Trial Outcomes & Findings for A Dispensing Clinical of Fanfilcon A Lens Against Lotrafilcon B Lens Over 1 Month Wear Per Lens (NCT NCT02716298)
NCT ID: NCT02716298
Last Updated: 2017-05-30
Results Overview
Subjective ratings on comfort at insertion (at baseline), comfort when lenses are first put in, comfort during the day's wear, and comfort prior to lens removal (1 month) for fanfilcon A and lotrafilcon B lens. (Scale 0-10, 10=Can't feel the lenses, 0=Painful).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
49 participants
Primary outcome timeframe
Baseline, 1 month
Results posted on
2017-05-30
Participant Flow
Participant milestones
| Measure |
Fanfilcon A Then Lotrafilcon B
Study participants are randomized to wear fanfilcon A lens for 1 month, then lotrafilcon B for 1 month during the crossover study
fanfilcon A: contact lens lotrafilcon B: contact lens
|
Lotrafilcon B Then Fanfilcon A
Study participants are randomized to wear lotrafilcon B for 1 month, then fanfilcon A lens for 1 month during the crossover study.
lotrafilcon B: contact lens fanfilcon A: contact lens
|
|---|---|---|
|
First Intervention (1 Month)
STARTED
|
25
|
24
|
|
First Intervention (1 Month)
COMPLETED
|
24
|
23
|
|
First Intervention (1 Month)
NOT COMPLETED
|
1
|
1
|
|
Second Intervention (1 Month)
STARTED
|
24
|
23
|
|
Second Intervention (1 Month)
COMPLETED
|
24
|
23
|
|
Second Intervention (1 Month)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Fanfilcon A Then Lotrafilcon B
Study participants are randomized to wear fanfilcon A lens for 1 month, then lotrafilcon B for 1 month during the crossover study
fanfilcon A: contact lens lotrafilcon B: contact lens
|
Lotrafilcon B Then Fanfilcon A
Study participants are randomized to wear lotrafilcon B for 1 month, then fanfilcon A lens for 1 month during the crossover study.
lotrafilcon B: contact lens fanfilcon A: contact lens
|
|---|---|---|
|
First Intervention (1 Month)
Lens discomfort
|
1
|
1
|
Baseline Characteristics
A Dispensing Clinical of Fanfilcon A Lens Against Lotrafilcon B Lens Over 1 Month Wear Per Lens
Baseline characteristics by cohort
| Measure |
Overall Participants
n=49 Participants
Study participants are randomized to wear fanfilcon A lens or lotrafilcon B lens for 1 month during the crossover study
fanfilcon A: contact lens lotrafilcon B: contact lens
|
|---|---|
|
Age, Continuous
|
27.1 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
38 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 1 monthSubjective ratings on comfort at insertion (at baseline), comfort when lenses are first put in, comfort during the day's wear, and comfort prior to lens removal (1 month) for fanfilcon A and lotrafilcon B lens. (Scale 0-10, 10=Can't feel the lenses, 0=Painful).
Outcome measures
| Measure |
Fanfilcon A
n=47 Participants
Study participants are randomized to wear fanfilcon A lens for 1 month during the crossover study
fanfilcon A: contact lens
|
Lotrafilcon B
n=47 Participants
Study participants are randomized to wear lotrafilcon B lens for 1 month during the crossover study.
