Myopia
Conditions
Brief summary
The objective of the study is to compare the overall subjective preference between two Daily Disposable hydrogel lenses when refitted into a third hydrogel lens.
Detailed description
This was a two-day, randomized, non-dispensing, double-masked, contralateral study with two parallel groups. Participants were recruited into one of two groups - participants who habitually wore etafilcon A lens and participants who habitually wore nelfilcon A lens.
Interventions
DEVICEfilcon II 3
Participants were randomized to wear filcon II 3 test lens.
DEVICEetafilcon A
Participants were randomized to wear etafilcon A control lens.
DEVICEnelfilcon A
Participants were randomized to wear nelfilcon A control lens.
Sponsors
CooperVision, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
17 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
1. Is at least 17 years of age and has full legal capacity to volunteer; 2. Has read and signed an information consent letter; 3. Is willing and able to follow instructions and maintain the appointment schedule; 4. Is correctable to a visual acuity of 20/40 or better (in each eye) with their habitual correction and the assigned study lenses; 5. Habitually wears either 1 Day Acuvue Moist or Dailies Aqua Comfort Plus contact lenses. 6. Demonstrates an acceptable fit with the study lenses
Exclusion criteria
1. Is participating in any concurrent clinical or research study; 2. Has any known active\* ocular disease and/or infection; 3. Has a systemic condition that in the opinion of the investigator may affect a study outcome variable; 4. Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable; 5. Has known sensitivity to the diagnostic pharmaceuticals to be used in the study; 6. Is pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit); 7. Is aphakic; 8. Has undergone refractive error surgery;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lens Preference - Filcon II 3 and Etafilcon A or Filcon II 3 and Nelfilcon A | Baseline visit | Participant'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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lens Comfort - Filcon II 3 and Nelficon A | Baseline, 3 hours, 6 hours | 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). |
| Lens Dryness - Filcon II 3 and Etafilcon A | 3 hours and 6 hours | 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). |
| Lens Dryness - Filcon II 3 and Nelfilcon A | 3 hours and 6 hours | 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). |
| Lens Handling - Filcon II 3 and Etafilcon A | Baseline visit | 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). |
| Lens Handling - Filcon II 3 and Nelfilcon A | Baseline visit | 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). |
| Lens Handling (Removal) - Filcon II 3 and Etafilcon A | 6 hours | 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). |
| Lens Handling (Removal) - Filcon II 3 and Nelfilcon A | 6 hours | 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). |
| Lens Wettability - Filcon II 3 and Etafilcon A | Baseline and 6 hours | 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). |
| Lens Wettability - Filcon II 3 and Nelfilcon A | Baseline and 6 hours | 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). |
| Lens Fit, Centration - Filcon II 3 and Etafilcon A | Baseline | 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 |
| Lens Fit, Centration - Filcon II 3 and Nelfilcon A | Baseline | 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 |
| Lens Comfort - Filcon II 3 and Etafilcon A | Baseline, 3 hours, 6 hours | 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). |
| Lens Fit, Post-Blink Movement - Filcon II 3 and Nelfilcon A | Baseline and 6 hours | 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). |
| Lens Fit, Tightness - Filcon II 3 and Etafilcon A | Baseline and 6 hours | 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). |
| Lens Fit, Tightness - Filcon II 3 and Nelfilcon A | Baseline and 6 hours | 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). |
| Lens Surface Deposition - Filcon II 3 and Etafilcon A | 6 hour | 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). |
| Lens Surface Deposition - Filcon II 3 and Nelfilcon A | 6 hour | 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). |
| High Contrast Visual Acuity - Filcon II 3 and Etafilcon A | Baseline and 6 hours | 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). |
| High Contrast Visual Acuity - Filcon II 3 and Nelfilcon A | Baseline and 6 hours | 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) |
| Ocular Health, Corneal Staining (Extent) - Filcon II 3 and Etafilcon A | 6 hours | 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 |
| Ocular Health, Corneal Staining (Extent) - Filcon II 3 and Nelfilcon A | 6 hours | 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 |
| Ocular Health, Conjunctival Hyperemia - Filcon II 3 and Etafilcon A | Baseline and 6 hours | 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). |
| Ocular Health, Conjunctival Hyperemia - Filcon II 3 and Nelfilcon A | Baseline and 6 hours | 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). |
| Lens Fit, Post-Blink Movement - Filcon II 3 and Etafilcon A | Baseline and 6 hours | 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). |
Countries
Canada
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 40 |
| 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. | 30 |
| Total | 70 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Screening | 3 | 1 |
Baseline characteristics
| Characteristic | Filcon II 3 and Etafilcon A | Filcon II 3 and Nelfilcon A | Total |
|---|---|---|---|
| Age, Continuous | 28 years STANDARD_DEVIATION 9 | 33.1 years STANDARD_DEVIATION 12.4 | 30.2 years STANDARD_DEVIATION 10.8 |
| Region of Enrollment Canada | 40 participants | 30 participants | 70 participants |
| Sex: Female, Male Female | 27 Participants | 23 Participants | 50 Participants |
| Sex: Female, Male Male | 13 Participants | 7 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 40 | 0 / 30 |
| serious Total, serious adverse events | 0 / 40 | 0 / 30 |
Outcome results
Primary
Lens Preference - Filcon II 3 and Etafilcon A or Filcon II 3 and Nelfilcon A
Participant'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).
