of the 44 participants enrolled, 16 were exited from the study prior to randomization (screen failures). Three subjects were randomized/fitted with lenses but discontinued prior to product dispense. This reporting group includes all participants enrolled and dispensed product. A 12-hour lens-free wear period preceded each phase.
Participant milestones
| Measure |
Lotrafilcon B / Senofilcon A
Lotrafilcon B worn first, with senofilcon A worn second, as randomized. Each product was worn bilaterally in 2-hour intervals, separated by lens-free (recovery) intervals of either 0, 30, 60, or 80 minutes, over the course of a 12-hour day, for a total of 4 cycles (days).
|
Senofilcon A / Lotrafilcon B
Senofilcon A worn first, with lotrafilcon B worn second, as randomized. Each product was worn bilaterally in 2-hour intervals, separated by lens-free (recovery) intervals of either 0, 30, 60, or 80 minutes, over the course of a 12-hour day, for a total of 4 cycles (days).
|
|---|---|---|
|
Phase 1: First Study Product
STARTED
|
12
|
13
|
|
Phase 1: First Study Product
COMPLETED
|
12
|
13
|
|
Phase 1: First Study Product
NOT COMPLETED
|
0
|
0
|
|
Phase 2: Second Study Product
STARTED
|
12
|
13
|
|
Phase 2: Second Study Product
COMPLETED
|
12
|
12
|
|
Phase 2: Second Study Product
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Lotrafilcon B / Senofilcon A
Lotrafilcon B worn first, with senofilcon A worn second, as randomized. Each product was worn bilaterally in 2-hour intervals, separated by lens-free (recovery) intervals of either 0, 30, 60, or 80 minutes, over the course of a 12-hour day, for a total of 4 cycles (days).
|
Senofilcon A / Lotrafilcon B
Senofilcon A worn first, with lotrafilcon B worn second, as randomized. Each product was worn bilaterally in 2-hour intervals, separated by lens-free (recovery) intervals of either 0, 30, 60, or 80 minutes, over the course of a 12-hour day, for a total of 4 cycles (days).
|
|---|---|---|
|
Phase 2: Second Study Product
Adverse Event
|
0
|
1
|
Baseline Characteristics
Lens Wear Schedules and End-of-Day Comfort
Baseline characteristics by cohort
| Measure |
Overall
n=25 Participants
Lotrafilcon B and Senofilcon A worn in cross-over fashion as randomized. Each product was worn bilaterally in 2-hour intervals, separated by lens-free (recovery) intervals of either 0, 30, 60, or 80 minutes, over the course of a 12-hour day, for a total of 4 cycles (days).
|
|---|---|
|
Age, Customized
|
25 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
25 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Hour 12Population: All participants who participated in both phases of the study.
As assessed by the participant using a visual analog scale ranging from 0 (extremely uncomfortable) to 100 (very comfortable and fresh) at the end of each 12-hour (approximate) cycle. During each cycle, contact lenses were worn for 2-hour intervals, separated by lens-free (recovery) intervals of either 0, 30, 60, or 80 minutes. A new pair of contact lenses was dispensed for each 2-hour interval of lens wear.
Outcome measures
| Measure |
Lotrafilcon B
n=25 Participants
Lotrafilcon B worn worn bilaterally in 2-hour intervals, separated by lens-free (recovery) intervals of either 0, 30, 60, or 80 minutes, over the course of a 12-hour day, for a total of 4 cycles (days).
|
Senofilcon A
n=25 Participants
Senofilcon A worn bilaterally in 2-hour intervals, separated by lens-free (recovery) intervals of either 0, 30, 60, or 80 minutes, over the course of a 12-hour day, for a total of 4 cycles (days).
|
|---|---|---|
|
Mean End-of-Day Comfort
Six 2-hr wear intervals/0-min recovery intervals
|
48.9 Units on a scale
Standard Deviation 17.8
|
56.0 Units on a scale
Standard Deviation 15.9
|
|
Mean End-of-Day Comfort
Five 2-hr wear intervals/30-min recovery intervals
|
51.4 Units on a scale
Standard Deviation 17.6
|
53.7 Units on a scale
Standard Deviation 15.9
|
|
Mean End-of-Day Comfort
Four 2-hr wear intervals/60-min recovery intervals
|
56.0 Units on a scale
Standard Deviation 19.8
|
58.8 Units on a scale
Standard Deviation 13.9
|
|
Mean End-of-Day Comfort
Four 2-hr wear intervals/80-min recovery intervals
|
51.5 Units on a scale
Standard Deviation 13.1
|
58.8 Units on a scale
Standard Deviation 18.0
|
SECONDARY outcome
Timeframe: Hour 12Population: All participants who participated in both phases of the study.
