Trial Outcomes & Findings for Daily Disposable Comparison Study (NCT NCT02094677)
NCT ID: NCT02094677
Last Updated: 2020-07-28
Results Overview
Participant's subjective response for lens preference of filcon II 3 and etafilcon A after 3 hours lens wear rated by questionnaire. (5 possible ratings: Strongly prefer filcon II 3, Slightly prefer filcon II 3, No preference, Slightly prefer etafilcon A/nelfilcon A, Strongly prefer etafilcon A/nelfilcon A).
COMPLETED
NA
70 participants
3 hours
2020-07-28
Participant Flow
Seventy four participants were enrolled into the study and 70 participants were randomized and completed the study. 40 were habitual wearers of etafilcon A lens and 30 were habitual wearers of nelfilcon A lens.
Participant milestones
| Measure |
Filcon II 3 and Etafilcon A
Participants were randomized to a test and control lens in a contralateral design.
filcon II 3: Participants were randomized to wear filcon II 3 test lens.
etafilcon A: Participants were randomized to wear etafilcon A control lens.
|
Filcon II 3 and Nelfilcon A
Participants were randomized to a test and control lens in a contralateral design.
filcon II 3: Participants were randomized to wear filcon II 3 test lens.
nelfilcon A: Participants were randomized to wear nelfilcon A control lens.
|
|---|---|---|
|
Overall Study
STARTED
|
43
|
31
|
|
Overall Study
COMPLETED
|
40
|
30
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
| Measure |
Filcon II 3 and Etafilcon A
Participants were randomized to a test and control lens in a contralateral design.
filcon II 3: Participants were randomized to wear filcon II 3 test lens.
etafilcon A: Participants were randomized to wear etafilcon A control lens.
|
Filcon II 3 and Nelfilcon A
Participants were randomized to a test and control lens in a contralateral design.
filcon II 3: Participants were randomized to wear filcon II 3 test lens.
nelfilcon A: Participants were randomized to wear nelfilcon A control lens.
|
|---|---|---|
|
Overall Study
Screening
|
3
|
1
|
Baseline Characteristics
Daily Disposable Comparison Study
Baseline characteristics by cohort
| Measure |
Filcon II 3 and Etafilcon A
n=40 Participants
Participants were randomized to a test and control lens in a contralateral design.
filcon II 3: Participants were randomized to wear filcon II 3 test lens.
etafilcon A: Participants were randomized to wear etafilcon A control lens.
|
Filcon II 3 and Nelfilcon A
n=30 Participants
Participants were randomized to a test and control lens in a contralateral design.
filcon II 3: Participants were randomized to wear filcon II 3 test lens.
nelfilcon A: Participants were randomized to wear nelfilcon A control lens.
|
Total
n=70 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
28 years
STANDARD_DEVIATION 9 • n=5 Participants
|
33.1 years
STANDARD_DEVIATION 12.4 • n=7 Participants
|
30.2 years
STANDARD_DEVIATION 10.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
40 participants
n=5 Participants
|
30 participants
n=7 Participants
|
70 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline visitParticipant's subjective response for lens preference of filcon II 3 and etafilcon A or filcon II 3 and nelfilcon A at baseline visit, following insertion, after settling 10-15mins (surveyed at baseline visit) rated by questionnaire. (5 possible ratings: Strongly prefer filcon II 3, Slightly prefer filcon II 3, No preference, Slightly prefer etafilcon A/nelfilcon A, Strongly prefer etafilcon A/nelfilcon A).
Outcome measures
| Measure |
Filcon II 3 and Etafilcon A
n=40 Participants
Participants were randomized to a test and control lens in a contralateral design.
filcon II 3: Participants were randomized to wear filcon II 3 test lens.
etafilcon A: Participants were randomized to wear etafilcon A control lens.
|
Filcon II 3 and Nelfilcon A
n=30 Participants
Participants were randomized to a test and control lens in a contralateral design.
filcon II 3: Participants were randomized to wear filcon II 3 test lens.
nelfilcon A: Participants were randomized to wear nelfilcon A control lens.
|
|---|---|---|
|
Lens Preference - Filcon II 3 and Etafilcon A or Filcon II 3 and Nelfilcon A
Strongly prefer filcon II 3
|
1 participants
|
3 participants
|
|
Lens Preference - Filcon II 3 and Etafilcon A or Filcon II 3 and Nelfilcon A
Slightly prefer filcon II 3
|
14 participants
|
8 participants
|
|
Lens Preference - Filcon II 3 and Etafilcon A or Filcon II 3 and Nelfilcon A
No preference
|
8 participants
|
10 participants
|
|
Lens Preference - Filcon II 3 and Etafilcon A or Filcon II 3 and Nelfilcon A
Slightly prefer etafilcon A/nelfilcon A
|
8 participants
|
6 participants
|
|
Lens Preference - Filcon II 3 and Etafilcon A or Filcon II 3 and Nelfilcon A
Strongly prefer etafilcon A/nelfilcon A
|
9 participants
|
3 participants
|
PRIMARY outcome
Timeframe: 3 hoursParticipant's subjective response for lens preference of filcon II 3 and etafilcon A after 3 hours lens wear rated by questionnaire. (5 possible ratings: Strongly prefer filcon II 3, Slightly prefer filcon II 3, No preference, Slightly prefer etafilcon A/nelfilcon A, Strongly prefer etafilcon A/nelfilcon A).
Outcome measures
| Measure |
Filcon II 3 and Etafilcon A
n=40 Participants
Participants were randomized to a test and control lens in a contralateral design.
filcon II 3: Participants were randomized to wear filcon II 3 test lens.
etafilcon A: Participants were randomized to wear etafilcon A control lens.
|
Filcon II 3 and Nelfilcon A
n=30 Participants
Participants were randomized to a test and control lens in a contralateral design.
filcon II 3: Participants were randomized to wear filcon II 3 test lens.
nelfilcon A: Participants were randomized to wear nelfilcon A control lens.
|
|---|---|---|
|
Lens Preference - Filcon II 3 and Etafilcon A or Filcon II 3 and Nelfilcon A
Strongly prefer filcon II 3
|
1 participants
|
3 participants
|
|
Lens Preference - Filcon II 3 and Etafilcon A or Filcon II 3 and Nelfilcon A
Slightly prefer filcon II 3
|
10 participants
|
12 participants
|
|
Lens Preference - Filcon II 3 and Etafilcon A or Filcon II 3 and Nelfilcon A
No preference
|
7 participants
|
5 participants
|
|
Lens Preference - Filcon II 3 and Etafilcon A or Filcon II 3 and Nelfilcon A
Slightly prefer etafilcon A/nelfilcon A
|
13 participants
|
8 participants
|
|
Lens Preference - Filcon II 3 and Etafilcon A or Filcon II 3 and Nelfilcon A
Strongly prefer etafilcon A/nelfilcon A
|
9 participants
|
2 participants
|
PRIMARY outcome
Timeframe: 6 hoursParticipant's subjective response for lens preference of filcon II 3 and etafilcon A after 6 hours lens wear rated by questionnaire (5 possible ratings: Strongly prefer filcon II 3, Slightly prefer filcon II 3, No preference, Slightly prefer etafilcon A/nelfilcon A, Strongly prefer etafilcon A/nelfilcon A).