lotrafilcon B: contact lens
|
No Preference
|
Slightly Prefer Lotrafilcon B
Study participants are randomized to wear lotrafilcon B lens for 1 month during the crossover study
lotrafilcon B: contact lens
|
Strongly Prefer Lotrafilcon B
Study participants are randomized to wear lotrafilcon B lens for 1 month during the crossover study
lotrafilcon B: contact lens
|
|---|---|---|---|---|---|
|
Subjective Comfort
1 Month - Comfort just prior to lens removal
|
8 units on a scale
Standard Deviation 1.78
|
7 units on a scale
Standard Deviation 2.14
|
—
|
—
|
—
|
|
Subjective Comfort
Baseline - Comfort at Insertion
|
10 units on a scale
Standard Deviation 0.93
|
9 units on a scale
Standard Deviation 1.83
|
—
|
—
|
—
|
|
Subjective Comfort
1 Month - Comfort when lenses are first put in
|
10 units on a scale
Standard Deviation 1.26
|
9 units on a scale
Standard Deviation 1.44
|
—
|
—
|
—
|
|
Subjective Comfort
1 Month - Comfort during the day's wear
|
9 units on a scale
Standard Deviation 1.32
|
8 units on a scale
Standard Deviation 1.53
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 1 monthSubjective ratings on preference for fanfilcon A and lotrafilcon B lens. (Strongly prefer fanfilcon A, slightly prefer fanfilcon A, no preference, slightly prefer lotrafilcon B, strongly prefer lotrafilcon B). Subject preference in terms of comfort, dryness, clear vision, Lens Handling, digital devices, all day natural comfort, All day comfort, same comfort at the end of the day (EOD), comfortable after the end of 4 weeks, Same comfort at 4 weeks as initial, comfortable in dry environments, help focus effortlessly while using digital devices, help with end of day (EOD) dryness, help eyes feel less tired at EOD (including computer or digital device use), offering clear vision during driving.
Outcome measures
| Measure |
Fanfilcon A
n=47 Participants
Study participants are randomized to wear fanfilcon A lens for 1 month during the crossover study
fanfilcon A: contact lens
|
Lotrafilcon B
n=47 Participants
Study participants are randomized to wear lotrafilcon B lens for 1 month during the crossover study.
lotrafilcon B: contact lens
|
No Preference
n=47 Participants
|
Slightly Prefer Lotrafilcon B
n=47 Participants
Study participants are randomized to wear lotrafilcon B lens for 1 month during the crossover study
lotrafilcon B: contact lens
|
Strongly Prefer Lotrafilcon B
n=47 Participants
Study participants are randomized to wear lotrafilcon B lens for 1 month during the crossover study
lotrafilcon B: contact lens
|
|---|---|---|---|---|---|
|
Subjective Preference
Comfort
|
52 percentage of participants
|
16 percentage of participants
|
9 percentage of participants
|
16 percentage of participants
|
7 percentage of participants
|
|
Subjective Preference
Dryness
|
43 percentage of participants
|
23 percentage of participants
|
11 percentage of participants
|
14 percentage of participants
|
9 percentage of participants
|
|
Subjective Preference
Clear vision
|
38.64 percentage of participants
|
25.0 percentage of participants
|
29.55 percentage of participants
|
4.55 percentage of participants
|
2.27 percentage of participants
|
|
Subjective Preference
Lens Handling
|
9 percentage of participants
|
16 percentage of participants
|
52 percentage of participants
|
23 percentage of participants
|
0 percentage of participants
|
|
Subjective Preference
Digital devices
|
27.27 percentage of participants
|
27.27 percentage of participants
|
40.91 percentage of participants
|
2.27 percentage of participants
|
2.27 percentage of participants
|
|
Subjective Preference
All day natural comfort
|
45 percentage of participants
|
20 percentage of participants
|
14 percentage of participants
|
14 percentage of participants
|
7 percentage of participants
|
|
Subjective Preference
All day comfort
|
27 percentage of participants
|
39 percentage of participants
|
11 percentage of participants
|
18 percentage of participants
|
5 percentage of participants
|
|
Subjective Preference
Same comfort at EOD
|
41 percentage of participants
|
25 percentage of participants
|
11 percentage of participants
|
14 percentage of participants
|
9 percentage of participants
|
|
Subjective Preference
Comfortable after the end of 4 weeks
|
50 percentage of participants
|
18 percentage of participants
|
7 percentage of participants
|
20 percentage of participants
|
5 percentage of participants
|
|
Subjective Preference
Same comfort at 4 weeks as initial
|
43 percentage of participants
|
25 percentage of participants
|
11 percentage of participants
|
14 percentage of participants
|
7 percentage of participants
|
|
Subjective Preference
Comfortable in dry environments
|
38.64 percentage of participants
|
15.91 percentage of participants
|
29.55 percentage of participants
|
4.55 percentage of participants
|
11.36 percentage of participants
|
|
Subjective Preference
Help focus effortlessly while using digital device
|
29.55 percentage of participants
|
27.27 percentage of participants
|
34.09 percentage of participants
|
4.55 percentage of participants
|
4.55 percentage of participants
|
|
Subjective Preference
Help with EOD dryness
|
34 percentage of participants
|
25 percentage of participants
|
23 percentage of participants
|
11 percentage of participants
|
7 percentage of participants
|
|
Subjective Preference
Help eyes feel less tired at EOD
|
36.36 percentage of participants
|
18.18 percentage of participants
|
31.82 percentage of participants
|
11.36 percentage of participants
|
2.27 percentage of participants
|
|
Subjective Preference
Offering clear vision during driving.
