Trial Outcomes & Findings for Performance Evaluation of a New Daily Disposable Silicone Hydrogel Lens (NCT NCT01371552)
NCT ID: NCT01371552
Last Updated: 2012-10-31
Results Overview
The participant recorded a number from 0 to 100 in response to the question, "How would you rate the comfort of your lenses over the last hour?" in which 0 = very poor and 100 = excellent. Comfort was assessed at 4 hours, 8 hours, and 12 hours, and the responses were averaged.
COMPLETED
NA
119 participants
Part 1: Day 2 at 4 hours, 8 hours, and 12 hours
2012-10-31
Participant Flow
Participants were recruited from 1 study center in Canada.
10 people were enrolled but not dispensed into Part 1 due to failing inclusion/exclusion criteria.
Participant milestones
| Measure |
Delefilcon A / Filcon II 3 / Narafilcon A
Part 1: Delefilcon A, then Filcon II 3, then Narafilcon A, 3 days each. Part 2: Delefilcon A for 1 week.
|
Narafilcon A / Filcon II 3 / Delefilcon A
Part 1: Narafilcon A, then Filcon II 3, then Delefilcon A, 3 days each. Part 2: Delefilcon A for 1 week.
|
Filcon II 3 / Narafilcon A / Delefilcon A
Part 1: Filcon II 3, then Narafilcon A, the Delefilcon A, 3 days each. Part 2: Delefilcon A for 1 week.
|
Delefilcon A / Narafilcon A / Filcon II 3
Part 1: Delefilcon A, then Narafilcon A, then Filcon II 3, 3 days each. Part 2: Delefilcon A for 1 week.
|
Narafilcon A / Delefilcon A / Filcon II 3
Part 1: Narafilcon A, then Delefilcon A, then Filcon II 3, 3 days each. Part 2: Delefilcon A for 1 week.
|
Filcon II 3 / Delefilcon A / Narafilcon A
Part 1: Filcon II 3, then Delefilcon A, then Narafilcon A, 3 days each. Part 2: Delefilcon A for 1 week.
|
|---|---|---|---|---|---|---|
|
Part 1, First 3 Days
STARTED
|
19
|
17
|
20
|
20
|
15
|
18
|
|
Part 1, First 3 Days
COMPLETED
|
19
|
17
|
19
|
20
|
15
|
18
|
|
Part 1, First 3 Days
NOT COMPLETED
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Part 1, Second 3 Days
STARTED
|
19
|
17
|
18
|
20
|
15
|
18
|
|
Part 1, Second 3 Days
COMPLETED
|
18
|
17
|
18
|
20
|
15
|
18
|
|
Part 1, Second 3 Days
NOT COMPLETED
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Part 1, Third 3 Days
STARTED
|
19
|
17
|
18
|
20
|
15
|
18
|
|
Part 1, Third 3 Days
COMPLETED
|
19
|
17
|
18
|
20
|
14
|
17
|
|
Part 1, Third 3 Days
NOT COMPLETED
|
0
|
0
|
0
|
0
|
1
|
1
|
|
Part 2, One Week
STARTED
|
18
|
17
|
18
|
20
|
15
|
18
|
|
Part 2, One Week
COMPLETED
|
18
|
17
|
18
|
20
|
15
|
18
|
|
Part 2, One Week
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Delefilcon A / Filcon II 3 / Narafilcon A
Part 1: Delefilcon A, then Filcon II 3, then Narafilcon A, 3 days each. Part 2: Delefilcon A for 1 week.
|
Narafilcon A / Filcon II 3 / Delefilcon A
Part 1: Narafilcon A, then Filcon II 3, then Delefilcon A, 3 days each. Part 2: Delefilcon A for 1 week.
|
Filcon II 3 / Narafilcon A / Delefilcon A
Part 1: Filcon II 3, then Narafilcon A, the Delefilcon A, 3 days each. Part 2: Delefilcon A for 1 week.
|
Delefilcon A / Narafilcon A / Filcon II 3
Part 1: Delefilcon A, then Narafilcon A, then Filcon II 3, 3 days each. Part 2: Delefilcon A for 1 week.
