Trial Outcomes & Findings for Lubricity Post-Wear - Competitive Lenses Pilot (NCT NCT02402127)
NCT ID: NCT02402127
Last Updated: 2016-09-02
Results Overview
Worn contact lenses were removed from the participant's eye and the coefficient of friction was measured by the inclined plane method. A lower coefficient of friction may indicate higher contact lens lubricity. The ex-vivo lubricity was carried out on one lens (one eye) only.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
24 participants
Primary outcome timeframe
Day 1, Hour 16, each product
Results posted on
2016-09-02
Participant Flow
Participants were recruited from three investigational centers located in the United States.
All enrolled participants (24)
Participant milestones
| Measure |
TruEye, MyDay, Clariti 1day
Narafilcon A contact lenses in Period 1, followed by stenfilcon A contact lenses in Period 2 and somofilcon A contact lenses in Period 3
|
TruEye, Clariti 1day, MyDay
Narafilcon A contact lenses in Period 1, followed by somofilcon A contact lenses in Period 2 and stenfilcon A contact lenses in Period 3
|
MyDay, TruEye, Clariti 1day
Stenfilcon A contact lenses in Period 1, followed by narafilcon A contact lenses in Period 2 and somofilcon A contact lenses in Period 3
|
MyDay, Clariti 1day, TruEye
Stenfilcon A contact lenses in Period 1, followed by somofilcon A contact lenses in Period 2 and narafilcon A contact lenses in Period 3
|
Clariti 1day, TruEye, MyDay
Somofilcon A contact lenses in Period 1, followed by narafilcon A contact lenses in Period 2 and stenfilcon A contact lenses in Period 3
|
Clariti 1day, MyDay, TruEye
Somofilcon A contact lenses in Period 1, followed by stenfilcon A contact lenses in Period 2 and narafilcon A contact lenses in Period 3
|
|---|---|---|---|---|---|---|
|
First Wear Period (1 Day)
STARTED
|
4
|
4
|
4
|
4
|
4
|
4
|
|
First Wear Period (1 Day)
Randomized and Treated
|
4
|
4
|
4
|
4
|
4
|
4
|
|
First Wear Period (1 Day)
COMPLETED
|
4
|
4
|
4
|
4
|
4
|
4
|
|
First Wear Period (1 Day)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Second Wear Period (1 Day)
STARTED
|
4
|
4
|
4
|
4
|
4
|
4
|
|
Second Wear Period (1 Day)
COMPLETED
|
4
|
4
|
4
|
4
|
4
|
4
|
|
Second Wear Period (1 Day)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Third Wear Period (1 Day)
STARTED
|
4
|
4
|
4
|
4
|
4
|
4
|
|
Third Wear Period (1 Day)
COMPLETED
|
4
|
4
|
4
|
4
|
4
|
4
|
|
Third Wear Period (1 Day)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Lubricity Post-Wear - Competitive Lenses Pilot
Baseline characteristics by cohort
| Measure |
TruEye, MyDay, Clariti 1day
n=4 Participants
Narafilcon A contact lenses in Period 1, followed by stenfilcon A contact lenses in Period 2 and somofilcon A contact lenses in Period 3
|
TruEye, Clariti 1day, MyDay
n=4 Participants
Narafilcon A contact lenses in Period 1, followed by somofilcon A contact lenses in Period 2 and stenfilcon A contact lenses in Period 3
|
MyDay, TruEye, Clariti 1day
n=4 Participants
Stenfilcon A contact lenses in Period 1, followed by narafilcon A contact lenses in Period 2 and somofilcon A contact lenses in Period 3
|
MyDay, Clariti 1day, TruEye
n=4 Participants
Stenfilcon A contact lenses in Period 1, followed by somofilcon A contact lenses in Period 2 and narafilcon A contact lenses in Period 3
|
Clariti 1day, TruEye, MyDay
n=4 Participants
Somofilcon A contact lenses in Period 1, followed by narafilcon A contact lenses in Period 2 and stenfilcon A contact lenses in Period 3
|
Clariti 1day, MyDay, TruEye
n=4 Participants
Somofilcon A contact lenses in Period 1, followed by stenfilcon A contact lenses in Period 2 and narafilcon A contact lenses in Period 3
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
34.0 years
STANDARD_DEVIATION 9.6 • n=5 Participants
|
27.5 years
STANDARD_DEVIATION 4.0 • n=7 Participants
|
33.0 years
STANDARD_DEVIATION 7.3 • n=5 Participants
|
35.3 years
STANDARD_DEVIATION 4.6 • n=4 Participants
|
26.3 years
STANDARD_DEVIATION 6.2 • n=21 Participants
|
24.3 years
STANDARD_DEVIATION 2.4 • n=8 Participants
|
30.0 years
STANDARD_DEVIATION 6.9 • n=8 Participants
|
|
Age, Customized
18-64 years
|
4 participants
n=5 Participants
|
4 participants
n=7 Participants
|
4 participants
n=5 Participants
|
4 participants
n=4 Participants
|
4 participants
n=21 Participants
|
4 participants
n=8 Participants
|
24 participants
n=8 Participants
|
|
Age, Customized
≥65 years
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=8 Participants
|
0 participants
n=8 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
15 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
9 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Day 1, Hour 16, each productPopulation: Intention to treat participants with non-missing observations
Worn contact lenses were removed from the participant's eye and the coefficient of friction was measured by the inclined plane method. A lower coefficient of friction may indicate higher contact lens lubricity. The ex-vivo lubricity was carried out on one lens (one eye) only.
Outcome measures
| Measure |
TruEye
n=18 Participants
Narafilcon A contact lenses worn for 16 hours in Period 1, Period 2, or Period 3
|
MyDay
n=18 Participants
Stenfilcon A contact lenses worn for 16 hours in Period 1, Period 2, or Period 3
|
Clariti 1day
n=18 Participants
Somofilcon A contact lenses worn for 16 hours in Period 1, Period 2, or Period 3
|
|---|---|---|---|
|
Average Coefficient of Friction of Worn Lenses at 16 Hours
|
0.0602 unitless
Standard Deviation 0.00474
|
0.0576 unitless
Standard Deviation 0.00338
|
0.0578 unitless
Standard Deviation 0.00439
|
SECONDARY outcome
Timeframe: Day 1 (each product)Population: Intention to treat participants with non-missing observations
Unworn contact lenses were removed from the commercial packaging and the coefficient of friction of the unworn lenses was measured by the inclined plane method. A lower coefficient of friction may indicate higher contact lens lubricity.
Outcome measures
| Measure |
TruEye
n=18 contact lenses
Narafilcon A contact lenses worn for 16 hours in Period 1, Period 2, or Period 3
|
MyDay
n=18 contact lenses
Stenfilcon A contact lenses worn for 16 hours in Period 1, Period 2, or Period 3
|
Clariti 1day
n=18 contact lenses
Somofilcon A contact lenses worn for 16 hours in Period 1, Period 2, or Period 3
|
|---|---|---|---|
|
Average Coefficient of Friction of Unworn Lenses
|
0.0571 unitless
Standard Deviation 0.00324
|
0.0571 unitless
Standard Deviation 0.00260
|
0.0552 unitless
Standard Deviation 0.00305
|
Adverse Events
TruEye
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
MyDay
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Clariti 1day
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Global Medical Affairs Franchise Head, Vision Care
Alcon Research, Ltd.
Phone: 1-888-451-3937
Email: [email protected]
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