Outcome measures
| Measure |
Filcon II 3 and Etafilcon A
n=40 Participants
Participants were randomized to a test and control lens in a contralateral design.
filcon II 3: Participants were randomized to wear filcon II 3 test lens.
etafilcon A: Participants were randomized to wear etafilcon A control lens.
|
Filcon II 3 and Nelfilcon A
n=30 Participants
Participants were randomized to a test and control lens in a contralateral design.
filcon II 3: Participants were randomized to wear filcon II 3 test lens.
nelfilcon A: Participants were randomized to wear nelfilcon A control lens.
|
|---|---|---|
|
Lens Preference - Filcon II 3 and Etafilcon A or Filcon II 3 and Nelfilcon A
Strongly prefer filcon II 3
|
2 participants
|
5 participants
|
|
Lens Preference - Filcon II 3 and Etafilcon A or Filcon II 3 and Nelfilcon A
Slightly prefer filcon II 3
|
9 participants
|
8 participants
|
|
Lens Preference - Filcon II 3 and Etafilcon A or Filcon II 3 and Nelfilcon A
No preference
|
7 participants
|
9 participants
|
|
Lens Preference - Filcon II 3 and Etafilcon A or Filcon II 3 and Nelfilcon A
Slightly prefer etafilcon A/nelfilcon A
|
11 participants
|
5 participants
|
|
Lens Preference - Filcon II 3 and Etafilcon A or Filcon II 3 and Nelfilcon A
Strongly prefer etafilcon A/nelfilcon A
|
11 participants
|
3 participants
|
SECONDARY outcome
Timeframe: Baseline, 3 hours, 6 hoursPopulation: These results are between the filcon II 3 and etafilcon A group which comprises of 40 participants. Habitual data collected before study lens dispensed.
Participant's subjective response for lens comfort of filcon II 3 and etafilcon A after settling 10-15mins (surveyed at baseline visit, 3 hours, and 6 hours) rated by questionnaire (Scale 0-100, 0=cannot be worn, causes pain, 100=cannot be felt ever).
Outcome measures
| Measure |
Filcon II 3 and Etafilcon A
n=40 Participants
Participants were randomized to a test and control lens in a contralateral design.
filcon II 3: Participants were randomized to wear filcon II 3 test lens.
etafilcon A: Participants were randomized to wear etafilcon A control lens.
|
Filcon II 3 and Nelfilcon A
n=40 Participants
Participants were randomized to a test and control lens in a contralateral design.
filcon II 3: Participants were randomized to wear filcon II 3 test lens.
nelfilcon A: Participants were randomized to wear nelfilcon A control lens.
|
|---|---|---|
|
Lens Comfort - Filcon II 3 and Etafilcon A
Habitual lens (before study lens dispensed)
|
78 units on a scale
Standard Deviation 18
|
77 units on a scale
Standard Deviation 20
|
|
Lens Comfort - Filcon II 3 and Etafilcon A
Baseline (study lens)
|
84 units on a scale
Standard Deviation 18
|
90 units on a scale
Standard Deviation 10
|
|
Lens Comfort - Filcon II 3 and Etafilcon A
3 hours
|
79 units on a scale
Standard Deviation 22
|
87 units on a scale
Standard Deviation 14
|
|
Lens Comfort - Filcon II 3 and Etafilcon A
6 hours
|
75 units on a scale
Standard Deviation 24
|
83 units on a scale
Standard Deviation 18
|
SECONDARY outcome
Timeframe: Baseline, 3 hours, 6 hoursPopulation: These results are between the filcon II 3 and nelfilcon A group which comprises of 30 participants. Habitual data collected before study lens dispensed.
Participant's subjective response for lens comfort of filcon II 3 and nelfilcon A after settling 10-15mins (surveyed at baseline visit, 3 hours, and 6 hours) rated by questionnaire (Scale 0-100, 0=cannot be worn, causes pain, 100=cannot be felt ever).
Outcome measures
| Measure |
Filcon II 3 and Etafilcon A
n=30 Participants
Participants were randomized to a test and control lens in a contralateral design.
filcon II 3: Participants were randomized to wear filcon II 3 test lens.
etafilcon A: Participants were randomized to wear etafilcon A control lens.
|
Filcon II 3 and Nelfilcon A
n=30 Participants
Participants were randomized to a test and control lens in a contralateral design.
filcon II 3: Participants were randomized to wear filcon II 3 test lens.
nelfilcon A: Participants were randomized to wear nelfilcon A control lens.
|
|---|---|---|
|
Lens Comfort - Filcon II 3 and Nelficon A
Habitual lens (before study lens dispensed)
|
67 units on a scale
Standard Deviation 17
|
67 units on a scale
Standard Deviation 18
|
|
Lens Comfort - Filcon II 3 and Nelficon A
Baseline (study lens)
|
85 units on a scale
Standard Deviation 14
|
88 units on a scale
Standard Deviation 14
|
|
Lens Comfort - Filcon II 3 and Nelficon A
3 hours
|
79 units on a scale
Standard Deviation 16
|
75 units on a scale
Standard Deviation 17
|
|
Lens Comfort - Filcon II 3 and Nelficon A
6 hours
|
76 units on a scale
Standard Deviation 24
|
72 units on a scale
Standard Deviation 23
|
SECONDARY outcome
Timeframe: 3 hours and 6 hoursPopulation: These results are between the filcon II 3 and etafilcon A group which comprises of 40 participants. Habitual data collected before study lens dispensed.
Participant's subjective response for lens dryness of filcon II 3 and etafilcon A (surveyed at 3 and 6 hours after baseline visit) rated by questionnaire (Scale 0-100, 0=cannot be worn, extremely dry 100=no dryness experienced).