|
Narafilcon A / Delefilcon A / Filcon II 3
Part 1: Narafilcon A, then Delefilcon A, then Filcon II 3, 3 days each. Part 2: Delefilcon A for 1 week.
|
Filcon II 3 / Delefilcon A / Narafilcon A
Part 1: Filcon II 3, then Delefilcon A, then Narafilcon A, 3 days each. Part 2: Delefilcon A for 1 week.
|
|---|---|---|---|---|---|---|
|
Part 1, First 3 Days
Inconvenience
|
0
|
0
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Performance Evaluation of a New Daily Disposable Silicone Hydrogel Lens
Baseline characteristics by cohort
| Measure |
Overall Study
n=119 Participants
This reporting group includes all enrolled participants.
|
|---|---|
|
Age Continuous
|
27 years
STANDARD_DEVIATION 9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
89 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
119 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Part 1: Day 2 at 4 hours, 8 hours, and 12 hoursPopulation: This reporting group includes all participants who completed 12 hours of lens wear on Day 2.
The participant recorded a number from 0 to 100 in response to the question, "How would you rate the comfort of your lenses over the last hour?" in which 0 = very poor and 100 = excellent. Comfort was assessed at 4 hours, 8 hours, and 12 hours, and the responses were averaged.
Outcome measures
| Measure |
Delefilcon A
n=94 Participants
Delefilcon A contact lenses worn in a daily disposable mode for 3 days in Part 1
|
Filcon II 3
n=88 Participants
Filcon II 3 contact lenses worn in a daily disposable mode for 3 days in Part 1
|
Narafilcon A
n=85 Participants
Narafilcon A contact lenses worn in a daily disposable mode for 3 days in Part 1
|
|---|---|---|---|
|
Mean Value of Comfort During the Day
|
89 Units on a scale
Standard Deviation 11
|
85 Units on a scale
Standard Deviation 13
|
86 Units on a scale
Standard Deviation 13
|
PRIMARY outcome
Timeframe: Part 1: Day 3Population: This reporting group includes all participants who completed all three lens wear periods in Part 1.
The participant recorded a number from 0 to 100 in response to the question, "How would you rate the overall comfort of these lenses?" in which 0 = very poor and 100 = excellent. The end of wear questionnaire was completed at time of lens removal for that day.
Outcome measures
| Measure |
Delefilcon A
n=104 Participants
Delefilcon A contact lenses worn in a daily disposable mode for 3 days in Part 1
|
Filcon II 3
n=104 Participants
Filcon II 3 contact lenses worn in a daily disposable mode for 3 days in Part 1
|
Narafilcon A
n=104 Participants
Narafilcon A contact lenses worn in a daily disposable mode for 3 days in Part 1
|
|---|---|---|---|
|
Mean Overall Comfort Given at End of Wear
|
90 Units on a scale
Standard Deviation 10
|
83 Units on a scale
Standard Deviation 16
|
86 Units on a scale
Standard Deviation 15
|
PRIMARY outcome
Timeframe: Part 1: Day 3Population: This reporting group includes all participants who completed all three lens wear periods in Part 1.
The participant recorded a number from 0 to 100 in response to the question, "How would you rate the overall quality of vision while wearing these lenses?" in which 0 = very poor and 100 = excellent. The end of wear questionnaire was completed at time of lens removal for that day.
Outcome measures
| Measure |
Delefilcon A
n=104 Participants
Delefilcon A contact lenses worn in a daily disposable mode for 3 days in Part 1
|
Filcon II 3
n=104 Participants
Filcon II 3 contact lenses worn in a daily disposable mode for 3 days in Part 1
|
Narafilcon A
n=104 Participants
Narafilcon A contact lenses worn in a daily disposable mode for 3 days in Part 1
|
|---|---|---|---|
|
Mean Overall Quality of Vision at End of Wear
|
91 Units on a scale
Standard Deviation 10
|
87 Units on a scale
Standard Deviation 12
|
88 Units on a scale
Standard Deviation 13
|
PRIMARY outcome
Timeframe: Part 1: Day 3Population: This reporting group includes all participants who completed all three lens wear periods in Part 1.
