Trial Outcomes & Findings for Clinical Evaluation of Daily Disposable Contact Lenses (NCT NCT02097030)
NCT ID: NCT02097030
Last Updated: 2020-07-31
Results Overview
Participant's subjective response for overall lens preference after 3 days of daily disposable wear of each pair of lenses. Surveyed at exit. (4 possible ratings: Strongly prefer pair#1, Slightly prefer pair #1, Slightly prefer pair #2, Strongly prefer pair #2).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
35 participants
Primary outcome timeframe
Study Exit
Results posted on
2020-07-31
Participant Flow
Single center evaluation. Thirty five subjects were recruited and 30 subjects completed the trial.
Three participants were enrolled in the study but did not meet inclusion criteria, therefore discontinued before lens randomization.
Participant milestones
| Measure |
Etafilcon A, Then Filcon II 3
Participants wear a first pair of lenses for three days and then crossover and wear a second pair of lenses for three days.
etafilcon A: contact lens filcon II 3: contact lens
|
Nelfilcon A, Then Filcon II 3
Participants wear a first pair of lenses for three days and then crossover and wear a second pair of lenses for three days.
nelfilcon A: contact lens filcon II 3: contact lens
|
|---|---|---|
|
First Intervention (3 Days)
STARTED
|
15
|
17
|
|
First Intervention (3 Days)
COMPLETED
|
14
|
16
|
|
First Intervention (3 Days)
NOT COMPLETED
|
1
|
1
|
|
Second Intervention (3 Days)
STARTED
|
14
|
16
|
|
Second Intervention (3 Days)
COMPLETED
|
14
|
16
|
|
Second Intervention (3 Days)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Etafilcon A, Then Filcon II 3
Participants wear a first pair of lenses for three days and then crossover and wear a second pair of lenses for three days.
etafilcon A: contact lens filcon II 3: contact lens
|
Nelfilcon A, Then Filcon II 3
Participants wear a first pair of lenses for three days and then crossover and wear a second pair of lenses for three days.
nelfilcon A: contact lens filcon II 3: contact lens
|
|---|---|---|
|
First Intervention (3 Days)
Lost to Follow-up
|
1
|
0
|
|
First Intervention (3 Days)
Visual Acuity
|
0
|
1
|
Baseline Characteristics
Clinical Evaluation of Daily Disposable Contact Lenses
Baseline characteristics by cohort
| Measure |
Etafilcon A, Then Filcon II 3
n=14 Participants
Participants wear a first pair of lenses for three days and then crossover and wear a second pair of lenses for three days.
etafilcon A: contact lens filcon II 3: contact lens
|
Nelfilcon A, Then Filcon II 3
n=16 Participants
Participants wear a first pair of lenses for three days and then crossover and wear a second pair of lenses for three days.
nelfilcon A: contact lens filcon II 3: contact lens
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
21.5 years
STANDARD_DEVIATION 4.9 • n=5 Participants
|
21.2 years
STANDARD_DEVIATION 5.0 • n=7 Participants
|
21.4 years
STANDARD_DEVIATION 5.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Study ExitPopulation: Subjects were randomized to wear one or the other of the conventional hydrogel lenses; all subjects wore the Clariti silicone hydrogel lenses.
Participant's subjective response for overall lens preference after 3 days of daily disposable wear of each pair of lenses. Surveyed at exit. (4 possible ratings: Strongly prefer pair#1, Slightly prefer pair #1, Slightly prefer pair #2, Strongly prefer pair #2).
Outcome measures
| Measure |
Nelfilcon A
n=16 Participants
Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
|
Etafilcon A
n=14 Participants
Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
|
Filcon II 3
n=30 Participants
Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
|
|---|---|---|---|
|
Overall Lens Preference - All Study Lenses
Strongly Prefer
|
5 participants
|
3 participants
|
8 participants
|
|
Overall Lens Preference - All Study Lenses
Slightly Prefer
|
4 participants
|
3 participants
|
7 participants
|
PRIMARY outcome
Timeframe: Study ExitPopulation: 30 subjects
Participant's subjective response for overall lens preference after 3 days of daily disposable wear of each pair. Surveyed at exit. (4 possible ratings: Strongly prefer pair#1, Slightly prefer pair #1, Slightly prefer pair #2, Strongly prefer pair #2).
