Myopia
Conditions
Brief summary
Clinical evaluation of stenfilcon A compared with narafilcon A and delefilcon A This is a total 120 subject, randomized, open label, bilateral wear, two week crossover study (each lens for 1 week) evaluating the clinical performance of stenfilcon A spherical lenses compared to narafilcon A or delefilcon A spherical lenses.
Detailed description
The aim of this study is to evaluate the clinical performance of stenfilcon A compared with narafilcon A and delefilcon A. The study participants will be allocated to two parallel groups (Group 1 and Group 2), 60 subjects each, based on the control lenses, narafilcon A and delefilcon A spherical lenses. Study groups: Group 1: stenfilcon A vs. narafilcon A Group 2: stenfilcon A vs. delefilcon A
Interventions
Sponsors
CooperVision, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
Study participants will be allocated in to 2 parallel groups: Group 1: stenfilcon A and narafilcon A, and Group 2: stenfilcon A and delefilcon A. Each participant will be randomized to wear either lens pair in a bilateral design for 1 week, and then cross over to the alternative pair.
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
\- A person is eligible for inclusion in the study if he/she: * Is over 18 years of age (inclusive) * Has had a self-reported visual exam in the last two years * Is an adapted daily disposable non-silicone hydrogel spherical contact lens wearer * Can achieve best corrected spectacle distance visual acuity of 20/25 or better in each eye. * Can achieve a distance visual acuity of 20/30 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. * Has a CL (Contact Lens) spherical prescription between - 0.75 and - 8.00 (inclusive) * Is willing to comply with the wear schedule. * Is willing to comply with the visit schedule
Exclusion criteria
\- A person will be excluded from the study if he/she: * Is not a habitual wearer of daily disposable non-silicone hydrogel spherical contact lenses * Has a CL prescription outside the range of the inclusion power range * 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 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 * Has a known history of corneal hypoesthesia (reduced corneal sensitivity) * Has aphakia, keratoconus or a highly irregular cornea. * 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 |
|---|---|---|
| Pain and Foreign Body Sensation | 1 week | Subjective ratings of pain and foreign body sensation for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A assessed at 1 week. Grade 0-3, 0=No sensation, 1=Slightly: sometimes felt sensation without any trouble in wearing contact lenses, 2=Mild: always felt sensation without any trouble in wearing contact lenses, 3=Heavy: could not wear contact lense due to sensation |
| Itching Sensation on Removal | 1 week | Subjective ratings of itching sensation on insertion for each lens pair assessed at 1 week. Grade 0-3, 0=No sensation, 1=Slightly: sometimes felt sensation without any trouble in wearing contact lenses, 2=Mild: always felt sensation without any trouble in wearing contact lenses, 3=Heavy: could not wear contact lense due to sensation |
| Red Eye Sensation | 1 week | Subjective ratings of red eye sensation for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A assessed at 1 week. Grade 0-3, 0=No sensation, 1=Slightly: sometimes felt sensation without any trouble in wearing contact lenses, 2=Mild: always felt sensation without any trouble in wearing contact lenses, 3=Heavy: could not wear contact lense due to sensation |
| Dryness | 1 week | Subjective ratings of dryness (right after insertion, right before removal, all day long) for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A assessed at 1 week. (Scale 0-10, 0=very dry, 10=no dryness at all. |
| Comfort | 1 week | Subjective ratings of comfort (right after insertion, right before removal, all day long) for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A assessed at 1 week. (Scale 0-10, 0=very poor comfort, 10=very good comfort). |
| Vision | 1 week | Subjective ratings of vision (right after insertion, right before removal, all day long) for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A assessed at 1 week. (Scale 0-10, 0=very poor vision, 10=very good vision). |
| Handling | 1 week | Subjective ratings of handling (lens insertion and lens removal) for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A assessed at 1 week. (Scale 0-10, 0=very poor handling, 10=very good handling. |
