Trial Outcomes & Findings for Multi-Centre Clinical Evaluation of Two Reusable Soft Contact Lenses (NCT NCT02815735)
NCT ID: NCT02815735
Last Updated: 2017-05-08
Results Overview
Comfort (insertion, end of the day, and overall) for habitual lenses assessed at baseline and comfilcon A and lotrafilcon B lenses assessed at 2 weeks and 4 weeks. Scale 0-10, 0=painful, 10=can't feel the lenses.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
85 participants
Primary outcome timeframe
Baseline, 2 weeks, 4 weeks
Results posted on
2017-05-08
Participant Flow
Four subjects were not dispensed lenses due to screen failure. Seven subjects discontinued from the study due to the investigational site withdrawing from the study.
Participant milestones
| Measure |
Comfilcon A, Then Lotrafilcon B
Participants wear comfilcon A lens, then lotrafilcon B for 4 weeks during the cross over study.
comfilcon A: contact lens
lotrafilcon B: contact lens
|
Lotrafilcon B, Then Comfilcon A
Participants wear lotrafilcon B lens, then comfilcon A lens for 4 weeks during the cross over study.
lotrafilcon B: contact lens
comfilcon A: contact lens
|
|---|---|---|
|
First Intervention (4 Weeks)
STARTED
|
36
|
38
|
|
First Intervention (4 Weeks)
COMPLETED
|
34
|
37
|
|
First Intervention (4 Weeks)
NOT COMPLETED
|
2
|
1
|
|
Second Intervention (4 Weeks)
STARTED
|
34
|
37
|
|
Second Intervention (4 Weeks)
COMPLETED
|
33
|
37
|
|
Second Intervention (4 Weeks)
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Comfilcon A, Then Lotrafilcon B
Participants wear comfilcon A lens, then lotrafilcon B for 4 weeks during the cross over study.
comfilcon A: contact lens
lotrafilcon B: contact lens
|
Lotrafilcon B, Then Comfilcon A
Participants wear lotrafilcon B lens, then comfilcon A lens for 4 weeks during the cross over study.
lotrafilcon B: contact lens
comfilcon A: contact lens
|
|---|---|---|
|
First Intervention (4 Weeks)
Discomfort
|
1
|
0
|
|
First Intervention (4 Weeks)
Lost to Follow-up
|
1
|
0
|
|
First Intervention (4 Weeks)
Poor fitting characteristics
|
0
|
1
|
|
Second Intervention (4 Weeks)
Protocol Violation
|
1
|
0
|
Baseline Characteristics
Multi-Centre Clinical Evaluation of Two Reusable Soft Contact Lenses
Baseline characteristics by cohort
| Measure |
Overall Participants
n=74 Participants
Participants wear comfilcon A and lotrafilcon B lens for 4 weeks during the cross over study.
comfilcon A: contact lens
lotrafilcon B: contact lens
|
|---|---|
|
Age, Continuous
|
26.5 years
STANDARD_DEVIATION 4.5 • n=99 Participants
|
|
Sex: Female, Male
Female
|
51 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Baseline, 2 weeks, 4 weeksComfort (insertion, end of the day, and overall) for habitual lenses assessed at baseline and comfilcon A and lotrafilcon B lenses assessed at 2 weeks and 4 weeks. Scale 0-10, 0=painful, 10=can't feel the lenses.
Outcome measures
| Measure |
Habitual (Baseline)
n=73 Participants
Habitual data assessed at baseline.
|
Comfilcon A (2 Weeks)
n=71 Participants
Participants wear comfilcon A lens for 4 weeks during the cross over study.
comfilcon A: contact lens
|
Lotrafilcon B (2 Weeks)
n=69 Participants
Participants wear lotrafilcon B lens for 4 weeks during the cross over study.
lotrafilcon B: contact lens
|
Comfilcon A (4 Weeks)
n=70 Participants
Participants wear comfilcon A lens for 4 weeks during the cross over study.
comfilcon A: contact lens
|
Lotrafilcon B (4 Weeks)
n=70 Participants
Participants wear lotrafilcon B lens for 4 weeks during the cross over study.
lotrafilcon B: contact lens
|
Lotrafilcon B (Day 26)
Participants wear lotrafilcon B lens for 4 weeks during the cross over study.
