Trial Outcomes & Findings for Clinical Evaluation of a Daily Disposable Contact Lens in Symptomatic Weekly/Monthly Lens Wearers (NCT NCT01614600)
NCT ID: NCT01614600
Last Updated: 2013-12-04
Results Overview
Contact lens symptoms were evaluated using the Contact Lens Dry Eye Questionnaire (CLDEQ). Subjects rated 8 common contact lens-related ocular surface dryness symptoms at Baseline, Week 1, and Week 2 using a 5-point scale (1=never or not at all intense, 5=constantly or very intense). A scoring algorithm was used to calculate a composite score for each visit for all symptoms (-6.5 to 10). A higher composite score would indicate more contact lens related dry eye and a lower score, less contact lens related dry eye.
COMPLETED
NA
88 participants
Baseline, Week 1, Week 2
2013-12-04
Participant Flow
Participants were recruited from 8 study centers located in the United States.
Of the 91 participants enrolled, 3 were exited as screen failures prior to dispensing of the study product. This reporting group includes all enrolled and dispensed participants.
Participant milestones
| Measure |
DAILIES® AquaComfort Plus®
Nelfilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for 2 weeks
|
|---|---|
|
Overall Study
STARTED
|
88
|
|
Overall Study
COMPLETED
|
84
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
DAILIES® AquaComfort Plus®
Nelfilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for 2 weeks
|
|---|---|
|
Overall Study
Unacceptable fit
|
1
|
|
Overall Study
Discomfort
|
1
|
|
Overall Study
Unable to remove lens at the end of day
|
1
|
|
Overall Study
Protocol deviation
|
1
|
Baseline Characteristics
Clinical Evaluation of a Daily Disposable Contact Lens in Symptomatic Weekly/Monthly Lens Wearers
Baseline characteristics by cohort
| Measure |
DAILIES® AquaComfort Plus®
n=88 Participants
Nelfilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for 2 weeks
|
|---|---|
|
Age Continuous
|
32.2 years
STANDARD_DEVIATION 9.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
66 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
88 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 1, Week 2Population: Per Protocol: All enrolled and dispensed participants, minus any major protocol deviators as determined by masked review.
Contact lens symptoms were evaluated using the Contact Lens Dry Eye Questionnaire (CLDEQ). Subjects rated 8 common contact lens-related ocular surface dryness symptoms at Baseline, Week 1, and Week 2 using a 5-point scale (1=never or not at all intense, 5=constantly or very intense). A scoring algorithm was used to calculate a composite score for each visit for all symptoms (-6.5 to 10). A higher composite score would indicate more contact lens related dry eye and a lower score, less contact lens related dry eye.
Outcome measures
| Measure |
DAILIES® AquaComfort Plus®
n=74 Participants
Nelfilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for 2 weeks
|
|---|---|
|
Mean Change From Baseline in Contact Lens-Related Dryness Symptoms at Week 1 and Week 2
Change from Baseline at Week 1
|
-0.09 Units on a scale
Standard Deviation 1.24
|
|
Mean Change From Baseline in Contact Lens-Related Dryness Symptoms at Week 1 and Week 2
Change from Baseline at Week 2
|
-0.29 Units on a scale
Standard Deviation 1.06
|
Adverse Events
DAILIES® AquaComfort Plus®
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 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