Outcome measures
| Measure |
Nelfilcon A
n=30 Participants
Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
|
Etafilcon A
n=30 Participants
Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
|
Filcon II 3
Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
|
|---|---|---|---|
|
Overall Lens Preference - Hydrogel vs. Filcon II 3
Strongly Prefer
|
8 participants
|
8 participants
|
—
|
|
Overall Lens Preference - Hydrogel vs. Filcon II 3
Slightly Prefer
|
7 participants
|
7 participants
|
—
|
SECONDARY outcome
Timeframe: Baseline and 3 day follow-upPopulation: Subjects were randomized to wear one or the other of the conventional hydrogel lenses; all subjects wore the Clariti silicone hydrogel lenses.
Participant's subjective response for comfort measured at baseline and 3 day follow-up. (Continuous Comfort Scale 0-100, 0=cannot be worn/causes pain, 100=cannot be felt ever)
Outcome measures
| Measure |
Nelfilcon A
n=16 Participants
Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
|
Etafilcon A
n=14 Participants
Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
|
Filcon II 3
n=30 Participants
Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
|
|---|---|---|---|
|
Subjective Response for Comfort
Baseline
|
90.3 units on a scale
Standard Deviation 15.9
|
94.1 units on a scale
Standard Deviation 8.7
|
93.2 units on a scale
Standard Deviation 9.5
|
|
Subjective Response for Comfort
3 day follow up
|
84.5 units on a scale
Standard Deviation 12.2
|
82.0 units on a scale
Standard Deviation 16.3
|
81.5 units on a scale
Standard Deviation 20.1
|
SECONDARY outcome
Timeframe: Baseline and 3 day follow-upPopulation: Subjects were randomized to wear one or the other of the conventional hydrogel lenses; all subjects wore the Clariti silicone hydrogel lenses.
Participant's subjective response for vision measured at baseline and at 3 day follow-up of daily disposable wear of lenses. (Vision Scale 0-100, 0=very blurry, 100=very clear).
Outcome measures
| Measure |
Nelfilcon A
n=16 Participants
Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
|
Etafilcon A
n=14 Participants
Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
|
Filcon II 3
n=30 Participants
Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
|
|---|---|---|---|
|
Subjective Response for Vision
Baseline
|
93.8 units on a scale
Standard Deviation 8.2
|
93.0 units on a scale
Standard Deviation 9.6
|
94.1 units on a scale
Standard Deviation 6.1
|
|
Subjective Response for Vision
3 day follow up
|
94.8 units on a scale
Standard Deviation 5.4
|
90.6 units on a scale
Standard Deviation 15.8
|
95.2 units on a scale
Standard Deviation 5.1
|
SECONDARY outcome
Timeframe: BaselinePopulation: Subjects were randomized to wear one or the other of the conventional hydrogel lenses; all subjects wore the Clariti silicone hydrogel lenses.
Participant's subjective response for insertion measured at baseline. (Insertion Handling Scale 0-100, 0=very hard to handle, 100=very easy to handle).
Outcome measures
| Measure |
Nelfilcon A
n=16 Participants
Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
|
Etafilcon A
n=14 Participants
Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
|
Filcon II 3
n=30 Participants
Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
|
|---|---|---|---|
|
Subjective Response for Insertion
|
94.6 units on a scale
Standard Deviation 8.5
|
86.4 units on a scale
Standard Deviation 18.4
|
91.0 units on a scale
Standard Deviation 15.1
|
SECONDARY outcome
Timeframe: 3 days follow-upPopulation: Subjects were randomized to wear one or the other of the conventional hydrogel lenses; all subjects wore the Clariti silicone hydrogel lenses.
Participant's subjective response for handling (insertion and removal) measured at 3 day follow-up of daily disposable wear of lenses. (Handling Scale 0-100, 0=very hard to handle, 100=very easy to handle).
Outcome measures
| Measure |
Nelfilcon A
n=16 Participants
Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
|
Etafilcon A
n=14 Participants
Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
|
Filcon II 3
n=30 Participants
Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
|
|---|---|---|---|
|
Subjective Response for Handling (Insertion and Removal)
Insertion
|
92.9 units on a scale
Standard Deviation 11.6
|
74.1 units on a scale
Standard Deviation 23.6
|
91.3 units on a scale
Standard Deviation 10.1
|
|
Subjective Response for Handling (Insertion and Removal)
Removal
|
88.6 units on a scale
Standard Deviation 14.8
|
94.8 units on a scale
Standard Deviation 8.0
|
93.9 units on a scale
Standard Deviation 11.8
|
SECONDARY outcome
Timeframe: 3 Days Follow-upPopulation: Subjects were randomized to wear one or the other of the conventional hydrogel lenses; all subjects wore the Clariti silicone hydrogel lenses.
Participant's subjective response for dryness, measured at baseline and after 3 day follow-up of daily disposable wear of lenses. (Dryness Scale 0-100, 0=Cannot be worn/extremely dry, 100=no dryness experienced at any time).
Outcome measures
| Measure |
Nelfilcon A
n=16 Participants
Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
|
Etafilcon A
n=14 Participants
Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
|
Filcon II 3
n=30 Participants
Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
|
|---|---|---|---|
|
Subjective Response for Dryness
|
80.6 units on a scale
Standard Deviation 16.8
|
81.6 units on a scale
Standard Deviation 19.0
|
76.4 units on a scale
Standard Deviation 21.5
|
SECONDARY outcome
Timeframe: 3 Days Follow-upPopulation: Subjects were randomized to wear one or the other of the conventional hydrogel lenses; all subjects wore the Clariti silicone hydrogel lenses.
Participant's subjective response for overall vision satisfaction. Measured after 3 days daily disposable wear of lenses. (4 point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied.
Outcome measures
| Measure |
Nelfilcon A
n=16 Participants
Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
|
Etafilcon A
n=14 Participants
Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
|
Filcon II 3
n=30 Participants
Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
|
|---|---|---|---|
|
Overall Satisfaction, Vision
Completely Dissatisfied
|
0 participants
|
0 participants
|
0 participants
|
|
Overall Satisfaction, Vision
Somewhat Dissatisfied
|
0 participants
|
1 participants
|
0 participants
|
|
Overall Satisfaction, Vision
Somewhat Satisfied
|
2 participants
|
2 participants
|
6 participants
|
|
Overall Satisfaction, Vision
Completely Satisfied
|
14 participants
|
11 participants
|
24 participants
|
SECONDARY outcome
Timeframe: 3 Days Follow-upPopulation: Subjects were randomized to wear one or the other of the conventional hydrogel lenses; all subjects wore the Clariti silicone hydrogel lenses.
Participant's subjective response for overall comfort satisfaction. Measured after 3 days daily disposable wear of lenses. (4 point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied.
Outcome measures
| Measure |
Nelfilcon A
n=16 Participants
Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
|
Etafilcon A
n=14 Participants
Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
|
Filcon II 3
n=30 Participants
Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
|
|---|---|---|---|
|
Overall Satisfaction, Comfort
Completely Dissatisfied
|
0 participants
|
0 participants
|
0 participants
|
|
Overall Satisfaction, Comfort
Somewhat Dissatisfied
|
3 participants
|
1 participants
|
5 participants
|
|
Overall Satisfaction, Comfort
Somewhat Satisfied
|
5 participants
|
8 participants
|
9 participants
|
|
Overall Satisfaction, Comfort
Completely Satisfied
|
8 participants
|
5 participants
|
16 participants
|
SECONDARY outcome
Timeframe: 3 DaysPopulation: Subjects were randomized to wear one or the other of the conventional hydrogel lenses; all subjects wore the Clariti silicone hydrogel lenses.
Participant's subjective response for overall handling satisfaction. Measured after 3 days of daily disposable lens wear. (4 point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied.
Outcome measures
| Measure |
Nelfilcon A
n=16 Participants
Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
|
Etafilcon A
n=14 Participants
Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
|
Filcon II 3
n=30 Participants
Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
|
|---|---|---|---|
|
Overall Satisfaction, Handling
Completely Dissatisfied
|
0 participants
|
0 participants
|
0 participants
|
|
Overall Satisfaction, Handling
Somewhat Dissatisfied
|
1 participants
|
4 participants
|
4 participants
|
|
Overall Satisfaction, Handling
Somewhat Satisfied
|
6 participants
|
3 participants
|
10 participants
|
|
Overall Satisfaction, Handling
Completely Satisfied
|
9 participants
|
7 participants
|
16 participants
|
SECONDARY outcome
Timeframe: 3 Days Follow-upPopulation: Subjects were randomized to wear one or the other of the conventional hydrogel lenses; all subjects wore the Clariti silicone hydrogel lenses.
Participant's subjective response for overall dryness satisfaction. Measured after 3 days daily disposable wear of lenses. (4 point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied.
Outcome measures
| Measure |
Nelfilcon A
n=16 Participants
Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
|
Etafilcon A
n=14 Participants
Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
|
Filcon II 3
n=30 Participants
Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
|
|---|---|---|---|
|
Overall Satisfaction, Dryness
Completely Dissatisfied
|
1 participants
|
0 participants
|
2 participants
|
|
Overall Satisfaction, Dryness
Somewhat Dissatisfied
|
4 participants
|
3 participants
|
5 participants
|
|
Overall Satisfaction, Dryness
Somewhat Satisfied
|
6 participants
|
5 participants
|
12 participants
|
|
Overall Satisfaction, Dryness
Completely Satisfied
|
5 participants
|
6 participants
|
11 participants
|
SECONDARY outcome
Timeframe: 3 Days Follow-upPopulation: Subjects were randomized to wear one or the other of the conventional hydrogel lenses; all subjects wore the Clariti silicone hydrogel lenses.
Participant's subjective response for overall satisfaction. Measured after 3 days of daily disposable lens wear. (4 point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied.
Outcome measures
| Measure |
Nelfilcon A
n=16 Participants
Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
|
Etafilcon A
n=14 Participants
Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
|
Filcon II 3
n=30 Participants
Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
|
|---|---|---|---|
|
Overall Satisfaction
Somewhat Satisfied
|
8 participants
|
9 participants
|
11 participants
|
|
Overall Satisfaction
Completely Dissatisfied
|
0 participants
|
0 participants
|
1 participants
|
|
Overall Satisfaction
Somewhat Dissatisfied
|
1 participants
|
1 participants
|
3 participants
|
|
Overall Satisfaction
Completely Satisfied
|
7 participants
|
4 participants
|
15 participants
|
SECONDARY outcome
Timeframe: Baseline and 3 days follow-upThe investigator's objective assessment for contact lens fit and performance - wettability. Measured at baseline (10-15mins settling) for both study pairs. Wettability (scale 0-4, 0.25 steps, 0=excellent, 4 severely reduced).