| Lens Preference - Stenfilcon A/Narafilcon A (Group 1) | 1 week | Subjective ratings of lens preference for stenfilcon A/narafilcon A assessed at 1 week. (5 possible ratings: Prefer stenfilcon A, Little Prefer stenfilcon A, No preference, little prefer narafilcon A, prefer narafilcon A). |
| Lens Preference - Stenfilcon A/Delefilcon A (Group 2) | 1 week | Subjective ratings of lens preference for stenfilcon A/narafilcon A assessed at 1 week. (5 possible ratings: Prefer stenfilcon A, Little Prefer stenfilcon A, No preference, little prefer delefilcon A, prefer delefilcon A). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Corneal Oedema | 1 week | Corneal oedema for for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A is assessed at 1 week. (Grading scale 0-4, 0.5 steps 0=Normal, 1=Trace 2=MIld, 3=Moderate 4=Severe) |
| Lens Fit - Horizontal Centration | Baseline | Lens fit evaluation of horizontal centration for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A assessed at baseline. (Temporal, Little temporal, Centered, Little nasal, Nasal) |
| Papillary Conjunctivitis | 1 week | Papillary conjunctivitis for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A is assessed at 1 week. (Grading scale 0-4, 0.5 steps 0=Normal, 1=Trace 2=MIld, 3=Moderate 4=Severe) |
| Lens Fit - Vertical Centration | Baseline | Lens fit evaluation of vertical centration for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A is assessed at baseline. (Upper, Little upper, Centered, Little lower, Lower) |
| Lens Fit - Post-blink Movement | Baseline | Lens fit evaluation of post-blink movement for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A is assessed at baseline. (Tight, Little tight, Optimal, Little loose, Loose) |
| Lens Fit Overall | Baseline | Lens fit evaluation overall for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A is assessed at baseline. (Optimum, Good, Acceptable, Not acceptable (cannot wear)) |
| Corneal Staining | 1 week | Corneal staining for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A is assessed at 1 week. (Grading scale 0-4, 0.5 steps 0=Normal, 1=Trace 2=MIld, 3=Moderate 4=Severe) |
| Limbal Redness | 1 week | Limbal redness for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A is assessed at 1 week. (Grading scale 0-4, 0.5 steps 0=Normal, 1=Trace 2=MIld, 3=Moderate 4=Severe) |
| Conjunctival Redness | 1 week | Conjunctival redness for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A is assessed at 1 week. (Grading scale 0-4, 0.5 steps 0=Normal, 1=Trace 2=MIld, 3=Moderate 4=Severe) |
| Corneal Neovascularization | 1 week | Corneal neovascularization for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A is assessed at 1 week. (Grading scale 0-4, 0.5 steps 0=Normal, 1=Trace 2=MIld, 3=Moderate 4=Severe) |
| Conjunctival Staining | 1 week | Conjunctival staining for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A is assessed at 1 week. (Grading scale 0-4, 0.5 steps 0=Normal, 1=Trace 2=MIld, 3=Moderate 4=Severe) |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Overall Characteristics - Group 1:Stenfilcon A & Narafilcon A Participants are randomized to wear either stenfilcon A lens pair or narafilcon A lens pair, bilaterally, for 1 week during the cross over study.
stenfilcon A: contact lens
narafilcon A: contact lens | 55 |
| Overall Characteristics - Group 2: Stenfilcon A & Delefilcon A Participants are randomized to wear either stenfilcon A lens pair or delefilcon A lens pair, bilaterally, for 1 week during the cross over study.
stenfilcon A: contact lens
delefilcon A: contact lens | 51 |
| Total | 106 |
Baseline characteristics
| Characteristic | Overall Characteristics - Group 1:Stenfilcon A & Narafilcon A | Overall Characteristics - Group 2: Stenfilcon A & Delefilcon A | Total |
|---|---|---|---|
| Age, Continuous | 34 years STANDARD_DEVIATION 11 | 33 years STANDARD_DEVIATION 11 | 34 years STANDARD_DEVIATION 11 |
| Region of Enrollment Japan | 55 participants | 51 participants | 106 participants |
| Sex: Female, Male Female | 47 Participants | 41 Participants | 88 Participants |
| Sex: Female, Male Male | 8 Participants | 10 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 55 | 0 / 55 | 0 / 51 | 0 / 51 |
| serious Total, serious adverse events | 0 / 55 | 0 / 55 | 0 / 51 | 0 / 51 |
Outcome results
Primary
Comfort
Subjective ratings of comfort (right after insertion, right before removal, all day long) for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A assessed at 1 week. (Scale 0-10, 0=very poor comfort, 10=very good comfort).
Time frame: 1 week
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stenfilcon A (Group 1) | Comfort | Right before removal | 8.00 units on a scale | Standard Deviation 1.85 |
| Stenfilcon A (Group 1) | Comfort | Right after insertion | 9.22 units on a scale | Standard Deviation 1.43 |
| Stenfilcon A (Group 1) | Comfort | All day long | 8.49 units on a scale | Standard Deviation 1.72 |
| Narafilcon A (Group 1) | Comfort | Right after insertion | 9.16 units on a scale | Standard Deviation 1.52 |
| Narafilcon A (Group 1) | Comfort | Right before removal | 8.17 units on a scale | Standard Deviation 2 |
| Narafilcon A (Group 1) | Comfort | All day long | 8.52 units on a scale | Standard Deviation 1.76 |
| Stenfilcon A (Group 2) | Comfort | Right after insertion | 9.67 units on a scale | Standard Deviation 0.63 |
| Stenfilcon A (Group 2) | Comfort | All day long | 8.86 units on a scale | Standard Deviation 1.48 |
| Stenfilcon A (Group 2) | Comfort | Right before removal | 8.43 units on a scale | Standard Deviation 2.02 |
| Delefilcon A (Group 2) | Comfort | Right before removal | 8.29 units on a scale | Standard Deviation 1.94 |
| Delefilcon A (Group 2) | Comfort | Right after insertion | 9.69 units on a scale | Standard Deviation 0.62 |
| Delefilcon A (Group 2) | Comfort | All day long | 8.67 units on a scale | Standard Deviation 1.67 |
Primary
Dryness
Subjective ratings of dryness (right after insertion, right before removal, all day long) for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A assessed at 1 week. (Scale 0-10, 0=very dry, 10=no dryness at all.
Time frame: 1 week
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stenfilcon A (Group 1) | Dryness | Right before removal | 7.37 units on a scale | Standard Deviation 2.21 |
| Stenfilcon A (Group 1) | Dryness | All day long | 8.08 units on a scale | Standard Deviation 1.89 |
| Stenfilcon A (Group 1) | Dryness | Right after insertion | 9.56 units on a scale | Standard Deviation 1.14 |
| Narafilcon A (Group 1) | Dryness | Right after insertion | 9.40 units on a scale | Standard Deviation 1.36 |
| Narafilcon A (Group 1) | Dryness | All day long | 8.36 units on a scale | Standard Deviation 1.74 |
| Narafilcon A (Group 1) | Dryness | Right before removal | 7.70 units on a scale | Standard Deviation 2.1 |
| Stenfilcon A (Group 2) | Dryness | Right before removal | 7.61 units on a scale | Standard Deviation 2.02 |
| Stenfilcon A (Group 2) | Dryness | All day long | 8.27 units on a scale | Standard Deviation 1.66 |
| Stenfilcon A (Group 2) | Dryness | Right after insertion | 9.84 units on a scale | Standard Deviation 0.5 |
| Delefilcon A (Group 2) | Dryness | Right after insertion | 9.76 units on a scale | Standard Deviation 0.9 |
| Delefilcon A (Group 2) | Dryness | All day long | 8.40 units on a scale | Standard Deviation 1.92 |
| Delefilcon A (Group 2) | Dryness | Right before removal | 7.71 units on a scale | Standard Deviation 2.45 |
Primary
Handling
Subjective ratings of handling (lens insertion and lens removal) for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A assessed at 1 week. (Scale 0-10, 0=very poor handling, 10=very good handling.
Time frame: 1 week
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stenfilcon A (Group 1) | Handling | Lens insertion | 9.07 units on a scale | Standard Deviation 1.54 |
| Stenfilcon A (Group 1) | Handling | Lens removal | 8.63 units on a scale | Standard Deviation 1.72 |
| Narafilcon A (Group 1) | Handling | Lens removal | 9.32 units on a scale | Standard Deviation 1.25 |
| Narafilcon A (Group 1) | Handling | Lens insertion | 9.64 units on a scale | Standard Deviation 0.92 |
| Stenfilcon A (Group 2) | Handling | Lens insertion | 9.27 units on a scale | Standard Deviation 1.5 |
| Stenfilcon A (Group 2) | Handling | Lens removal | 8.88 units on a scale | Standard Deviation 1.75 |