Time frame: 6 hours
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Filcon II 3 and Etafilcon A | Lens Preference - Filcon II 3 and Etafilcon A or Filcon II 3 and Nelfilcon A | Slightly prefer filcon II 3 | 9 participants |
| Filcon II 3 and Etafilcon A | Lens Preference - Filcon II 3 and Etafilcon A or Filcon II 3 and Nelfilcon A | Slightly prefer etafilcon A/nelfilcon A | 11 participants |
| Filcon II 3 and Etafilcon A | Lens Preference - Filcon II 3 and Etafilcon A or Filcon II 3 and Nelfilcon A | No preference | 7 participants |
| Filcon II 3 and Etafilcon A | Lens Preference - Filcon II 3 and Etafilcon A or Filcon II 3 and Nelfilcon A | Strongly prefer etafilcon A/nelfilcon A | 11 participants |
| Filcon II 3 and Etafilcon A | Lens Preference - Filcon II 3 and Etafilcon A or Filcon II 3 and Nelfilcon A | Strongly prefer filcon II 3 | 2 participants |
| Filcon II 3 and Nelfilcon A | Lens Preference - Filcon II 3 and Etafilcon A or Filcon II 3 and Nelfilcon A | Strongly prefer etafilcon A/nelfilcon A | 3 participants |
| Filcon II 3 and Nelfilcon A | Lens Preference - Filcon II 3 and Etafilcon A or Filcon II 3 and Nelfilcon A | Strongly prefer filcon II 3 | 5 participants |
| Filcon II 3 and Nelfilcon A | Lens Preference - Filcon II 3 and Etafilcon A or Filcon II 3 and Nelfilcon A | Slightly prefer filcon II 3 | 8 participants |
| Filcon II 3 and Nelfilcon A | Lens Preference - Filcon II 3 and Etafilcon A or Filcon II 3 and Nelfilcon A | No preference | 9 participants |
| Filcon II 3 and Nelfilcon A | Lens Preference - Filcon II 3 and Etafilcon A or Filcon II 3 and Nelfilcon A | Slightly prefer etafilcon A/nelfilcon A | 5 participants |
Primary
Lens Preference - Filcon II 3 and Etafilcon A or Filcon II 3 and Nelfilcon A
Participant'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).
Time frame: Baseline visit
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Filcon II 3 and Etafilcon A | Lens Preference - Filcon II 3 and Etafilcon A or Filcon II 3 and Nelfilcon A | Slightly prefer filcon II 3 | 14 participants |
| Filcon II 3 and Etafilcon A | Lens Preference - Filcon II 3 and Etafilcon A or Filcon II 3 and Nelfilcon A | Slightly prefer etafilcon A/nelfilcon A | 8 participants |
| Filcon II 3 and Etafilcon A | Lens Preference - Filcon II 3 and Etafilcon A or Filcon II 3 and Nelfilcon A | Strongly prefer filcon II 3 | 1 participants |
| Filcon II 3 and Etafilcon A | Lens Preference - Filcon II 3 and Etafilcon A or Filcon II 3 and Nelfilcon A | Strongly prefer etafilcon A/nelfilcon A | 9 participants |
| Filcon II 3 and Etafilcon A | Lens Preference - Filcon II 3 and Etafilcon A or Filcon II 3 and Nelfilcon A | No preference | 8 participants |
| Filcon II 3 and Nelfilcon A | Lens Preference - Filcon II 3 and Etafilcon A or Filcon II 3 and Nelfilcon A | Strongly prefer etafilcon A/nelfilcon A | 3 participants |
| Filcon II 3 and Nelfilcon A | Lens Preference - Filcon II 3 and Etafilcon A or Filcon II 3 and Nelfilcon A | Slightly prefer filcon II 3 | 8 participants |
| Filcon II 3 and Nelfilcon A | Lens Preference - Filcon II 3 and Etafilcon A or Filcon II 3 and Nelfilcon A | No preference | 10 participants |
| Filcon II 3 and Nelfilcon A | Lens Preference - Filcon II 3 and Etafilcon A or Filcon II 3 and Nelfilcon A | Slightly prefer etafilcon A/nelfilcon A | 6 participants |
| Filcon II 3 and Nelfilcon A | Lens Preference - Filcon II 3 and Etafilcon A or Filcon II 3 and Nelfilcon A | Strongly prefer filcon II 3 | 3 participants |
Primary
Lens Preference - Filcon II 3 and Etafilcon A or Filcon II 3 and Nelfilcon A
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).
Time frame: 3 hours
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Filcon II 3 and Etafilcon A | Lens Preference - Filcon II 3 and Etafilcon A or Filcon II 3 and Nelfilcon A | Slightly prefer filcon II 3 | 10 participants |
| Filcon II 3 and Etafilcon A | Lens Preference - Filcon II 3 and Etafilcon A or Filcon II 3 and Nelfilcon A | Slightly prefer etafilcon A/nelfilcon A | 13 participants |
| Filcon II 3 and Etafilcon A | Lens Preference - Filcon II 3 and Etafilcon A or Filcon II 3 and Nelfilcon A | No preference | 7 participants |
| Filcon II 3 and Etafilcon A | Lens Preference - Filcon II 3 and Etafilcon A or Filcon II 3 and Nelfilcon A | Strongly prefer etafilcon A/nelfilcon A | 9 participants |
| Filcon II 3 and Etafilcon A | Lens Preference - Filcon II 3 and Etafilcon A or Filcon II 3 and Nelfilcon A | Strongly prefer filcon II 3 | 1 participants |
| Filcon II 3 and Nelfilcon A | Lens Preference - Filcon II 3 and Etafilcon A or Filcon II 3 and Nelfilcon A | Strongly prefer etafilcon A/nelfilcon A | 2 participants |
| Filcon II 3 and Nelfilcon A | Lens Preference - Filcon II 3 and Etafilcon A or Filcon II 3 and Nelfilcon A | Strongly prefer filcon II 3 | 3 participants |
| Filcon II 3 and Nelfilcon A | Lens Preference - Filcon II 3 and Etafilcon A or Filcon II 3 and Nelfilcon A | Slightly prefer filcon II 3 | 12 participants |
| Filcon II 3 and Nelfilcon A | Lens Preference - Filcon II 3 and Etafilcon A or Filcon II 3 and Nelfilcon A | No preference | 5 participants |
| Filcon II 3 and Nelfilcon A | Lens Preference - Filcon II 3 and Etafilcon A or Filcon II 3 and Nelfilcon A | Slightly prefer etafilcon A/nelfilcon A | 8 participants |
Secondary
High Contrast Visual Acuity - Filcon II 3 and Etafilcon A
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).
