Trial Outcomes & Findings for A Multi-Center Study Comparing the Clinical Performance of Two Silicone Hydrogel Lenses Over 1 Month of Daily Wear (NCT NCT01952665)
NCT ID: NCT01952665
Last Updated: 2017-06-26
Results Overview
Participant rating for lens comfort on insertion. Collected at dispense for both study lens pairs. (0-10, 0= Very Uncomfortable, 10= Cannot feel).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
63 participants
Primary outcome timeframe
Dispense
Results posted on
2017-06-26
Participant Flow
This was a 1 month, cross-over dispensing study conducted at 6 clinical sites in the US. 63 subjects were enrolled, 12 were discontinued and 51 completed the study.
Participant milestones
| Measure |
Comfilcon A Then Lotrafilcon B
Each subject randomized to wear either the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
|
Lotrafilcon B Then Comfilcon A
Each subject randomized to wear either the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
|
|---|---|---|
|
Overall Study
STARTED
|
37
|
26
|
|
Overall Study
COMPLETED
|
31
|
20
|
|
Overall Study
NOT COMPLETED
|
6
|
6
|
Reasons for withdrawal
| Measure |
Comfilcon A Then Lotrafilcon B
Each subject randomized to wear either the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
|
Lotrafilcon B Then Comfilcon A
Each subject randomized to wear either the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
|
|---|---|---|
|
Overall Study
Physician Decision
|
3
|
2
|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
|
Overall Study
Adverse Event
|
2
|
1
|
|
Overall Study
Protocol Violation
|
0
|
1
|
Baseline Characteristics
A Multi-Center Study Comparing the Clinical Performance of Two Silicone Hydrogel Lenses Over 1 Month of Daily Wear
Baseline characteristics by cohort
| Measure |
Comfilcon A Then Lotrafilcon B
n=37 Participants
Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
|
Lotrafilcon B Then Comfilcon A
n=26 Participants
Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
|
Total
n=63 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
37 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
63 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
38 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
37 participants
n=99 Participants
|
26 participants
n=107 Participants
|
63 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: DispenseParticipant rating for lens comfort on insertion. Collected at dispense for both study lens pairs. (0-10, 0= Very Uncomfortable, 10= Cannot feel).
Outcome measures
| Measure |
Comfilcon A
n=63 Participants
Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
|
Lotrafilcon B
n=60 Participants
Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
|
Habitual Lens
Subjects attended baseline visit wearing habitual lenses prior to dispense of study lens.
|
|---|---|---|---|
|
Comfort at Insertion
|
9.21 units on a scale
Standard Deviation 1.06
|
8.22 units on a scale
Standard Deviation 1.98
|
—
|
PRIMARY outcome
Timeframe: DispenseParticipant rating of visual quality. Collected at dispense for both study pairs. (0-10, 0= Very Poor Vision, 10= Perfectly Sharp, Clear Vision)
Outcome measures
| Measure |
Comfilcon A
n=63 Participants
Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
|
Lotrafilcon B
n=60 Participants
Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
|
Habitual Lens
Subjects attended baseline visit wearing habitual lenses prior to dispense of study lens.
|
|---|---|---|---|
|
Visual Quality
|
9.27 units on a scale
Standard Deviation 1.02
|
8.87 units on a scale
Standard Deviation 1.89
|
—
|
PRIMARY outcome
Timeframe: 2 weeksParticipants measure of average daily wear time for study lenses at 2 Weeks.
Outcome measures
| Measure |
Comfilcon A
n=58 Participants
Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
|
Lotrafilcon B
n=57 Participants
Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
|
Habitual Lens
Subjects attended baseline visit wearing habitual lenses prior to dispense of study lens.
|
|---|---|---|---|
|
Average Daily Wearing Time
|
13.72 hours
Standard Deviation 2.66
|
13.82 hours
Standard Deviation 2.95
|
—
|
PRIMARY outcome
Timeframe: 2 weeksParticipant rating of lens Comfortable Wearing Time for both study pairs. After 2 weeks wear for each pair. (The hours of average comfortable wearing time)
Outcome measures
| Measure |
Comfilcon A
n=58 Participants
Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
|
Lotrafilcon B
n=57 Participants
Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
|
Habitual Lens
Subjects attended baseline visit wearing habitual lenses prior to dispense of study lens.
|
|---|---|---|---|
|
Comfortable Wearing Time
|
11.07 hours
Standard Deviation 3.87
|
11.14 hours
Standard Deviation 3.72
|
—
|
PRIMARY outcome
Timeframe: 2 weeksParticipant rating for lens comfort. After 2 weeks wear for each study pair. (0-10, 0= Very Uncomfortable, 10= Cannot Feel).
Outcome measures
| Measure |
Comfilcon A
n=58 Participants
Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
|
Lotrafilcon B
n=57 Participants
Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
|
Habitual Lens
Subjects attended baseline visit wearing habitual lenses prior to dispense of study lens.
|
|---|---|---|---|
|
Comfort
Insertion
|
8.78 units on a scale
Standard Deviation 1.48
|
8.35 units on a scale
Standard Deviation 1.68
|
—
|
|
Comfort
During Day
|
8.29 units on a scale
Standard Deviation 1.63
|
8.09 units on a scale
Standard Deviation 1.76
|
—
|
|
Comfort
Prior to Removal
|
7.31 units on a scale
Standard Deviation 2.20
|
7.00 units on a scale
Standard Deviation 1.95
|
—
|
|
Comfort
Overall
|
8.28 units on a scale
Standard Deviation 1.58
|
7.84 units on a scale
Standard Deviation 1.75
|
—
|
PRIMARY outcome
Timeframe: 2 weeksParticipant rating for lens dryness. After 2 weeks wear for each study pair. (0-10, 0= Very Dry, 10= No Dryness).
Outcome measures
| Measure |
Comfilcon A
n=58 Participants
Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
|
Lotrafilcon B
n=57 Participants
Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
|
Habitual Lens
Subjects attended baseline visit wearing habitual lenses prior to dispense of study lens.
|
|---|---|---|---|
|
Dryness
During Day
|
8.19 units on a scale
Standard Deviation 1.76
|
7.95 units on a scale
Standard Deviation 1.71
|
—
|
|
Dryness
Prior to Removal
|
7.21 units on a scale
Standard Deviation 2.27
|
6.89 units on a scale
Standard Deviation 1.93
|
—
|
|
Dryness
Overall
|
7.97 units on a scale
Standard Deviation 1.90
|
7.60 units on a scale
Standard Deviation 1.70
|
—
|
PRIMARY outcome
Timeframe: 2 weeksParticipant rating for lens handling. After 2 weeks wear for each study pair. (0-10, 0= Very Difficult, 10= Very Easy).
