Trial Outcomes & Findings for Clinical Performance of Habitual Wearers of Bioclear 1-day Lenses When Refitted With Biomedics 1-day Extra for 1 Week (NCT NCT02406495)
NCT ID: NCT02406495
Last Updated: 2020-07-29
Results Overview
Lens fit, centration for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale: optimum, decentration acceptable, and decentration unacceptable
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
40 participants
Primary outcome timeframe
Baseline and 1 Week
Results posted on
2020-07-29
Participant Flow
Participant milestones
| Measure |
Overall Participants
Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.
filcon IV 1: contact lens
ocufilcon D: contact lens
|
|---|---|
|
Overall Study
STARTED
|
40
|
|
Overall Study
COMPLETED
|
40
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Clinical Performance of Habitual Wearers of Bioclear 1-day Lenses When Refitted With Biomedics 1-day Extra for 1 Week
Baseline characteristics by cohort
| Measure |
Overall Participants
n=40 Participants
Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.
filcon IV 1: contact lens
ocufilcon D: contact lens
|
|---|---|
|
Age, Continuous
|
23.92 years
STANDARD_DEVIATION 5.43 • n=5 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 1 WeekLens fit, centration for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale: optimum, decentration acceptable, and decentration unacceptable
Outcome measures
| Measure |
Filcon IV 1
n=40 Participants
Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.
filcon IV 1: contact lens
ocufilcon D: contact lens
|
Ocufilcon D
n=40 Participants
Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.
filcon IV 1: contact lens
ocufilcon D: contact lens
|
Ocufilcon D OD (Oculus Dexter)
n=40 Participants
Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.
filcon IV 1: contact lens
ocufilcon D: contact lens
|
Ocufilcon D OS (Oculus Sinister)
n=40 Participants
Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.
filcon IV 1: contact lens
ocufilcon D: contact lens
|
|---|---|---|---|---|
|
Lens Fit, Centration - Filcon IV 1 and Ocufilcon D
Decentration unacceptable
|
0 percentage of eyes
|
0 percentage of eyes
|
0 percentage of eyes
|
0 percentage of eyes
|
|
Lens Fit, Centration - Filcon IV 1 and Ocufilcon D
Optimum
|
58 percentage of eyes
|
70 percentage of eyes
|
98 percentage of eyes
|
98 percentage of eyes
|
|
Lens Fit, Centration - Filcon IV 1 and Ocufilcon D
Decentration acceptable
|
43 percentage of eyes
|
30 percentage of eyes
|
3 percentage of eyes
|
3 percentage of eyes
|
PRIMARY outcome
Timeframe: Baseline and 1 WeekLens fit, post-blink movement for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. (Scale 0-4, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement).
Outcome measures
| Measure |
Filcon IV 1
n=40 Participants
Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.
filcon IV 1: contact lens
ocufilcon D: contact lens
|
Ocufilcon D
n=40 Participants
Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.
filcon IV 1: contact lens
ocufilcon D: contact lens
|
Ocufilcon D OD (Oculus Dexter)
n=40 Participants
Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.
filcon IV 1: contact lens
ocufilcon D: contact lens
|
Ocufilcon D OS (Oculus Sinister)
n=40 Participants
Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.
filcon IV 1: contact lens
ocufilcon D: contact lens
|
|---|---|---|---|---|
|
Lens Fit, Post-blink Movement - Filcon IV 1 and Ocufilcon D
0=Insufficient, unacceptable movement
|
0 percentage of eyes
|
0 percentage of eyes
|
0 percentage of eyes
|
0 percentage of eyes
|
|
Lens Fit, Post-blink Movement - Filcon IV 1 and Ocufilcon D
1=Minimal, but acceptable movement
|
10 percentage of eyes
|
10 percentage of eyes
|
0 percentage of eyes
|
0 percentage of eyes
|
|
Lens Fit, Post-blink Movement - Filcon IV 1 and Ocufilcon D
2=Optimal movement
|
23 percentage of eyes
|
18 percentage of eyes
|
10 percentage of eyes
|
10 percentage of eyes
|
|
Lens Fit, Post-blink Movement - Filcon IV 1 and Ocufilcon D
3=Moderate, but acceptable movement
|
65 percentage of eyes
|
70 percentage of eyes
|
90 percentage of eyes
|
90 percentage of eyes
|
|
Lens Fit, Post-blink Movement - Filcon IV 1 and Ocufilcon D
4=Excessive, unacceptable movement
|
3 percentage of eyes
|
3 percentage of eyes
|
0 percentage of eyes
|
0 percentage of eyes
|
PRIMARY outcome
Timeframe: Baseline and 1 WeekLens fit, lens tightness for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale 0%-100% continuous scale 0% - Falls from cornea without lid support 50% - Optimum 100% - No movement
Outcome measures
| Measure |
Filcon IV 1
n=40 Participants
Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.