Time frame: Baseline and 6 hours
Population: These results are between the filcon II 3 and etafilcon A group which comprises of 40 participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filcon II 3 and Etafilcon A | High Contrast Visual Acuity - Filcon II 3 and Etafilcon A | Baseline | -0.08 logMAR | Standard Deviation 0.07 |
| Filcon II 3 and Etafilcon A | High Contrast Visual Acuity - Filcon II 3 and Etafilcon A | 6 hours | -0.09 logMAR | Standard Deviation 0.07 |
| Filcon II 3 and Nelfilcon A | High Contrast Visual Acuity - Filcon II 3 and Etafilcon A | Baseline | -0.06 logMAR | Standard Deviation 0.07 |
| Filcon II 3 and Nelfilcon A | High Contrast Visual Acuity - Filcon II 3 and Etafilcon A | 6 hours | -0.07 logMAR | Standard Deviation 0.08 |
Secondary
High Contrast Visual Acuity - Filcon II 3 and Nelfilcon A
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)
Time frame: Baseline and 6 hours
Population: These results are between the filcon II 3 and nelfilcon A group which comprises of 30 participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filcon II 3 and Etafilcon A | High Contrast Visual Acuity - Filcon II 3 and Nelfilcon A | Baseline | -0.07 logMAR | Standard Deviation 0.07 |
| Filcon II 3 and Etafilcon A | High Contrast Visual Acuity - Filcon II 3 and Nelfilcon A | 6 hours | -0.08 logMAR | Standard Deviation 0.07 |
| Filcon II 3 and Nelfilcon A | High Contrast Visual Acuity - Filcon II 3 and Nelfilcon A | Baseline | -0.07 logMAR | Standard Deviation 0.07 |
| Filcon II 3 and Nelfilcon A | High Contrast Visual Acuity - Filcon II 3 and Nelfilcon A | 6 hours | -0.10 logMAR | Standard Deviation 0.08 |
Secondary
Lens Comfort - Filcon II 3 and Etafilcon A
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).
Time frame: Baseline, 3 hours, 6 hours
Population: These results are between the filcon II 3 and etafilcon A group which comprises of 40 participants. Habitual data collected before study lens dispensed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filcon II 3 and Etafilcon A | Lens Comfort - Filcon II 3 and Etafilcon A | Habitual lens (before study lens dispensed) | 78 units on a scale | Standard Deviation 18 |
| Filcon II 3 and Etafilcon A | Lens Comfort - Filcon II 3 and Etafilcon A | Baseline (study lens) | 84 units on a scale | Standard Deviation 18 |
| Filcon II 3 and Etafilcon A | Lens Comfort - Filcon II 3 and Etafilcon A | 3 hours | 79 units on a scale | Standard Deviation 22 |
| Filcon II 3 and Etafilcon A | Lens Comfort - Filcon II 3 and Etafilcon A | 6 hours | 75 units on a scale | Standard Deviation 24 |
| Filcon II 3 and Nelfilcon A | Lens Comfort - Filcon II 3 and Etafilcon A | 6 hours | 83 units on a scale | Standard Deviation 18 |
| Filcon II 3 and Nelfilcon A | Lens Comfort - Filcon II 3 and Etafilcon A | Habitual lens (before study lens dispensed) | 77 units on a scale | Standard Deviation 20 |
| Filcon II 3 and Nelfilcon A | Lens Comfort - Filcon II 3 and Etafilcon A | 3 hours | 87 units on a scale | Standard Deviation 14 |
| Filcon II 3 and Nelfilcon A | Lens Comfort - Filcon II 3 and Etafilcon A | Baseline (study lens) | 90 units on a scale | Standard Deviation 10 |
Secondary
Lens Comfort - Filcon II 3 and Nelficon A
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).
Time frame: Baseline, 3 hours, 6 hours
Population: These results are between the filcon II 3 and nelfilcon A group which comprises of 30 participants. Habitual data collected before study lens dispensed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filcon II 3 and Etafilcon A | Lens Comfort - Filcon II 3 and Nelficon A | Habitual lens (before study lens dispensed) | 67 units on a scale | Standard Deviation 17 |
| Filcon II 3 and Etafilcon A | Lens Comfort - Filcon II 3 and Nelficon A | Baseline (study lens) | 85 units on a scale | Standard Deviation 14 |
| Filcon II 3 and Etafilcon A | Lens Comfort - Filcon II 3 and Nelficon A | 3 hours | 79 units on a scale | Standard Deviation 16 |
| Filcon II 3 and Etafilcon A | Lens Comfort - Filcon II 3 and Nelficon A | 6 hours | 76 units on a scale | Standard Deviation 24 |
| Filcon II 3 and Nelfilcon A | Lens Comfort - Filcon II 3 and Nelficon A | 6 hours | 72 units on a scale | Standard Deviation 23 |
| Filcon II 3 and Nelfilcon A | Lens Comfort - Filcon II 3 and Nelficon A | Habitual lens (before study lens dispensed) | 67 units on a scale | Standard Deviation 18 |
| Filcon II 3 and Nelfilcon A | Lens Comfort - Filcon II 3 and Nelficon A | 3 hours | 75 units on a scale | Standard Deviation 17 |
| Filcon II 3 and Nelfilcon A | Lens Comfort - Filcon II 3 and Nelficon A | Baseline (study lens) | 88 units on a scale | Standard Deviation 14 |
Secondary
Lens Dryness - Filcon II 3 and Etafilcon A
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).
Time frame: 3 hours and 6 hours
Population: These results are between the filcon II 3 and etafilcon A group which comprises of 40 participants. Habitual data collected before study lens dispensed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filcon II 3 and Etafilcon A | Lens Dryness - Filcon II 3 and Etafilcon A | Habitual lens (before study lens dispensed) | 72 units on a scale | Standard Deviation 19 |
| Filcon II 3 and Etafilcon A | Lens Dryness - Filcon II 3 and Etafilcon A | 3 hours | 78 units on a scale | Standard Deviation 24 |
| Filcon II 3 and Etafilcon A | Lens Dryness - Filcon II 3 and Etafilcon A | 6 hours | 75 units on a scale | Standard Deviation 23 |
| Filcon II 3 and Nelfilcon A | Lens Dryness - Filcon II 3 and Etafilcon A | 6 hours | 82 units on a scale | Standard Deviation 18 |
| Filcon II 3 and Nelfilcon A | Lens Dryness - Filcon II 3 and Etafilcon A | Habitual lens (before study lens dispensed) | 70 units on a scale | Standard Deviation 20 |
| Filcon II 3 and Nelfilcon A | Lens Dryness - Filcon II 3 and Etafilcon A | 3 hours | 85 units on a scale | Standard Deviation 15 |
Secondary
Lens Dryness - Filcon II 3 and Nelfilcon A
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).