| Delefilcon A (Group 2) | Handling | Lens insertion | 9.33 units on a scale | Standard Deviation 1.33 |
| Delefilcon A (Group 2) | Handling | Lens removal | 7.63 units on a scale | Standard Deviation 2.62 |
Primary
Itching Sensation on Removal
Subjective ratings of itching sensation on insertion for each lens pair assessed at 1 week. Grade 0-3, 0=No sensation, 1=Slightly: sometimes felt sensation without any trouble in wearing contact lenses, 2=Mild: always felt sensation without any trouble in wearing contact lenses, 3=Heavy: could not wear contact lense due to sensation
Time frame: 1 week
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stenfilcon A (Group 1) | Itching Sensation on Removal | No sensation | 98 Eyes |
| Stenfilcon A (Group 1) | Itching Sensation on Removal | Slight sensation | 9 Eyes |
| Stenfilcon A (Group 1) | Itching Sensation on Removal | Mild sensation | 3 Eyes |
| Stenfilcon A (Group 1) | Itching Sensation on Removal | Heavy sensation | 0 Eyes |
| Narafilcon A (Group 1) | Itching Sensation on Removal | Slight sensation | 8 Eyes |
| Narafilcon A (Group 1) | Itching Sensation on Removal | Mild sensation | 0 Eyes |
| Narafilcon A (Group 1) | Itching Sensation on Removal | Heavy sensation | 0 Eyes |
| Narafilcon A (Group 1) | Itching Sensation on Removal | No sensation | 102 Eyes |
| Stenfilcon A (Group 2) | Itching Sensation on Removal | Mild sensation | 0 Eyes |
| Stenfilcon A (Group 2) | Itching Sensation on Removal | Slight sensation | 10 Eyes |
| Stenfilcon A (Group 2) | Itching Sensation on Removal | Heavy sensation | 0 Eyes |
| Stenfilcon A (Group 2) | Itching Sensation on Removal | No sensation | 92 Eyes |
| Delefilcon A (Group 2) | Itching Sensation on Removal | Heavy sensation | 2 Eyes |
| Delefilcon A (Group 2) | Itching Sensation on Removal | Slight sensation | 10 Eyes |
| Delefilcon A (Group 2) | Itching Sensation on Removal | No sensation | 90 Eyes |
| Delefilcon A (Group 2) | Itching Sensation on Removal | Mild sensation | 0 Eyes |
Primary
Lens Preference - Stenfilcon A/Delefilcon A (Group 2)
Subjective ratings of lens preference for stenfilcon A/narafilcon A assessed at 1 week. (5 possible ratings: Prefer stenfilcon A, Little Prefer stenfilcon A, No preference, little prefer delefilcon A, prefer delefilcon A).
Time frame: 1 week
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Stenfilcon A (Group 1) | Lens Preference - Stenfilcon A/Delefilcon A (Group 2) | 14 Participants |
| Narafilcon A (Group 1) | Lens Preference - Stenfilcon A/Delefilcon A (Group 2) | 8 Participants |
| Stenfilcon A (Group 2) | Lens Preference - Stenfilcon A/Delefilcon A (Group 2) | 3 Participants |
| Delefilcon A (Group 2) | Lens Preference - Stenfilcon A/Delefilcon A (Group 2) | 9 Participants |
| Prefer Narafilcon A | Lens Preference - Stenfilcon A/Delefilcon A (Group 2) | 17 Participants |
Primary
Lens Preference - Stenfilcon A/Narafilcon A (Group 1)
Subjective ratings of lens preference for stenfilcon A/narafilcon A assessed at 1 week. (5 possible ratings: Prefer stenfilcon A, Little Prefer stenfilcon A, No preference, little prefer narafilcon A, prefer narafilcon A).
Time frame: 1 week
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Stenfilcon A (Group 1) | Lens Preference - Stenfilcon A/Narafilcon A (Group 1) | 15 Participants |
| Narafilcon A (Group 1) | Lens Preference - Stenfilcon A/Narafilcon A (Group 1) | 12 Participants |
| Stenfilcon A (Group 2) | Lens Preference - Stenfilcon A/Narafilcon A (Group 1) | 5 Participants |
| Delefilcon A (Group 2) | Lens Preference - Stenfilcon A/Narafilcon A (Group 1) | 10 Participants |
| Prefer Narafilcon A | Lens Preference - Stenfilcon A/Narafilcon A (Group 1) | 13 Participants |
Primary
Pain and Foreign Body Sensation