lotrafilcon B: contact lens
|
|---|---|---|---|---|---|---|
|
Comfort
Comfort on insertion
|
8.90 units on a scale
Standard Deviation 1.38
|
9.03 units on a scale
Standard Deviation 1.10
|
8.70 units on a scale
Standard Deviation 1.57
|
8.74 units on a scale
Standard Deviation 1.25
|
8.60 units on a scale
Standard Deviation 1.62
|
—
|
|
Comfort
Overall comfort
|
8.86 units on a scale
Standard Deviation 1.38
|
8.13 units on a scale
Standard Deviation 1.69
|
8.43 units on a scale
Standard Deviation 1.54
|
8.11 units on a scale
Standard Deviation 1.57
|
8.24 units on a scale
Standard Deviation 1.65
|
—
|
|
Comfort
End-of-Day Comfort
|
8.03 units on a scale
Standard Deviation 1.78
|
7.31 units on a scale
Standard Deviation 2.21
|
7.45 units on a scale
Standard Deviation 2.23
|
7.23 units on a scale
Standard Deviation 2.17
|
7.34 units on a scale
Standard Deviation 2.34
|
—
|
PRIMARY outcome
Timeframe: Days 3, 12, 26Population: Missing data from one participant.
Comfort during the day for comfilcon A and lotrafilcon B lenses assessed via via SMS (short message service) text message at days 3,12, and 26 at hours 8:00 am, 12:00 pm, 4:00 pm, and 8:00 pm. Scale 0-10, 0=painful, 10=can't feel the lenses.
Outcome measures
| Measure |
Habitual (Baseline)
n=69 Participants
Habitual data assessed at baseline.
|
Comfilcon A (2 Weeks)
n=69 Participants
Participants wear comfilcon A lens for 4 weeks during the cross over study.
comfilcon A: contact lens
|
Lotrafilcon B (2 Weeks)
n=72 Participants
Participants wear lotrafilcon B lens for 4 weeks during the cross over study.
lotrafilcon B: contact lens
|
Comfilcon A (4 Weeks)
n=70 Participants
Participants wear comfilcon A lens for 4 weeks during the cross over study.
comfilcon A: contact lens
|
Lotrafilcon B (4 Weeks)
n=70 Participants
Participants wear lotrafilcon B lens for 4 weeks during the cross over study.
lotrafilcon B: contact lens
|
Lotrafilcon B (Day 26)
n=68 Participants
Participants wear lotrafilcon B lens for 4 weeks during the cross over study.
lotrafilcon B: contact lens
|
|---|---|---|---|---|---|---|
|
Comfort During the Day
4:00 pm
|
8.51 units on a scale
Standard Deviation 1.58
|
8.74 units on a scale
Standard Deviation 1.31
|
8.51 units on a scale
Standard Deviation 1.49
|
8.70 units on a scale
Standard Deviation 1.45
|
8.31 units on a scale
Standard Deviation 1.56
|
8.27 units on a scale
Standard Deviation 1.62
|
|
Comfort During the Day
8:00 am
|
8.98 units on a scale
Standard Deviation 1.34
|
8.78 units on a scale
Standard Deviation 1.60
|
8.67 units on a scale
Standard Deviation 1.21
|
8.96 units on a scale
Standard Deviation 1.26
|
8.78 units on a scale
Standard Deviation 1.00
|
8.59 units on a scale
Standard Deviation 1.48
|
|
Comfort During the Day
12:00 pm
|
8.94 units on a scale
Standard Deviation 1.48
|
8.95 units on a scale
Standard Deviation 1.22
|
8.59 units on a scale
Standard Deviation 1.26
|
8.73 units on a scale
Standard Deviation 1.41
|
8.72 units on a scale
Standard Deviation 1.39
|
8.60 units on a scale
Standard Deviation 1.32
|
|
Comfort During the Day
8:00 pm
|
8.15 units on a scale
Standard Deviation 1.94
|
8.14 units on a scale
Standard Deviation 1.59
|
7.91 units on a scale
Standard Deviation 1.89
|
8.25 units on a scale
Standard Deviation 1.77
|
7.85 units on a scale
Standard Deviation 1.70
|
7.89 units on a scale
Standard Deviation 1.92
|
Adverse Events
Comfilcon 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 Inc.
Phone: 925 621-3761
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER