Trial Outcomes & Findings for Clinical Evaluation of Two Daily Disposable Silicone Hydrogel Contact Lenses (NCT NCT01561560)
NCT ID: NCT01561560
Last Updated: 2014-01-07
Results Overview
End-of-day comfort was interpreted and reported by the participant on a questionnaire as a single, retrospective measurement of two weeks of wear. Participants were asked, "Please rate the study lenses you have been wearing the in the following area: End-of-day comfort" and recorded their response on a continuous 1-10 Likert scale (1=poor and 10=excellent).
COMPLETED
NA
123 participants
Week 2
2014-01-07
Participant Flow
Participants were recruited from two study centers in Finland, three study centers in German, and three study centers in the UK.
Of the 123 participants enrolled, two were excluded prior to randomization. This reporting group includes all participants enrolled and exposed to Test Article (121).
Participant milestones
| Measure |
DAILIES TOTAL1, Then TRUEYE
Delefilcon A contact lenses worn first, followed by narafilcon A contact lenses. Each product was worn bilaterally on a daily wear, daily disposable basis for two weeks.
|
TRUEYE, Then DAILIES TOTAL1
Narafilcon A contact lenses worn first, followed by delefilcon A contact lenses. Each product was worn bilaterally on a daily wear, daily disposable basis for two weeks.
|
|---|---|---|
|
First Two Weeks of Wear
STARTED
|
60
|
61
|
|
First Two Weeks of Wear
COMPLETED
|
60
|
59
|
|
First Two Weeks of Wear
NOT COMPLETED
|
0
|
2
|
|
Second Two Weeks of Wear
STARTED
|
60
|
59
|
|
Second Two Weeks of Wear
COMPLETED
|
60
|
58
|
|
Second Two Weeks of Wear
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
DAILIES TOTAL1, Then TRUEYE
Delefilcon A contact lenses worn first, followed by narafilcon A contact lenses. Each product was worn bilaterally on a daily wear, daily disposable basis for two weeks.
|
TRUEYE, Then DAILIES TOTAL1
Narafilcon A contact lenses worn first, followed by delefilcon A contact lenses. Each product was worn bilaterally on a daily wear, daily disposable basis for two weeks.
|
|---|---|---|
|
First Two Weeks of Wear
Time/job conflict
|
0
|
1
|
|
First Two Weeks of Wear
Adverse Event
|
0
|
1
|
|
Second Two Weeks of Wear
Adverse Event
|
0
|
1
|
Baseline Characteristics
Clinical Evaluation of Two Daily Disposable Silicone Hydrogel Contact Lenses
Baseline characteristics by cohort
| Measure |
OVERALL
n=121 Participants
Delefilcon A contact lenses and narafilcon A contact lenses worn in randomized order. Each product was worn bilaterally on a daily wear, daily disposable basis for two weeks.
|
|---|---|
|
Age, Continuous
|
34.0 years
STANDARD_DEVIATION 10.4 • n=39 Participants
|
|
Sex: Female, Male
Female
|
85 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=39 Participants
|
PRIMARY outcome
Timeframe: Week 2Population: This reporting group includes all participants who finished the study, minus any major protocol deviations as determined by masked review.
End-of-day comfort was interpreted and reported by the participant on a questionnaire as a single, retrospective measurement of two weeks of wear. Participants were asked, "Please rate the study lenses you have been wearing the in the following area: End-of-day comfort" and recorded their response on a continuous 1-10 Likert scale (1=poor and 10=excellent).
Outcome measures
| Measure |
DAILIES TOTAL1
n=116 Participants
Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks
|
TRUEYE
n=116 Participants
Narafilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks
|
|---|---|---|
|
End-of-day Comfort
|
8.3 Units on a scale
Standard Deviation 1.91
|
6.6 Units on a scale
Standard Deviation 2.22
|
Adverse Events
DAILIES TOTAL1
TRUEYE
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 Study data should not be disclosed to any third party for a period of three years after the termination of the study without prior written consent.
- Publication restrictions are in place
Restriction type: OTHER