Outcome measures
| Measure |
Nelfilcon A
n=16 Participants
Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
|
Etafilcon A
n=14 Participants
Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
|
Filcon II 3
n=30 Participants
Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
|
|---|---|---|---|
|
Lens Fit and Performance - Wettability (Baseline and 3 Days Follow-up)
Baseline
|
3.5 units on a scale
Standard Deviation 0.3
|
3.3 units on a scale
Standard Deviation 0.5
|
3.4 units on a scale
Standard Deviation 0.4
|
|
Lens Fit and Performance - Wettability (Baseline and 3 Days Follow-up)
3 days follow up
|
3.6 units on a scale
Standard Deviation 0.2
|
3.2 units on a scale
Standard Deviation 0.6
|
3.5 units on a scale
Standard Deviation 0.4
|
SECONDARY outcome
Timeframe: Baseline and 3 days follow-upThe investigator's objective assessment for contact lens fit and performance - deposits. Measured at baseline (10-15mins settling) for both study pairs. Deposits (scale 0-4, 0.25 steps, 0=excellent, 4 severely reduced);
Outcome measures
| Measure |
Nelfilcon A
n=16 Participants
Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
|
Etafilcon A
n=14 Participants
Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
|
Filcon II 3
n=30 Participants
Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
|
|---|---|---|---|
|
Lens Fit and Performance - Deposits (Baseline and 3 Days Follow-up)
Baseline
|
0.0 units on a scale
Standard Deviation 0.0
|
0.1 units on a scale
Standard Deviation 0.3
|
0.0 units on a scale
Standard Deviation 0.0
|
|
Lens Fit and Performance - Deposits (Baseline and 3 Days Follow-up)
3 days follow up
|
0.0 units on a scale
Standard Deviation 0.0
|
0.0 units on a scale
Standard Deviation 0.0
|
0.0 units on a scale
Standard Deviation 0.0
|
SECONDARY outcome
Timeframe: Baseline and 3 day follow-upThe investigator's objective assessment for contact lens fit and performance - debris. Measured at baseline (10-15mins settling) for both study pairs. (Debris scale 0-4; 0.25 steps; 0=no debris, 4=significant debris)
Outcome measures
| Measure |
Nelfilcon A
n=16 Participants
Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
|
Etafilcon A
n=14 Participants
Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
|
Filcon II 3
n=30 Participants
Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
|
|---|---|---|---|
|
Lens Fit and Performance - Debris (Baseline and 3 Day Follow-up)
Baseline
|
0.0 units on a scale
Standard Deviation 0.0
|
0.0 units on a scale
Standard Deviation 0.0
|
0.0 units on a scale
Standard Deviation 0.0
|
|
Lens Fit and Performance - Debris (Baseline and 3 Day Follow-up)
3 days follow up
|
0.0 units on a scale
Standard Deviation 0.0
|
0.0 units on a scale
Standard Deviation 0.0
|
0.1 units on a scale
Standard Deviation 0.6
|
SECONDARY outcome
Timeframe: Baseline and 3 days follow-upThe investigator's objective assessment for contact lens fit and performance - movement. Measured at baseline (10-15mins settling) for both study pairs. Movement (scale in millimeters).
Outcome measures
| Measure |
Nelfilcon A
n=16 Participants
Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
|
Etafilcon A
n=14 Participants
Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
|
Filcon II 3
n=30 Participants
Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
|
|---|---|---|---|
|
Lens Fit and Performance - Movement (Baseline and 3 Days Follow-up)
Baseline
|
0.3 units on a scale
Standard Deviation 0.2
|
0.3 units on a scale
Standard Deviation 0.2
|
0.3 units on a scale
Standard Deviation 0.1
|
|
Lens Fit and Performance - Movement (Baseline and 3 Days Follow-up)
3 days follow up
|
0.2 units on a scale
Standard Deviation 0.2
|
0.3 units on a scale
Standard Deviation 0.2
|
0.3 units on a scale
Standard Deviation 0.2
|
SECONDARY outcome
Timeframe: Baseline and 3 day follow-upThe investigator's objective assessment for contact lens fit and performance - fit acceptance. Measured at baseline and 3 day follow-up (10-15mins settling) for both study pairs. Fit acceptance (Scale 0-4, 0.25 steps, 0=Should not be worn, 4=Perfect).