Outcome measures
| Measure |
Filcon II 3 and Etafilcon A
n=40 Participants
Participants were randomized to a test and control lens in a contralateral design.
filcon II 3: Participants were randomized to wear filcon II 3 test lens.
etafilcon A: Participants were randomized to wear etafilcon A control lens.
|
Filcon II 3 and Nelfilcon A
n=40 Participants
Participants were randomized to a test and control lens in a contralateral design.
filcon II 3: Participants were randomized to wear filcon II 3 test lens.
nelfilcon A: Participants were randomized to wear nelfilcon A control lens.
|
|---|---|---|
|
Lens Dryness - Filcon II 3 and Etafilcon A
Habitual lens (before study lens dispensed)
|
72 units on a scale
Standard Deviation 19
|
70 units on a scale
Standard Deviation 20
|
|
Lens Dryness - Filcon II 3 and Etafilcon A
3 hours
|
78 units on a scale
Standard Deviation 24
|
85 units on a scale
Standard Deviation 15
|
|
Lens Dryness - Filcon II 3 and Etafilcon A
6 hours
|
75 units on a scale
Standard Deviation 23
|
82 units on a scale
Standard Deviation 18
|
SECONDARY outcome
Timeframe: 3 hours and 6 hoursPopulation: These results are between the filcon II 3 and nelfilcon A group which comprises of 30 participants. Habitual data collected before study lens dispensed.
Participant's subjective response for lens dryness of filcon II 3 and nelfilcon A (surveyed at 3 and 6 hours after baseline visit) rated by questionnaire (Scale 0-100, 0=cannot be worn, extremely dry, 100=no dryness experienced).
Outcome measures
| Measure |
Filcon II 3 and Etafilcon A
n=30 Participants
Participants were randomized to a test and control lens in a contralateral design.
filcon II 3: Participants were randomized to wear filcon II 3 test lens.
etafilcon A: Participants were randomized to wear etafilcon A control lens.
|
Filcon II 3 and Nelfilcon A
n=30 Participants
Participants were randomized to a test and control lens in a contralateral design.
filcon II 3: Participants were randomized to wear filcon II 3 test lens.
nelfilcon A: Participants were randomized to wear nelfilcon A control lens.
|
|---|---|---|
|
Lens Dryness - Filcon II 3 and Nelfilcon A
Habitual lens (before study lens dispensedl
|
66 units on a scale
Standard Deviation 20
|
66 units on a scale
Standard Deviation 19
|
|
Lens Dryness - Filcon II 3 and Nelfilcon A
3 hours
|
79 units on a scale
Standard Deviation 16
|
76 units on a scale
Standard Deviation 19
|
|
Lens Dryness - Filcon II 3 and Nelfilcon A
6 hours
|
77 units on a scale
Standard Deviation 21
|
74 units on a scale
Standard Deviation 23
|
SECONDARY outcome
Timeframe: Baseline visitPopulation: These results are between the filcon II 3 and etafilcon A group which comprises of 40 participants. Habitual data collected before study lens dispensed.
Participant's subjective response for lens handling of filcon II 3 and etafilcon A following insertion (surveyed at baseline visit) rated by questionnaire (Scale 0-100, 0=very hard to handle causes pain, 100=very easy to handle).
Outcome measures
| Measure |
Filcon II 3 and Etafilcon A
n=40 Participants
Participants were randomized to a test and control lens in a contralateral design.
filcon II 3: Participants were randomized to wear filcon II 3 test lens.
etafilcon A: Participants were randomized to wear etafilcon A control lens.
|
Filcon II 3 and Nelfilcon A
n=40 Participants
Participants were randomized to a test and control lens in a contralateral design.
filcon II 3: Participants were randomized to wear filcon II 3 test lens.
nelfilcon A: Participants were randomized to wear nelfilcon A control lens.
|
|---|---|---|
|
Lens Handling - Filcon II 3 and Etafilcon A
Habitual lens (before study lens dispensed)
|
92 units on a scale
Standard Deviation 10
|
92 units on a scale
Standard Deviation 10
|
|
Lens Handling - Filcon II 3 and Etafilcon A
Baseline (study lens)
|
93 units on a scale
Standard Deviation 9
|
91 units on a scale
Standard Deviation 10
|
SECONDARY outcome
Timeframe: Baseline visitPopulation: These results are between the filcon II 3 and nelfilcon A group which comprises of 30 participants. Habitual data collected before study lens dispensed.
Participant's subjective response for lens handling of filcon II 3 and nelfilcon A following insertion (surveyed at baseline visit) rated by questionnaire (Scale 0-100, 0=very hard to handle, causes pain, 100=very easy to handle).
Outcome measures
| Measure |
Filcon II 3 and Etafilcon A
n=30 Participants
Participants were randomized to a test and control lens in a contralateral design.
filcon II 3: Participants were randomized to wear filcon II 3 test lens.
etafilcon A: Participants were randomized to wear etafilcon A control lens.
|
Filcon II 3 and Nelfilcon A
n=30 Participants
Participants were randomized to a test and control lens in a contralateral design.
filcon II 3: Participants were randomized to wear filcon II 3 test lens.
nelfilcon A: Participants were randomized to wear nelfilcon A control lens.
|
|---|---|---|
|
Lens Handling - Filcon II 3 and Nelfilcon A
Habitual lens (before study lens dispensed)
|
90 units on a scale
Standard Deviation 14
|
90 units on a scale
Standard Deviation 14
|
|
Lens Handling - Filcon II 3 and Nelfilcon A
Baseline (study lens)
|
92 units on a scale
Standard Deviation 14
|
92 units on a scale
Standard Deviation 14
|
SECONDARY outcome
Timeframe: 6 hoursPopulation: These results are between the filcon II 3 and etafilcon A group which comprises of 40 participants. Habitual data collected before study lens dispensed.
Participant's subjective response for lens handling of filcon II 3 and etafilcon A following insertion (surveyed 6 hours after baseline visit) rated by questionnaire (Scale 0-100, 0=very hard to handle, causes pain, 100=very easy to handle).