Outcome measures
| Measure |
Comfilcon A
n=58 Participants
Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
|
Lotrafilcon B
n=57 Participants
Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
|
Habitual Lens
Subjects attended baseline visit wearing habitual lenses prior to dispense of study lens.
|
|---|---|---|---|
|
Handling
Insertion/Removal
|
9.19 units on a scale
Standard Deviation 1.48
|
9.37 units on a scale
Standard Deviation 0.90
|
—
|
|
Handling
Overall
|
9.21 units on a scale
Standard Deviation 1.42
|
9.39 units on a scale
Standard Deviation 0.90
|
—
|
PRIMARY outcome
Timeframe: 2 weeksParticipant rating for vision satisfaction. After 2 weeks wear for each study pair. (0-10, 0= Very Unsatisfied, 10= Very Satisfied)
Outcome measures
| Measure |
Comfilcon A
n=58 Participants
Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
|
Lotrafilcon B
n=57 Participants
Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
|
Habitual Lens
Subjects attended baseline visit wearing habitual lenses prior to dispense of study lens.
|
|---|---|---|---|
|
Vision Satisfaction
|
9.10 units on a scale
Standard Deviation 1.83
|
8.82 units on a scale
Standard Deviation 1.69
|
—
|
PRIMARY outcome
Timeframe: 2 weeksParticipant rating for Eye Whiteness/Redness. After 2 weeks wear for each study pair. (0-10, 0= Significant Redness, 10= Totally White)
Outcome measures
| Measure |
Comfilcon A
n=58 Participants
Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
|
Lotrafilcon B
n=57 Participants
Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
|
Habitual Lens
Subjects attended baseline visit wearing habitual lenses prior to dispense of study lens.
|
|---|---|---|---|
|
Eye Whiteness/Redness
|
8.69 units on a scale
Standard Deviation 1.90
|
8.72 units on a scale
Standard Deviation 1.61
|
—
|
PRIMARY outcome
Timeframe: 2 weeksParticipant rating of overall sensation for moistness (hydration). After 2 weeks wear for each study pair. 5-point Likert Scale; 1=Excellent, 2=Good, 3=Average, 4=Below Average, 5=Poor.
Outcome measures
| Measure |
Comfilcon A
n=58 Participants
Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
|
Lotrafilcon B
n=57 Participants
Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
|
Habitual Lens
Subjects attended baseline visit wearing habitual lenses prior to dispense of study lens.
|
|---|---|---|---|
|
Overall Sensation of Moistness
Excellent
|
17 participants
|
12 participants
|
—
|
|
Overall Sensation of Moistness
Good
|
25 participants
|
24 participants
|
—
|
|
Overall Sensation of Moistness
Average
|
9 participants
|
12 participants
|
—
|
|
Overall Sensation of Moistness
Fair
|
6 participants
|
7 participants
|
—
|
|
Overall Sensation of Moistness
Poor
|
1 participants
|
2 participants
|
—
|
PRIMARY outcome
Timeframe: 2 weeksParticipant rating of overall sensation for smoothness (deposit resistance). After 2 weeks wear for each study pair. 5-point Likert Scale; 1=Excellent, 2=Good, 3=Average, 4=Below Average, 5=Poor.
Outcome measures
| Measure |
Comfilcon A
n=58 Participants
Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
|
Lotrafilcon B
n=57 Participants
Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
|
Habitual Lens
Subjects attended baseline visit wearing habitual lenses prior to dispense of study lens.
|
|---|---|---|---|
|
Overall Sensation of Smoothness
Excellent
|
23 participants
|
21 participants
|
—
|
|
Overall Sensation of Smoothness
Good
|
17 participants
|
20 participants
|
—
|
|
Overall Sensation of Smoothness
Average
|
13 participants
|
12 participants
|
—
|
|
Overall Sensation of Smoothness
Fair
|
5 participants
|
1 participants
|
—
|
|
Overall Sensation of Smoothness
Poor
|
0 participants
|
3 participants
|
—
|
PRIMARY outcome
Timeframe: 2 weeksParticipant rating of satisfaction regarding comfort. After 2 weeks wear for each study pair. 4-point Likert Scale; 1=Completely Satisfied, 2=Somewhat Satisfied, 3=Somewhat Dissatisfied, 4=Completely Dissatisfied
Outcome measures
| Measure |
Comfilcon A
n=58 Participants
Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
|
Lotrafilcon B
n=57 Participants
Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
|
Habitual Lens
Subjects attended baseline visit wearing habitual lenses prior to dispense of study lens.
|
|---|---|---|---|
|
Overall Comfort Satisfaction
Completely Satisfied
|
30 participants
|
20 participants
|
—
|
|
Overall Comfort Satisfaction
Somewhat Satisfied
|
18 participants
|
26 participants
|
—
|
|
Overall Comfort Satisfaction
Somewhat Dissatisfied
|
9 participants
|
7 participants
|
—
|
|
Overall Comfort Satisfaction
Completely Dissatisfied
|
1 participants
|
4 participants
|
—
|
PRIMARY outcome
Timeframe: 2 weeksParticipant rating of satisfaction regarding dryness. After 2 weeks wear for each study pair. 4-point Likert Scale; 1=Completely Satisfied, 2=Somewhat Satisfied, 3=Somewhat Dissatisfied, 4=Completely Dissatisfied
Outcome measures
| Measure |
Comfilcon A
n=58 Participants
Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
|
Lotrafilcon B
n=57 Participants
Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
|
Habitual Lens
Subjects attended baseline visit wearing habitual lenses prior to dispense of study lens.
|
|---|---|---|---|
|
Overall Dryness Satisfaction
Completely Satisfied
|
24 participants
|
20 participants
|
—
|
|
Overall Dryness Satisfaction
Somewhat Satisfied
|
23 participants
|
22 participants
|
—
|
|
Overall Dryness Satisfaction
Somewhat Dissatisfied
|
9 participants
|
11 participants
|
—
|
|
Overall Dryness Satisfaction
Completely Dissatisfied
|
2 participants
|
4 participants
|
—
|
PRIMARY outcome
Timeframe: 2 weeksParticipant rating of satisfaction regarding handling. After 2 weeks wear for each study pair. 4-point Likert Scale; 1=Completely Satisfied, 2=Somewhat Satisfied, 3=Somewhat Dissatisfied, 4=Completely Dissatisfied
Outcome measures
| Measure |
Comfilcon A
n=58 Participants
Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
|
Lotrafilcon B
n=57 Participants
Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
|
Habitual Lens
Subjects attended baseline visit wearing habitual lenses prior to dispense of study lens.
|
|---|---|---|---|
|
Overall Handling Satisfaction
Completely Satisfied
|
49 participants
|
43 participants
|
—
|
|
Overall Handling Satisfaction
Somewhat Satisfied
|
6 participants
|
13 participants
|
—
|
|
Overall Handling Satisfaction
Somewhat Dissatisfied
|
3 participants
|
1 participants
|
—
|
|
Overall Handling Satisfaction
Completely Dissatisfied
|
0 participants
|
0 participants
|
—
|
PRIMARY outcome
Timeframe: 2 weeksParticipant rating of satisfaction regarding vision. After 2 weeks wear for each study pair. 4-point Likert Scale; 1=Completely Satisfied, 2=Somewhat Satisfied, 3=Somewhat Dissatisfied, 4=Completely Dissatisfied
Outcome measures
| Measure |
Comfilcon A
n=58 Participants
Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
|
Lotrafilcon B
n=57 Participants
Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
|
Habitual Lens
Subjects attended baseline visit wearing habitual lenses prior to dispense of study lens.