Time frame: 3 hours and 6 hours
Population: These results are between the filcon II 3 and nelfilcon A group which comprises of 30 participants. Habitual data collected before study lens dispensed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filcon II 3 and Etafilcon A | Lens Dryness - Filcon II 3 and Nelfilcon A | Habitual lens (before study lens dispensedl | 66 units on a scale | Standard Deviation 20 |
| Filcon II 3 and Etafilcon A | Lens Dryness - Filcon II 3 and Nelfilcon A | 3 hours | 79 units on a scale | Standard Deviation 16 |
| Filcon II 3 and Etafilcon A | Lens Dryness - Filcon II 3 and Nelfilcon A | 6 hours | 77 units on a scale | Standard Deviation 21 |
| Filcon II 3 and Nelfilcon A | Lens Dryness - Filcon II 3 and Nelfilcon A | Habitual lens (before study lens dispensedl | 66 units on a scale | Standard Deviation 19 |
| Filcon II 3 and Nelfilcon A | Lens Dryness - Filcon II 3 and Nelfilcon A | 3 hours | 76 units on a scale | Standard Deviation 19 |
| Filcon II 3 and Nelfilcon A | Lens Dryness - Filcon II 3 and Nelfilcon A | 6 hours | 74 units on a scale | Standard Deviation 23 |
Secondary
Lens Fit, Centration - Filcon II 3 and Etafilcon A
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
Time frame: Baseline
Population: These results are between the filcon II 3 and etafilcon A group which comprises of 40 participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Filcon II 3 and Etafilcon A | Lens Fit, Centration - Filcon II 3 and Etafilcon A | Optimum | 13 participants |
| Filcon II 3 and Etafilcon A | Lens Fit, Centration - Filcon II 3 and Etafilcon A | I | 5 participants |
| Filcon II 3 and Etafilcon A | Lens Fit, Centration - Filcon II 3 and Etafilcon A | T | 8 participants |
| Filcon II 3 and Etafilcon A | Lens Fit, Centration - Filcon II 3 and Etafilcon A | N/S | 0 participants |
| Filcon II 3 and Etafilcon A | Lens Fit, Centration - Filcon II 3 and Etafilcon A | N | 0 participants |
| Filcon II 3 and Etafilcon A | Lens Fit, Centration - Filcon II 3 and Etafilcon A | N/I | 0 participants |
| Filcon II 3 and Etafilcon A | Lens Fit, Centration - Filcon II 3 and Etafilcon A | S | 2 participants |
| Filcon II 3 and Etafilcon A | Lens Fit, Centration - Filcon II 3 and Etafilcon A | T/S | 5 participants |
| Filcon II 3 and Etafilcon A | Lens Fit, Centration - Filcon II 3 and Etafilcon A | T/I | 7 participants |
| Filcon II 3 and Nelfilcon A | Lens Fit, Centration - Filcon II 3 and Etafilcon A | S | 4 participants |
| Filcon II 3 and Nelfilcon A | Lens Fit, Centration - Filcon II 3 and Etafilcon A | T/S | 1 participants |
| Filcon II 3 and Nelfilcon A | Lens Fit, Centration - Filcon II 3 and Etafilcon A | Optimum | 13 participants |
| Filcon II 3 and Nelfilcon A | Lens Fit, Centration - Filcon II 3 and Etafilcon A | N | 1 participants |
| Filcon II 3 and Nelfilcon A | Lens Fit, Centration - Filcon II 3 and Etafilcon A | T | 9 participants |
| Filcon II 3 and Nelfilcon A | Lens Fit, Centration - Filcon II 3 and Etafilcon A | T/I | 8 participants |
| Filcon II 3 and Nelfilcon A | Lens Fit, Centration - Filcon II 3 and Etafilcon A | I | 3 participants |
| Filcon II 3 and Nelfilcon A | Lens Fit, Centration - Filcon II 3 and Etafilcon A | N/S | 0 participants |
| Filcon II 3 and Nelfilcon A | Lens Fit, Centration - Filcon II 3 and Etafilcon A | N/I | 1 participants |
Secondary
Lens Fit, Centration - Filcon II 3 and Etafilcon A
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
Time frame: 6 hours
Population: These results are between the filcon II 3 and etafilcon A group which comprises of 40 participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Filcon II 3 and Etafilcon A | Lens Fit, Centration - Filcon II 3 and Etafilcon A | Optimum | 16 participants |
| Filcon II 3 and Etafilcon A | Lens Fit, Centration - Filcon II 3 and Etafilcon A | I | 2 participants |
| Filcon II 3 and Etafilcon A | Lens Fit, Centration - Filcon II 3 and Etafilcon A | N | 0 participants |
| Filcon II 3 and Etafilcon A | Lens Fit, Centration - Filcon II 3 and Etafilcon A | T | 9 participants |
| Filcon II 3 and Etafilcon A | Lens Fit, Centration - Filcon II 3 and Etafilcon A | S | 2 participants |
| Filcon II 3 and Etafilcon A | Lens Fit, Centration - Filcon II 3 and Etafilcon A | N/S | 1 participants |
| Filcon II 3 and Etafilcon A | Lens Fit, Centration - Filcon II 3 and Etafilcon A | N/I | 0 participants |
| Filcon II 3 and Etafilcon A | Lens Fit, Centration - Filcon II 3 and Etafilcon A | T/S | 6 participants |
| Filcon II 3 and Etafilcon A | Lens Fit, Centration - Filcon II 3 and Etafilcon A | T/I | 4 participants |
| Filcon II 3 and Nelfilcon A | Lens Fit, Centration - Filcon II 3 and Etafilcon A | N/I | 0 participants |
| Filcon II 3 and Nelfilcon A | Lens Fit, Centration - Filcon II 3 and Etafilcon A | S | 5 participants |
| Filcon II 3 and Nelfilcon A | Lens Fit, Centration - Filcon II 3 and Etafilcon A | T/I | 6 participants |
| Filcon II 3 and Nelfilcon A | Lens Fit, Centration - Filcon II 3 and Etafilcon A | I | 1 participants |
| Filcon II 3 and Nelfilcon A | Lens Fit, Centration - Filcon II 3 and Etafilcon A | Optimum | 14 participants |
| Filcon II 3 and Nelfilcon A | Lens Fit, Centration - Filcon II 3 and Etafilcon A | N/S | 0 participants |
| Filcon II 3 and Nelfilcon A | Lens Fit, Centration - Filcon II 3 and Etafilcon A | N | 1 participants |
| Filcon II 3 and Nelfilcon A | Lens Fit, Centration - Filcon II 3 and Etafilcon A | T/S | 4 participants |
| Filcon II 3 and Nelfilcon A | Lens Fit, Centration - Filcon II 3 and Etafilcon A | T | 9 participants |
Secondary
Lens Fit, Centration - Filcon II 3 and Nelfilcon A
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
Time frame: After 6 hours
Population: These results are between the filcon II 3 and nelfilcon A group which comprises of 30 participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Filcon II 3 and Etafilcon A | Lens Fit, Centration - Filcon II 3 and Nelfilcon A | Nasal | 1 participants |
| Filcon II 3 and Etafilcon A | Lens Fit, Centration - Filcon II 3 and Nelfilcon A | N/S | 1 participants |
| Filcon II 3 and Etafilcon A | Lens Fit, Centration - Filcon II 3 and Nelfilcon A | S | 4 participants |
| Filcon II 3 and Etafilcon A | Lens Fit, Centration - Filcon II 3 and Nelfilcon A | N/I | 0 participants |
| Filcon II 3 and Etafilcon A | Lens Fit, Centration - Filcon II 3 and Nelfilcon A | T | 4 participants |
| Filcon II 3 and Etafilcon A | Lens Fit, Centration - Filcon II 3 and Nelfilcon A | T/S | 7 participants |
| Filcon II 3 and Etafilcon A | Lens Fit, Centration - Filcon II 3 and Nelfilcon A | I | 0 participants |
| Filcon II 3 and Etafilcon A | Lens Fit, Centration - Filcon II 3 and Nelfilcon A | T/I | 2 participants |
| Filcon II 3 and Etafilcon A | Lens Fit, Centration - Filcon II 3 and Nelfilcon A | Optimum | 11 participants |
| Filcon II 3 and Nelfilcon A | Lens Fit, Centration - Filcon II 3 and Nelfilcon A | T/I | 4 participants |
| Filcon II 3 and Nelfilcon A | Lens Fit, Centration - Filcon II 3 and Nelfilcon A | Optimum | 12 participants |
| Filcon II 3 and Nelfilcon A | Lens Fit, Centration - Filcon II 3 and Nelfilcon A | Nasal | 1 participants |
| Filcon II 3 and Nelfilcon A | Lens Fit, Centration - Filcon II 3 and Nelfilcon A | T | 4 participants |
| Filcon II 3 and Nelfilcon A | Lens Fit, Centration - Filcon II 3 and Nelfilcon A | S | 2 participants |
| Filcon II 3 and Nelfilcon A | Lens Fit, Centration - Filcon II 3 and Nelfilcon A | I | 1 participants |
| Filcon II 3 and Nelfilcon A | Lens Fit, Centration - Filcon II 3 and Nelfilcon A | N/S | 1 participants |
| Filcon II 3 and Nelfilcon A | Lens Fit, Centration - Filcon II 3 and Nelfilcon A | N/I | 1 participants |
| Filcon II 3 and Nelfilcon A | Lens Fit, Centration - Filcon II 3 and Nelfilcon A | T/S | 4 participants |
Secondary
Lens Fit, Centration - Filcon II 3 and Nelfilcon A
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
Time frame: Baseline
Population: These results are between the filcon II 3 and nelfilcon A group which comprises of 30 participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Filcon II 3 and Etafilcon A | Lens Fit, Centration - Filcon II 3 and Nelfilcon A | S | 2 participants |
| Filcon II 3 and Etafilcon A | Lens Fit, Centration - Filcon II 3 and Nelfilcon A | N/S | 1 participants |
| Filcon II 3 and Etafilcon A | Lens Fit, Centration - Filcon II 3 and Nelfilcon A | N | 1 participants |
| Filcon II 3 and Etafilcon A | Lens Fit, Centration - Filcon II 3 and Nelfilcon A | N/I | 0 participants |
| Filcon II 3 and Etafilcon A | Lens Fit, Centration - Filcon II 3 and Nelfilcon A | Optimum | 11 participants |
| Filcon II 3 and Etafilcon A | Lens Fit, Centration - Filcon II 3 and Nelfilcon A | T/S | 7 participants |
| Filcon II 3 and Etafilcon A | Lens Fit, Centration - Filcon II 3 and Nelfilcon A | I | 3 participants |
| Filcon II 3 and Etafilcon A | Lens Fit, Centration - Filcon II 3 and Nelfilcon A | T/I | 2 participants |
| Filcon II 3 and Etafilcon A | Lens Fit, Centration - Filcon II 3 and Nelfilcon A | T | 3 participants |
| Filcon II 3 and Nelfilcon A | Lens Fit, Centration - Filcon II 3 and Nelfilcon A | T/I | 3 participants |
| Filcon II 3 and Nelfilcon A | Lens Fit, Centration - Filcon II 3 and Nelfilcon A | T | 2 participants |
| Filcon II 3 and Nelfilcon A | Lens Fit, Centration - Filcon II 3 and Nelfilcon A | S | 2 participants |
| Filcon II 3 and Nelfilcon A | Lens Fit, Centration - Filcon II 3 and Nelfilcon A | Optimum | 14 participants |
| Filcon II 3 and Nelfilcon A | Lens Fit, Centration - Filcon II 3 and Nelfilcon A | N | 0 participants |
| Filcon II 3 and Nelfilcon A | Lens Fit, Centration - Filcon II 3 and Nelfilcon A | I | 2 participants |
| Filcon II 3 and Nelfilcon A | Lens Fit, Centration - Filcon II 3 and Nelfilcon A | N/S | 1 participants |
| Filcon II 3 and Nelfilcon A | Lens Fit, Centration - Filcon II 3 and Nelfilcon A | N/I | 2 participants |
| Filcon II 3 and Nelfilcon A | Lens Fit, Centration - Filcon II 3 and Nelfilcon A | T/S | 4 participants |
Secondary
Lens Fit, Post-Blink Movement - Filcon II 3 and Etafilcon A
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).
Time frame: Baseline and 6 hours
Population: These results are between the filcon II 3 and etafilcon A group which comprises of 40 participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filcon II 3 and Etafilcon A | Lens Fit, Post-Blink Movement - Filcon II 3 and Etafilcon A | Baseline | 0.28 mm steps | Standard Deviation 0.15 |
| Filcon II 3 and Etafilcon A | Lens Fit, Post-Blink Movement - Filcon II 3 and Etafilcon A | 6 hours | 0.30 mm steps | Standard Deviation 0.16 |
| Filcon II 3 and Nelfilcon A | Lens Fit, Post-Blink Movement - Filcon II 3 and Etafilcon A | Baseline | 0.24 mm steps | Standard Deviation 0.15 |
| Filcon II 3 and Nelfilcon A | Lens Fit, Post-Blink Movement - Filcon II 3 and Etafilcon A | 6 hours | 0.26 mm steps | Standard Deviation 0.14 |
Secondary
Lens Fit, Post-Blink Movement - Filcon II 3 and Nelfilcon A
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).
Time frame: Baseline and 6 hours
Population: These results are between the filcon II 3 and nelfilcon A group which comprises of 30 participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filcon II 3 and Etafilcon A | Lens Fit, Post-Blink Movement - Filcon II 3 and Nelfilcon A | 6 hours | 0.23 mm steps | Standard Deviation 0.08 |
| Filcon II 3 and Etafilcon A | Lens Fit, Post-Blink Movement - Filcon II 3 and Nelfilcon A | Baseline | 0.26 mm steps | Standard Deviation 0.11 |
| Filcon II 3 and Nelfilcon A | Lens Fit, Post-Blink Movement - Filcon II 3 and Nelfilcon A | Baseline | 0.24 mm steps | Standard Deviation 0.1 |
| Filcon II 3 and Nelfilcon A | Lens Fit, Post-Blink Movement - Filcon II 3 and Nelfilcon A | 6 hours | 0.24 mm steps | Standard Deviation 0.11 |
Secondary
Lens Fit, Tightness - Filcon II 3 and Etafilcon A
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).
Time frame: Baseline and 6 hours
Population: These results are between the filcon II 3 and etafilcon A group which comprises of 40 participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filcon II 3 and Etafilcon A | Lens Fit, Tightness - Filcon II 3 and Etafilcon A | 6 hours | 49 percentage of tightness | Standard Deviation 5 |
| Filcon II 3 and Etafilcon A | Lens Fit, Tightness - Filcon II 3 and Etafilcon A | Baseline | 48 percentage of tightness | Standard Deviation 6 |
| Filcon II 3 and Nelfilcon A | Lens Fit, Tightness - Filcon II 3 and Etafilcon A | Baseline | 50 percentage of tightness | Standard Deviation 6 |
| Filcon II 3 and Nelfilcon A | Lens Fit, Tightness - Filcon II 3 and Etafilcon A | 6 hours | 51 percentage of tightness | Standard Deviation 6 |
Secondary
Lens Fit, Tightness - Filcon II 3 and Nelfilcon A
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).
Time frame: Baseline and 6 hours
Population: These results are between the filcon II 3 and nelfilcon A group which comprises of 30 participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filcon II 3 and Etafilcon A | Lens Fit, Tightness - Filcon II 3 and Nelfilcon A | Baseline | 50 percentage of tightness | Standard Deviation 7 |
| Filcon II 3 and Etafilcon A | Lens Fit, Tightness - Filcon II 3 and Nelfilcon A | 6 hours | 52 percentage of tightness | Standard Deviation 6 |
| Filcon II 3 and Nelfilcon A | Lens Fit, Tightness - Filcon II 3 and Nelfilcon A | Baseline | 52 percentage of tightness | Standard Deviation 7 |
| Filcon II 3 and Nelfilcon A | Lens Fit, Tightness - Filcon II 3 and Nelfilcon A | 6 hours | 53 percentage of tightness | Standard Deviation 8 |
Secondary
Lens Handling - Filcon II 3 and Etafilcon A
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).
Time frame: Baseline visit
Population: These results are between the filcon II 3 and etafilcon A group which comprises of 40 participants. Habitual data collected before study lens dispensed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filcon II 3 and Etafilcon A | Lens Handling - Filcon II 3 and Etafilcon A | Habitual lens (before study lens dispensed) | 92 units on a scale | Standard Deviation 10 |
| Filcon II 3 and Etafilcon A | Lens Handling - Filcon II 3 and Etafilcon A | Baseline (study lens) | 93 units on a scale | Standard Deviation 9 |
| Filcon II 3 and Nelfilcon A | Lens Handling - Filcon II 3 and Etafilcon A | Habitual lens (before study lens dispensed) | 92 units on a scale | Standard Deviation 10 |
| Filcon II 3 and Nelfilcon A | Lens Handling - Filcon II 3 and Etafilcon A | Baseline (study lens) | 91 units on a scale | Standard Deviation 10 |
Secondary
Lens Handling - Filcon II 3 and Nelfilcon A
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).
Time frame: Baseline visit
Population: These results are between the filcon II 3 and nelfilcon A group which comprises of 30 participants. Habitual data collected before study lens dispensed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filcon II 3 and Etafilcon A | Lens Handling - Filcon II 3 and Nelfilcon A | Habitual lens (before study lens dispensed) | 90 units on a scale | Standard Deviation 14 |
| Filcon II 3 and Etafilcon A | Lens Handling - Filcon II 3 and Nelfilcon A | Baseline (study lens) | 92 units on a scale | Standard Deviation 14 |
| Filcon II 3 and Nelfilcon A | Lens Handling - Filcon II 3 and Nelfilcon A | Habitual lens (before study lens dispensed) | 90 units on a scale | Standard Deviation 14 |
| Filcon II 3 and Nelfilcon A | Lens Handling - Filcon II 3 and Nelfilcon A | Baseline (study lens) | 92 units on a scale | Standard Deviation 14 |
Secondary
Lens Handling (Removal) - Filcon II 3 and Etafilcon A
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).