Outcome measures
| Measure |
Filcon II 3 and Etafilcon A
n=40 Participants
Participants were randomized to a test and control lens in a contralateral design.
filcon II 3: Participants were randomized to wear filcon II 3 test lens.
etafilcon A: Participants were randomized to wear etafilcon A control lens.
|
Filcon II 3 and Nelfilcon A
n=40 Participants
Participants were randomized to a test and control lens in a contralateral design.
filcon II 3: Participants were randomized to wear filcon II 3 test lens.
nelfilcon A: Participants were randomized to wear nelfilcon A control lens.
|
|---|---|---|
|
Lens Handling (Removal) - Filcon II 3 and Etafilcon A
Habitual lens (before study lens dispensed)
|
95 units on a scale
Standard Deviation 10
|
95 units on a scale
Standard Deviation 10
|
|
Lens Handling (Removal) - Filcon II 3 and Etafilcon A
6 hours
|
95 units on a scale
Standard Deviation 12
|
97 units on a scale
Standard Deviation 6
|
SECONDARY outcome
Timeframe: 6 hoursPopulation: These results are between the filcon II 3 and nelfilcon A group which comprises of 30 participants. Habitual data collected before study lens dispensed.
Participant's subjective response for lens handling of filcon II 3 and nelfilcon A following removal (surveyed 6 hours after baseline visit) rated by questionnaire (Scale 0-100, 0=very hard to handle, causes pain, 100=very easy to handle).
Outcome measures
| Measure |
Filcon II 3 and Etafilcon A
n=30 Participants
Participants were randomized to a test and control lens in a contralateral design.
filcon II 3: Participants were randomized to wear filcon II 3 test lens.
etafilcon A: Participants were randomized to wear etafilcon A control lens.
|
Filcon II 3 and Nelfilcon A
n=30 Participants
Participants were randomized to a test and control lens in a contralateral design.
filcon II 3: Participants were randomized to wear filcon II 3 test lens.
nelfilcon A: Participants were randomized to wear nelfilcon A control lens.
|
|---|---|---|
|
Lens Handling (Removal) - Filcon II 3 and Nelfilcon A
Habitual lens (before study lens dispensed)
|
90 units on a scale
Standard Deviation 14
|
89 units on a scale
Standard Deviation 15
|
|
Lens Handling (Removal) - Filcon II 3 and Nelfilcon A
6 hours
|
94 units on a scale
Standard Deviation 16
|
94 units on a scale
Standard Deviation 10
|
SECONDARY outcome
Timeframe: Baseline and 6 hoursPopulation: These results are between the filcon II 3 and etafilcon A group which comprises of 40 participants.
The ophthalmologist's objective assessment for lens wettability of filcon II 3 and etafilcon A following insertion (assessed at baseline visit and 6 hours) by biomicroscopy (Scale 0-4, 0.25 increments, 0=excellent wettability, 4=severely reduced wettability).
Outcome measures
| Measure |
Filcon II 3 and Etafilcon A
n=40 Participants
Participants were randomized to a test and control lens in a contralateral design.
filcon II 3: Participants were randomized to wear filcon II 3 test lens.
etafilcon A: Participants were randomized to wear etafilcon A control lens.
|
Filcon II 3 and Nelfilcon A
n=40 Participants
Participants were randomized to a test and control lens in a contralateral design.
filcon II 3: Participants were randomized to wear filcon II 3 test lens.
nelfilcon A: Participants were randomized to wear nelfilcon A control lens.
|
|---|---|---|
|
Lens Wettability - Filcon II 3 and Etafilcon A
Baseline
|
0.40 units on a scale
Standard Deviation 0.73
|
0.33 units on a scale
Standard Deviation 0.57
|
|
Lens Wettability - Filcon II 3 and Etafilcon A
6 hours
|
0.95 units on a scale
Standard Deviation 0.89
|
1.03 units on a scale
Standard Deviation 1.12
|
SECONDARY outcome
Timeframe: Baseline and 6 hoursPopulation: These results are between the filcon II 3 and nelfilcon A group which comprises of 30 participants.
The ophthalmologist's objective assessment for lens wettability of filcon II 3 and nelficon A following insertion (assessed at baseline visit and 6 hours) by biomicroscopy (Scale 0-4, 0.25 increments, 0=excellent wettability, 4=severely reduced wettability).
Outcome measures
| Measure |
Filcon II 3 and Etafilcon A
n=30 Participants
Participants were randomized to a test and control lens in a contralateral design.
filcon II 3: Participants were randomized to wear filcon II 3 test lens.
etafilcon A: Participants were randomized to wear etafilcon A control lens.
|
Filcon II 3 and Nelfilcon A
n=30 Participants
Participants were randomized to a test and control lens in a contralateral design.
filcon II 3: Participants were randomized to wear filcon II 3 test lens.
nelfilcon A: Participants were randomized to wear nelfilcon A control lens.
|
|---|---|---|
|
Lens Wettability - Filcon II 3 and Nelfilcon A
Baseline
|
0.38 units on a scale
Standard Deviation 0.46
|
0.25 units on a scale
Standard Deviation 0.35
|
|
Lens Wettability - Filcon II 3 and Nelfilcon A
6 hours
|
0.93 units on a scale
Standard Deviation 0.82
|
0.73 units on a scale
Standard Deviation 0.79
|
SECONDARY outcome
Timeframe: BaselinePopulation: These results are between the filcon II 3 and etafilcon A group which comprises of 40 participants.
The ophthalmologist's objective assessment for lens fit for centration of filcon II 3 and etafilcon A following insertion (assessed at baseline visit) by biomicroscopy (Optimum or Decentered N T S I). N - Nasal, T - Temporal, S - Superior, I - Interior, N/S - Nasal/Superior, N/I - Nasal/Interior, T/S - Temporal/Superior T/I - Temporal/Interior
Outcome measures
| Measure |
Filcon II 3 and Etafilcon A
n=40 Participants
Participants were randomized to a test and control lens in a contralateral design.
filcon II 3: Participants were randomized to wear filcon II 3 test lens.
etafilcon A: Participants were randomized to wear etafilcon A control lens.
|
Filcon II 3 and Nelfilcon A
n=40 Participants
Participants were randomized to a test and control lens in a contralateral design.
filcon II 3: Participants were randomized to wear filcon II 3 test lens.
nelfilcon A: Participants were randomized to wear nelfilcon A control lens.
|
|---|---|---|
|
Lens Fit, Centration - Filcon II 3 and Etafilcon A
Optimum
|
13 participants
|
13 participants
|
|
Lens Fit, Centration - Filcon II 3 and Etafilcon A
N
|
0 participants
|
1 participants
|
|
Lens Fit, Centration - Filcon II 3 and Etafilcon A
T
|
8 participants
|
9 participants
|
|
Lens Fit, Centration - Filcon II 3 and Etafilcon A
S
|
2 participants
|
4 participants
|
|
Lens Fit, Centration - Filcon II 3 and Etafilcon A
I
|
5 participants
|
3 participants
|
|
Lens Fit, Centration - Filcon II 3 and Etafilcon A
N/S
|
0 participants
|
0 participants
|
|
Lens Fit, Centration - Filcon II 3 and Etafilcon A
N/I
|
0 participants
|
1 participants
|
|
Lens Fit, Centration - Filcon II 3 and Etafilcon A
T/S
|
5 participants
|
1 participants
|
|
Lens Fit, Centration - Filcon II 3 and Etafilcon A
T/I
|
7 participants
|
8 participants
|
SECONDARY outcome
Timeframe: 6 hoursPopulation: These results are between the filcon II 3 and etafilcon A group which comprises of 40 participants.
