Trial Outcomes & Findings for Clinical Validation of the New Print on Focus DAILIES Toric (NCT NCT01097863)
NCT ID: NCT01097863
Last Updated: 2012-07-10
Results Overview
As assessed by the participant retrospectively after one week of wear and recorded on a questionnaire as a yes or no response to the question, "Did you notice an OK mark on the study lens while it was on your finger, for example, during lens insertion?" The positive "yes" responses are reported.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
280 participants
Primary outcome timeframe
1 week
Results posted on
2012-07-10
Participant Flow
This reporting group includes all enrolled and dispensed participants. Note: One subject was enrolled but not dispensed due to failing inclusion/exclusion criteria.
Participant milestones
| Measure |
Nelfilcon A, Modified Inversion Indicator
nelfilcon A investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for one week
|
Nelfilcon A, No Inversion Indicator
nelfilcon A investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for one week
|
Nelfilcon A, Inversion Indicator
nelfilcon A commercially marketed contact lenses worn in both eyes on a daily wear, daily disposable basis for one week.
|
|---|---|---|---|
|
Overall Study
STARTED
|
90
|
98
|
91
|
|
Overall Study
COMPLETED
|
89
|
98
|
89
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
2
|
Reasons for withdrawal
| Measure |
Nelfilcon A, Modified Inversion Indicator
nelfilcon A investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for one week
|
Nelfilcon A, No Inversion Indicator
nelfilcon A investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for one week
|
Nelfilcon A, Inversion Indicator
nelfilcon A commercially marketed contact lenses worn in both eyes on a daily wear, daily disposable basis for one week.
|
|---|---|---|---|
|
Overall Study
Discomfort
|
1
|
0
|
1
|
|
Overall Study
Did not return for final visit
|
0
|
0
|
1
|
Baseline Characteristics
Clinical Validation of the New Print on Focus DAILIES Toric
Baseline characteristics by cohort
| Measure |
Nelfilcon A, Modified Inversion Indicator
n=90 Participants
nelfilcon A investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for one week
|
Nelfilcon A, No Inversion Indicator
n=98 Participants
nelfilcon A investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for one week
|
Nelfilcon A, Inversion Indicator
n=91 Participants
nelfilcon A commercially marketed contact lenses worn in both eyes on a daily wear, daily disposable basis for one week.
|
Total
n=279 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age Continuous
|
36.2 years
STANDARD_DEVIATION 10.6 • n=93 Participants
|
33.3 years
STANDARD_DEVIATION 11.7 • n=4 Participants
|
34.1 years
STANDARD_DEVIATION 10.8 • n=27 Participants
|
34.5 years
STANDARD_DEVIATION 11.1 • n=483 Participants
|
|
Sex: Female, Male
Female
|
52 Participants
n=93 Participants
|
69 Participants
n=4 Participants
|
69 Participants
n=27 Participants
|
190 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
38 Participants
n=93 Participants
|
29 Participants
n=4 Participants
|
22 Participants
n=27 Participants
|
89 Participants
n=483 Participants
|
PRIMARY outcome
Timeframe: 1 weekPopulation: Analysis conducted per protocol, with exclusions due to protocol deviations as determined by masked review (9), and unavailable data due to discontinuations (3).
As assessed by the participant retrospectively after one week of wear and recorded on a questionnaire as a yes or no response to the question, "Did you notice an OK mark on the study lens while it was on your finger, for example, during lens insertion?" The positive "yes" responses are reported.
Outcome measures
| Measure |
Nelfilcon A, Modified Inversion Indicator
n=86 Participants
nelfilcon A investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for one week
|
Nelfilcon A, No Inversion Indicator
n=97 Participants
nelfilcon A investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for one week
|
Nelfilcon A, Inversion Indicator
n=84 Participants
nelfilcon A commercially marketed contact lenses worn in both eyes on a daily wear, daily disposable basis for one week.
|
|---|---|---|---|
|
Visibility of the Inversion Indicator on Lens When Lens Was on Participant's Finger, for Example, During Lens Insertion.
|
77 participants
|
15 participants
|
84 participants
|
Adverse Events
Nelfilcon A, Modified Inversion Indicator
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Nelfilcon A, No Inversion Indicator
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Nelfilcon A, Inversion Indicator
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Nelfilcon A, Modified Inversion Indicator
n=90 participants at risk
nelfilcon A investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for one week
|
Nelfilcon A, No Inversion Indicator
n=98 participants at risk
nelfilcon A investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for one week
|
Nelfilcon A, Inversion Indicator
n=92 participants at risk
nelfilcon A commercially marketed contact lenses worn in both eyes on a daily wear, daily disposable basis for one week.
|
|---|---|---|---|
|
Eye disorders
Other contact lens symptoms not requiring treatment
|
6.7%
6/90 • Number of events 6 • Adverse event data was collected for the duration of the trial: 78 days
This reporting group includes all enrolled and exposed participants: 280
|
13.3%
13/98 • Number of events 13 • Adverse event data was collected for the duration of the trial: 78 days
This reporting group includes all enrolled and exposed participants: 280
|
14.1%
13/92 • Number of events 13 • Adverse event data was collected for the duration of the trial: 78 days
This reporting group includes all enrolled and exposed participants: 280
|
Additional Information
Priya Janakiraman, OD, FAAO / Head, Global Clinical Affairs
CIBA VISION
Phone: 1-800-241-7629
Email: [email protected]
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 discussion, presenting, publicizing, or otherwise disclosing any preclinical and/or clinical data or impressions from this trial.
- Publication restrictions are in place
Restriction type: OTHER