As assessed by the investigator using a corneal topographer. NITBUT was assessed at the end of each 12-hour (approximate) cycle. During each cycle, contact lenses were worn for 2-hour intervals, separated by lens-free (recovery) intervals of either 0, 30, 60, or 80 minutes. A new pair of contact lenses was dispensed for each 2-hour interval of lens wear. A longer tear film break-up time indicates a more stable tear film and may lead to a more comfortable lens-wearing experience.
Outcome measures
| Measure |
Lotrafilcon B
n=25 Participants
Lotrafilcon B worn worn bilaterally in 2-hour intervals, separated by lens-free (recovery) intervals of either 0, 30, 60, or 80 minutes, over the course of a 12-hour day, for a total of 4 cycles (days).
|
Senofilcon A
n=25 Participants
Senofilcon A worn bilaterally in 2-hour intervals, separated by lens-free (recovery) intervals of either 0, 30, 60, or 80 minutes, over the course of a 12-hour day, for a total of 4 cycles (days).
|
|---|---|---|
|
Mean Non-Invasive Tear Film Break-Up Time (NITBUT)
Four 2-hr wear intervals/80-min recovery intervals
|
4.9 Seconds
Standard Deviation 2.6
|
4.8 Seconds
Standard Deviation 2.2
|
|
Mean Non-Invasive Tear Film Break-Up Time (NITBUT)
Five 2-hr wear intervals/30-min recovery intervals
|
5.3 Seconds
Standard Deviation 2.2
|
4.7 Seconds
Standard Deviation 2.4
|
|
Mean Non-Invasive Tear Film Break-Up Time (NITBUT)
Four 2-hr wear intervals/60-min recovery intervals
|
4.4 Seconds
Standard Deviation 2.2
|
4.4 Seconds
Standard Deviation 2.4
|
|
Mean Non-Invasive Tear Film Break-Up Time (NITBUT)
Six 2-hr wear intervals/0-min recovery intervals
|
4.6 Seconds
Standard Deviation 1.9
|
4.3 Seconds
Standard Deviation 1.2
|
Adverse Events
Lotrafilcon B
Senofilcon A
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Lotrafilcon B
n=28 participants at risk
Lotrafilcon B worn worn bilaterally in 2-hour intervals, separated by lens-free (recovery) intervals of either 0, 30, 60, or 80 minutes, over the course of a 12-hour day, for a total of 4 cycles (days).
|
Senofilcon A
n=28 participants at risk
Senofilcon A worn bilaterally in 2-hour intervals, separated by lens-free (recovery) intervals of either 0, 30, 60, or 80 minutes, over the course of a 12-hour day, for a total of 4 cycles (days).
|
|---|---|---|
|
Eye disorders
Redness with Indentation
|
17.9%
5/28 • Adverse events were collected for the duration of the study (6 months). The safety population is defined as all subjects exposed to product and includes three subjects randomized/fitted with lenses but discontinued prior to product dispense.
The lens wear regimen in this study was not typical. The study protocol required multiple lens insertions and removals within a wear day, which may have negatively impacted ocular surface characteristics in some subjects.
|
0.00%
0/28 • Adverse events were collected for the duration of the study (6 months). The safety population is defined as all subjects exposed to product and includes three subjects randomized/fitted with lenses but discontinued prior to product dispense.
The lens wear regimen in this study was not typical. The study protocol required multiple lens insertions and removals within a wear day, which may have negatively impacted ocular surface characteristics in some subjects.
|
|
Eye disorders
Staining
|
10.7%
3/28 • Adverse events were collected for the duration of the study (6 months). The safety population is defined as all subjects exposed to product and includes three subjects randomized/fitted with lenses but discontinued prior to product dispense.
The lens wear regimen in this study was not typical. The study protocol required multiple lens insertions and removals within a wear day, which may have negatively impacted ocular surface characteristics in some subjects.
|
0.00%
0/28 • Adverse events were collected for the duration of the study (6 months). The safety population is defined as all subjects exposed to product and includes three subjects randomized/fitted with lenses but discontinued prior to product dispense.
The lens wear regimen in this study was not typical. The study protocol required multiple lens insertions and removals within a wear day, which may have negatively impacted ocular surface characteristics in some subjects.
|
Additional Information
R. Alan Landers, O.D., M.S., F.A.A.O.
Alcon Research, Ltd.
Results disclosure agreements
- Principal investigator is a sponsor employee For a period of 10 years, the clinical investigator must hold all trial-related information and documents confidential and must obtain sponsor's written consent before discussing, presenting, publicizing, or otherwise disclosing any preclinical and/or clinical data or impressions from this trial.
- Publication restrictions are in place
Restriction type: OTHER