filcon IV 1: contact lens
ocufilcon D: contact lens
|
Ocufilcon D
n=40 Participants
Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.
filcon IV 1: contact lens
ocufilcon D: contact lens
|
Ocufilcon D OD (Oculus Dexter)
Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.
filcon IV 1: contact lens
ocufilcon D: contact lens
|
Ocufilcon D OS (Oculus Sinister)
Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.
filcon IV 1: contact lens
ocufilcon D: contact lens
|
|---|---|---|---|---|
|
Lens Fit, Lens Tightness - Filcon IV 1 and Ocufilcon D
OD
|
49.1 percentage of mean lens tightness
Standard Deviation 5.9
|
50.1 percentage of mean lens tightness
Standard Deviation 0.79
|
—
|
—
|
|
Lens Fit, Lens Tightness - Filcon IV 1 and Ocufilcon D
OS
|
48.9 percentage of mean lens tightness
Standard Deviation 5.2
|
50.0 percentage of mean lens tightness
Standard Deviation 1.9
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline and 1 WeekLens fit, overall fit acceptance for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale 0-4, 0=Should not be worn, 4=Perfect.
Outcome measures
| Measure |
Filcon IV 1
n=40 Participants
Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.
filcon IV 1: contact lens
ocufilcon D: contact lens
|
Ocufilcon D
n=40 Participants
Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.
filcon IV 1: contact lens
ocufilcon D: contact lens
|
Ocufilcon D OD (Oculus Dexter)
n=40 Participants
Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.
filcon IV 1: contact lens
ocufilcon D: contact lens
|
Ocufilcon D OS (Oculus Sinister)
n=40 Participants
Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.
filcon IV 1: contact lens
ocufilcon D: contact lens
|
|---|---|---|---|---|
|
Lens Fit, Overall Fit Acceptance - Filcon IV 1 and Ocufilcon D
Should not be worn
|
0 percentage of eyes
|
0 percentage of eyes
|
0 percentage of eyes
|
0 percentage of eyes
|
|
Lens Fit, Overall Fit Acceptance - Filcon IV 1 and Ocufilcon D
Borderline but acceptable
|
0 percentage of eyes
|
0 percentage of eyes
|
0 percentage of eyes
|
0 percentage of eyes
|
|
Lens Fit, Overall Fit Acceptance - Filcon IV 1 and Ocufilcon D
Min. acceptable
|
0 percentage of eyes
|
0 percentage of eyes
|
0 percentage of eyes
|
0 percentage of eyes
|
|
Lens Fit, Overall Fit Acceptance - Filcon IV 1 and Ocufilcon D
Not perfect but OK
|
38 percentage of eyes
|
35 percentage of eyes
|
0 percentage of eyes
|
0 percentage of eyes
|
|
Lens Fit, Overall Fit Acceptance - Filcon IV 1 and Ocufilcon D
Perfect
|
63 percentage of eyes
|
65 percentage of eyes
|
100 percentage of eyes
|
100 percentage of eyes
|
SECONDARY outcome
Timeframe: Baseline and 1 WeekVisual acuity for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week using logMAR chart (a logMAR of 0.0=20/20 in Snellen notation and negative values indicate better visual acuity).
Outcome measures
| Measure |
Filcon IV 1
n=40 Participants
Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.
filcon IV 1: contact lens
ocufilcon D: contact lens
|
Ocufilcon D
n=40 Participants
Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.
filcon IV 1: contact lens
ocufilcon D: contact lens
|
Ocufilcon D OD (Oculus Dexter)
Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.
filcon IV 1: contact lens
ocufilcon D: contact lens
|
Ocufilcon D OS (Oculus Sinister)
Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.
filcon IV 1: contact lens
ocufilcon D: contact lens
|
|---|---|---|---|---|
|
Visual Acuity - Filcon IV 1 and Ocufilcon D
OD
|
0 LogMAR
Standard Deviation 0
|
0 LogMAR
Standard Deviation 0
|
—
|
—
|
|
Visual Acuity - Filcon IV 1 and Ocufilcon D
OS
|
0 LogMAR
Standard Deviation 0
|
0 LogMAR
Standard Deviation 0
|
—
|
—
|
|
Visual Acuity - Filcon IV 1 and Ocufilcon D
Binocular
|
-0.01 LogMAR
Standard Deviation 0.03
|
-0.01 LogMAR
Standard Deviation 0.04
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and 1 WeekSubjective ratings for comfort for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. (Scale 0-10, 0=could feel, 10=cannot feel).