The ophthalmologist's objective assessment for lens fit for centration of filcon II 3 and etafilcon A following insertion (assessed at 6 hours) by biomicroscopy (Optimum or Decentered N T S I) N - Nasal, T - Temporal, S - Superior, I - Interior, N/S - Nasal/Superior, N/I - Nasal/Interior, T/S - Temporal/Superior, T/I - Temporal/Interior
Outcome measures
| Measure |
Filcon II 3 and Etafilcon A
n=40 Participants
Participants were randomized to a test and control lens in a contralateral design.
filcon II 3: Participants were randomized to wear filcon II 3 test lens.
etafilcon A: Participants were randomized to wear etafilcon A control lens.
|
Filcon II 3 and Nelfilcon A
n=40 Participants
Participants were randomized to a test and control lens in a contralateral design.
filcon II 3: Participants were randomized to wear filcon II 3 test lens.
nelfilcon A: Participants were randomized to wear nelfilcon A control lens.
|
|---|---|---|
|
Lens Fit, Centration - Filcon II 3 and Etafilcon A
Optimum
|
16 participants
|
14 participants
|
|
Lens Fit, Centration - Filcon II 3 and Etafilcon A
N
|
0 participants
|
1 participants
|
|
Lens Fit, Centration - Filcon II 3 and Etafilcon A
T
|
9 participants
|
9 participants
|
|
Lens Fit, Centration - Filcon II 3 and Etafilcon A
S
|
2 participants
|
5 participants
|
|
Lens Fit, Centration - Filcon II 3 and Etafilcon A
I
|
2 participants
|
1 participants
|
|
Lens Fit, Centration - Filcon II 3 and Etafilcon A
N/S
|
1 participants
|
0 participants
|
|
Lens Fit, Centration - Filcon II 3 and Etafilcon A
N/I
|
0 participants
|
0 participants
|
|
Lens Fit, Centration - Filcon II 3 and Etafilcon A
T/S
|
6 participants
|
4 participants
|
|
Lens Fit, Centration - Filcon II 3 and Etafilcon A
T/I
|
4 participants
|
6 participants
|
SECONDARY outcome
Timeframe: BaselinePopulation: These results are between the filcon II 3 and nelfilcon A group which comprises of 30 participants.
The ophthalmologist's objective assessment for lens fit for centration of filcon II 3 and nelfilcon A following insertion (assessed at baseline) by biomicroscopy (Optimum or Decentered N T S I) N - Nasal, T - Temporal, S - Superior, I - Interior, N/S - Nasal/Superior, N/I - Nasal/Interior, T/S - Temporal/Superior, T/I - Temporal/Interior
Outcome measures
| Measure |
Filcon II 3 and Etafilcon A
n=30 Participants
Participants were randomized to a test and control lens in a contralateral design.
filcon II 3: Participants were randomized to wear filcon II 3 test lens.
etafilcon A: Participants were randomized to wear etafilcon A control lens.
|
Filcon II 3 and Nelfilcon A
n=30 Participants
Participants were randomized to a test and control lens in a contralateral design.
filcon II 3: Participants were randomized to wear filcon II 3 test lens.
nelfilcon A: Participants were randomized to wear nelfilcon A control lens.
|
|---|---|---|
|
Lens Fit, Centration - Filcon II 3 and Nelfilcon A
Optimum
|
11 participants
|
14 participants
|
|
Lens Fit, Centration - Filcon II 3 and Nelfilcon A
N
|
1 participants
|
0 participants
|
|
Lens Fit, Centration - Filcon II 3 and Nelfilcon A
T
|
3 participants
|
2 participants
|
|
Lens Fit, Centration - Filcon II 3 and Nelfilcon A
S
|
2 participants
|
2 participants
|
|
Lens Fit, Centration - Filcon II 3 and Nelfilcon A
I
|
3 participants
|
2 participants
|
|
Lens Fit, Centration - Filcon II 3 and Nelfilcon A
N/S
|
1 participants
|
1 participants
|
|
Lens Fit, Centration - Filcon II 3 and Nelfilcon A
N/I
|
0 participants
|
2 participants
|
|
Lens Fit, Centration - Filcon II 3 and Nelfilcon A
T/S
|
7 participants
|
4 participants
|
|
Lens Fit, Centration - Filcon II 3 and Nelfilcon A
T/I
|
2 participants
|
3 participants
|
SECONDARY outcome
Timeframe: After 6 hoursPopulation: These results are between the filcon II 3 and nelfilcon A group which comprises of 30 participants.
The ophthalmologist's objective assessment for lens fit for centration of filcon II 3 and nelfilcon A following insertion (assessed at 6 hours) by biomicroscopy (Optimum or Decentered N T S I) N - Nasal, T - Temporal, S - Superior, I - Interior, N/S - Nasal/Superior, N/I - Nasal/Interior, T/S - Temporal/Superior, T/I - Temporal/Interior
Outcome measures
| Measure |
Filcon II 3 and Etafilcon A
n=30 Participants
Participants were randomized to a test and control lens in a contralateral design.
filcon II 3: Participants were randomized to wear filcon II 3 test lens.
etafilcon A: Participants were randomized to wear etafilcon A control lens.
|
Filcon II 3 and Nelfilcon A
n=30 Participants
Participants were randomized to a test and control lens in a contralateral design.
filcon II 3: Participants were randomized to wear filcon II 3 test lens.
nelfilcon A: Participants were randomized to wear nelfilcon A control lens.