Time frame: 6 hours
Population: These results are between the filcon II 3 and etafilcon A group which comprises of 40 participants. Habitual data collected before study lens dispensed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filcon II 3 and Etafilcon A | Lens Handling (Removal) - Filcon II 3 and Etafilcon A | 6 hours | 95 units on a scale | Standard Deviation 12 |
| Filcon II 3 and Etafilcon A | Lens Handling (Removal) - Filcon II 3 and Etafilcon A | Habitual lens (before study lens dispensed) | 95 units on a scale | Standard Deviation 10 |
| Filcon II 3 and Nelfilcon A | Lens Handling (Removal) - Filcon II 3 and Etafilcon A | 6 hours | 97 units on a scale | Standard Deviation 6 |
| Filcon II 3 and Nelfilcon A | Lens Handling (Removal) - Filcon II 3 and Etafilcon A | Habitual lens (before study lens dispensed) | 95 units on a scale | Standard Deviation 10 |
Secondary
Lens Handling (Removal) - Filcon II 3 and Nelfilcon A
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).
Time frame: 6 hours
Population: These results are between the filcon II 3 and nelfilcon A group which comprises of 30 participants. Habitual data collected before study lens dispensed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filcon II 3 and Etafilcon A | Lens Handling (Removal) - Filcon II 3 and Nelfilcon A | Habitual lens (before study lens dispensed) | 90 units on a scale | Standard Deviation 14 |
| Filcon II 3 and Etafilcon A | Lens Handling (Removal) - Filcon II 3 and Nelfilcon A | 6 hours | 94 units on a scale | Standard Deviation 16 |
| Filcon II 3 and Nelfilcon A | Lens Handling (Removal) - Filcon II 3 and Nelfilcon A | Habitual lens (before study lens dispensed) | 89 units on a scale | Standard Deviation 15 |
| Filcon II 3 and Nelfilcon A | Lens Handling (Removal) - Filcon II 3 and Nelfilcon A | 6 hours | 94 units on a scale | Standard Deviation 10 |
Secondary
Lens Surface Deposition - Filcon II 3 and Etafilcon A
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).
Time frame: 6 hour
Population: These results are between the filcon II 3 and etafilcon A group which comprises of 40 participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Filcon II 3 and Etafilcon A | Lens Surface Deposition - Filcon II 3 and Etafilcon A | 0.26 units on a scale | Standard Deviation 0.27 |
| Filcon II 3 and Nelfilcon A | Lens Surface Deposition - Filcon II 3 and Etafilcon A | 0.37 units on a scale | Standard Deviation 0.47 |
Secondary
Lens Surface Deposition - Filcon II 3 and Nelfilcon A
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).
Time frame: 6 hour
Population: These results are between the filcon II 3 and nelfilcon A group which comprises of 30 participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Filcon II 3 and Etafilcon A | Lens Surface Deposition - Filcon II 3 and Nelfilcon A | 0.27 units on a scale | Standard Deviation 0.33 |
| Filcon II 3 and Nelfilcon A | Lens Surface Deposition - Filcon II 3 and Nelfilcon A | 0.30 units on a scale | Standard Deviation 0.32 |
Secondary
Lens Wettability - Filcon II 3 and Etafilcon A
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).
Time frame: Baseline and 6 hours
Population: These results are between the filcon II 3 and etafilcon A group which comprises of 40 participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filcon II 3 and Etafilcon A | Lens Wettability - Filcon II 3 and Etafilcon A | Baseline | 0.40 units on a scale | Standard Deviation 0.73 |
| Filcon II 3 and Etafilcon A | Lens Wettability - Filcon II 3 and Etafilcon A | 6 hours | 0.95 units on a scale | Standard Deviation 0.89 |
| Filcon II 3 and Nelfilcon A | Lens Wettability - Filcon II 3 and Etafilcon A | Baseline | 0.33 units on a scale | Standard Deviation 0.57 |
| Filcon II 3 and Nelfilcon A | Lens Wettability - Filcon II 3 and Etafilcon A | 6 hours | 1.03 units on a scale | Standard Deviation 1.12 |
Secondary
Lens Wettability - Filcon II 3 and Nelfilcon A
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).
Time frame: Baseline and 6 hours
Population: These results are between the filcon II 3 and nelfilcon A group which comprises of 30 participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filcon II 3 and Etafilcon A | Lens Wettability - Filcon II 3 and Nelfilcon A | Baseline | 0.38 units on a scale | Standard Deviation 0.46 |
| Filcon II 3 and Etafilcon A | Lens Wettability - Filcon II 3 and Nelfilcon A | 6 hours | 0.93 units on a scale | Standard Deviation 0.82 |
| Filcon II 3 and Nelfilcon A | Lens Wettability - Filcon II 3 and Nelfilcon A | Baseline | 0.25 units on a scale | Standard Deviation 0.35 |
| Filcon II 3 and Nelfilcon A | Lens Wettability - Filcon II 3 and Nelfilcon A | 6 hours | 0.73 units on a scale | Standard Deviation 0.79 |
Secondary
Ocular Health, Conjunctival Hyperemia - Filcon II 3 and Etafilcon A
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).
Time frame: Baseline and 6 hours
Population: These results are between the filcon II 3 and etafilcon A group which comprises of 40 participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filcon II 3 and Etafilcon A | Ocular Health, Conjunctival Hyperemia - Filcon II 3 and Etafilcon A | Bulbar | 1.89 units on a scale | Standard Deviation 0.38 |
| Filcon II 3 and Etafilcon A | Ocular Health, Conjunctival Hyperemia - Filcon II 3 and Etafilcon A | Limbal | 1.75 units on a scale | Standard Deviation 0.47 |
| Filcon II 3 and Nelfilcon A | Ocular Health, Conjunctival Hyperemia - Filcon II 3 and Etafilcon A | Bulbar | 1.81 units on a scale | Standard Deviation 0.39 |
| Filcon II 3 and Nelfilcon A | Ocular Health, Conjunctival Hyperemia - Filcon II 3 and Etafilcon A | Limbal | 1.68 units on a scale | Standard Deviation 0.51 |
Secondary
Ocular Health, Conjunctival Hyperemia - Filcon II 3 and Nelfilcon A
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).