The participant recorded a number from 0 to 100 in response to the question, "How would you rate the overall ease of handling these lenses?" in which 0 = very difficult and 100 = very easy. The end of wear questionnaire was completed at time of lens removal for that day.
Outcome measures
| Measure |
Delefilcon A
n=104 Participants
Delefilcon A contact lenses worn in a daily disposable mode for 3 days in Part 1
|
Filcon II 3
n=104 Participants
Filcon II 3 contact lenses worn in a daily disposable mode for 3 days in Part 1
|
Narafilcon A
n=104 Participants
Narafilcon A contact lenses worn in a daily disposable mode for 3 days in Part 1
|
|---|---|---|---|
|
Mean Overall Ease of Handling at End of Wear
|
90 Units on a scale
Standard Deviation 13
|
91 Units on a scale
Standard Deviation 12
|
93 Units on a scale
Standard Deviation 10
|
PRIMARY outcome
Timeframe: Part 1: Day 2Population: This reporting group includes all participants who completed all three lens wear periods in Part 1.
The participant circled a number from 0 to 4 in response to the question, "Over the entire day while wearing these contact lenses, how often did your eyes feel dry?" in which 0 = never, 1 = rarely, 2 = sometimes, 3 = frequently, 4 = constantly. The end of wear questionnaire was completed at time of lens removal for that day.
Outcome measures
| Measure |
Delefilcon A
n=104 Participants
Delefilcon A contact lenses worn in a daily disposable mode for 3 days in Part 1
|
Filcon II 3
n=104 Participants
Filcon II 3 contact lenses worn in a daily disposable mode for 3 days in Part 1
|
Narafilcon A
n=104 Participants
Narafilcon A contact lenses worn in a daily disposable mode for 3 days in Part 1
|
|---|---|---|---|
|
Percentage of Participants Reporting That Their Eyes Rarely or Never Felt Dry at End of Wear
|
63 Percentage of participants
|
38 Percentage of participants
|
57 Percentage of participants
|
PRIMARY outcome
Timeframe: Part 1: Day 3Population: This reporting group includes all participants who completed all three lens wear periods in Part 1.
The participant circled a number from 1 to 5 in response to the question, "Overall, which lens do you prefer - the lens you wore today or your regular lenses?" in which 1 = strongly prefer my regular lenses, 2 = prefer my regular lenses, 3 = no preference, 4 = prefer test lens, 5 = strongly prefer test lens. The end of wear questionnaire was completed at time of lens removal for that day.
Outcome measures
| Measure |
Delefilcon A
n=104 Participants
Delefilcon A contact lenses worn in a daily disposable mode for 3 days in Part 1
|
Filcon II 3
n=104 Participants
Filcon II 3 contact lenses worn in a daily disposable mode for 3 days in Part 1
|
Narafilcon A
n=104 Participants
Narafilcon A contact lenses worn in a daily disposable mode for 3 days in Part 1
|
|---|---|---|---|
|
Percentage of Participants Preferring Study Lens Either Strongly or Slightly (of Those With a Preference) vs. Their Habitual Lenses at End of Wear
|
62 Percentage of participants
|
35 Percentage of participants
|
54 Percentage of participants
|
PRIMARY outcome
Timeframe: Part 1: Day 1 at Dispense, Day 1 at 8 hours, Day 3 at 8 hoursPopulation: This reporting group includes all participants who completed all three lens wear periods in Part 1.
Lens wettability was assessed by the investigator during slit-lamp examination and graded on a 0-4 scale in 0.25 steps, where 0 = excellent and 4 = severely reduced.