|
|---|---|---|
|
Lens Fit, Centration - Filcon II 3 and Nelfilcon A
Optimum
|
11 participants
|
12 participants
|
|
Lens Fit, Centration - Filcon II 3 and Nelfilcon A
Nasal
|
1 participants
|
1 participants
|
|
Lens Fit, Centration - Filcon II 3 and Nelfilcon A
T
|
4 participants
|
4 participants
|
|
Lens Fit, Centration - Filcon II 3 and Nelfilcon A
S
|
4 participants
|
2 participants
|
|
Lens Fit, Centration - Filcon II 3 and Nelfilcon A
I
|
0 participants
|
1 participants
|
|
Lens Fit, Centration - Filcon II 3 and Nelfilcon A
N/S
|
1 participants
|
1 participants
|
|
Lens Fit, Centration - Filcon II 3 and Nelfilcon A
N/I
|
0 participants
|
1 participants
|
|
Lens Fit, Centration - Filcon II 3 and Nelfilcon A
T/S
|
7 participants
|
4 participants
|
|
Lens Fit, Centration - Filcon II 3 and Nelfilcon A
T/I
|
2 participants
|
4 participants
|
SECONDARY outcome
Timeframe: Baseline and 6 hoursPopulation: These results are between the filcon II 3 and etafilcon A group which comprises of 40 participants.
The ophthalmologist's objective assessment for lens fit for Post-Blink Movement of filcon II 3 and etafilcon A following insertion (assessed at baseline visit and 6 hours) by biomicroscopy (measured in Primary Gaze and recorded in 0.1mm steps).
Outcome measures
| Measure |
Filcon II 3 and Etafilcon A
n=40 Participants
Participants were randomized to a test and control lens in a contralateral design.
filcon II 3: Participants were randomized to wear filcon II 3 test lens.
etafilcon A: Participants were randomized to wear etafilcon A control lens.
|
Filcon II 3 and Nelfilcon A
n=40 Participants
Participants were randomized to a test and control lens in a contralateral design.
filcon II 3: Participants were randomized to wear filcon II 3 test lens.
nelfilcon A: Participants were randomized to wear nelfilcon A control lens.
|
|---|---|---|
|
Lens Fit, Post-Blink Movement - Filcon II 3 and Etafilcon A
Baseline
|
0.28 mm steps
Standard Deviation 0.15
|
0.24 mm steps
Standard Deviation 0.15
|
|
Lens Fit, Post-Blink Movement - Filcon II 3 and Etafilcon A
6 hours
|
0.30 mm steps
Standard Deviation 0.16
|
0.26 mm steps
Standard Deviation 0.14
|
SECONDARY outcome
Timeframe: Baseline and 6 hoursPopulation: These results are between the filcon II 3 and nelfilcon A group which comprises of 30 participants.
The ophthalmologist's objective assessment for lens fit for Post-Blink Movement of filcon II 3 and nelfilcon A following insertion (assessed at baseline visit and 6 hours) by biomicroscopy (measured in Primary Gaze and recorded in 0.1mm steps).
Outcome measures
| Measure |
Filcon II 3 and Etafilcon A
n=30 Participants
Participants were randomized to a test and control lens in a contralateral design.
filcon II 3: Participants were randomized to wear filcon II 3 test lens.
etafilcon A: Participants were randomized to wear etafilcon A control lens.
|
Filcon II 3 and Nelfilcon A
n=30 Participants
Participants were randomized to a test and control lens in a contralateral design.
filcon II 3: Participants were randomized to wear filcon II 3 test lens.
nelfilcon A: Participants were randomized to wear nelfilcon A control lens.
|
|---|---|---|
|
Lens Fit, Post-Blink Movement - Filcon II 3 and Nelfilcon A
Baseline
|
0.26 mm steps
Standard Deviation 0.11
|
0.24 mm steps
Standard Deviation 0.10
|
|
Lens Fit, Post-Blink Movement - Filcon II 3 and Nelfilcon A
6 hours
|
0.23 mm steps
Standard Deviation 0.08
|
0.24 mm steps
Standard Deviation 0.11
|
SECONDARY outcome
Timeframe: Baseline and 6 hoursPopulation: These results are between the filcon II 3 and etafilcon A group which comprises of 40 participants.
The ophthalmologist's objective assessment for lens fit for tightness of filcon II 3 and etafilcon A following insertion (assessed at baseline visit and 6 hours) by biomicroscopy (Percentage of tightness, 5 increments, 0-100, 0=extremely loose, 100=extremely tight).
Outcome measures
| Measure |
Filcon II 3 and Etafilcon A
n=40 Participants
Participants were randomized to a test and control lens in a contralateral design.
filcon II 3: Participants were randomized to wear filcon II 3 test lens.
etafilcon A: Participants were randomized to wear etafilcon A control lens.
|
Filcon II 3 and Nelfilcon A
n=40 Participants
Participants were randomized to a test and control lens in a contralateral design.
filcon II 3: Participants were randomized to wear filcon II 3 test lens.
nelfilcon A: Participants were randomized to wear nelfilcon A control lens.
|
|---|---|---|
|
Lens Fit, Tightness - Filcon II 3 and Etafilcon A
Baseline
|
48 percentage of tightness
Standard Deviation 6
|
50 percentage of tightness
Standard Deviation 6
|
|
Lens Fit, Tightness - Filcon II 3 and Etafilcon A
6 hours
|
49 percentage of tightness
Standard Deviation 5
|
51 percentage of tightness
Standard Deviation 6
|
SECONDARY outcome
Timeframe: Baseline and 6 hoursPopulation: These results are between the filcon II 3 and nelfilcon A group which comprises of 30 participants.
The ophthalmologist's objective assessment for lens fit for tightness of filcon II 3 and nelfilcon A following insertion (assessed at baseline visit and 6 hours) by biomicroscopy (Percentage of tightness, 5 increments, 0-100, 0=extremely loose, 100=extremely tight).
Outcome measures
| Measure |
Filcon II 3 and Etafilcon A
n=30 Participants
Participants were randomized to a test and control lens in a contralateral design.
filcon II 3: Participants were randomized to wear filcon II 3 test lens.
etafilcon A: Participants were randomized to wear etafilcon A control lens.
|
Filcon II 3 and Nelfilcon A
n=30 Participants
Participants were randomized to a test and control lens in a contralateral design.
filcon II 3: Participants were randomized to wear filcon II 3 test lens.
nelfilcon A: Participants were randomized to wear nelfilcon A control lens.
|
|---|---|---|
|
Lens Fit, Tightness - Filcon II 3 and Nelfilcon A
Baseline
|
50 percentage of tightness
Standard Deviation 7
|
52 percentage of tightness
Standard Deviation 7
|
|
Lens Fit, Tightness - Filcon II 3 and Nelfilcon A
6 hours
|
52 percentage of tightness
Standard Deviation 6
|
53 percentage of tightness
Standard Deviation 8
|
SECONDARY outcome
Timeframe: 6 hourPopulation: These results are between the filcon II 3 and etafilcon A group which comprises of 40 participants.