Outcome measures
| Measure |
Nelfilcon A
n=16 Participants
Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
|
Etafilcon A
n=14 Participants
Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
|
Filcon II 3
n=30 Participants
Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
|
|---|---|---|---|
|
Lens Fit and Performance - Fit Acceptance
Baseline
|
3.6 units on a scale
Standard Deviation 0.2
|
3.6 units on a scale
Standard Deviation 0.2
|
3.7 units on a scale
Standard Deviation 0.2
|
|
Lens Fit and Performance - Fit Acceptance
3 days follow up
|
3.6 units on a scale
Standard Deviation 0.3
|
3.6 units on a scale
Standard Deviation 0.2
|
3.7 units on a scale
Standard Deviation 0.2
|
SECONDARY outcome
Timeframe: Baseline and 3 day follow-upThe investigator's objective assessment for contact lens fit and performance - tightness. Measured at baseline (10-15mins settling) for both study pairs. Tightness (Scale 0-4, 0.25 steps, 0=Should not be worn, 4=Perfect).
Outcome measures
| Measure |
Nelfilcon A
n=16 Participants
Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
|
Etafilcon A
n=14 Participants
Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
|
Filcon II 3
n=30 Participants
Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
|
|---|---|---|---|
|
Lens Fit and Performance - Tightness (Baseline and 3 Day Follow-up)
Baseline
|
54.0 units on a scale
Standard Deviation 12.0
|
56.0 units on a scale
Standard Deviation 11.0
|
53.0 units on a scale
Standard Deviation 12
|
|
Lens Fit and Performance - Tightness (Baseline and 3 Day Follow-up)
3 days follow up
|
58.0 units on a scale
Standard Deviation 12
|
55 units on a scale
Standard Deviation 12.0
|
54 units on a scale
Standard Deviation 11
|
SECONDARY outcome
Timeframe: 3 Days Follow-upPopulation: Only right eye data shown. Left eye data virtually identical. One subject had non-contact lens related adverse event in the nelfilcon A group. Subject temporarily discontinued and went on to complete the study.
The investigator's objective assessment of ocular health assessed for each study Pair after 3 days wear by biomicroscopy. Bulbar and Limbal Hyperemia; Corneal Staining Type, Extent and Depth, Conjunctival Staining and Indentation. BrienHolden Vision Institute Continuous Scale: 1-4, 0.5 steps (1=Very, 2=Slight, 3=Moderate, 4=Severe)
Outcome measures
| Measure |
Nelfilcon A
n=16 Participants
Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
|
Etafilcon A
n=14 Participants
Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
|
Filcon II 3
n=30 Participants
Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
|
|---|---|---|---|
|
Ocular Health - Biomicroscopy
Bulbar Hyperemia (Nasal)
|
0.88 units on a scale
Standard Deviation 0.2
|
0.96 units on a scale
Standard Deviation 0.3
|
0.95 units on a scale
Standard Deviation 0.4
|
|
Ocular Health - Biomicroscopy
Bulbar Hyperemia (Temporal)
|
0.81 units on a scale
Standard Deviation 0.3
|
0.96 units on a scale
Standard Deviation 0.2
|
0.98 units on a scale
Standard Deviation 0.4
|
|
Ocular Health - Biomicroscopy
Bulbar Hyperemia (Superior)
|
0.63 units on a scale
Standard Deviation 0.4
|
0.64 units on a scale
Standard Deviation 0.5
|
0.72 units on a scale
Standard Deviation 0.5
|
|
Ocular Health - Biomicroscopy
Bulbar Hyperemia (Inferior)
|
0.72 units on a scale
Standard Deviation 0.4
|
0.64 units on a scale
Standard Deviation 0.5
|
0.75 units on a scale
Standard Deviation 0.5
|
|
Ocular Health - Biomicroscopy
Limbal Hyperemia (Nasal)
|
0.53 units on a scale
Standard Deviation 0.5
|
0.96 units on a scale
Standard Deviation 0.7
|
0.47 units on a scale
Standard Deviation 0.6
|
|
Ocular Health - Biomicroscopy
Limbal Hyperemia (Temporal)
|
0.44 units on a scale
Standard Deviation 0.4
|
0.89 units on a scale
Standard Deviation 0.7
|
0.38 units on a scale
Standard Deviation 0.5
|
|
Ocular Health - Biomicroscopy
Limbal Hyperemia (Superior)
|
0.38 units on a scale
Standard Deviation 0.4
|
0.68 units on a scale
Standard Deviation 0.7
|
0.30 units on a scale
Standard Deviation 0.4
|
|
Ocular Health - Biomicroscopy
Limbal Hyperemia (Inferior)
|
0.41 units on a scale
Standard Deviation 0.5
|
0.75 units on a scale
Standard Deviation 0.8
|
0.33 units on a scale
Standard Deviation 0.5
|
|
Ocular Health - Biomicroscopy
Corneal Staining Type (Central)
|
0.00 units on a scale
Standard Deviation 0.0
|
0.18 units on a scale
Standard Deviation 0.5
|
0.17 units on a scale
Standard Deviation 0.6
|
|
Ocular Health - Biomicroscopy
Corneal Staining Type (Nasal)
|
0.19 units on a scale
Standard Deviation 0.8
|
0.14 units on a scale
Standard Deviation 0.5
|
0.07 units on a scale
Standard Deviation 0.4
|
|
Ocular Health - Biomicroscopy
Corneal Staining Type (Temporal)
|
0.16 units on a scale
Standard Deviation 0.4
|
0.25 units on a scale
Standard Deviation 0.7
|
0.32 units on a scale
Standard Deviation 0.8
|
|
Ocular Health - Biomicroscopy
Corneal Staining Type (Superior)
|
0.34 units on a scale
Standard Deviation 0.7
|
0.07 units on a scale
Standard Deviation 0.3
|
0.38 units on a scale
Standard Deviation 0.8
|
|
Ocular Health - Biomicroscopy
Corneal Staining Type (Inferior)
|
0.50 units on a scale
Standard Deviation 1.0
|
0.50 units on a scale
Standard Deviation 0.9
|
0.67 units on a scale
Standard Deviation 0.9
|
|
Ocular Health - Biomicroscopy
Corneal Staining Extent (Central)
|
0.00 units on a scale
Standard Deviation 0.0
|
0.07 units on a scale
Standard Deviation 0.2
|
0.08 units on a scale
Standard Deviation 0.3
|
|
Ocular Health - Biomicroscopy
Corneal Staining Extent (Nasal)
|
0.03 units on a scale
Standard Deviation 0.1
|
0.04 units on a scale
Standard Deviation 0.1
|
0.02 units on a scale
Standard Deviation 0.1
|
|
Ocular Health - Biomicroscopy
Corneal Staining Extent (Temporal)
|
0.09 units on a scale
Standard Deviation 0.3
|
0.11 units on a scale
Standard Deviation 0.3
|
0.10 units on a scale
Standard Deviation 0.2
|
|
Ocular Health - Biomicroscopy
Corneal Staining Extent (Superior)
|
0.22 units on a scale
Standard Deviation 0.4
|
0.04 units on a scale
Standard Deviation 0.1
|
0.22 units on a scale
Standard Deviation 0.5
|
|
Ocular Health - Biomicroscopy
Corneal Staining Extent (Inferior)
|
0.41 units on a scale
Standard Deviation 0.7
|
0.32 units on a scale
Standard Deviation 0.6
|
0.38 units on a scale
Standard Deviation 0.6
|
|
Ocular Health - Biomicroscopy
Corneal Staining Depth (Central)
|
0.00 units on a scale
Standard Deviation 0.0
|
0.14 units on a scale
Standard Deviation 0.4
|
0.10 units on a scale
Standard Deviation 0.3
|
|
Ocular Health - Biomicroscopy
Corneal Staining Depth (Nasal)
|
0.06 units on a scale
Standard Deviation 0.3
|
0.07 units on a scale
Standard Deviation 0.3
|
0.03 units on a scale
Standard Deviation 0.2
|
|
Ocular Health - Biomicroscopy