Subjective ratings of pain and foreign body sensation for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A assessed at 1 week. Grade 0-3, 0=No sensation, 1=Slightly: sometimes felt sensation without any trouble in wearing contact lenses, 2=Mild: always felt sensation without any trouble in wearing contact lenses, 3=Heavy: could not wear contact lense due to sensation
Time frame: 1 week
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stenfilcon A (Group 1) | Pain and Foreign Body Sensation | No sensation | 89 eyes |
| Stenfilcon A (Group 1) | Pain and Foreign Body Sensation | Mild sensation | 0 eyes |
| Stenfilcon A (Group 1) | Pain and Foreign Body Sensation | Slight sensation | 21 eyes |
| Stenfilcon A (Group 1) | Pain and Foreign Body Sensation | Heavy sensation | 0 eyes |
| Narafilcon A (Group 1) | Pain and Foreign Body Sensation | Mild sensation | 3 eyes |
| Narafilcon A (Group 1) | Pain and Foreign Body Sensation | Heavy sensation | 0 eyes |
| Narafilcon A (Group 1) | Pain and Foreign Body Sensation | Slight sensation | 28 eyes |
| Narafilcon A (Group 1) | Pain and Foreign Body Sensation | No sensation | 79 eyes |
| Stenfilcon A (Group 2) | Pain and Foreign Body Sensation | Slight sensation | 19 eyes |
| Stenfilcon A (Group 2) | Pain and Foreign Body Sensation | Mild sensation | 0 eyes |
| Stenfilcon A (Group 2) | Pain and Foreign Body Sensation | No sensation | 83 eyes |
| Stenfilcon A (Group 2) | Pain and Foreign Body Sensation | Heavy sensation | 0 eyes |
| Delefilcon A (Group 2) | Pain and Foreign Body Sensation | Heavy sensation | 0 eyes |
| Delefilcon A (Group 2) | Pain and Foreign Body Sensation | No sensation | 87 eyes |
| Delefilcon A (Group 2) | Pain and Foreign Body Sensation | Mild sensation | 2 eyes |
| Delefilcon A (Group 2) | Pain and Foreign Body Sensation | Slight sensation | 13 eyes |
Primary
Red Eye Sensation
Subjective ratings of red eye sensation for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A assessed at 1 week. Grade 0-3, 0=No sensation, 1=Slightly: sometimes felt sensation without any trouble in wearing contact lenses, 2=Mild: always felt sensation without any trouble in wearing contact lenses, 3=Heavy: could not wear contact lense due to sensation
Time frame: 1 week
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stenfilcon A (Group 1) | Red Eye Sensation | No sensation | 98 Eyes |
| Stenfilcon A (Group 1) | Red Eye Sensation | Slight sensation | 12 Eyes |
| Stenfilcon A (Group 1) | Red Eye Sensation | Mild sensation | 0 Eyes |
| Stenfilcon A (Group 1) | Red Eye Sensation | Heavy sensation | 0 Eyes |
| Narafilcon A (Group 1) | Red Eye Sensation | Slight sensation | 10 Eyes |
| Narafilcon A (Group 1) | Red Eye Sensation | Mild sensation | 2 Eyes |
| Narafilcon A (Group 1) | Red Eye Sensation | Heavy sensation | 0 Eyes |
| Narafilcon A (Group 1) | Red Eye Sensation | No sensation | 98 Eyes |
| Stenfilcon A (Group 2) | Red Eye Sensation | Mild sensation | 2 Eyes |
| Stenfilcon A (Group 2) | Red Eye Sensation | Slight sensation | 8 Eyes |
| Stenfilcon A (Group 2) | Red Eye Sensation | Heavy sensation | 0 Eyes |
| Stenfilcon A (Group 2) | Red Eye Sensation | No sensation | 92 Eyes |
| Delefilcon A (Group 2) | Red Eye Sensation | Heavy sensation | 0 Eyes |
| Delefilcon A (Group 2) | Red Eye Sensation | Slight sensation | 15 Eyes |
| Delefilcon A (Group 2) | Red Eye Sensation | No sensation | 87 Eyes |
| Delefilcon A (Group 2) | Red Eye Sensation | Mild sensation | 0 Eyes |
Primary
Vision
Subjective ratings of vision (right after insertion, right before removal, all day long) for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A assessed at 1 week. (Scale 0-10, 0=very poor vision, 10=very good vision).
Time frame: 1 week
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stenfilcon A (Group 1) | Vision | Right after insertion | 9.29 units on a scale | Standard Deviation 1.55 |
| Stenfilcon A (Group 1) | Vision | All day long | 8.80 units on a scale | Standard Deviation 1.59 |
| Stenfilcon A (Group 1) | Vision | Right before removal | 8.46 units on a scale | Standard Deviation 1.76 |
| Narafilcon A (Group 1) | Vision | Right after insertion | 9.32 units on a scale | Standard Deviation 1.4 |
| Narafilcon A (Group 1) | Vision | All day long | 8.81 units on a scale | Standard Deviation 1.76 |
| Narafilcon A (Group 1) | Vision | Right before removal | 8.52 units on a scale | Standard Deviation 2.08 |
| Stenfilcon A (Group 2) | Vision | Right before removal | 8.87 units on a scale | Standard Deviation 1.18 |
| Stenfilcon A (Group 2) | Vision | Right after insertion | 9.66 units on a scale | Standard Deviation 0.81 |
| Stenfilcon A (Group 2) | Vision | All day long | 9.13 units on a scale | Standard Deviation 0.94 |
| Delefilcon A (Group 2) | Vision | Right after insertion | 9.57 units on a scale | Standard Deviation 0.9 |
| Delefilcon A (Group 2) | Vision | All day long | 9.02 units on a scale | Standard Deviation 1.35 |
| Delefilcon A (Group 2) | Vision | Right before removal | 8.83 units on a scale | Standard Deviation 1.61 |
Secondary
Conjunctival Redness
Conjunctival redness for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A is assessed at 1 week. (Grading scale 0-4, 0.5 steps 0=Normal, 1=Trace 2=MIld, 3=Moderate 4=Severe)
Time frame: 1 week
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stenfilcon A (Group 1) | Conjunctival Redness | Moderate | 0 Eyes |
| Stenfilcon A (Group 1) | Conjunctival Redness | Trace | 6 Eyes |
| Stenfilcon A (Group 1) | Conjunctival Redness | Severe | 0 Eyes |
| Stenfilcon A (Group 1) | Conjunctival Redness | Mild | 0 Eyes |
| Stenfilcon A (Group 1) | Conjunctival Redness | Normal | 104 Eyes |
| Narafilcon A (Group 1) | Conjunctival Redness | Mild | 0 Eyes |
| Narafilcon A (Group 1) | Conjunctival Redness | Moderate | 0 Eyes |
| Narafilcon A (Group 1) | Conjunctival Redness | Severe | 0 Eyes |
| Narafilcon A (Group 1) | Conjunctival Redness | Trace | 11 Eyes |
| Narafilcon A (Group 1) | Conjunctival Redness | Normal | 99 Eyes |
| Stenfilcon A (Group 2) | Conjunctival Redness | Mild | 0 Eyes |
| Stenfilcon A (Group 2) | Conjunctival Redness | Normal | 100 Eyes |
| Stenfilcon A (Group 2) | Conjunctival Redness | Trace | 2 Eyes |
| Stenfilcon A (Group 2) | Conjunctival Redness | Moderate | 0 Eyes |
| Stenfilcon A (Group 2) | Conjunctival Redness | Severe | 0 Eyes |
| Delefilcon A (Group 2) | Conjunctival Redness | Moderate | 0 Eyes |
| Delefilcon A (Group 2) | Conjunctival Redness | Trace | 2 Eyes |
| Delefilcon A (Group 2) | Conjunctival Redness | Normal | 100 Eyes |
| Delefilcon A (Group 2) | Conjunctival Redness | Mild | 0 Eyes |
| Delefilcon A (Group 2) | Conjunctival Redness | Severe | 0 Eyes |
Secondary
Conjunctival Staining
Conjunctival staining for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A is assessed at 1 week. (Grading scale 0-4, 0.5 steps 0=Normal, 1=Trace 2=MIld, 3=Moderate 4=Severe)
Time frame: 1 week
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stenfilcon A (Group 1) | Conjunctival Staining | Moderate | 0 Eyes |
| Stenfilcon A (Group 1) | Conjunctival Staining | Trace | 28 Eyes |
| Stenfilcon A (Group 1) | Conjunctival Staining | Severe | 0 Eyes |
| Stenfilcon A (Group 1) | Conjunctival Staining | Mild | 7 Eyes |
| Stenfilcon A (Group 1) | Conjunctival Staining | Normal | 75 Eyes |
| Narafilcon A (Group 1) | Conjunctival Staining | Mild | 14 Eyes |
| Narafilcon A (Group 1) | Conjunctival Staining | Moderate | 0 Eyes |
| Narafilcon A (Group 1) | Conjunctival Staining | Severe | 0 Eyes |
| Narafilcon A (Group 1) | Conjunctival Staining | Trace | 29 Eyes |
| Narafilcon A (Group 1) | Conjunctival Staining | Normal | 67 Eyes |
| Stenfilcon A (Group 2) | Conjunctival Staining | Mild | 4 Eyes |
| Stenfilcon A (Group 2) | Conjunctival Staining | Normal | 76 Eyes |
| Stenfilcon A (Group 2) | Conjunctival Staining | Trace | 22 Eyes |
| Stenfilcon A (Group 2) | Conjunctival Staining | Moderate | 0 Eyes |
| Stenfilcon A (Group 2) | Conjunctival Staining | Severe | 0 Eyes |
| Delefilcon A (Group 2) | Conjunctival Staining | Moderate | 0 Eyes |
| Delefilcon A (Group 2) | Conjunctival Staining | Trace | 16 Eyes |
| Delefilcon A (Group 2) | Conjunctival Staining | Normal | 80 Eyes |
| Delefilcon A (Group 2) | Conjunctival Staining | Mild | 6 Eyes |
| Delefilcon A (Group 2) | Conjunctival Staining | Severe | 0 Eyes |
Secondary
Corneal Neovascularization
Corneal neovascularization for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A is assessed at 1 week. (Grading scale 0-4, 0.5 steps 0=Normal, 1=Trace 2=MIld, 3=Moderate 4=Severe)
Time frame: 1 week
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stenfilcon A (Group 1) | Corneal Neovascularization | Moderate | 0 Eyes |
| Stenfilcon A (Group 1) | Corneal Neovascularization | Trace | 2 Eyes |
| Stenfilcon A (Group 1) | Corneal Neovascularization | Severe | 0 Eyes |
| Stenfilcon A (Group 1) | Corneal Neovascularization | Mild | 0 Eyes |
| Stenfilcon A (Group 1) | Corneal Neovascularization | Normal | 108 Eyes |
| Narafilcon A (Group 1) | Corneal Neovascularization | Mild | 0 Eyes |
| Narafilcon A (Group 1) | Corneal Neovascularization | Moderate | 0 Eyes |
| Narafilcon A (Group 1) | Corneal Neovascularization | Severe | 0 Eyes |
| Narafilcon A (Group 1) | Corneal Neovascularization | Trace | 2 Eyes |
| Narafilcon A (Group 1) | Corneal Neovascularization | Normal | 108 Eyes |
| Stenfilcon A (Group 2) | Corneal Neovascularization | Mild | 0 Eyes |
| Stenfilcon A (Group 2) | Corneal Neovascularization | Normal | 102 Eyes |
| Stenfilcon A (Group 2) | Corneal Neovascularization | Trace | 0 Eyes |
| Stenfilcon A (Group 2) | Corneal Neovascularization | Moderate | 0 Eyes |
| Stenfilcon A (Group 2) | Corneal Neovascularization | Severe | 0 Eyes |
| Delefilcon A (Group 2) | Corneal Neovascularization | Moderate | 0 Eyes |
| Delefilcon A (Group 2) | Corneal Neovascularization | Trace | 0 Eyes |
| Delefilcon A (Group 2) | Corneal Neovascularization | Normal | 102 Eyes |
| Delefilcon A (Group 2) | Corneal Neovascularization | Mild | 0 Eyes |
| Delefilcon A (Group 2) | Corneal Neovascularization | Severe | 0 Eyes |
Secondary
Corneal Oedema
Corneal oedema for for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A is assessed at 1 week. (Grading scale 0-4, 0.5 steps 0=Normal, 1=Trace 2=MIld, 3=Moderate 4=Severe)
Time frame: 1 week
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stenfilcon A (Group 1) | Corneal Oedema | Moderate | 0 Eyes |
| Stenfilcon A (Group 1) | Corneal Oedema | Trace | 0 Eyes |
| Stenfilcon A (Group 1) | Corneal Oedema | Severe | 0 Eyes |
| Stenfilcon A (Group 1) | Corneal Oedema | Mild | 0 Eyes |
| Stenfilcon A (Group 1) | Corneal Oedema | Normal | 110 Eyes |
| Narafilcon A (Group 1) | Corneal Oedema | Mild | 0 Eyes |
| Narafilcon A (Group 1) | Corneal Oedema | Moderate | 0 Eyes |
| Narafilcon A (Group 1) | Corneal Oedema | Severe | 0 Eyes |
| Narafilcon A (Group 1) | Corneal Oedema | Trace | 0 Eyes |
| Narafilcon A (Group 1) | Corneal Oedema | Normal | 110 Eyes |
| Stenfilcon A (Group 2) | Corneal Oedema | Mild | 0 Eyes |
| Stenfilcon A (Group 2) | Corneal Oedema | Normal | 102 Eyes |
| Stenfilcon A (Group 2) | Corneal Oedema | Trace | 0 Eyes |
| Stenfilcon A (Group 2) | Corneal Oedema | Moderate | 0 Eyes |
| Stenfilcon A (Group 2) | Corneal Oedema | Severe | 0 Eyes |
| Delefilcon A (Group 2) | Corneal Oedema | Moderate | 0 Eyes |
| Delefilcon A (Group 2) | Corneal Oedema | Trace | 0 Eyes |
| Delefilcon A (Group 2) | Corneal Oedema | Normal | 102 Eyes |
| Delefilcon A (Group 2) | Corneal Oedema | Mild | 0 Eyes |
| Delefilcon A (Group 2) | Corneal Oedema | Severe | 0 Eyes |
Secondary
Corneal Staining
Corneal staining for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A is assessed at 1 week. (Grading scale 0-4, 0.5 steps 0=Normal, 1=Trace 2=MIld, 3=Moderate 4=Severe)