The ophthalmologist's objective assessment for lens surface deposition of filcon II 3 and etafilcon A following insertion (assessed at 6 hour visit) by biomicroscopy (Scale 0-4, 0.25 steps, 0=no deposits, 4=severe deposits).
Outcome measures
| Measure |
Filcon II 3 and Etafilcon A
n=40 Participants
Participants were randomized to a test and control lens in a contralateral design.
filcon II 3: Participants were randomized to wear filcon II 3 test lens.
etafilcon A: Participants were randomized to wear etafilcon A control lens.
|
Filcon II 3 and Nelfilcon A
n=40 Participants
Participants were randomized to a test and control lens in a contralateral design.
filcon II 3: Participants were randomized to wear filcon II 3 test lens.
nelfilcon A: Participants were randomized to wear nelfilcon A control lens.
|
|---|---|---|
|
Lens Surface Deposition - Filcon II 3 and Etafilcon A
|
0.26 units on a scale
Standard Deviation 0.27
|
0.37 units on a scale
Standard Deviation 0.47
|
SECONDARY outcome
Timeframe: 6 hourPopulation: These results are between the filcon II 3 and nelfilcon A group which comprises of 30 participants.
The ophthalmologist's objective assessment for lens surface deposition of filcon II 3 and nelfilcon A following insertion (assessed at 6 hour visit) by biomicroscopy (Scale 0-4, 0.25 steps, 0=no deposits, 4=severe deposits).
Outcome measures
| Measure |
Filcon II 3 and Etafilcon A
n=30 Participants
Participants were randomized to a test and control lens in a contralateral design.
filcon II 3: Participants were randomized to wear filcon II 3 test lens.
etafilcon A: Participants were randomized to wear etafilcon A control lens.
|
Filcon II 3 and Nelfilcon A
n=30 Participants
Participants were randomized to a test and control lens in a contralateral design.
filcon II 3: Participants were randomized to wear filcon II 3 test lens.
nelfilcon A: Participants were randomized to wear nelfilcon A control lens.
|
|---|---|---|
|
Lens Surface Deposition - Filcon II 3 and Nelfilcon A
|
0.27 units on a scale
Standard Deviation 0.33
|
0.30 units on a scale
Standard Deviation 0.32
|
SECONDARY outcome
Timeframe: Baseline and 6 hoursPopulation: These results are between the filcon II 3 and etafilcon A group which comprises of 40 participants.
The ophthalmologist's objective assessment of High Contrast Visual Acuity following filcon II 3 and etafilcon A insertion (assessed at baseline visit and 6 hours) by computerized charts. (Positive logMAR values indicate poorer vision, negative values denote better vision than baseline 20/20 value).
Outcome measures
| Measure |
Filcon II 3 and Etafilcon A
n=40 Participants
Participants were randomized to a test and control lens in a contralateral design.
filcon II 3: Participants were randomized to wear filcon II 3 test lens.
etafilcon A: Participants were randomized to wear etafilcon A control lens.
|
Filcon II 3 and Nelfilcon A
n=40 Participants
Participants were randomized to a test and control lens in a contralateral design.
filcon II 3: Participants were randomized to wear filcon II 3 test lens.
nelfilcon A: Participants were randomized to wear nelfilcon A control lens.
|
|---|---|---|
|
High Contrast Visual Acuity - Filcon II 3 and Etafilcon A
Baseline
|
-0.08 logMAR
Standard Deviation 0.07
|
-0.06 logMAR
Standard Deviation 0.07
|
|
High Contrast Visual Acuity - Filcon II 3 and Etafilcon A
6 hours
|
-0.09 logMAR
Standard Deviation 0.07
|
-0.07 logMAR
Standard Deviation 0.08
|
SECONDARY outcome
Timeframe: Baseline and 6 hoursPopulation: These results are between the filcon II 3 and nelfilcon A group which comprises of 30 participants.
The ophthalmologist's objective assessment of High Contrast Visual Acuity following filcon II 3 and nelfilcon A insertion (assessed at baseline visit and 6 hours) by computerized charts. (Positive logMAR values indicate poorer vision, negative values denote better vision than baseline 20/20 value)
Outcome measures
| Measure |
Filcon II 3 and Etafilcon A
n=30 Participants
Participants were randomized to a test and control lens in a contralateral design.
filcon II 3: Participants were randomized to wear filcon II 3 test lens.
etafilcon A: Participants were randomized to wear etafilcon A control lens.
|
Filcon II 3 and Nelfilcon A
n=30 Participants
Participants were randomized to a test and control lens in a contralateral design.
filcon II 3: Participants were randomized to wear filcon II 3 test lens.
nelfilcon A: Participants were randomized to wear nelfilcon A control lens.
|
|---|---|---|
|
High Contrast Visual Acuity - Filcon II 3 and Nelfilcon A
Baseline
|
-0.07 logMAR
Standard Deviation 0.07
|
-0.07 logMAR
Standard Deviation 0.07
|
|
High Contrast Visual Acuity - Filcon II 3 and Nelfilcon A
6 hours
|
-0.08 logMAR
Standard Deviation 0.07
|
-0.10 logMAR
Standard Deviation 0.08
|
SECONDARY outcome
Timeframe: 6 hoursPopulation: These results are between the filcon II 3 and etafilcon A group which comprises of 40 participants.