|
|---|---|---|---|
|
Overall Vision Satisfaction
Completely Satisfied
|
43 participants
|
35 participants
|
—
|
|
Overall Vision Satisfaction
Somewhat Satisfied
|
12 participants
|
14 participants
|
—
|
|
Overall Vision Satisfaction
Somewhat Dissatisfied
|
1 participants
|
5 participants
|
—
|
|
Overall Vision Satisfaction
Completely Dissatisfied
|
2 participants
|
3 participants
|
—
|
PRIMARY outcome
Timeframe: 2 weeksParticipant rating of satisfaction overall. After 2 weeks wear for each study pair. 4-point Likert Scale; 1=Completely Satisfied, 2=Somewhat Satisfied, 3=Somewhat Dissatisfied, 4=Completely Dissatisfied
Outcome measures
| Measure |
Comfilcon A
n=58 Participants
Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
|
Lotrafilcon B
n=57 Participants
Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
|
Habitual Lens
Subjects attended baseline visit wearing habitual lenses prior to dispense of study lens.
|
|---|---|---|---|
|
Overall Satisfaction
Completely Satisfied
|
30 participants
|
20 participants
|
—
|
|
Overall Satisfaction
Somewhat Satisfied
|
18 participants
|
26 participants
|
—
|
|
Overall Satisfaction
Somewhat Dissatisfied
|
9 participants
|
7 participants
|
—
|
|
Overall Satisfaction
Completely Dissatisfied
|
1 participants
|
4 participants
|
—
|
PRIMARY outcome
Timeframe: 2 weeksParticipant preference for habitual lenses or study lenses with regard to comfort, dryness, handling, vision and overall. Collected at 2 weeks for study pair 1. (Randomized to comfilcon A as pair 1; Forced choice: Pair 1 or Habitual)
Outcome measures
| Measure |
Comfilcon A
n=58 Participants
Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
|
Lotrafilcon B
n=58 Participants
Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
|
Habitual Lens
Subjects attended baseline visit wearing habitual lenses prior to dispense of study lens.
|
|---|---|---|---|
|
Lens Preference, Pair 1 Comfilcon A
Comfort
|
26 participants
|
32 participants
|
—
|
|
Lens Preference, Pair 1 Comfilcon A
Dryness
|
26 participants
|
32 participants
|
—
|
|
Lens Preference, Pair 1 Comfilcon A
Handling
|
29 participants
|
29 participants
|
—
|
|
Lens Preference, Pair 1 Comfilcon A
Vision
|
27 participants
|
31 participants
|
—
|
|
Lens Preference, Pair 1 Comfilcon A
Overall
|
26 participants
|
32 participants
|
—
|
PRIMARY outcome
Timeframe: 2 weeksParticipant preference for habitual lenses or study lenses with regard to comfort, dryness, handling, vision and overall. Collected at 2 weeks for study pair 1. (Randomized to lotrafilcon B as pair 1; Forced choice: Pair 1 or Habitual )
Outcome measures
| Measure |
Comfilcon A
n=57 Participants
Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
|
Lotrafilcon B
n=57 Participants
Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
|
Habitual Lens
Subjects attended baseline visit wearing habitual lenses prior to dispense of study lens.
|
|---|---|---|---|
|
Lens Preference, Pair 1 Lotrafilcon B
Comfort
|
19 participants
|
38 participants
|
—
|
|
Lens Preference, Pair 1 Lotrafilcon B
Dryness
|
18 participants
|
39 participants
|
—
|
|
Lens Preference, Pair 1 Lotrafilcon B
Handling
|
25 participants
|
32 participants
|
—
|
|
Lens Preference, Pair 1 Lotrafilcon B
Vision
|
23 participants
|
31 participants
|
—
|
|
Lens Preference, Pair 1 Lotrafilcon B
Overall
|
19 participants
|
38 participants
|
—
|
PRIMARY outcome
Timeframe: 4 weeksParticipant rating of lens Comfortable Wearing Time for both study pairs. Collected at 4 weeks wear. (The hours of average comfortable wearing time)
Outcome measures
| Measure |
Comfilcon A
n=57 Participants
Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
|
Lotrafilcon B
n=56 Participants
Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
|
Habitual Lens
Subjects attended baseline visit wearing habitual lenses prior to dispense of study lens.
|
|---|---|---|---|
|
Comfortable Wearing Time
|
11.07 hours
Standard Deviation 3.33
|
10.67 hours
Standard Deviation 4.15
|
—
|
PRIMARY outcome
Timeframe: 4 weeksParticipants measure of average daily wear time for study lenses at 4 weeks.
Outcome measures
| Measure |
Comfilcon A
n=57 Participants
Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
|
Lotrafilcon B
n=56 Participants
Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
|
Habitual Lens
Subjects attended baseline visit wearing habitual lenses prior to dispense of study lens.
|
|---|---|---|---|
|
Average Daily Wearing Time
|
13.57 hours
Standard Deviation 2.88
|
13.91 hours
Standard Deviation 2.82
|
—
|
PRIMARY outcome
Timeframe: 4 weeksParticipant use of rewetting drops. Collected at 4 weeks wear for both study lens pairs. (Uses rewetting drops / Does not use rewetting drops).
Outcome measures
| Measure |
Comfilcon A
n=56 Participants
Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
|
Lotrafilcon B
n=57 Participants
Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
|
Habitual Lens
Subjects attended baseline visit wearing habitual lenses prior to dispense of study lens.
|
|---|---|---|---|
|
Rewetting Drops
Uses
|
46 participants
|
48 participants
|
—
|
|
Rewetting Drops
Does Not Use
|
10 participants
|
9 participants
|
—
|
PRIMARY outcome
Timeframe: 4 weeksParticipant rating for lens comfort. Collected at 4 weeks wear for both study lens pairs. (0-10, 0= Very Uncomfortable, 10= Cannot Feel).
Outcome measures
| Measure |
Comfilcon A
n=56 Participants
Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
|
Lotrafilcon B
n=57 Participants
Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
|
Habitual Lens
Subjects attended baseline visit wearing habitual lenses prior to dispense of study lens.
|
|---|---|---|---|
|
Comfort
Insertion
|
8.70 units on a scale
Standard Deviation 1.62
|
8.12 units on a scale
Standard Deviation 1.83
|
—
|
|
Comfort
During Day
|
8.29 units on a scale
Standard Deviation 1.79
|
7.77 units on a scale
Standard Deviation 1.80
|
—
|
|
Comfort
Prior to Removal
|
7.38 units on a scale
Standard Deviation 2.00
|
6.58 units on a scale
Standard Deviation 2.20
|
—
|
|
Comfort
Overall
|
8.07 units on a scale
Standard Deviation 1.79
|
7.56 units on a scale
Standard Deviation 1.87
|
—
|
PRIMARY outcome
Timeframe: 4 weeksParticipant rating for lens dryness. Collected at 4 weeks wear for both study lens pairs. (0-10, 0= Very Dry, 10= No Dryness).
Outcome measures
| Measure |
Comfilcon A
n=56 Participants
Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
|
Lotrafilcon B
n=57 Participants
Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
|
Habitual Lens
Subjects attended baseline visit wearing habitual lenses prior to dispense of study lens.
|
|---|---|---|---|
|
Dryness
During Day
|
8.34 units on a scale
Standard Deviation 1.72
|
7.70 units on a scale
Standard Deviation 2.04
|
—
|
|
Dryness
Prior to Removal
|
7.38 units on a scale
Standard Deviation 1.77
|
6.74 units on a scale
Standard Deviation 2.31
|
—
|
|
Dryness
Overall
|
8.04 units on a scale
Standard Deviation 1.79
|
7.39 units on a scale
Standard Deviation 2.05
|
—
|
PRIMARY outcome
Timeframe: 4 weeksParticipant rating for lens handling. Collected at 4 weeks. (0-10, 0= Very Difficult, 10= Very Easy).