Time frame: Baseline and 6 hours
Population: These results are between the filcon II 3 and nelfilcon A group which comprises of 30 participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filcon II 3 and Etafilcon A | Ocular Health, Conjunctival Hyperemia - Filcon II 3 and Nelfilcon A | Bulbar | 1.67 units on a scale | Standard Deviation 0.46 |
| Filcon II 3 and Etafilcon A | Ocular Health, Conjunctival Hyperemia - Filcon II 3 and Nelfilcon A | Limbal | 1.35 units on a scale | Standard Deviation 0.49 |
| Filcon II 3 and Nelfilcon A | Ocular Health, Conjunctival Hyperemia - Filcon II 3 and Nelfilcon A | Bulbar | 1.57 units on a scale | Standard Deviation 0.29 |
| Filcon II 3 and Nelfilcon A | Ocular Health, Conjunctival Hyperemia - Filcon II 3 and Nelfilcon A | Limbal | 1.27 units on a scale | Standard Deviation 0.37 |
Secondary
Ocular Health, Corneal Staining (Extent) - Filcon II 3 and Etafilcon A
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
Time frame: 6 hours
Population: These results are between the filcon II 3 and etafilcon A group which comprises of 40 participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filcon II 3 and Etafilcon A | Ocular Health, Corneal Staining (Extent) - Filcon II 3 and Etafilcon A | N | 4 percentage of the area of each zone | Standard Deviation 8 |
| Filcon II 3 and Etafilcon A | Ocular Health, Corneal Staining (Extent) - Filcon II 3 and Etafilcon A | I | 9 percentage of the area of each zone | Standard Deviation 12 |
| Filcon II 3 and Etafilcon A | Ocular Health, Corneal Staining (Extent) - Filcon II 3 and Etafilcon A | T | 1 percentage of the area of each zone | Standard Deviation 6 |
| Filcon II 3 and Etafilcon A | Ocular Health, Corneal Staining (Extent) - Filcon II 3 and Etafilcon A | C | 0 percentage of the area of each zone | Standard Deviation 2 |
| Filcon II 3 and Etafilcon A | Ocular Health, Corneal Staining (Extent) - Filcon II 3 and Etafilcon A | S | 3 percentage of the area of each zone | Standard Deviation 8 |
| Filcon II 3 and Nelfilcon A | Ocular Health, Corneal Staining (Extent) - Filcon II 3 and Etafilcon A | C | 0 percentage of the area of each zone | Standard Deviation 1 |
| Filcon II 3 and Nelfilcon A | Ocular Health, Corneal Staining (Extent) - Filcon II 3 and Etafilcon A | S | 2 percentage of the area of each zone | Standard Deviation 5 |
| Filcon II 3 and Nelfilcon A | Ocular Health, Corneal Staining (Extent) - Filcon II 3 and Etafilcon A | I | 4 percentage of the area of each zone | Standard Deviation 6 |
| Filcon II 3 and Nelfilcon A | Ocular Health, Corneal Staining (Extent) - Filcon II 3 and Etafilcon A | N | 0 percentage of the area of each zone | Standard Deviation 1 |
| Filcon II 3 and Nelfilcon A | Ocular Health, Corneal Staining (Extent) - Filcon II 3 and Etafilcon A | T | 1 percentage of the area of each zone | Standard Deviation 2 |
Secondary
Ocular Health, Corneal Staining (Extent) - Filcon II 3 and Nelfilcon A
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
Time frame: 6 hours
Population: These results are between the filcon II 3 and nelfilcon A group which comprises of 30 participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filcon II 3 and Etafilcon A | Ocular Health, Corneal Staining (Extent) - Filcon II 3 and Nelfilcon A | T | 1 percentage of the area of each zone | Standard Deviation 5 |
| Filcon II 3 and Etafilcon A | Ocular Health, Corneal Staining (Extent) - Filcon II 3 and Nelfilcon A | I | 6 percentage of the area of each zone | Standard Deviation 8 |
| Filcon II 3 and Etafilcon A | Ocular Health, Corneal Staining (Extent) - Filcon II 3 and Nelfilcon A | S | 2 percentage of the area of each zone | Standard Deviation 5 |
| Filcon II 3 and Etafilcon A | Ocular Health, Corneal Staining (Extent) - Filcon II 3 and Nelfilcon A | C | 2 percentage of the area of each zone | Standard Deviation 9 |
| Filcon II 3 and Etafilcon A | Ocular Health, Corneal Staining (Extent) - Filcon II 3 and Nelfilcon A | N | 2 percentage of the area of each zone | Standard Deviation 5 |
| Filcon II 3 and Nelfilcon A | Ocular Health, Corneal Staining (Extent) - Filcon II 3 and Nelfilcon A | C | 0 percentage of the area of each zone | Standard Deviation 1 |
| Filcon II 3 and Nelfilcon A | Ocular Health, Corneal Staining (Extent) - Filcon II 3 and Nelfilcon A | N | 2 percentage of the area of each zone | Standard Deviation 5 |
| Filcon II 3 and Nelfilcon A | Ocular Health, Corneal Staining (Extent) - Filcon II 3 and Nelfilcon A | T | 0 percentage of the area of each zone | Standard Deviation 1 |
| Filcon II 3 and Nelfilcon A | Ocular Health, Corneal Staining (Extent) - Filcon II 3 and Nelfilcon A | S | 2 percentage of the area of each zone | Standard Deviation 7 |
| Filcon II 3 and Nelfilcon A | Ocular Health, Corneal Staining (Extent) - Filcon II 3 and Nelfilcon A | I | 4 percentage of the area of each zone | Standard Deviation 5 |