The ophthalmologist's objective assessment of corneal staining (extent) assessed at screening (before lens insertion) by biomicroscopy (Grade as a % of each zone). N - Nasal, T - Temporal, S - Superior, I - Interior, C - Central
Outcome measures
| Measure |
Filcon II 3 and Etafilcon A
n=40 Participants
Participants were randomized to a test and control lens in a contralateral design.
filcon II 3: Participants were randomized to wear filcon II 3 test lens.
etafilcon A: Participants were randomized to wear etafilcon A control lens.
|
Filcon II 3 and Nelfilcon A
n=40 Participants
Participants were randomized to a test and control lens in a contralateral design.
filcon II 3: Participants were randomized to wear filcon II 3 test lens.
nelfilcon A: Participants were randomized to wear nelfilcon A control lens.
|
|---|---|---|
|
Ocular Health, Corneal Staining (Extent) - Filcon II 3 and Etafilcon A
N
|
4 percentage of the area of each zone
Standard Deviation 8
|
0 percentage of the area of each zone
Standard Deviation 1
|
|
Ocular Health, Corneal Staining (Extent) - Filcon II 3 and Etafilcon A
T
|
1 percentage of the area of each zone
Standard Deviation 6
|
1 percentage of the area of each zone
Standard Deviation 2
|
|
Ocular Health, Corneal Staining (Extent) - Filcon II 3 and Etafilcon A
S
|
3 percentage of the area of each zone
Standard Deviation 8
|
2 percentage of the area of each zone
Standard Deviation 5
|
|
Ocular Health, Corneal Staining (Extent) - Filcon II 3 and Etafilcon A
I
|
9 percentage of the area of each zone
Standard Deviation 12
|
4 percentage of the area of each zone
Standard Deviation 6
|
|
Ocular Health, Corneal Staining (Extent) - Filcon II 3 and Etafilcon A
C
|
0 percentage of the area of each zone
Standard Deviation 2
|
0 percentage of the area of each zone
Standard Deviation 1
|
SECONDARY outcome
Timeframe: 6 hoursPopulation: These results are between the filcon II 3 and nelfilcon A group which comprises of 30 participants.
The ophthalmologist's objective assessment of corneal staining (extent) assessed at 6 hours by biomicroscopy (Grade as a % of each zone). N - Nasal, T - Temporal, S - Superior, I - Interior, C - Central
Outcome measures
| Measure |
Filcon II 3 and Etafilcon A
n=30 Participants
Participants were randomized to a test and control lens in a contralateral design.
filcon II 3: Participants were randomized to wear filcon II 3 test lens.
etafilcon A: Participants were randomized to wear etafilcon A control lens.
|
Filcon II 3 and Nelfilcon A
n=30 Participants
Participants were randomized to a test and control lens in a contralateral design.
filcon II 3: Participants were randomized to wear filcon II 3 test lens.
nelfilcon A: Participants were randomized to wear nelfilcon A control lens.
|
|---|---|---|
|
Ocular Health, Corneal Staining (Extent) - Filcon II 3 and Nelfilcon A
N
|
2 percentage of the area of each zone
Standard Deviation 5
|
2 percentage of the area of each zone
Standard Deviation 5
|
|
Ocular Health, Corneal Staining (Extent) - Filcon II 3 and Nelfilcon A
T
|
1 percentage of the area of each zone
Standard Deviation 5
|
0 percentage of the area of each zone
Standard Deviation 1
|
|
Ocular Health, Corneal Staining (Extent) - Filcon II 3 and Nelfilcon A
S
|
2 percentage of the area of each zone
Standard Deviation 5
|
2 percentage of the area of each zone
Standard Deviation 7
|
|
Ocular Health, Corneal Staining (Extent) - Filcon II 3 and Nelfilcon A
I
|
6 percentage of the area of each zone
Standard Deviation 8
|
4 percentage of the area of each zone
Standard Deviation 5
|
|
Ocular Health, Corneal Staining (Extent) - Filcon II 3 and Nelfilcon A
C
|
2 percentage of the area of each zone
Standard Deviation 9
|
0 percentage of the area of each zone
Standard Deviation 1
|
SECONDARY outcome
Timeframe: Baseline and 6 hoursPopulation: These results are between the filcon II 3 and etafilcon A group which comprises of 40 participants.
The ophthalmologist's objective assessment of conjunctival bulbar and limbal hyperemia assessed at screening (before lens insertion) by biomicroscopy (Scale 0-4, 0.5 increments, 0=no redness, 4=redness).
Outcome measures
| Measure |
Filcon II 3 and Etafilcon A
n=40 Participants
Participants were randomized to a test and control lens in a contralateral design.
filcon II 3: Participants were randomized to wear filcon II 3 test lens.
etafilcon A: Participants were randomized to wear etafilcon A control lens.
|
Filcon II 3 and Nelfilcon A
n=40 Participants
Participants were randomized to a test and control lens in a contralateral design.
filcon II 3: Participants were randomized to wear filcon II 3 test lens.
nelfilcon A: Participants were randomized to wear nelfilcon A control lens.
|
|---|---|---|
|
Ocular Health, Conjunctival Hyperemia - Filcon II 3 and Etafilcon A
Bulbar
|
1.89 units on a scale
Standard Deviation 0.38
|
1.81 units on a scale
Standard Deviation 0.39
|
|
Ocular Health, Conjunctival Hyperemia - Filcon II 3 and Etafilcon A
Limbal
|
1.75 units on a scale
Standard Deviation 0.47
|
1.68 units on a scale
Standard Deviation 0.51
|
SECONDARY outcome
Timeframe: Baseline and 6 hoursPopulation: These results are between the filcon II 3 and nelfilcon A group which comprises of 30 participants.
The ophthalmologist's objective assessment of conjunctival bulbar and limbal hyperemia assessed at screening (before lens insertion of filcon II 3 and nelfilcon A) by biomicroscopy (Scale 0-4, 0.5 increments, 0=no redness, 4=redness).
Outcome measures
| Measure |
Filcon II 3 and Etafilcon A
n=30 Participants
Participants were randomized to a test and control lens in a contralateral design.
filcon II 3: Participants were randomized to wear filcon II 3 test lens.
etafilcon A: Participants were randomized to wear etafilcon A control lens.
|
Filcon II 3 and Nelfilcon A
n=30 Participants
Participants were randomized to a test and control lens in a contralateral design.
filcon II 3: Participants were randomized to wear filcon II 3 test lens.
nelfilcon A: Participants were randomized to wear nelfilcon A control lens.
|
|---|---|---|
|
Ocular Health, Conjunctival Hyperemia - Filcon II 3 and Nelfilcon A
Bulbar
|
1.67 units on a scale
Standard Deviation 0.46
|
1.57 units on a scale
Standard Deviation 0.29
|
|
Ocular Health, Conjunctival Hyperemia - Filcon II 3 and Nelfilcon A
Limbal
|
1.35 units on a scale
Standard Deviation 0.49
|
1.27 units on a scale
Standard Deviation 0.37
|
Adverse Events
Filcon II 3 and Etafilcon A
Filcon II 3 and Nelfilcon A
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
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