Outcome measures
| Measure |
Comfilcon A
n=56 Participants
Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
|
Lotrafilcon B
n=57 Participants
Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
|
Habitual Lens
Subjects attended baseline visit wearing habitual lenses prior to dispense of study lens.
|
|---|---|---|---|
|
Handling
Insertion/Removal
|
9.21 units on a scale
Standard Deviation 1.26
|
9.25 units on a scale
Standard Deviation 1.31
|
—
|
|
Handling
Overall
|
9.27 units on a scale
Standard Deviation 1.17
|
9.25 units on a scale
Standard Deviation 1.31
|
—
|
PRIMARY outcome
Timeframe: 4 weeksParticipant rating for vision satisfaction. Collected at 4 weeks wear for both study lens pairs. (0-10, 0= Very Unsatisfied, 10= Very Satisfied)
Outcome measures
| Measure |
Comfilcon A
n=56 Participants
Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
|
Lotrafilcon B
n=57 Participants
Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
|
Habitual Lens
Subjects attended baseline visit wearing habitual lenses prior to dispense of study lens.
|
|---|---|---|---|
|
Vision Satisfaction
|
9.13 units on a scale
Standard Deviation 1.60
|
8.51 units on a scale
Standard Deviation 1.94
|
—
|
PRIMARY outcome
Timeframe: 4 weeksParticipant rating for Eye Whiteness/Redness. Collected at 4 weeks wear for both study lens pairs. (0-10, 0= Significant Redness, 10= Totally White)
Outcome measures
| Measure |
Comfilcon A
n=56 Participants
Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
|
Lotrafilcon B
n=57 Participants
Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
|
Habitual Lens
Subjects attended baseline visit wearing habitual lenses prior to dispense of study lens.
|
|---|---|---|---|
|
Eye Whiteness/Redness
|
8.93 units on a scale
Standard Deviation 1.28
|
8.53 units on a scale
Standard Deviation 1.91
|
—
|
PRIMARY outcome
Timeframe: 4 weeksParticipant rating of overall sensation for moistness (hydration). Collected at 4 weeks wear for both study lens pairs. 5-point Likert Scale; 1=Excellent, 2=Good, 3=Average, 4=Below Average, 5=Poor.
Outcome measures
| Measure |
Comfilcon A
n=56 Participants
Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
|
Lotrafilcon B
n=57 Participants
Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
|
Habitual Lens
Subjects attended baseline visit wearing habitual lenses prior to dispense of study lens.
|
|---|---|---|---|
|
Overall Sensation of Moistness
Excellent
|
17 participants
|
13 participants
|
—
|
|
Overall Sensation of Moistness
Good
|
25 participants
|
21 participants
|
—
|
|
Overall Sensation of Moistness
Average
|
9 participants
|
14 participants
|
—
|
|
Overall Sensation of Moistness
Fair
|
4 participants
|
6 participants
|
—
|
|
Overall Sensation of Moistness
Poor
|
1 participants
|
3 participants
|
—
|
PRIMARY outcome
Timeframe: 4 weeksParticipant rating of overall sensation for smoothness (deposit resistance). Collected at 4 weeks wear for both study lens pairs. 5-point Likert Scale; 1=Excellent, 2=Good, 3=Average, 4=Below Average, 5=Poor.
Outcome measures
| Measure |
Comfilcon A
n=56 Participants
Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
|
Lotrafilcon B
n=57 Participants
Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
|
Habitual Lens
Subjects attended baseline visit wearing habitual lenses prior to dispense of study lens.
|
|---|---|---|---|
|
Overall Sensation of Smoothness
Excellent
|
22 participants
|
18 participants
|
—
|
|
Overall Sensation of Smoothness
Good
|
23 participants
|
16 participants
|
—
|
|
Overall Sensation of Smoothness
Average
|
8 participants
|
16 participants
|
—
|
|
Overall Sensation of Smoothness
Fair
|
3 participants
|
6 participants
|
—
|
|
Overall Sensation of Smoothness
Poor
|
0 participants
|
1 participants
|
—
|
PRIMARY outcome
Timeframe: 4 weeksParticipant rating of satisfaction regarding comfort. Collected at 4 weeks wear for both study lens pairs. 4-point Likert Scale; 1=Completely Satisfied, 2=Somewhat Satisfied, 3=Somewhat Dissatisfied, 4=Completely Dissatisfied
Outcome measures
| Measure |
Comfilcon A
n=56 Participants
Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
|
Lotrafilcon B
n=57 Participants
Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
|
Habitual Lens
Subjects attended baseline visit wearing habitual lenses prior to dispense of study lens.
|
|---|---|---|---|
|
Overall Comfort Satisfaction
Completely Satisfied
|
28 participants
|
20 participants
|
—
|
|
Overall Comfort Satisfaction
Somewhat Satisfied
|
21 participants
|
25 participants
|
—
|
|
Overall Comfort Satisfaction
Somewhat Dissatisfied
|
5 participants
|
8 participants
|
—
|
|
Overall Comfort Satisfaction
Completely Dissatisfied
|
2 participants
|
4 participants
|
—
|
PRIMARY outcome
Timeframe: 4 weeksParticipant rating of satisfaction regarding dryness. Collected at 4 weeks wear for both study lens pairs. 4-point Likert Scale; 1=Completely Satisfied, 2=Somewhat Satisfied, 3=Somewhat Dissatisfied, 4=Completely Dissatisfied
Outcome measures
| Measure |
Comfilcon A
n=56 Participants
Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
|
Lotrafilcon B
n=57 Participants
Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
|
Habitual Lens
Subjects attended baseline visit wearing habitual lenses prior to dispense of study lens.
|
|---|---|---|---|
|
Overall Dryness Satisfaction
Completely Satisfied
|
22 participants
|
21 participants
|
—
|
|
Overall Dryness Satisfaction
Somewhat Satisfied
|
27 participants
|
22 participants
|
—
|
|
Overall Dryness Satisfaction
Somewhat Dissatisfied
|
5 participants
|
8 participants
|
—
|
|
Overall Dryness Satisfaction
Completely Dissatisfied
|
2 participants
|
6 participants
|
—
|
PRIMARY outcome
Timeframe: 4 weeksParticipant rating of satisfaction regarding handling. Collected at 4 weeks wear for both study lens pairs. 4-point Likert Scale; 1=Completely Satisfied, 2=Somewhat Satisfied, 3=Somewhat Dissatisfied, 4=Completely Dissatisfied
Outcome measures
| Measure |
Comfilcon A
n=56 Participants
Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
|
Lotrafilcon B
n=57 Participants
Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
|
Habitual Lens
Subjects attended baseline visit wearing habitual lenses prior to dispense of study lens.
