Trial Outcomes & Findings for Clinical Comparison of Two Daily Disposable Contact Lenses in a Population of Daily Disposable Contact Lens Wearers (NCT NCT01233076)
NCT ID: NCT01233076
Last Updated: 2012-07-10
Results Overview
Overall vision quality, as interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear. Overall vision quality is evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent.
COMPLETED
NA
60 participants
1 week of wear
2012-07-10
Participant Flow
This reporting group includes all enrolled and dispensed participants.
Participant milestones
| Measure |
Nelfilcon A / Narafilcon B
Nelfilcon A worn first, with narafilcon B worn second. Each product worn bilaterally in a daily wear, daily disposable basis for one week.
|
Narafilcon B / Nelfilcon A
Narafilcon B worn first, with nelfilcon A worn second. Each product worn bilaterally in a daily wear, daily disposable basis for one week.
|
|---|---|---|
|
Period 1, One Week
STARTED
|
30
|
30
|
|
Period 1, One Week
COMPLETED
|
30
|
30
|
|
Period 1, One Week
NOT COMPLETED
|
0
|
0
|
|
Period 2, One Week
STARTED
|
30
|
30
|
|
Period 2, One Week
COMPLETED
|
29
|
30
|
|
Period 2, One Week
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Nelfilcon A / Narafilcon B
Nelfilcon A worn first, with narafilcon B worn second. Each product worn bilaterally in a daily wear, daily disposable basis for one week.
|
Narafilcon B / Nelfilcon A
Narafilcon B worn first, with nelfilcon A worn second. Each product worn bilaterally in a daily wear, daily disposable basis for one week.
|
|---|---|---|
|
Period 2, One Week
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
Clinical Comparison of Two Daily Disposable Contact Lenses in a Population of Daily Disposable Contact Lens Wearers
Baseline characteristics by cohort
| Measure |
Overall
n=60 Participants
This reporting group includes all enrolled and dispensed participants.
|
|---|---|
|
Age Continuous
|
30.6 years
STANDARD_DEVIATION 12.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 week of wearPopulation: 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 quality, as interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear. Overall vision quality is evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent.
Outcome measures
| Measure |
Nelfilcon A
n=59 Participants
Commercially marketed, spherical contact lenses worn bilaterally in a daily wear, daily disposable manner for one week.
|
Narafilcon B
n=59 Participants
Commercially marketed (US), spherical contact lenses worn bilaterally in a daily wear, daily disposable manner for one week.
|
|---|---|---|
|
Overall Vision Quality
|
8.2 units on a scale
Standard Deviation 1.7
|
8.7 units on a scale
Standard Deviation 1.5
|
Adverse Events
Nelfilcon A
Narafilcon B
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Joe Rappon, OD, MS, FAAO / Head, Clinical Trial Management
CIBA VISION
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