Trial Outcomes & Findings for Comparison of Clinical Performance and Subjective Preference of Three Contact Lenses (NCT NCT03134599)
NCT ID: NCT03134599
Last Updated: 2019-12-19
Results Overview
Subjective ratings of comfort for each lens pair was assessed. Scale 0-100, 0=causes pain, 100=very comfortable.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
60 participants
Primary outcome timeframe
1 week per intervention
Results posted on
2019-12-19
Participant Flow
Participant milestones
| Measure |
Etafilcon A, Methafilcon A-Interozzo, Methafilcon A (CVI)
etafilcon A first, then methafilcon A - Interozzo then methafilcon A (CVI) contact lens
|
Etafilcon A, Methafilcon A (CVI), Methafilcon A-Interozzo
etafilcon A first, then methafilcon A (CVI) then methafilcon A - Interozzo contact lens
|
Methafilcon A-Interozzo, Methafilcon A (CVI), Etafilcon A
methafilcon A - Interozzo first, then methafilcon A (CVI), then etafilcon A contact lens
|
Methafilcon A-Interozzo, Etafilcon A Methafilcon A (CVI)
methafilcon A - Interozzo first, then etafilcon A contact lens, then methafilcon A (CVI)
|
Methafilcon A (CVI), Methafilcon A-Interozzo, Etafilcon A
methafilcon A (CVI) first, then methafilcon A - Interozzo, then etafilcon A contact lens
|
Methafilcon A (CVI), Etafilcon A, Methafilcon A-Interozzo
methafilcon A (CVI) first, then etafilcon A contact lens, then methafilcon A - Interozzo
|
|---|---|---|---|---|---|---|
|
Week 1
STARTED
|
10
|
10
|
10
|
11
|
10
|
9
|
|
Week 1
COMPLETED
|
10
|
10
|
10
|
11
|
9
|
9
|
|
Week 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Week 2
STARTED
|
10
|
10
|
10
|
11
|
9
|
9
|
|
Week 2
COMPLETED
|
9
|
10
|
10
|
10
|
8
|
9
|
|
Week 2
NOT COMPLETED
|
1
|
0
|
0
|
1
|
1
|
0
|
|
Week 3
STARTED
|
9
|
10
|
10
|
10
|
8
|
9
|
|
Week 3
COMPLETED
|
9
|
10
|
10
|
9
|
8
|
8
|
|
Week 3
NOT COMPLETED
|
0
|
0
|
0
|
1
|
0
|
1
|
Reasons for withdrawal
| Measure |
Etafilcon A, Methafilcon A-Interozzo, Methafilcon A (CVI)
etafilcon A first, then methafilcon A - Interozzo then methafilcon A (CVI) contact lens
|
Etafilcon A, Methafilcon A (CVI), Methafilcon A-Interozzo
etafilcon A first, then methafilcon A (CVI) then methafilcon A - Interozzo contact lens
|
Methafilcon A-Interozzo, Methafilcon A (CVI), Etafilcon A
methafilcon A - Interozzo first, then methafilcon A (CVI), then etafilcon A contact lens
|
Methafilcon A-Interozzo, Etafilcon A Methafilcon A (CVI)
methafilcon A - Interozzo first, then etafilcon A contact lens, then methafilcon A (CVI)
|
Methafilcon A (CVI), Methafilcon A-Interozzo, Etafilcon A
methafilcon A (CVI) first, then methafilcon A - Interozzo, then etafilcon A contact lens
|
Methafilcon A (CVI), Etafilcon A, Methafilcon A-Interozzo
methafilcon A (CVI) first, then etafilcon A contact lens, then methafilcon A - Interozzo
|
|---|---|---|---|---|---|---|
|
Week 1
Lost to Follow-up
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Week 2
Lost to Follow-up
|
1
|
0
|
0
|
1
|
1
|
0
|
|
Week 3
Lost to Follow-up
|
0
|
0
|
0
|
1
|
0
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
All Study Participants
n=60 Participants
All study participants wore enfilcon A, methafilcon A (Interozzo) and methafilcon A (CooperVision) contact lenses.
|
|---|---|
|
Age, Continuous
|
22.3 years
STANDARD_DEVIATION 1.7 • n=60 Participants
|
|
Sex: Female, Male
Female
|
60 Participants
n=60 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=60 Participants
|
|
Region of Enrollment
South Korea
|
60 Participants
n=60 Participants
|
PRIMARY outcome
Timeframe: 1 week per interventionSubjective ratings of comfort for each lens pair was assessed. Scale 0-100, 0=causes pain, 100=very comfortable.
Outcome measures
| Measure |
Etafilcon A
n=54 Participants
etafilcon A contact lens
|
Methafilcon A - Interozzo
n=54 Participants
methafilcon A - Interozzo: contact lens
|
Methafilcon A - CVI
n=54 Participants
methafilcon A - CVI (CooperVision): contact lens
|
|---|---|---|---|
|
Comfort
|
64.19 units on a scale
Standard Deviation 21.70
|
58.57 units on a scale
Standard Deviation 22.48
|
59.31 units on a scale
Standard Deviation 21.53
|
Adverse Events
Etafilcon A
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Methafilcon A-Interozzo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Methafilcon A (CVI)
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
Results disclosure agreements
- Principal investigator is a sponsor employee Disclosure restriction on the PI is that the sponsor should be notified of any results communications and has ability to review.
- Publication restrictions are in place
Restriction type: OTHER