|
|---|---|---|---|
|
Overall Handling Satisfaction
Completely Satisfied
|
42 participants
|
44 participants
|
—
|
|
Overall Handling Satisfaction
Somewhat Satisfied
|
12 participants
|
11 participants
|
—
|
|
Overall Handling Satisfaction
Somewhat Dissatisfied
|
1 participants
|
2 participants
|
—
|
|
Overall Handling Satisfaction
Completely Dissatisfied
|
1 participants
|
0 participants
|
—
|
PRIMARY outcome
Timeframe: 4 weeksParticipant rating of overall satisfaction for vision. Collected at 4 weeks wear for both study lens pairs. 4-point Likert Scale; 1=Completely Satisfied, 2=Somewhat Satisfied, 3=Somewhat Dissatisfied, 4=Completely Dissatisfied
Outcome measures
| Measure |
Comfilcon A
n=56 Participants
Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
|
Lotrafilcon B
n=57 Participants
Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
|
Habitual Lens
Subjects attended baseline visit wearing habitual lenses prior to dispense of study lens.
|
|---|---|---|---|
|
Overall Vision Satisfaction
Completely Satisfied
|
45 participants
|
38 participants
|
—
|
|
Overall Vision Satisfaction
Somewhat Satisfied
|
8 participants
|
12 participants
|
—
|
|
Overall Vision Satisfaction
Somewhat Dissatisfied
|
2 participants
|
3 participants
|
—
|
|
Overall Vision Satisfaction
Completely Dissatisfied
|
1 participants
|
4 participants
|
—
|
PRIMARY outcome
Timeframe: 4 weeksParticipant rating of satisfaction overall. Collected at 4 weeks wear for both study lens pairs. 4-point Likert Scale; 1=Completely Satisfied, 2=Somewhat Satisfied, 3=Somewhat Dissatisfied, 4=Completely Dissatisfied
Outcome measures
| Measure |
Comfilcon A
n=56 Participants
Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
|
Lotrafilcon B
n=57 Participants
Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
|
Habitual Lens
Subjects attended baseline visit wearing habitual lenses prior to dispense of study lens.
|
|---|---|---|---|
|
Overall Satisfaction
Completely Satisfied
|
28 participants
|
23 participants
|
—
|
|
Overall Satisfaction
Somewhat Satisfied
|
22 participants
|
23 participants
|
—
|
|
Overall Satisfaction
Somewhat Dissatisfied
|
5 participants
|
9 participants
|
—
|
|
Overall Satisfaction
Completely Dissatisfied
|
1 participants
|
2 participants
|
—
|
PRIMARY outcome
Timeframe: 4 weeksParticipant lens preference in regard for comfort, dryness, handling, vision and overall. Collected at 4 weeks. (Forced Choice; Study Pair 1, Study Pair 2).
Outcome measures
| Measure |
Comfilcon A
n=53 Participants
Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
|
Lotrafilcon B
n=53 Participants
Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
|
Habitual Lens
Subjects attended baseline visit wearing habitual lenses prior to dispense of study lens.
|
|---|---|---|---|
|
Lens Preference
Comfort
|
32 participants
|
21 participants
|
—
|
|
Lens Preference
Dryness
|
32 participants
|
21 participants
|
—
|
|
Lens Preference
Handling
|
30 participants
|
23 participants
|
—
|
|
Lens Preference
Vision
|
33 participants
|
20 participants
|
—
|
|
Lens Preference
Overall
|
32 participants
|
21 participants
|
—
|
PRIMARY outcome
Timeframe: 4 weeksParticipant lens preference regarding comfort, dryness, vision and overall. Collected at study exit. (Forced Choice; Study Pair 1, Study Pair 2, Habitual).
Outcome measures
| Measure |
Comfilcon A
n=53 Participants
Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
|
Lotrafilcon B
n=53 Participants
Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
|
Habitual Lens
n=53 Participants
Subjects attended baseline visit wearing habitual lenses prior to dispense of study lens.
|
|---|---|---|---|
|
Lens Preference Comfort, Dryness, Vision and Overall.
Comfort
|
24 participants
|
10 participants
|
19 participants
|
|
Lens Preference Comfort, Dryness, Vision and Overall.
Dryness
|
23 participants
|
11 participants
|
19 participants
|
|
Lens Preference Comfort, Dryness, Vision and Overall.
Vision
|
23 participants
|
10 participants
|
20 participants
|
|
Lens Preference Comfort, Dryness, Vision and Overall.
Overall
|
22 participants
|
10 participants
|
21 participants
|
PRIMARY outcome
Timeframe: 4 weeksParticipant lens preference regarding handling. Collected at study exit. (Forced Choice; Study Pair 1, Study Pair 2, Habitual).
Outcome measures
| Measure |
Comfilcon A
n=54 Participants
Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
|
Lotrafilcon B
n=54 Participants
Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
|
Habitual Lens
n=54 Participants
Subjects attended baseline visit wearing habitual lenses prior to dispense of study lens.
|
|---|---|---|---|
|
Lens Preference for Handling
|
21 participants
|
14 participants
|
19 participants
|
SECONDARY outcome
Timeframe: DispenseAssessment of visual acuity (VA). Collected at 2 weeks for both study lens pairs. Binocular High Contrast Distance. logMAR (negative logMAR values indicates better Visual Acuity (VA)). 0.0 logMAR = 20/20 snellen chart
Outcome measures
| Measure |
Comfilcon A
n=63 Participants
Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
|
Lotrafilcon B
n=60 Participants
Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
|
Habitual Lens
Subjects attended baseline visit wearing habitual lenses prior to dispense of study lens.
|
|---|---|---|---|
|
Binocular Visual Acuity logMAR
|
-0.052 logMAR
Standard Deviation 0.048
|
-0.054 logMAR
Standard Deviation 0.050
|
—
|
SECONDARY outcome
Timeframe: DispenseAssessment of surface wetting by slit lamp. Collected at dispense for both study pairs. 0=Non-wettable surface, 1= \> 1 non-wetting area of some magnitude., 2=One non-wetting area of some magnitude, 3=Hazy surface that resolves with a blink. Typical soft lens appearance with long drying time., 4=Smooth uniformly reflective surface. Appearance of a healthy cornea (Grade 0-4 in ½ steps)
Outcome measures
| Measure |
Comfilcon A
n=126 eyes
Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
|
Lotrafilcon B
n=120 eyes
Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
|
Habitual Lens
Subjects attended baseline visit wearing habitual lenses prior to dispense of study lens.
|
|---|---|---|---|
|
Surface Wetting
|
7.59 units on a scale
Standard Deviation 1.45
|
7.75 units on a scale
Standard Deviation 1.09
|
—
|
SECONDARY outcome
Timeframe: DispenseAssessment of surface deposition by slit lamp. Collected at dispense for both study pairs. (Grade 0-4 in ½ steps; Clean= 0; Deposited = 4)
Outcome measures
| Measure |
Comfilcon A
n=126 eyes
Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
|
Lotrafilcon B
n=120 eyes
Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
|
Habitual Lens
Subjects attended baseline visit wearing habitual lenses prior to dispense of study lens.
|
|---|---|---|---|
|
Surface Deposition
|
0.37 units on a scale
Standard Deviation 1.46
|
0.23 units on a scale
Standard Deviation 1.10
|
—
|
SECONDARY outcome
Timeframe: DispenseAssessment of lens centration. Collected at dispense for both study pairs. Biomicroscopy; by degree and direction in the primary position. (Rated as Optimal Centration or Not Optimal)
Outcome measures
| Measure |
Comfilcon A
n=126 lenses
Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
|
Lotrafilcon B
n=120 lenses
Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
|
Habitual Lens
Subjects attended baseline visit wearing habitual lenses prior to dispense of study lens.