Corneal Staining Depth (Temporal)
|
0.13 units on a scale
Standard Deviation 0.3
|
0.14 units on a scale
Standard Deviation 0.4
|
0.17 units on a scale
Standard Deviation 0.4
|
|
Ocular Health - Biomicroscopy
Corneal Staining Depth (Superior)
|
.025 units on a scale
Standard Deviation 0.5
|
0.07 units on a scale
Standard Deviation 0.3
|
0.20 units on a scale
Standard Deviation 0.4
|
|
Ocular Health - Biomicroscopy
Corneal Staining Depth (Inferior)
|
0.25 units on a scale
Standard Deviation 0.5
|
0.29 units on a scale
Standard Deviation 0.5
|
0.40 units on a scale
Standard Deviation 0.5
|
|
Ocular Health - Biomicroscopy
Conjunctival Staining (Nasal)
|
0.34 units on a scale
Standard Deviation 0.6
|
1.29 units on a scale
Standard Deviation 1.2
|
1.65 units on a scale
Standard Deviation 0.9
|
|
Ocular Health - Biomicroscopy
Conjunctival Staining (Temporal)
|
0.28 units on a scale
Standard Deviation 0.5
|
0.68 units on a scale
Standard Deviation 0.9
|
1.65 units on a scale
Standard Deviation 0.9
|
|
Ocular Health - Biomicroscopy
Conjunctival Staining (Superior)
|
0.13 units on a scale
Standard Deviation 0.3
|
0.04 units on a scale
Standard Deviation 0.1
|
1.48 units on a scale
Standard Deviation 0.8
|
|
Ocular Health - Biomicroscopy
Conjunctival Staining (Inferior)
|
0.19 units on a scale
Standard Deviation 0.4
|
0.64 units on a scale
Standard Deviation 0.9
|
1.55 units on a scale
Standard Deviation 0.8
|
|
Ocular Health - Biomicroscopy
Conjunctival Indent (Nasal)
|
0.00 units on a scale
Standard Deviation 0.0
|
0.00 units on a scale
Standard Deviation 0.0
|
0.28 units on a scale
Standard Deviation 0.5
|
|
Ocular Health - Biomicroscopy
Conjunctival Indent (Temporal)
|
0.00 units on a scale
Standard Deviation 0.0
|
0.00 units on a scale
Standard Deviation 0.0
|
0.28 units on a scale
Standard Deviation 0.5
|
|
Ocular Health - Biomicroscopy
Conjunctival Indent (Superior)
|
0.06 units on a scale
Standard Deviation 0.3
|
0.00 units on a scale
Standard Deviation 0.0
|
0.22 units on a scale
Standard Deviation 0.5
|
|
Ocular Health - Biomicroscopy
Conjunctival Indent (Inferior)
|
0.06 units on a scale
Standard Deviation 0.3
|
0.00 units on a scale
Standard Deviation 0.0
|
0.20 units on a scale
Standard Deviation 0.5
|
Adverse Events
Nelfilcon A
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Etafilcon A
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Filcon II 3
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Nelfilcon A
n=16 participants at risk
Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
|
Etafilcon A
n=14 participants at risk
Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
|
Filcon II 3
n=30 participants at risk
Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
|
|---|---|---|---|
|
Eye disorders
Non-lens related
|
6.2%
1/16 • Number of events 1 • From dispense up to 3 days for each study lenses
|
0.00%
0/14 • From dispense up to 3 days for each study lenses
|
0.00%
0/30 • From dispense up to 3 days for each study lenses
|
Additional Information
Jose A. Vega, OD, Sr. Manager Global Medical Scientific Affairs
CooperVision
Phone: (925) 621-3761
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The investigators will not be permitted to publish or present at scientific meetings results obtained from the clinical study without prior written consent from the sponsor.
- Publication restrictions are in place
Restriction type: OTHER