|
34 percentage of participants
|
29 percentage of participants
|
26 percentage of participants
|
11 percentage of participants
|
0 percentage of participants
|
PRIMARY outcome
Timeframe: Baseline, 1 monthPopulation: One participant excluded from analysis at 1 month.
Lens wettability for fanfilcon A and lotrafilcon B lens. (Scale 0-4, 0.25 steps, 0=excellent, 4=severely reduced)
Outcome measures
| Measure |
Fanfilcon A
n=47 Participants
Study participants are randomized to wear fanfilcon A lens for 1 month during the crossover study
fanfilcon A: contact lens
|
Lotrafilcon B
n=47 Participants
Study participants are randomized to wear lotrafilcon B lens for 1 month during the crossover study.
lotrafilcon B: contact lens
|
No Preference
|
Slightly Prefer Lotrafilcon B
Study participants are randomized to wear lotrafilcon B lens for 1 month during the crossover study
lotrafilcon B: contact lens
|
Strongly Prefer Lotrafilcon B
Study participants are randomized to wear lotrafilcon B lens for 1 month during the crossover study
lotrafilcon B: contact lens
|
|---|---|---|---|---|---|
|
Lens Wettability
Baseline
|
0.76 units on a scale
Standard Deviation 0.61
|
0.56 units on a scale
Standard Deviation 0.46
|
—
|
—
|
—
|
|
Lens Wettability
1 month
|
0.85 units on a scale
Standard Deviation 0.71
|
1.08 units on a scale
Standard Deviation 0.71
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline, 1 monthPopulation: One participant excluded from analysis at 1 month.
Surface deposits for fanfilcon A and lotrafilcon B lens. (Scale 0-4, 0.25 steps, 0=excellent, 4=severely reduced)
Outcome measures
| Measure |
Fanfilcon A
n=47 Participants
Study participants are randomized to wear fanfilcon A lens for 1 month during the crossover study
fanfilcon A: contact lens
|
Lotrafilcon B
n=47 Participants
Study participants are randomized to wear lotrafilcon B lens for 1 month during the crossover study.
lotrafilcon B: contact lens
|
No Preference
|
Slightly Prefer Lotrafilcon B
Study participants are randomized to wear lotrafilcon B lens for 1 month during the crossover study
lotrafilcon B: contact lens
|
Strongly Prefer Lotrafilcon B
Study participants are randomized to wear lotrafilcon B lens for 1 month during the crossover study
lotrafilcon B: contact lens
|
|---|---|---|---|---|---|
|
Surface Deposits
Baseline
|
0.14 units on a scale
Standard Deviation 0.22
|
0.26 units on a scale
Standard Deviation 0.26
|
—
|
—
|
—
|
|
Surface Deposits
1 Month
|
0.34 units on a scale
Standard Deviation 0.45
|
0.41 units on a scale
Standard Deviation 0.56
|
—
|
—
|
—
|
Adverse Events
Fanfilcon A
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Lotrafilcon B
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
Senior Manager Global Medical Scientific Affairs
CooperVision
Phone: 925-621-3761
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER