Myopia, Hyperopia
Conditions
Brief summary
Open label, 1-week daily disposable, dispensing study
Detailed description
Evaluate the clinical performance of habitual wearers of FILCON IV 1 sphere lenses when refitted with ocufilcon D asphere for 1 week of daily disposable wear.
Interventions
DEVICEocufilcon D
contact lens
DEVICEfilcon IV 1
contact lens
Sponsors
CooperVision, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* Is between 18 and 40 years of age (inclusive) * Has had a self-reported visual exam in the last two years * Is an adapted Avaira sphere contact lens wearer (at least 1 week in Avaira sphere) * Has a contact lens spherical prescription between + 2.25 to - 8.00 (inclusive) * Has a spectacle cylinder up to 0.75D in each eye. * Can achieve best corrected spectacle distance visual acuity of 20/25 (0.10 logMAR) or better in each eye. * Can achieve a distance visual acuity of 20/30 (0.18 logMAR) or better in each eye with the study contact lenses. * Has clear corneas and no active ocular disease * Has read, understood and signed the information consent letter. * Patient contact lens refraction should fit within the available parameters of the study lenses. * Is willing to comply with the wear schedule (at least 5 days per week, \> 8 hours/day assuming there are no contraindications for doing so). * Is willing to comply with the visit schedule
Exclusion criteria
* Is not a habitual wearer of Avaira sphere lenses * Has a CL prescription outside the range of the available parameters of the study lenses. * Has a spectacle cylinder ≥1.00D of cylinder in either eye. * Has a history of not achieving comfortable CL wear (5 days per week; \> 8 hours/day) * Has contact lens best corrected distance vision worse than 20/25 (0.10 logMAR) in either eye. * Presence of clinically significant (grade 2-4) anterior segment abnormalities * Presence of ocular or systemic disease or need of medications which might interfere with contact lens wear. * Slit lamp findings that would contraindicate contact lens wear such as: * Pathological dry eye or associated findings * Pterygium, pinguecula, or corneal scars within the visual axis * Neovascularization \> 0.75 mm in from of the limbus * Giant papillary conjunctivitis (GCP) worse than grade 1 * Anterior uveitis or iritis (past or present) * Seborrheic eczema, Seborrheic conjunctivitis * History of corneal ulcers or fungal infections * Poor personal hygiene * Has a known history of corneal hypoesthesia (reduced corneal sensitivity) * Has aphakia, keratoconus or a highly irregular cornea. * Has Presbyopia or has dependence on spectacles for near work over the contact lenses. * Has undergone corneal refractive surgery. * Is participating in any other type of eye related clinical or research study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lens Fit, Centration - Filcon IV 1 and Ocufilcon D | Baseline and 1 Week | Lens fit, centration for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale: optimum, decentration acceptable, and decentration unacceptable |
| Lens Fit, Post-blink Movement - Filcon IV 1 and Ocufilcon D | Baseline and 1 Week | Lens fit, post-blink movement for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. (Scale 0-4, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement). |
| Lens Fit, Lens Tightness - Filcon IV 1 and Ocufilcon D | Baseline and 1 Week | Lens fit, lens tightness for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale 0%-100% continuous scale 0% - Falls from cornea without lid support 50% - Optimum 100% - No movement |
| Lens Fit, Overall Fit Acceptance - Filcon IV 1 and Ocufilcon D | Baseline and 1 Week | Lens fit, overall fit acceptance for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale 0-4, 0=Should not be worn, 4=Perfect. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Vision Satisfaction (Subjective Ratings) - Filcon IV 1 and Ocufilcon D | Baseline and 1 Week | Subjective ratings of vision satisfaction for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. (Scale 0-10, 0=dissatisfied, 10=very satisfied). |
| Lens Preference (Subjective Ratings) - Filcon IV 1 and Ocufilcon D | 1 Week | Subjective ratings of participant's lens preference for either filcon IV 1 or ocufilcon D on comfort, dryness, handling, vision, and overall. Forced choice: filcon IV 1 or ocufilcon D. |
| Lens Satisfaction, Comfort - Filcon IV 1 and Ocufilcon D | Baseline and 1 Week | Lens satisfaction of comfort for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale 1-4, 1=completely satisfied, 4=completely dissatisfied. |
| Visual Acuity - Filcon IV 1 and Ocufilcon D | Baseline and 1 Week | Visual acuity for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week using logMAR chart (a logMAR of 0.0=20/20 in Snellen notation and negative values indicate better visual acuity). |
| Lens Satisfaction, Handling - Filcon IV 1 and Ocufilcon D | Baseline and 1 Week | Lens satisfaction of handling forfilcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale 1-4, 1=completely satisfied, 4=completely dissatisfied. |
| Lens Satisfaction, Vision - Filcon IV 1 and Ocufilcon D | Baseline and 1 Week | Lens satisfaction of vision for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale 1-4, 1=completely satisfied, 4=completely dissatisfied. |
| Lens Satisfaction, Overall - Filcon IV 1 and Ocufilcon D | Baseline and 1 Week | Lens satisfaction overall for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale 1-4, 1=completely satisfied, 4=completely dissatisfied. |
| Lens Satisfaction, Dryness - Filcon IV 1 and Ocufilcon D | Baseline and 1 Week | Lens satisfaction of dryness for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale 1-4, 1=completely satisfied, 4=completely dissatisfied. |
| Comfort (Subjective Ratings) - Filcon IV 1 and Ocufilcon D | Baseline and 1 Week | Subjective ratings for comfort for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. (Scale 0-10, 0=could feel, 10=cannot feel). |
| Dryness (Subjective Ratings) - Filcon IV 1 and Ocufilcon D | Baseline and 1 Week | Subjective ratings of dryness for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. (Scale 0-10, 0=dryness, 10=no dryness). |
| Handling (Subjective Ratings) - Filcon IV 1 and Ocufilcon D | Baseline and 1 Week | Subjective ratings of handling for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. (Scale 0-10, 0=very difficult to handle, 10=very easy to handle). |
Countries
Spain
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Overall Participants Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.
filcon IV 1: contact lens
ocufilcon D: contact lens | 40 |
| Total | 40 |
Baseline characteristics
| Characteristic | Overall Participants |
|---|---|
| Age, Continuous | 23.92 years STANDARD_DEVIATION 5.43 |
| Sex: Female, Male Female | 31 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 40 |
| serious Total, serious adverse events | 0 / 40 |
Outcome results
Primary
Lens Fit, Centration - Filcon IV 1 and Ocufilcon D
Lens fit, centration for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale: optimum, decentration acceptable, and decentration unacceptable
Time frame: Baseline and 1 Week
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Filcon IV 1 | Lens Fit, Centration - Filcon IV 1 and Ocufilcon D | Optimum | 58 percentage of eyes |
| Filcon IV 1 | Lens Fit, Centration - Filcon IV 1 and Ocufilcon D | Decentration acceptable | 43 percentage of eyes |
| Filcon IV 1 | Lens Fit, Centration - Filcon IV 1 and Ocufilcon D | Decentration unacceptable | 0 percentage of eyes |
| Ocufilcon D | Lens Fit, Centration - Filcon IV 1 and Ocufilcon D | Decentration acceptable | 30 percentage of eyes |
| Ocufilcon D | Lens Fit, Centration - Filcon IV 1 and Ocufilcon D | Decentration unacceptable | 0 percentage of eyes |
| Ocufilcon D | Lens Fit, Centration - Filcon IV 1 and Ocufilcon D | Optimum | 70 percentage of eyes |
| Ocufilcon D OD (Oculus Dexter) | Lens Fit, Centration - Filcon IV 1 and Ocufilcon D | Optimum | 98 percentage of eyes |
| Ocufilcon D OD (Oculus Dexter) | Lens Fit, Centration - Filcon IV 1 and Ocufilcon D | Decentration unacceptable | 0 percentage of eyes |
| Ocufilcon D OD (Oculus Dexter) | Lens Fit, Centration - Filcon IV 1 and Ocufilcon D | Decentration acceptable | 3 percentage of eyes |
| Ocufilcon D OS (Oculus Sinister) | Lens Fit, Centration - Filcon IV 1 and Ocufilcon D | Decentration unacceptable | 0 percentage of eyes |
| Ocufilcon D OS (Oculus Sinister) | Lens Fit, Centration - Filcon IV 1 and Ocufilcon D | Optimum | 98 percentage of eyes |
| Ocufilcon D OS (Oculus Sinister) | Lens Fit, Centration - Filcon IV 1 and Ocufilcon D | Decentration acceptable | 3 percentage of eyes |
Primary
Lens Fit, Lens Tightness - Filcon IV 1 and Ocufilcon D
Lens fit, lens tightness for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale 0%-100% continuous scale 0% - Falls from cornea without lid support 50% - Optimum 100% - No movement
Time frame: Baseline and 1 Week
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filcon IV 1 | Lens Fit, Lens Tightness - Filcon IV 1 and Ocufilcon D | OD | 49.1 percentage of mean lens tightness | Standard Deviation 5.9 |
| Filcon IV 1 | Lens Fit, Lens Tightness - Filcon IV 1 and Ocufilcon D | OS | 48.9 percentage of mean lens tightness | Standard Deviation 5.2 |
| Ocufilcon D | Lens Fit, Lens Tightness - Filcon IV 1 and Ocufilcon D | OD | 50.1 percentage of mean lens tightness | Standard Deviation 0.79 |
| Ocufilcon D | Lens Fit, Lens Tightness - Filcon IV 1 and Ocufilcon D | OS | 50.0 percentage of mean lens tightness | Standard Deviation 1.9 |
Primary
Lens Fit, Overall Fit Acceptance - Filcon IV 1 and Ocufilcon D
Lens fit, overall fit acceptance for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale 0-4, 0=Should not be worn, 4=Perfect.
Time frame: Baseline and 1 Week
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Filcon IV 1 | Lens Fit, Overall Fit Acceptance - Filcon IV 1 and Ocufilcon D | Not perfect but OK | 38 percentage of eyes |
| Filcon IV 1 | Lens Fit, Overall Fit Acceptance - Filcon IV 1 and Ocufilcon D | Perfect | 63 percentage of eyes |
| Filcon IV 1 | Lens Fit, Overall Fit Acceptance - Filcon IV 1 and Ocufilcon D | Should not be worn | 0 percentage of eyes |
| Filcon IV 1 | Lens Fit, Overall Fit Acceptance - Filcon IV 1 and Ocufilcon D | Borderline but acceptable | 0 percentage of eyes |
| Filcon IV 1 | Lens Fit, Overall Fit Acceptance - Filcon IV 1 and Ocufilcon D | Min. acceptable | 0 percentage of eyes |
| Ocufilcon D | Lens Fit, Overall Fit Acceptance - Filcon IV 1 and Ocufilcon D | Borderline but acceptable | 0 percentage of eyes |
| Ocufilcon D | Lens Fit, Overall Fit Acceptance - Filcon IV 1 and Ocufilcon D | Min. acceptable | 0 percentage of eyes |
| Ocufilcon D | Lens Fit, Overall Fit Acceptance - Filcon IV 1 and Ocufilcon D | Should not be worn | 0 percentage of eyes |
| Ocufilcon D | Lens Fit, Overall Fit Acceptance - Filcon IV 1 and Ocufilcon D | Not perfect but OK | 35 percentage of eyes |
| Ocufilcon D | Lens Fit, Overall Fit Acceptance - Filcon IV 1 and Ocufilcon D | Perfect | 65 percentage of eyes |
| Ocufilcon D OD (Oculus Dexter) | Lens Fit, Overall Fit Acceptance - Filcon IV 1 and Ocufilcon D | Not perfect but OK | 0 percentage of eyes |
| Ocufilcon D OD (Oculus Dexter) | Lens Fit, Overall Fit Acceptance - Filcon IV 1 and Ocufilcon D | Should not be worn | 0 percentage of eyes |
| Ocufilcon D OD (Oculus Dexter) | Lens Fit, Overall Fit Acceptance - Filcon IV 1 and Ocufilcon D | Perfect | 100 percentage of eyes |
| Ocufilcon D OD (Oculus Dexter) | Lens Fit, Overall Fit Acceptance - Filcon IV 1 and Ocufilcon D | Min. acceptable | 0 percentage of eyes |
| Ocufilcon D OD (Oculus Dexter) | Lens Fit, Overall Fit Acceptance - Filcon IV 1 and Ocufilcon D | Borderline but acceptable | 0 percentage of eyes |
| Ocufilcon D OS (Oculus Sinister) | Lens Fit, Overall Fit Acceptance - Filcon IV 1 and Ocufilcon D | Should not be worn | 0 percentage of eyes |
| Ocufilcon D OS (Oculus Sinister) | Lens Fit, Overall Fit Acceptance - Filcon IV 1 and Ocufilcon D | Not perfect but OK | 0 percentage of eyes |
| Ocufilcon D OS (Oculus Sinister) | Lens Fit, Overall Fit Acceptance - Filcon IV 1 and Ocufilcon D | Perfect | 100 percentage of eyes |
| Ocufilcon D OS (Oculus Sinister) | Lens Fit, Overall Fit Acceptance - Filcon IV 1 and Ocufilcon D | Min. acceptable | 0 percentage of eyes |
| Ocufilcon D OS (Oculus Sinister) | Lens Fit, Overall Fit Acceptance - Filcon IV 1 and Ocufilcon D | Borderline but acceptable | 0 percentage of eyes |
Primary
Lens Fit, Post-blink Movement - Filcon IV 1 and Ocufilcon D
Lens fit, post-blink movement for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. (Scale 0-4, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement).
Time frame: Baseline and 1 Week
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Filcon IV 1 | Lens Fit, Post-blink Movement - Filcon IV 1 and Ocufilcon D | 2=Optimal movement | 23 percentage of eyes |
| Filcon IV 1 | Lens Fit, Post-blink Movement - Filcon IV 1 and Ocufilcon D | 0=Insufficient, unacceptable movement | 0 percentage of eyes |
| Filcon IV 1 | Lens Fit, Post-blink Movement - Filcon IV 1 and Ocufilcon D | 3=Moderate, but acceptable movement | 65 percentage of eyes |
| Filcon IV 1 | Lens Fit, Post-blink Movement - Filcon IV 1 and Ocufilcon D | 4=Excessive, unacceptable movement | 3 percentage of eyes |
| Filcon IV 1 | Lens Fit, Post-blink Movement - Filcon IV 1 and Ocufilcon D | 1=Minimal, but acceptable movement | 10 percentage of eyes |
| Ocufilcon D | Lens Fit, Post-blink Movement - Filcon IV 1 and Ocufilcon D | 4=Excessive, unacceptable movement | 3 percentage of eyes |
| Ocufilcon D | Lens Fit, Post-blink Movement - Filcon IV 1 and Ocufilcon D | 2=Optimal movement | 18 percentage of eyes |
| Ocufilcon D | Lens Fit, Post-blink Movement - Filcon IV 1 and Ocufilcon D | 3=Moderate, but acceptable movement | 70 percentage of eyes |
| Ocufilcon D | Lens Fit, Post-blink Movement - Filcon IV 1 and Ocufilcon D | 1=Minimal, but acceptable movement | 10 percentage of eyes |
| Ocufilcon D | Lens Fit, Post-blink Movement - Filcon IV 1 and Ocufilcon D | 0=Insufficient, unacceptable movement | 0 percentage of eyes |
| Ocufilcon D OD (Oculus Dexter) | Lens Fit, Post-blink Movement - Filcon IV 1 and Ocufilcon D | 4=Excessive, unacceptable movement | 0 percentage of eyes |
| Ocufilcon D OD (Oculus Dexter) | Lens Fit, Post-blink Movement - Filcon IV 1 and Ocufilcon D | 3=Moderate, but acceptable movement | 90 percentage of eyes |
| Ocufilcon D OD (Oculus Dexter) | Lens Fit, Post-blink Movement - Filcon IV 1 and Ocufilcon D | 1=Minimal, but acceptable movement | 0 percentage of eyes |
| Ocufilcon D OD (Oculus Dexter) | Lens Fit, Post-blink Movement - Filcon IV 1 and Ocufilcon D | 2=Optimal movement | 10 percentage of eyes |
| Ocufilcon D OD (Oculus Dexter) | Lens Fit, Post-blink Movement - Filcon IV 1 and Ocufilcon D | 0=Insufficient, unacceptable movement | 0 percentage of eyes |
| Ocufilcon D OS (Oculus Sinister) | Lens Fit, Post-blink Movement - Filcon IV 1 and Ocufilcon D | 1=Minimal, but acceptable movement | 0 percentage of eyes |
| Ocufilcon D OS (Oculus Sinister) | Lens Fit, Post-blink Movement - Filcon IV 1 and Ocufilcon D | 3=Moderate, but acceptable movement | 90 percentage of eyes |
| Ocufilcon D OS (Oculus Sinister) | Lens Fit, Post-blink Movement - Filcon IV 1 and Ocufilcon D | 0=Insufficient, unacceptable movement | 0 percentage of eyes |
| Ocufilcon D OS (Oculus Sinister) | Lens Fit, Post-blink Movement - Filcon IV 1 and Ocufilcon D | 4=Excessive, unacceptable movement | 0 percentage of eyes |
| Ocufilcon D OS (Oculus Sinister) | Lens Fit, Post-blink Movement - Filcon IV 1 and Ocufilcon D | 2=Optimal movement | 10 percentage of eyes |
Secondary
Comfort (Subjective Ratings) - Filcon IV 1 and Ocufilcon D
Subjective ratings for comfort for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. (Scale 0-10, 0=could feel, 10=cannot feel).
Time frame: Baseline and 1 Week
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filcon IV 1 | Comfort (Subjective Ratings) - Filcon IV 1 and Ocufilcon D | Comfort overall | 7.3 units on a scale | Standard Deviation 1.3 |
| Filcon IV 1 | Comfort (Subjective Ratings) - Filcon IV 1 and Ocufilcon D | Comfort on insertion | 7.4 units on a scale | Standard Deviation 1.1 |
| Filcon IV 1 | Comfort (Subjective Ratings) - Filcon IV 1 and Ocufilcon D | Comfort prior to removal | 7.3 units on a scale | Standard Deviation 1.4 |
| Ocufilcon D | Comfort (Subjective Ratings) - Filcon IV 1 and Ocufilcon D | Comfort overall | 8.1 units on a scale | Standard Deviation 1.4 |
| Ocufilcon D | Comfort (Subjective Ratings) - Filcon IV 1 and Ocufilcon D | Comfort on insertion | 8.1 units on a scale | Standard Deviation 1.3 |
| Ocufilcon D | Comfort (Subjective Ratings) - Filcon IV 1 and Ocufilcon D | Comfort prior to removal | 8.1 units on a scale | Standard Deviation 1.3 |
Secondary
Dryness (Subjective Ratings) - Filcon IV 1 and Ocufilcon D
Subjective ratings of dryness for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. (Scale 0-10, 0=dryness, 10=no dryness).
Time frame: Baseline and 1 Week
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filcon IV 1 | Dryness (Subjective Ratings) - Filcon IV 1 and Ocufilcon D | Dryness during day | 7.2 units on a scale | Standard Deviation 1.3 |
| Filcon IV 1 | Dryness (Subjective Ratings) - Filcon IV 1 and Ocufilcon D | Dryness prior to removal | 7.3 units on a scale | Standard Deviation 1.3 |
| Filcon IV 1 | Dryness (Subjective Ratings) - Filcon IV 1 and Ocufilcon D | Overall dryness | 7.3 units on a scale | Standard Deviation 1.3 |
| Ocufilcon D | Dryness (Subjective Ratings) - Filcon IV 1 and Ocufilcon D | Dryness during day | 8.0 units on a scale | Standard Deviation 1.5 |
| Ocufilcon D | Dryness (Subjective Ratings) - Filcon IV 1 and Ocufilcon D | Dryness prior to removal | 8.0 units on a scale | Standard Deviation 1.5 |
| Ocufilcon D | Dryness (Subjective Ratings) - Filcon IV 1 and Ocufilcon D | Overall dryness | 8.1 units on a scale | Standard Deviation 1.5 |
Secondary
Handling (Subjective Ratings) - Filcon IV 1 and Ocufilcon D
Subjective ratings of handling for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. (Scale 0-10, 0=very difficult to handle, 10=very easy to handle).
Time frame: Baseline and 1 Week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Filcon IV 1 | Handling (Subjective Ratings) - Filcon IV 1 and Ocufilcon D | 7.4 units on a scale | Standard Deviation 1.2 |
| Ocufilcon D | Handling (Subjective Ratings) - Filcon IV 1 and Ocufilcon D | 8.2 units on a scale | Standard Deviation 1.3 |
Secondary
Lens Preference (Subjective Ratings) - Filcon IV 1 and Ocufilcon D
Subjective ratings of participant's lens preference for either filcon IV 1 or ocufilcon D on comfort, dryness, handling, vision, and overall. Forced choice: filcon IV 1 or ocufilcon D.
Time frame: 1 Week
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Filcon IV 1 | Lens Preference (Subjective Ratings) - Filcon IV 1 and Ocufilcon D | Comfort | 20 percentage of participants |
| Filcon IV 1 | Lens Preference (Subjective Ratings) - Filcon IV 1 and Ocufilcon D | Handling | 20 percentage of participants |
| Filcon IV 1 | Lens Preference (Subjective Ratings) - Filcon IV 1 and Ocufilcon D | Dryness | 20 percentage of participants |
| Filcon IV 1 | Lens Preference (Subjective Ratings) - Filcon IV 1 and Ocufilcon D | Vision | 20 percentage of participants |
| Filcon IV 1 | Lens Preference (Subjective Ratings) - Filcon IV 1 and Ocufilcon D | Overall | 20 percentage of participants |
| Ocufilcon D | Lens Preference (Subjective Ratings) - Filcon IV 1 and Ocufilcon D | Vision | 80 percentage of participants |
| Ocufilcon D | Lens Preference (Subjective Ratings) - Filcon IV 1 and Ocufilcon D | Overall | 80 percentage of participants |
| Ocufilcon D | Lens Preference (Subjective Ratings) - Filcon IV 1 and Ocufilcon D | Comfort | 80 percentage of participants |
| Ocufilcon D | Lens Preference (Subjective Ratings) - Filcon IV 1 and Ocufilcon D | Dryness | 80 percentage of participants |
| Ocufilcon D | Lens Preference (Subjective Ratings) - Filcon IV 1 and Ocufilcon D | Handling | 80 percentage of participants |
Secondary
Lens Satisfaction, Comfort - Filcon IV 1 and Ocufilcon D
Lens satisfaction of comfort for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale 1-4, 1=completely satisfied, 4=completely dissatisfied.
Time frame: Baseline and 1 Week
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Filcon IV 1 | Lens Satisfaction, Comfort - Filcon IV 1 and Ocufilcon D | Completely Satisfied | 20 percentage of participants |
| Filcon IV 1 | Lens Satisfaction, Comfort - Filcon IV 1 and Ocufilcon D | Somewhat Satisfied | 68 percentage of participants |
| Filcon IV 1 | Lens Satisfaction, Comfort - Filcon IV 1 and Ocufilcon D | Somewhat Dissatisfied | 13 percentage of participants |
| Filcon IV 1 | Lens Satisfaction, Comfort - Filcon IV 1 and Ocufilcon D | Completely Dissatisfied | 0 percentage of participants |
| Ocufilcon D | Lens Satisfaction, Comfort - Filcon IV 1 and Ocufilcon D | Completely Dissatisfied | 0 percentage of participants |
| Ocufilcon D | Lens Satisfaction, Comfort - Filcon IV 1 and Ocufilcon D | Completely Satisfied | 60 percentage of participants |
| Ocufilcon D | Lens Satisfaction, Comfort - Filcon IV 1 and Ocufilcon D | Somewhat Dissatisfied | 5 percentage of participants |
| Ocufilcon D | Lens Satisfaction, Comfort - Filcon IV 1 and Ocufilcon D | Somewhat Satisfied | 35 percentage of participants |
Secondary
Lens Satisfaction, Dryness - Filcon IV 1 and Ocufilcon D
Lens satisfaction of dryness for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale 1-4, 1=completely satisfied, 4=completely dissatisfied.
Time frame: Baseline and 1 Week
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Filcon IV 1 | Lens Satisfaction, Dryness - Filcon IV 1 and Ocufilcon D | Completely Satisfied | 20 percentage of participants |
| Filcon IV 1 | Lens Satisfaction, Dryness - Filcon IV 1 and Ocufilcon D | Somewhat Satisfied | 65 percentage of participants |
| Filcon IV 1 | Lens Satisfaction, Dryness - Filcon IV 1 and Ocufilcon D | Somewhat Dissatisfied | 15 percentage of participants |
| Filcon IV 1 | Lens Satisfaction, Dryness - Filcon IV 1 and Ocufilcon D | Completely Dissatisfied | 0 percentage of participants |
| Ocufilcon D | Lens Satisfaction, Dryness - Filcon IV 1 and Ocufilcon D | Completely Dissatisfied | 0 percentage of participants |
| Ocufilcon D | Lens Satisfaction, Dryness - Filcon IV 1 and Ocufilcon D | Completely Satisfied | 60 percentage of participants |
| Ocufilcon D | Lens Satisfaction, Dryness - Filcon IV 1 and Ocufilcon D | Somewhat Dissatisfied | 5 percentage of participants |
| Ocufilcon D | Lens Satisfaction, Dryness - Filcon IV 1 and Ocufilcon D | Somewhat Satisfied | 35 percentage of participants |
Secondary
Lens Satisfaction, Handling - Filcon IV 1 and Ocufilcon D
Lens satisfaction of handling forfilcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale 1-4, 1=completely satisfied, 4=completely dissatisfied.
Time frame: Baseline and 1 Week
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Filcon IV 1 | Lens Satisfaction, Handling - Filcon IV 1 and Ocufilcon D | Somewhat Dissatisfied | 13 percentage of participants |
| Filcon IV 1 | Lens Satisfaction, Handling - Filcon IV 1 and Ocufilcon D | Somewhat Satisfied | 65 percentage of participants |
| Filcon IV 1 | Lens Satisfaction, Handling - Filcon IV 1 and Ocufilcon D | Completely Dissatisfied | 0 percentage of participants |
| Filcon IV 1 | Lens Satisfaction, Handling - Filcon IV 1 and Ocufilcon D | Completely Satisfied | 23 percentage of participants |
| Ocufilcon D | Lens Satisfaction, Handling - Filcon IV 1 and Ocufilcon D | Completely Dissatisfied | 0 percentage of participants |
| Ocufilcon D | Lens Satisfaction, Handling - Filcon IV 1 and Ocufilcon D | Completely Satisfied | 60 percentage of participants |
| Ocufilcon D | Lens Satisfaction, Handling - Filcon IV 1 and Ocufilcon D | Somewhat Satisfied | 38 percentage of participants |
| Ocufilcon D | Lens Satisfaction, Handling - Filcon IV 1 and Ocufilcon D | Somewhat Dissatisfied | 3 percentage of participants |
Secondary
Lens Satisfaction, Overall - Filcon IV 1 and Ocufilcon D
Lens satisfaction overall for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale 1-4, 1=completely satisfied, 4=completely dissatisfied.
Time frame: Baseline and 1 Week
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Filcon IV 1 | Lens Satisfaction, Overall - Filcon IV 1 and Ocufilcon D | Completely Satisfied | 20 percentage of participants |
| Filcon IV 1 | Lens Satisfaction, Overall - Filcon IV 1 and Ocufilcon D | Somewhat Dissatisfied | 13 percentage of participants |
| Filcon IV 1 | Lens Satisfaction, Overall - Filcon IV 1 and Ocufilcon D | Somewhat Satisfied | 68 percentage of participants |
| Filcon IV 1 | Lens Satisfaction, Overall - Filcon IV 1 and Ocufilcon D | Completely Dissatisfied | 0 percentage of participants |
| Ocufilcon D | Lens Satisfaction, Overall - Filcon IV 1 and Ocufilcon D | Somewhat Satisfied | 35 percentage of participants |
| Ocufilcon D | Lens Satisfaction, Overall - Filcon IV 1 and Ocufilcon D | Completely Satisfied | 60 percentage of participants |
| Ocufilcon D | Lens Satisfaction, Overall - Filcon IV 1 and Ocufilcon D | Completely Dissatisfied | 0 percentage of participants |
| Ocufilcon D | Lens Satisfaction, Overall - Filcon IV 1 and Ocufilcon D | Somewhat Dissatisfied | 5 percentage of participants |
Secondary
Lens Satisfaction, Vision - Filcon IV 1 and Ocufilcon D
Lens satisfaction of vision for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale 1-4, 1=completely satisfied, 4=completely dissatisfied.
Time frame: Baseline and 1 Week
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Filcon IV 1 | Lens Satisfaction, Vision - Filcon IV 1 and Ocufilcon D | Somewhat Satisfied | 65 percentage of participants |
| Filcon IV 1 | Lens Satisfaction, Vision - Filcon IV 1 and Ocufilcon D | Completely Satisfied | 23 percentage of participants |
| Filcon IV 1 | Lens Satisfaction, Vision - Filcon IV 1 and Ocufilcon D | Somewhat Dissatisfied | 13 percentage of participants |
| Filcon IV 1 | Lens Satisfaction, Vision - Filcon IV 1 and Ocufilcon D | Completely Dissatisfied | 0 percentage of participants |
| Ocufilcon D | Lens Satisfaction, Vision - Filcon IV 1 and Ocufilcon D | Completely Dissatisfied | 0 percentage of participants |
| Ocufilcon D | Lens Satisfaction, Vision - Filcon IV 1 and Ocufilcon D | Somewhat Satisfied | 38 percentage of participants |
| Ocufilcon D | Lens Satisfaction, Vision - Filcon IV 1 and Ocufilcon D | Somewhat Dissatisfied | 3 percentage of participants |
| Ocufilcon D | Lens Satisfaction, Vision - Filcon IV 1 and Ocufilcon D | Completely Satisfied | 60 percentage of participants |
Secondary
Vision Satisfaction (Subjective Ratings) - Filcon IV 1 and Ocufilcon D
Subjective ratings of vision satisfaction for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. (Scale 0-10, 0=dissatisfied, 10=very satisfied).
Time frame: Baseline and 1 Week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Filcon IV 1 | Vision Satisfaction (Subjective Ratings) - Filcon IV 1 and Ocufilcon D | 7.5 units on a scale | Standard Deviation 1.3 |
| Ocufilcon D | Vision Satisfaction (Subjective Ratings) - Filcon IV 1 and Ocufilcon D | 8.2 units on a scale | Standard Deviation 1.3 |
Secondary
Visual Acuity - Filcon IV 1 and Ocufilcon D
Visual acuity for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week using logMAR chart (a logMAR of 0.0=20/20 in Snellen notation and negative values indicate better visual acuity).
Time frame: Baseline and 1 Week
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Filcon IV 1 | Visual Acuity - Filcon IV 1 and Ocufilcon D | OD | 0 LogMAR | Standard Deviation 0 |
| Filcon IV 1 | Visual Acuity - Filcon IV 1 and Ocufilcon D | OS | 0 LogMAR | Standard Deviation 0 |
| Filcon IV 1 | Visual Acuity - Filcon IV 1 and Ocufilcon D | Binocular | -0.01 LogMAR | Standard Deviation 0.03 |
| Ocufilcon D | Visual Acuity - Filcon IV 1 and Ocufilcon D | OD | 0 LogMAR | Standard Deviation 0 |
| Ocufilcon D | Visual Acuity - Filcon IV 1 and Ocufilcon D | OS | 0 LogMAR | Standard Deviation 0 |
| Ocufilcon D | Visual Acuity - Filcon IV 1 and Ocufilcon D | Binocular | -0.01 LogMAR | Standard Deviation 0.04 |