Outcome measures
| Measure |
Filcon IV 1
n=40 Participants
Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.
filcon IV 1: contact lens
ocufilcon D: contact lens
|
Ocufilcon D
n=40 Participants
Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.
filcon IV 1: contact lens
ocufilcon D: contact lens
|
Ocufilcon D OD (Oculus Dexter)
Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.
filcon IV 1: contact lens
ocufilcon D: contact lens
|
Ocufilcon D OS (Oculus Sinister)
Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.
filcon IV 1: contact lens
ocufilcon D: contact lens
|
|---|---|---|---|---|
|
Comfort (Subjective Ratings) - Filcon IV 1 and Ocufilcon D
Comfort on insertion
|
7.4 units on a scale
Standard Deviation 1.1
|
8.1 units on a scale
Standard Deviation 1.3
|
—
|
—
|
|
Comfort (Subjective Ratings) - Filcon IV 1 and Ocufilcon D
Comfort prior to removal
|
7.3 units on a scale
Standard Deviation 1.4
|
8.1 units on a scale
Standard Deviation 1.3
|
—
|
—
|
|
Comfort (Subjective Ratings) - Filcon IV 1 and Ocufilcon D
Comfort overall
|
7.3 units on a scale
Standard Deviation 1.3
|
8.1 units on a scale
Standard Deviation 1.4
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and 1 WeekSubjective ratings of dryness for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. (Scale 0-10, 0=dryness, 10=no dryness).
Outcome measures
| Measure |
Filcon IV 1
n=40 Participants
Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.
filcon IV 1: contact lens
ocufilcon D: contact lens
|
Ocufilcon D
n=40 Participants
Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.
filcon IV 1: contact lens
ocufilcon D: contact lens
|
Ocufilcon D OD (Oculus Dexter)
Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.
filcon IV 1: contact lens
ocufilcon D: contact lens
|
Ocufilcon D OS (Oculus Sinister)
Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.
filcon IV 1: contact lens
ocufilcon D: contact lens
|
|---|---|---|---|---|
|
Dryness (Subjective Ratings) - Filcon IV 1 and Ocufilcon D
Dryness during day
|
7.2 units on a scale
Standard Deviation 1.3
|
8.0 units on a scale
Standard Deviation 1.5
|
—
|
—
|
|
Dryness (Subjective Ratings) - Filcon IV 1 and Ocufilcon D
Dryness prior to removal
|
7.3 units on a scale
Standard Deviation 1.3
|
8.0 units on a scale
Standard Deviation 1.5
|
—
|
—
|
|
Dryness (Subjective Ratings) - Filcon IV 1 and Ocufilcon D
Overall dryness
|
7.3 units on a scale
Standard Deviation 1.3
|
8.1 units on a scale
Standard Deviation 1.5
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and 1 WeekSubjective ratings of handling for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. (Scale 0-10, 0=very difficult to handle, 10=very easy to handle).
Outcome measures
| Measure |
Filcon IV 1
n=40 Participants
Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.
filcon IV 1: contact lens
ocufilcon D: contact lens
|
Ocufilcon D
n=40 Participants
Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.
filcon IV 1: contact lens
ocufilcon D: contact lens
|
Ocufilcon D OD (Oculus Dexter)
Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.
filcon IV 1: contact lens
ocufilcon D: contact lens
|
Ocufilcon D OS (Oculus Sinister)
Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.
filcon IV 1: contact lens
ocufilcon D: contact lens
|
|---|---|---|---|---|
|
Handling (Subjective Ratings) - Filcon IV 1 and Ocufilcon D
|
7.4 units on a scale
Standard Deviation 1.2
|
8.2 units on a scale
Standard Deviation 1.3
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and 1 WeekSubjective ratings of vision satisfaction for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. (Scale 0-10, 0=dissatisfied, 10=very satisfied).
Outcome measures
| Measure |
Filcon IV 1
n=40 Participants
Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.
filcon IV 1: contact lens
ocufilcon D: contact lens
|
Ocufilcon D
n=40 Participants
Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.
filcon IV 1: contact lens
ocufilcon D: contact lens
|
Ocufilcon D OD (Oculus Dexter)
Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.
filcon IV 1: contact lens
ocufilcon D: contact lens
|
Ocufilcon D OS (Oculus Sinister)
Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.
filcon IV 1: contact lens
ocufilcon D: contact lens
|
|---|---|---|---|---|
|
Vision Satisfaction (Subjective Ratings) - Filcon IV 1 and Ocufilcon D
|
7.5 units on a scale
Standard Deviation 1.3
|
8.2 units on a scale
Standard Deviation 1.3
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 WeekSubjective ratings of participant's lens preference for either filcon IV 1 or ocufilcon D on comfort, dryness, handling, vision, and overall. Forced choice: filcon IV 1 or ocufilcon D.
Outcome measures
| Measure |
Filcon IV 1
n=40 Participants
Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.
filcon IV 1: contact lens
ocufilcon D: contact lens
|
Ocufilcon D
n=40 Participants
Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.
filcon IV 1: contact lens
ocufilcon D: contact lens
|
Ocufilcon D OD (Oculus Dexter)
Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.
filcon IV 1: contact lens
ocufilcon D: contact lens
|
Ocufilcon D OS (Oculus Sinister)
Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.
filcon IV 1: contact lens
ocufilcon D: contact lens
|
|---|---|---|---|---|
|
Lens Preference (Subjective Ratings) - Filcon IV 1 and Ocufilcon D
Comfort
|
20 percentage of participants
|
80 percentage of participants
|
—
|
—
|
|
Lens Preference (Subjective Ratings) - Filcon IV 1 and Ocufilcon D
Dryness
|
20 percentage of participants
|
80 percentage of participants
|
—
|
—
|
|
Lens Preference (Subjective Ratings) - Filcon IV 1 and Ocufilcon D
Handling
|
20 percentage of participants
|
80 percentage of participants
|
—
|
—
|
|
Lens Preference (Subjective Ratings) - Filcon IV 1 and Ocufilcon D
Vision
|
20 percentage of participants
|
80 percentage of participants
|
—
|
—
|
|
Lens Preference (Subjective Ratings) - Filcon IV 1 and Ocufilcon D
Overall
|
20 percentage of participants
|
80 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and 1 WeekLens satisfaction of comfort for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale 1-4, 1=completely satisfied, 4=completely dissatisfied.
Outcome measures
| Measure |
Filcon IV 1
n=40 Participants
Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.
filcon IV 1: contact lens
ocufilcon D: contact lens
|
Ocufilcon D
n=40 Participants
Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.
filcon IV 1: contact lens
ocufilcon D: contact lens
|
Ocufilcon D OD (Oculus Dexter)
Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.
filcon IV 1: contact lens
ocufilcon D: contact lens
|
Ocufilcon D OS (Oculus Sinister)
Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.
filcon IV 1: contact lens
ocufilcon D: contact lens
|
|---|---|---|---|---|
|
Lens Satisfaction, Comfort - Filcon IV 1 and Ocufilcon D
Completely Satisfied
|
20 percentage of participants
|
60 percentage of participants
|
—
|
—
|
|
Lens Satisfaction, Comfort - Filcon IV 1 and Ocufilcon D
Somewhat Satisfied
|
68 percentage of participants
|
35 percentage of participants
|
—
|
—
|
|
Lens Satisfaction, Comfort - Filcon IV 1 and Ocufilcon D
Somewhat Dissatisfied
|
13 percentage of participants
|
5 percentage of participants
|
—
|
—
|
|
Lens Satisfaction, Comfort - Filcon IV 1 and Ocufilcon D
Completely Dissatisfied
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and 1 WeekLens satisfaction of dryness for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale 1-4, 1=completely satisfied, 4=completely dissatisfied.
Outcome measures
| Measure |
Filcon IV 1
n=40 Participants
Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.
filcon IV 1: contact lens
ocufilcon D: contact lens
|
Ocufilcon D
n=40 Participants
Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.
filcon IV 1: contact lens
ocufilcon D: contact lens
|
Ocufilcon D OD (Oculus Dexter)
Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.
filcon IV 1: contact lens
ocufilcon D: contact lens
|
Ocufilcon D OS (Oculus Sinister)
Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.
filcon IV 1: contact lens
ocufilcon D: contact lens
|
|---|---|---|---|---|
|
Lens Satisfaction, Dryness - Filcon IV 1 and Ocufilcon D
Completely Satisfied
|
20 percentage of participants
|
60 percentage of participants
|
—
|
—
|
|
Lens Satisfaction, Dryness - Filcon IV 1 and Ocufilcon D
Somewhat Satisfied
|
65 percentage of participants
|
35 percentage of participants
|
—
|
—
|
|
Lens Satisfaction, Dryness - Filcon IV 1 and Ocufilcon D
Somewhat Dissatisfied
|
15 percentage of participants
|
5 percentage of participants
|
—
|
—
|
|
Lens Satisfaction, Dryness - Filcon IV 1 and Ocufilcon D
Completely Dissatisfied
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and 1 WeekLens satisfaction of handling forfilcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale 1-4, 1=completely satisfied, 4=completely dissatisfied.
Outcome measures
| Measure |
Filcon IV 1
n=40 Participants
Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.
filcon IV 1: contact lens
ocufilcon D: contact lens
|
Ocufilcon D
n=40 Participants
Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.
filcon IV 1: contact lens
ocufilcon D: contact lens
|
Ocufilcon D OD (Oculus Dexter)
Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.
filcon IV 1: contact lens
ocufilcon D: contact lens
|
Ocufilcon D OS (Oculus Sinister)
Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.
filcon IV 1: contact lens
ocufilcon D: contact lens
|
|---|---|---|---|---|
|
Lens Satisfaction, Handling - Filcon IV 1 and Ocufilcon D
Completely Satisfied
|
23 percentage of participants
|
60 percentage of participants
|
—
|
—
|
|
Lens Satisfaction, Handling - Filcon IV 1 and Ocufilcon D
Somewhat Satisfied
|
65 percentage of participants
|
38 percentage of participants
|
—
|
—
|
|
Lens Satisfaction, Handling - Filcon IV 1 and Ocufilcon D
Somewhat Dissatisfied
|
13 percentage of participants
|
3 percentage of participants
|
—
|
—
|
|
Lens Satisfaction, Handling - Filcon IV 1 and Ocufilcon D
Completely Dissatisfied
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and 1 WeekLens satisfaction of vision for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale 1-4, 1=completely satisfied, 4=completely dissatisfied.
Outcome measures
| Measure |
Filcon IV 1
n=40 Participants
Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.
filcon IV 1: contact lens
ocufilcon D: contact lens
|
Ocufilcon D
n=40 Participants
Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.
filcon IV 1: contact lens
ocufilcon D: contact lens
|
Ocufilcon D OD (Oculus Dexter)
Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.
filcon IV 1: contact lens
ocufilcon D: contact lens
|
Ocufilcon D OS (Oculus Sinister)
Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.
filcon IV 1: contact lens
ocufilcon D: contact lens
|
|---|---|---|---|---|
|
Lens Satisfaction, Vision - Filcon IV 1 and Ocufilcon D
Completely Satisfied
|
23 percentage of participants
|
60 percentage of participants
|
—
|
—
|
|
Lens Satisfaction, Vision - Filcon IV 1 and Ocufilcon D
Somewhat Satisfied
|
65 percentage of participants
|
38 percentage of participants
|
—
|
—
|
|
Lens Satisfaction, Vision - Filcon IV 1 and Ocufilcon D
Somewhat Dissatisfied
|
13 percentage of participants
|
3 percentage of participants
|
—
|
—
|
|
Lens Satisfaction, Vision - Filcon IV 1 and Ocufilcon D
Completely Dissatisfied
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and 1 WeekLens satisfaction overall for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale 1-4, 1=completely satisfied, 4=completely dissatisfied.
Outcome measures
| Measure |
Filcon IV 1
n=40 Participants
Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.
filcon IV 1: contact lens
ocufilcon D: contact lens
|
Ocufilcon D
n=40 Participants
Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.
filcon IV 1: contact lens
ocufilcon D: contact lens
|
Ocufilcon D OD (Oculus Dexter)
Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.
filcon IV 1: contact lens
ocufilcon D: contact lens
|
Ocufilcon D OS (Oculus Sinister)
Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.
filcon IV 1: contact lens
ocufilcon D: contact lens
|
|---|---|---|---|---|
|
Lens Satisfaction, Overall - Filcon IV 1 and Ocufilcon D
Somewhat Dissatisfied
|
13 percentage of participants
|
5 percentage of participants
|
—
|
—
|
|
Lens Satisfaction, Overall - Filcon IV 1 and Ocufilcon D
Completely Dissatisfied
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Lens Satisfaction, Overall - Filcon IV 1 and Ocufilcon D
Completely Satisfied
|
20 percentage of participants
|
60 percentage of participants
|
—
|
—
|
|
Lens Satisfaction, Overall - Filcon IV 1 and Ocufilcon D
Somewhat Satisfied
|
68 percentage of participants
|
35 percentage of participants
|
—
|
—
|
Adverse Events
Overall Participants
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
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 Principal Investigators are NOT employed by the organization sponsoring the study. There IS an agreement between the Principal Investigator and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. 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