Trial Outcomes & Findings for Lid Wiper Epitheliopathy Trial (NCT NCT01870856)
NCT ID: NCT01870856
Last Updated: 2014-10-29
Results Overview
LWE was measured by slit lamp evaluation of fluorescein and lissamine green staining of the upper eyelid. LWE was graded on a scale from 0 to 3, where 0=none and 3=severe. The percent of eyes experiencing at least a 1 grade reduction in LWE (from baseline) at the 2-week visit was compared between groups. One eye (study eye) contributed to the analysis.
TERMINATED
NA
187 participants
Baseline, Week 2
2014-10-29
Participant Flow
Participants were recruited from 23 study centers located in the US.
Of the 187 enrolled, 135 participants were exited as screen failures prior to randomization. This reporting group includes all randomized participants. Results from Stage 1 were planned to be used to appropriately power Stage 2 of the study. Since primary efficacy cannot be demonstrated in Stage 1, Stage 2 of this study was not conducted.
Participant milestones
| Measure |
Spectacles, Stage 1
Spectacles per participant's habitual perscription worn for 2 weeks
|
1-DAY ACUVUE, Stage 1
Contact lenses worn bilaterally (in both eyes) at least 5 days per week, at least 6 hours per day, for 2 weeks in a daily disposable mode
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
27
|
|
Overall Study
COMPLETED
|
25
|
27
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Lid Wiper Epitheliopathy Trial
Baseline characteristics by cohort
| Measure |
Spectacles, Stage 1
n=25 Participants
Spectacles per participant's habitual perscription worn for 2 weeks
|
1-DAY ACUVUE, Stage 1
n=27 Participants
Contact lenses worn bilaterally (in both eyes) at least 5 days per week, at least 6 hours per day, for 2 weeks in a daily disposable mode
|
Total
n=52 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
34.1 years
STANDARD_DEVIATION 10.9 • n=5 Participants
|
34.1 years
STANDARD_DEVIATION 9.4 • n=7 Participants
|
34.1 years
STANDARD_DEVIATION 10.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 2Population: This analysis population includes all randomized subjects who did not meet the critical deviation criteria as specified in the Deviations and Evaluability Plan. Denominator for percentages is the number of subjects with data available at both time points.
LWE was measured by slit lamp evaluation of fluorescein and lissamine green staining of the upper eyelid. LWE was graded on a scale from 0 to 3, where 0=none and 3=severe. The percent of eyes experiencing at least a 1 grade reduction in LWE (from baseline) at the 2-week visit was compared between groups. One eye (study eye) contributed to the analysis.
Outcome measures
| Measure |
Spectacles, Stage 1
n=21 Participants
Spectacles per participant's habitual perscription worn for 2 weeks
|
1-DAY ACUVUE, Stage 1
n=21 Participants
Contact lenses worn bilaterally (in both eyes) at least 5 days per week, at least 6 hours per day, for 2 weeks in a daily disposable mode
|
|---|---|---|
|
Stage 1: Percent of Eyes Experiencing at Least 1 Grade Reduction in LWE at 2 Weeks
|
100 percentage of subjects
|
81 percentage of subjects
|
PRIMARY outcome
Timeframe: Baseline, Week 2This outcome measure was not evaluated since primary efficacy was not demonstrated.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Week 2This outcome measure was not evaluated since primary efficacy was not demonstrated.
Outcome measures
Outcome data not reported
Adverse Events
Spectacles, Stage 1
1-DAY ACUVUE, Stage 1
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Anne Brobst, Clinical Project Lead
Alcon Research, Ltd.
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
- Publication restrictions are in place
Restriction type: OTHER