Trial Outcomes & Findings for Comparison of Two Multifocal Contact Lenses Worn on a Daily Disposable Basis (NCT NCT01254760)
NCT ID: NCT01254760
Last Updated: 2012-07-10
Results Overview
End of day comfort was interpreted and reported by the participant on a questionnaire as a single, retrospective evaluation of 5 days of wear. End of day comfort was measured on a 10-point scale, with 1 being poor and 10 being excellent.
COMPLETED
NA
79 participants
5 days of wear, lenses replaced daily
2012-07-10
Participant Flow
A total of 79 participants were recruited at 7 US sites from December 3, 2010, to January 20, 2011.
Seven participants were enrolled in the study but not dispensed due to failed inclusion/exclusion criteria (2); unsatisfactory vision (2); unacceptable comfort (1); and subject withdrawal (2). These participants are included in the Actual Enrollment calculation, but not Participant Flow or Baseline Characteristics calculations.
Participant milestones
| Measure |
Investigational Multifocal / Commercial Multifocal
Investigational multifocal contact lenses worn first, with commercial multifocal contact lenses worn second. Each product worn bilaterally on a daily wear, daily disposable basis for 5 days.
|
Commercial Multifocal / Investigational Multifocal
Commercial multifocal contact lenses worn first, with investigational multifocal contact lenses worn second. Each product worn bilaterally on a daily wear, daily disposable basis for 5 days.
|
|---|---|---|
|
First Period, 5 Days of Wear
STARTED
|
34
|
38
|
|
First Period, 5 Days of Wear
COMPLETED
|
34
|
38
|
|
First Period, 5 Days of Wear
NOT COMPLETED
|
0
|
0
|
|
Second Period, 5 Days of Wear
STARTED
|
34
|
38
|
|
Second Period, 5 Days of Wear
COMPLETED
|
34
|
38
|
|
Second Period, 5 Days of Wear
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparison of Two Multifocal Contact Lenses Worn on a Daily Disposable Basis
Baseline characteristics by cohort
| Measure |
Overall
n=72 Participants
This reporting group includes all enrolled and dispensed participants.
|
|---|---|
|
Age Continuous
|
50.1 years
STANDARD_DEVIATION 5.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
53 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 5 days of wear, lenses replaced dailyPopulation: Analysis conducted per protocol, with exclusions due to reasons such as: major protocol deviations as determined by masked review; discontinuations; and/or missing responses.
End of day comfort was interpreted and reported by the participant on a questionnaire as a single, retrospective evaluation of 5 days of wear. End of day comfort was measured on a 10-point scale, with 1 being poor and 10 being excellent.
Outcome measures
| Measure |
Nelfilcon A Investigational
n=71 Participants
Nelfilcon A investigational contact lenses worn bilaterally on a daily wear, daily disposable basis for 5 days
|
Nelfilcon A Commercial
n=71 Participants
Nelfilcon A commercial contact lenses worn bilaterally on a daily wear, daily disposable basis for 5 days
|
|---|---|---|
|
End of Day Comfort
|
7.7 Units on a scale
Standard Deviation 2.2
|
7.2 Units on a scale
Standard Deviation 2.3
|
PRIMARY outcome
Timeframe: 5 days of wear, lenses replaced dailyPopulation: Analysis conducted per protocol, with exclusions due to reasons such as: major protocol deviations as determined by masked review; discontinuations; and/or missing responses.
End of day dryness was interpreted and reported by the participant on a questionnaire as a single, retrospective evaluation of 5 days of wear. End of day dryness was measured on a 10-point scale, with 1 being very dry and 10 being not dry.
Outcome measures
| Measure |
Nelfilcon A Investigational
n=71 Participants
Nelfilcon A investigational contact lenses worn bilaterally on a daily wear, daily disposable basis for 5 days
|
Nelfilcon A Commercial
n=71 Participants
Nelfilcon A commercial contact lenses worn bilaterally on a daily wear, daily disposable basis for 5 days
|
|---|---|---|
|
End of Day Dryness
|
7.2 Units on a Scale
Standard Deviation 2.5
|
6.9 Units on a Scale
Standard Deviation 2.5
|
PRIMARY outcome
Timeframe: 5 days of wear, lenses replaced dailyPopulation: Analysis conducted per protocol, with exclusions due to reasons such as: major protocol deviations as determined by masked review; discontinuations; and/or missing responses.
Handling at removal was interpreted and reported by the participant on a questionnaire as a single, retrospective evaluation of 5 days of wear. Handling at removal was measured on a 10-point scale, with 1 being poor/difficult and 10 being excellent/easy.
Outcome measures
| Measure |
Nelfilcon A Investigational
n=71 Participants
Nelfilcon A investigational contact lenses worn bilaterally on a daily wear, daily disposable basis for 5 days
|
Nelfilcon A Commercial
n=70 Participants
Nelfilcon A commercial contact lenses worn bilaterally on a daily wear, daily disposable basis for 5 days
|
|---|---|---|
|
Handling at Removal
|
8.7 Units on a Scale
Standard Deviation 1.6
|
8.2 Units on a Scale
Standard Deviation 2.1
|
PRIMARY outcome
Timeframe: 5 days of wear, lenses replaced dailyPopulation: Analysis conducted per protocol, with exclusions due to reasons such as: major protocol deviations as determined by masked review; discontinuations; and/or missing responses.
Overall vision was interpreted and reported by the participant on a questionnaire as a single, retrospective evaluation of 5 days of wear. Overall vision was measured on a 10-point scale, with 1 being poor and 10 being excellent.
Outcome measures
| Measure |
Nelfilcon A Investigational
n=70 Participants
Nelfilcon A investigational contact lenses worn bilaterally on a daily wear, daily disposable basis for 5 days
|
Nelfilcon A Commercial
n=71 Participants
Nelfilcon A commercial contact lenses worn bilaterally on a daily wear, daily disposable basis for 5 days
|
|---|---|---|
|
Overall Vision
|
7.2 Units on a Scale
Standard Deviation 1.9
|
6.2 Units on a Scale
Standard Deviation 2.1
|
SECONDARY outcome
Timeframe: Day 5, lenses replaced dailyPopulation: Analysis conducted per protocol, with exclusions due to reasons such as: major protocol deviations as determined by masked review; discontinuations; and/or missing responses.
Overall lens fit was assessed by the investigator at study visit using a biomicroscope, which magnifies the appearance of the contact lens on the participant's eye. Lens fit was assessed by eye and graded on a 5-point scale, with 2=unacceptably loose, 1= acceptably loose, 0=optimal, -1=acceptably tight, and -2=unacceptably tight
Outcome measures
| Measure |
Nelfilcon A Investigational
n=138 Eyes
Nelfilcon A investigational contact lenses worn bilaterally on a daily wear, daily disposable basis for 5 days
|
Nelfilcon A Commercial
n=138 Eyes
Nelfilcon A commercial contact lenses worn bilaterally on a daily wear, daily disposable basis for 5 days
|
|---|---|---|
|
Overall Fit
|
0.0 Units on a Scale
Standard Deviation 0.5
|
-0.1 Units on a Scale
Standard Deviation 0.6
|
Adverse Events
Nelfilcon A Investigational
Nelfilcon A Commercial
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Director of Alcon Clinical
Alcon Research, Ltd.
Results disclosure agreements
- Principal investigator is a sponsor employee For a period of 10 years, the clinical investigator must hold all trial-related information and documents confidential and must agree to obtain sponsor's written consent before discussing, presenting, publicizing, or otherwise disclosing any preclinical and/or clinical data or impressions from this trial.
- Publication restrictions are in place
Restriction type: OTHER