Outcome measures
| Measure |
Delefilcon A
n=104 Participants
Delefilcon A contact lenses worn in a daily disposable mode for 3 days in Part 1
|
Filcon II 3
n=104 Participants
Filcon II 3 contact lenses worn in a daily disposable mode for 3 days in Part 1
|
Narafilcon A
n=104 Participants
Narafilcon A contact lenses worn in a daily disposable mode for 3 days in Part 1
|
|---|---|---|---|
|
Lens Wettability
Day 1 at Dispense
|
0.25 Units on a scale
Standard Deviation 0.39
|
0.49 Units on a scale
Standard Deviation 0.50
|
0.46 Units on a scale
Standard Deviation 0.46
|
|
Lens Wettability
Day 1 at 8 hours
|
0.46 Units on a scale
Standard Deviation 0.50
|
0.77 Units on a scale
Standard Deviation 0.55
|
0.89 Units on a scale
Standard Deviation 0.69
|
|
Lens Wettability
Day 3 at 8 hours
|
0.51 Units on a scale
Standard Deviation 0.47
|
0.76 Units on a scale
Standard Deviation 0.66
|
0.91 Units on a scale
Standard Deviation 0.72
|
PRIMARY outcome
Timeframe: Part 2: Day 7Population: This reporting group includes all participants who completed Part 2.
The participant responded to 11 subjective, performance-related statements on a questionnaire by circling 1 = yes, 2 = no, or 3 = don't know.
Outcome measures
| Measure |
Delefilcon A
n=106 Participants
Delefilcon A contact lenses worn in a daily disposable mode for 3 days in Part 1
|
Filcon II 3
Filcon II 3 contact lenses worn in a daily disposable mode for 3 days in Part 1
|
Narafilcon A
Narafilcon A contact lenses worn in a daily disposable mode for 3 days in Part 1
|
|---|---|---|---|
|
Percentage of Participants Responding "Yes"
These lenses provide excellent comfort
|
85 Percentage of participants
|
—
|
—
|
|
Percentage of Participants Responding "Yes"
These lenses provide excellent quality of vision
|
87 Percentage of participants
|
—
|
—
|
|
Percentage of Participants Responding "Yes"
These lenses are very easy to handle
|
83 Percentage of participants
|
—
|
—
|
|
Percentage of Participants Responding "Yes"
These lenses are very easy to insert on my eye
|
88 Percentage of participants
|
—
|
—
|
|
Percentage of Participants Responding "Yes"
Lenses provide excellent comfort during the day
|
89 Percentage of participants
|
—
|
—
|
|
Percentage of Participants Responding "Yes"
Lenses provide excellent comfort at the end of day
|
64 Percentage of participants
|
—
|
—
|
|
Percentage of Participants Responding "Yes"
So comfortable I almost forget I am wearing lenses
|
67 Percentage of participants
|
—
|
—
|
|
Percentage of Participants Responding "Yes"
Deliver comfort/vision long days/demanding schedul
|
72 Percentage of participants
|
—
|
—
|
|
Percentage of Participants Responding "Yes"
Total package-great vision, comfort, convenience
|
73 Percentage of participants
|
—
|
—
|
|
Percentage of Participants Responding "Yes"
My life is demanding. Lenses meet those demands
|
64 Percentage of participants
|
—
|
—
|
|
Percentage of Participants Responding "Yes"
I need high performance-these lenses deliver
|
70 Percentage of participants
|
—
|
—
|
Adverse Events
Delefilcon A
Filcon II 3
Narafilcon A
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Delefilcon A
n=117 participants at risk
Delefilcon A contact lenses worn in a daily disposable mode for 3 days in Part 1
|
Filcon II 3
n=117 participants at risk
Filcon II 3 contact lenses worn in a daily disposable mode for 3 days in Part 1
|
Narafilcon A
n=117 participants at risk
Narafilcon A contact lenses worn in a daily disposable mode for 3 days in Part 1
|
|---|---|---|---|
|
Eye disorders
Redness
|
0.00%
0/115 • Adverse events were collected for the duration of the study.
The safety reporting group includes all enrolled and exposed participants.
|
10.3%
12/117 • Adverse events were collected for the duration of the study.
The safety reporting group includes all enrolled and exposed participants.
|
0.87%
1/115 • Adverse events were collected for the duration of the study.
The safety reporting group includes all enrolled and exposed participants.
|
Additional Information
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