|
|---|---|---|---|
|
Centration
Optimal Centration
|
116 lenses
|
109 lenses
|
—
|
|
Centration
Not Optimal Centration
|
10 lenses
|
11 lenses
|
—
|
SECONDARY outcome
Timeframe: DispenseAssessment of lens corneal coverage. Collected at dispense for both study pairs. Biomicroscopy; assessed in primary gaze. (Rated as Normal Coverage or Not Covering)
Outcome measures
| Measure |
Comfilcon A
n=126 lenses
Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
|
Lotrafilcon B
n=120 lenses
Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
|
Habitual Lens
Subjects attended baseline visit wearing habitual lenses prior to dispense of study lens.
|
|---|---|---|---|
|
Corneal Coverage
Normal Coverage
|
126 lenses
|
118 lenses
|
—
|
|
Corneal Coverage
Not Covering
|
0 lenses
|
2 lenses
|
—
|
SECONDARY outcome
Timeframe: DispenseAssessment of post blink movement. Collected at dispense for both study lens pairs. Assessed immediately after the blink. (0-4, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement)
Outcome measures
| Measure |
Comfilcon A
n=126 lenses
Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
|
Lotrafilcon B
n=120 lenses
Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
|
Habitual Lens
Subjects attended baseline visit wearing habitual lenses prior to dispense of study lens.
|
|---|---|---|---|
|
Post Blink Movement
Movement Grade 0
|
0 lenses
|
0 lenses
|
—
|
|
Post Blink Movement
Movement Grade 1
|
11 lenses
|
13 lenses
|
—
|
|
Post Blink Movement
Movement Grade 2
|
104 lenses
|
92 lenses
|
—
|
|
Post Blink Movement
Movement Grade 3
|
11 lenses
|
15 lenses
|
—
|
|
Post Blink Movement
Movement Grade 4
|
0 lenses
|
0 lenses
|
—
|
SECONDARY outcome
Timeframe: DispenseAssessment of lens tightness. Collected at dispense for both study pairs. Digital push up test. Continuous Scale (0-100%, 0%=Falls from cornea without lid support, 50%= Optimum, 100%= No movement)
Outcome measures
| Measure |
Comfilcon A
n=120 lenses
Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
|
Lotrafilcon B
n=126 lenses
Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
|
Habitual Lens
Subjects attended baseline visit wearing habitual lenses prior to dispense of study lens.
|
|---|---|---|---|
|
Push Up Test
|
49.25 units on a scale
Standard Deviation 11.42
|
48.13 units on a scale
Standard Deviation 11.34
|
—
|
SECONDARY outcome
Timeframe: DispenseAssessment of overall lens fit acceptance. Collected at dispense for both study pairs. (0-4, 0=should not be worn, 1=borderline but unacceptable, 2=minimally acceptable, early review, 3=not perfect but okay to dispense, 4=perfect)
Outcome measures
| Measure |
Comfilcon A
n=126 lenses
Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
|
Lotrafilcon B
n=120 lenses
Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
|
Habitual Lens
Subjects attended baseline visit wearing habitual lenses prior to dispense of study lens.
|
|---|---|---|---|
|
Overall Fit Acceptance
|
3.74 units on a scale
Standard Deviation 0.48
|
3.68 units on a scale
Standard Deviation 0.47
|
—
|
SECONDARY outcome
Timeframe: 2 weeksParticipant use of rewetting drops. Collected at 2 weeks for both study lens pairs. (Uses rewetting drops / Does not use rewetting drops).
Outcome measures
| Measure |
Comfilcon A
n=58 Participants
Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
|
Lotrafilcon B
n=57 Participants
Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
|
Habitual Lens
Subjects attended baseline visit wearing habitual lenses prior to dispense of study lens.
|
|---|---|---|---|
|
Rewetting Drops
Uses
|
50 participants
|
47 participants
|
—
|
|
Rewetting Drops
Does Not Use
|
8 participants
|
10 participants
|
—
|
SECONDARY outcome
Timeframe: 2 WeeksAssessment of visual acuity (VA). Collected at 2 weeks for both study lens pairs. Binocular High Contrast Distance. logMAR (negative logMAR values indicates better Visual Acuity (VA)). 0.0 logMAR = 20/20 snellen chart
Outcome measures
| Measure |
Comfilcon A
n=58 Participants
Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
|
Lotrafilcon B
n=57 Participants
Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
|
Habitual Lens
Subjects attended baseline visit wearing habitual lenses prior to dispense of study lens.
|
|---|---|---|---|
|
Binocular Visual Acuity logMAR
|
-0.036 logMAR
Standard Deviation 0.076
|
-0.037 logMAR
Standard Deviation 0.048
|
—
|
SECONDARY outcome
Timeframe: 2 WeeksAssessment of surface wetting by slit lamp. Collected at 2 weeks for both study lens pairs. 0=Non-wettable surface, 1= \> 1 non-wetting area of some magnitude., 2=One non-wetting area of some magnitude, 3=Hazy surface that resolves with a blink. Typical soft lens appearance with long drying time., 4=Smooth uniformly reflective surface. Appearance of a healthy cornea (Grade 0-4 in ½ steps)
Outcome measures
| Measure |
Comfilcon A
n=58 Participants
Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
|
Lotrafilcon B
n=57 Participants
Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
|
Habitual Lens
Subjects attended baseline visit wearing habitual lenses prior to dispense of study lens.
|
|---|---|---|---|
|
Surface Wetting
|
7.23 units on a scale
Standard Deviation 1.83
|
7.05 units on a scale
Standard Deviation 1.61
|
—
|
SECONDARY outcome
Timeframe: 2 WeeksAssessment of surface deposition by slit lamp. Collected at 2 weeks for both study lens pairs. (Grade 0-4 in 1/2 steps; 0=clean, 4=deposited)
Outcome measures
| Measure |
Comfilcon A
n=116 eyes
Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
|
Lotrafilcon B
n=114 eyes
Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
|
Habitual Lens
Subjects attended baseline visit wearing habitual lenses prior to dispense of study lens.
|
|---|---|---|---|
|
Surface Deposition
|
0.46 units on a scale
Standard Deviation 0.85
|
1.05 units on a scale
Standard Deviation 1.62
|
—
|
SECONDARY outcome
Timeframe: 2 WeeksAssessment of lens centration. Collected at 2 weeks. Biomicroscopy; by degree and direction in the primary position. Optimal versus not optimal
Outcome measures
| Measure |
Comfilcon A
n=116 lenses
Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
|
Lotrafilcon B
n=114 lenses
Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
|
Habitual Lens
Subjects attended baseline visit wearing habitual lenses prior to dispense of study lens.
|
|---|---|---|---|
|
Centration
Optimal Centration
|
110 lenses
|
100 lenses
|
—
|
|
Centration
Not Optimal Centration
|
6 lenses
|
14 lenses
|
—
|
SECONDARY outcome
Timeframe: 2 WeeksAssessment of lens corneal coverage. Collected at 2 weeks for both study pairs. Biomicroscopy; assessed in primary gaze. (Rated as Normal Coverage or Not Covering)
Outcome measures
| Measure |
Comfilcon A
n=116 lenses
Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
|
Lotrafilcon B
n=114 lenses
Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
|
Habitual Lens
Subjects attended baseline visit wearing habitual lenses prior to dispense of study lens.
|
|---|---|---|---|
|
Corneal Coverage
Normal Coverage
|
116 lenses
|
113 lenses
|
—
|
|
Corneal Coverage
Not Covering
|
0 lenses
|
1 lenses
|
—
|
SECONDARY outcome
Timeframe: 2 WeeksAssessment of post blink movement. Collected at 2 weeks for both study lens pairs. Assessed immediately after the blink. (Graded 0-4, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement)
Outcome measures
| Measure |
Comfilcon A
n=116 lenses
Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
|
Lotrafilcon B
n=114 lenses
Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
|
Habitual Lens
Subjects attended baseline visit wearing habitual lenses prior to dispense of study lens.
|
|---|---|---|---|
|
Post Blink Movement
Movement Grade 0
|
0 lenses
|
0 lenses
|
—
|
|
Post Blink Movement
Movement Grade 1
|
9 lenses
|
18 lenses
|
—
|
|
Post Blink Movement
Movement Grade 2
|
107 lenses
|
83 lenses
|
—
|
|
Post Blink Movement
Movement Grade 3
|
0 lenses
|
12 lenses
|
—
|
|
Post Blink Movement
Movement Grade 4
|
0 lenses
|
1 lenses
|
—
|
SECONDARY outcome
Timeframe: 2 WeeksAssessment of lens tightness. Collected at 2 weeks for both study pairs. Digital push up test. (Continuous Scale 0-100%, 0%=Falls from cornea without lid support, 50%= Optimum, 100%= No movement)
Outcome measures
| Measure |
Comfilcon A
n=116 lenses
Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
|
Lotrafilcon B
n=114 lenses
Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
|
Habitual Lens
Subjects attended baseline visit wearing habitual lenses prior to dispense of study lens.
|
|---|---|---|---|
|
Push Up Test
|
50.78 units on a scale
Standard Deviation 10.71
|
51.9 units on a scale
Standard Deviation 11.66
|
—
|
SECONDARY outcome
Timeframe: 2 WeeksAssessment of overall lens fit acceptance. Collected at 2 weeks for both study pairs. (0-4, 0=should not be worn, 1=borderline but unacceptable, 2=minimally acceptable, early review, 3=not perfect but OK to dispense, 4=perfect)
Outcome measures
| Measure |
Comfilcon A
n=116 lenses
Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
|
Lotrafilcon B
n=114 lenses
Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
|
Habitual Lens
Subjects attended baseline visit wearing habitual lenses prior to dispense of study lens.
|
|---|---|---|---|
|
Overall Fit Acceptance
Grade 0
|
0 lenses
|
0 lenses
|
—
|
|
Overall Fit Acceptance
Grade 1
|
0 lenses
|
2 lenses
|
—
|
|
Overall Fit Acceptance
Grade 2
|
0 lenses
|
0 lenses
|
—
|
|
Overall Fit Acceptance
Grade 3
|
22 lenses
|
41 lenses
|
—
|
|
Overall Fit Acceptance
Grade 4
|
94 lenses
|
71 lenses
|
—
|
SECONDARY outcome
Timeframe: 4 WeeksAssessment of visual acuity (VA). Collected at 2 weeks for both study lens pairs. Binocular High Contrast Distance. logMAR (negative logMAR values indicates better Visual Acuity (VA)). 0.0 logMAR = 20/20 snellen chart
Outcome measures
| Measure |
Comfilcon A
n=56 Participants
Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
|
Lotrafilcon B
n=57 Participants
Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
|
Habitual Lens
Subjects attended baseline visit wearing habitual lenses prior to dispense of study lens.
|
|---|---|---|---|
|
Binocular Visual Acuity logMAR
|
-0.052 logMAR
Standard Deviation 0.0063
|
-0.047 logMAR
Standard Deviation 0.058
|
—
|
SECONDARY outcome
Timeframe: 4 WeeksAssessment of surface wetting by slit lamp. Collected at 4 weeks wear for both study lens pairs. 0=Non-wettable surface, 1= \> 1 non-wetting area of some magnitude., 2=One non-wetting area of some magnitude, 3=Hazy surface that resolves with a blink. Typical soft lens appearance with long drying time., 4=Smooth uniformly reflective surface. Appearance of a healthy cornea (Grade 0-4 in ½ steps)
Outcome measures
| Measure |
Comfilcon A
n=56 Participants
Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
|
Lotrafilcon B
n=57 Participants
Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
|
Habitual Lens
Subjects attended baseline visit wearing habitual lenses prior to dispense of study lens.
|
|---|---|---|---|
|
Surface Wetting
|
7.09 units on a scale
Standard Deviation 1.84
|
6.95 units on a scale
Standard Deviation 1.53
|
—
|
SECONDARY outcome
Timeframe: 4 WeeksAssessment of surface deposition by slit lamp. Collected at 4 weeks wear for both study lens pairs. (Grade 0-4 in 1/2 steps; 0=clean, 4=deposited)
Outcome measures
| Measure |
Comfilcon A
n=56 Participants
Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
|
Lotrafilcon B
n=57 Participants
Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
|
Habitual Lens
Subjects attended baseline visit wearing habitual lenses prior to dispense of study lens.
|
|---|---|---|---|
|
Surface Deposition
|
0.58 units on a scale
Standard Deviation 1.18
|
1.04 units on a scale
Standard Deviation 1.65
|
—
|
SECONDARY outcome
Timeframe: 4 WeeksAssessment of lens centration. Collected at 4 weeks wear for both study lens pairs.. Biomicroscopy, by degree and direction in the primary position. (Optimal Centration or Not Optimal)
Outcome measures
| Measure |
Comfilcon A
n=110 lenses
Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
|
Lotrafilcon B
n=114 lenses
Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
|
Habitual Lens
Subjects attended baseline visit wearing habitual lenses prior to dispense of study lens.
|
|---|---|---|---|
|
Centration
Optimal Centration
|
100 lenses
|
106 lenses
|
—
|
|
Centration
Not Optimal Centration
|
10 lenses
|
8 lenses
|
—
|
SECONDARY outcome
Timeframe: 4 WeeksAssessment of lens corneal coverage. Collected at 4 weeks. (Biomicroscopy; assessed in primary gaze, Normal Coverage or Not Covering)
Outcome measures
| Measure |
Comfilcon A
n=110 lenses
Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
|
Lotrafilcon B
n=114 lenses
Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
|
Habitual Lens
Subjects attended baseline visit wearing habitual lenses prior to dispense of study lens.
|
|---|---|---|---|
|
Corneal Coverage
Normal Coverage
|
110 lenses
|
114 lenses
|
—
|
|
Corneal Coverage
Not Covering
|
0 lenses
|
0 lenses
|
—
|
SECONDARY outcome
Timeframe: 4 WeeksAssessment of post blink movement. Collected at 4 weeks. Assessed immediately after the blink. (Graded 0-4, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement)
Outcome measures
| Measure |
Comfilcon A
n=110 lenses
Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
|
Lotrafilcon B
n=114 lenses
Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
|
Habitual Lens
Subjects attended baseline visit wearing habitual lenses prior to dispense of study lens.
|
|---|---|---|---|
|
Post Blink Movement
Movement Grade 0
|
0 units on a scale
|
0 units on a scale
|
—
|
|
Post Blink Movement
Movement Grade 1
|
8 units on a scale
|
11 units on a scale
|
—
|
|
Post Blink Movement
Movement Grade 2
|
96 units on a scale
|
92 units on a scale
|
—
|
|
Post Blink Movement
Movement Grade 3
|
6 units on a scale
|
9 units on a scale
|
—
|
|
Post Blink Movement
Movement Grade 4
|
0 units on a scale
|
2 units on a scale
|
—
|
SECONDARY outcome
Timeframe: 4 WeeksAssessment of lens tightness. Collected at 4 weeks. Digital push up test. (Continuous Scale 0-100%, 0%=Falls from cornea without lid support, 50%= Optimum, 100%= No movement)
Outcome measures
| Measure |
Comfilcon A
n=110 lenses
Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
|
Lotrafilcon B
n=114 lenses
Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
|
Habitual Lens
Subjects attended baseline visit wearing habitual lenses prior to dispense of study lens.
|
|---|---|---|---|
|
Push Up Test
|
51.73 units on a scale
Standard Deviation 10.80
|
52.24 units on a scale
Standard Deviation 10.46
|
—
|
SECONDARY outcome
Timeframe: 4 WeeksAssessment of overall lens fit acceptance. Collected at 4 weeks. (0-4, 0=should not be worn, 1=borderline but unacceptable, 2=minimally acceptable, early review, 3=not perfect but OK to dispense, 4=perfect)
Outcome measures
| Measure |
Comfilcon A
n=110 lenses
Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
|
Lotrafilcon B
n=114 lenses
Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
|
Habitual Lens
Subjects attended baseline visit wearing habitual lenses prior to dispense of study lens.
|
|---|---|---|---|
|
Overall Fit Acceptance
Grade 0
|
0 lenses
|
0 lenses
|
—
|
|
Overall Fit Acceptance
Grade 1
|
0 lenses
|
0 lenses
|
—
|
|
Overall Fit Acceptance
Grade 2
|
6 lenses
|
4 lenses
|
—
|
|
Overall Fit Acceptance
Grade 3
|
17 lenses
|
36 lenses
|
—
|
|
Overall Fit Acceptance
Grade 4
|
87 lenses
|
72 lenses
|
—
|
SECONDARY outcome
Timeframe: 4 weeksParticipant likelihood of switching from their habitual lens to the study lens. Collected at 4 weeks wear for both study lens pairs. 4-point Likert Scale; 1=very likely, 2=likely, 3=unlikely, 4=very unlikely
Outcome measures
| Measure |
Comfilcon A
n=56 Participants
Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
|
Lotrafilcon B
n=57 Participants
Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
|
Habitual Lens
Subjects attended baseline visit wearing habitual lenses prior to dispense of study lens.
|
|---|---|---|---|
|
Likelihood of Switching From Habitual Lens to Study Lens
very likely
|
10 participants
|
9 participants
|
—
|
|
Likelihood of Switching From Habitual Lens to Study Lens
likely
|
22 participants
|
9 participants
|
—
|
|
Likelihood of Switching From Habitual Lens to Study Lens
unlikely
|
13 participants
|
16 participants
|
—
|
|
Likelihood of Switching From Habitual Lens to Study Lens
very unlikely
|
11 participants
|
23 participants
|
—
|
SECONDARY outcome
Timeframe: 4 weeksParticipant likelihood of continuing wear of the study lense. Collected at 4 weeks wear for both study lens pairs. 4-point Likert Scale; 1=Very Likely, 2=Likely, 3=Unlikely, 4=Very Unlikely
Outcome measures
| Measure |
Comfilcon A
n=56 Participants
Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
|
Lotrafilcon B
n=57 Participants
Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
|
Habitual Lens
Subjects attended baseline visit wearing habitual lenses prior to dispense of study lens.
|
|---|---|---|---|
|
Likelihood to Continue Wearing the Study Lens
Very Likely
|
13 participants
|
6 participants
|
—
|
|
Likelihood to Continue Wearing the Study Lens
Likely
|
23 participants
|
13 participants
|
—
|
|
Likelihood to Continue Wearing the Study Lens
Unlikely
|
10 participants
|
19 participants
|
—
|
|
Likelihood to Continue Wearing the Study Lens
Very Unlikely
|
10 participants
|
19 participants
|
—
|
SECONDARY outcome
Timeframe: 4 weeksParticipant most likely recommendation of which study lens to friends, family or colleagues. Collected at study exit. (Forced Choice; Study Pair 1, Study Pair 2).
Outcome measures
| Measure |
Comfilcon A
n=53 Participants
Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
|
Lotrafilcon B
n=53 Participants
Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
|
Habitual Lens
Subjects attended baseline visit wearing habitual lenses prior to dispense of study lens.
|
|---|---|---|---|
|
Participant Recommendation of a Study Lens
|
31 participants
|
22 participants
|
—
|
SECONDARY outcome
Timeframe: 4 weeksParticipant likelihood of recommending a study lens to friends. Collected at study exit. (1-4; 1=Very Unlikely, 2=Unlikely, 3=Likely, 4=Very Likely).
Outcome measures
| Measure |
Comfilcon A
n=53 Participants
Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
|
Lotrafilcon B
n=53 Participants
Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
|
Habitual Lens
Subjects attended baseline visit wearing habitual lenses prior to dispense of study lens.
|
|---|---|---|---|
|
Participant Likelihood of Recommendation of a Study Lens
Very Unlikely
|
6 participants
|
12 participants
|
—
|
|
Participant Likelihood of Recommendation of a Study Lens
Unlikely
|
6 participants
|
11 participants
|
—
|
|
Participant Likelihood of Recommendation of a Study Lens
Likely
|
19 participants
|
16 participants
|
—
|
|
Participant Likelihood of Recommendation of a Study Lens
Very Likely
|
22 participants
|
14 participants
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: DispenseThe number of trials needed to achieve final dispensing pair of study lenses. Number of lenses required to dispense the final pair of study lenses. Collected at dispense for both study lens pairs. (Number required; 1, 2, 3, \>3)
Outcome measures
| Measure |
Comfilcon A
n=126 lenses
Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
|
Lotrafilcon B
n=120 lenses
Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
|
Habitual Lens
Subjects attended baseline visit wearing habitual lenses prior to dispense of study lens.
|
|---|---|---|---|
|
The Number of Trials Needed to Achieve Final Dispensing Pair of Study Lenses.
|
2.06 number of trial lenses
Standard Deviation 0.30
|
2.03 number of trial lenses
Standard Deviation 0.18
|
—
|
Adverse Events
Comfilcon A
Serious events: 1 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
| Measure |
Comfilcon A
n=63 participants at risk
Daily wear soft contact lens comfilcon A
lotrafilcon B: Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
|
Lotrafilcon B
n=63 participants at risk
Daily wear soft contact lens lotrafilcon B
comfilcon A: Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
|
|---|---|---|
|
Eye disorders
Peripheral Corneal Ulcer
|
1.6%
1/63 • Number of events 1
|
0.00%
0/63
|
Other adverse events
Adverse event data not reported
Additional Information
Donald Siegel, OD Principal Investigator
CooperVision
Phone: (949) 597-4700
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The investigators will not be permitted to publish or present at scientific meetings results obtained from the clinical study without prior written consent from the sponsor.
- Publication restrictions are in place
Restriction type: OTHER