Time frame: 1 week
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stenfilcon A (Group 1) | Corneal Staining | Severe | 0 Eyes |
| Stenfilcon A (Group 1) | Corneal Staining | Normal | 83 Eyes |
| Stenfilcon A (Group 1) | Corneal Staining | Trace | 25 Eyes |
| Stenfilcon A (Group 1) | Corneal Staining | Mild | 2 Eyes |
| Stenfilcon A (Group 1) | Corneal Staining | Moderate | 0 Eyes |
| Narafilcon A (Group 1) | Corneal Staining | Trace | 39 Eyes |
| Narafilcon A (Group 1) | Corneal Staining | Mild | 2 Eyes |
| Narafilcon A (Group 1) | Corneal Staining | Normal | 69 Eyes |
| Narafilcon A (Group 1) | Corneal Staining | Moderate | 0 Eyes |
| Narafilcon A (Group 1) | Corneal Staining | Severe | 0 Eyes |
| Stenfilcon A (Group 2) | Corneal Staining | Normal | 71 Eyes |
| Stenfilcon A (Group 2) | Corneal Staining | Trace | 31 Eyes |
| Stenfilcon A (Group 2) | Corneal Staining | Severe | 0 Eyes |
| Stenfilcon A (Group 2) | Corneal Staining | Mild | 0 Eyes |
| Stenfilcon A (Group 2) | Corneal Staining | Moderate | 0 Eyes |
| Delefilcon A (Group 2) | Corneal Staining | Mild | 3 Eyes |
| Delefilcon A (Group 2) | Corneal Staining | Trace | 29 Eyes |
| Delefilcon A (Group 2) | Corneal Staining | Normal | 70 Eyes |
| Delefilcon A (Group 2) | Corneal Staining | Moderate | 0 Eyes |
| Delefilcon A (Group 2) | Corneal Staining | Severe | 0 Eyes |
Secondary
Lens Fit - Horizontal Centration
Lens fit evaluation of horizontal centration for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A assessed at 1 week. (Temporal, Little temporal, Centered, Little nasal, Nasal)
Time frame: 1 week
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stenfilcon A (Group 1) | Lens Fit - Horizontal Centration | Little Nasal | 0 Eyes |
| Stenfilcon A (Group 1) | Lens Fit - Horizontal Centration | Little Temporal | 0 Eyes |
| Stenfilcon A (Group 1) | Lens Fit - Horizontal Centration | Nasal | 0 Eyes |
| Stenfilcon A (Group 1) | Lens Fit - Horizontal Centration | Central | 110 Eyes |
| Stenfilcon A (Group 1) | Lens Fit - Horizontal Centration | Temporal | 0 Eyes |
| Narafilcon A (Group 1) | Lens Fit - Horizontal Centration | Central | 102 Eyes |
| Narafilcon A (Group 1) | Lens Fit - Horizontal Centration | Little Nasal | 0 Eyes |
| Narafilcon A (Group 1) | Lens Fit - Horizontal Centration | Nasal | 0 Eyes |
| Narafilcon A (Group 1) | Lens Fit - Horizontal Centration | Little Temporal | 8 Eyes |
| Narafilcon A (Group 1) | Lens Fit - Horizontal Centration | Temporal | 0 Eyes |
| Stenfilcon A (Group 2) | Lens Fit - Horizontal Centration | Central | 102 Eyes |
| Stenfilcon A (Group 2) | Lens Fit - Horizontal Centration | Temporal | 0 Eyes |
| Stenfilcon A (Group 2) | Lens Fit - Horizontal Centration | Little Temporal | 0 Eyes |
| Stenfilcon A (Group 2) | Lens Fit - Horizontal Centration | Little Nasal | 0 Eyes |
| Stenfilcon A (Group 2) | Lens Fit - Horizontal Centration | Nasal | 0 Eyes |
| Delefilcon A (Group 2) | Lens Fit - Horizontal Centration | Little Nasal | 1 Eyes |
| Delefilcon A (Group 2) | Lens Fit - Horizontal Centration | Little Temporal | 1 Eyes |
| Delefilcon A (Group 2) | Lens Fit - Horizontal Centration | Temporal | 0 Eyes |
| Delefilcon A (Group 2) | Lens Fit - Horizontal Centration | Central | 100 Eyes |
| Delefilcon A (Group 2) | Lens Fit - Horizontal Centration | Nasal | 0 Eyes |
Secondary
Lens Fit - Horizontal Centration
Lens fit evaluation of horizontal centration for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A assessed at baseline. (Temporal, Little temporal, Centered, Little nasal, Nasal)
Time frame: Baseline
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stenfilcon A (Group 1) | Lens Fit - Horizontal Centration | Little Nasal | 0 Eyes |
| Stenfilcon A (Group 1) | Lens Fit - Horizontal Centration | Little Temporal | 1 Eyes |
| Stenfilcon A (Group 1) | Lens Fit - Horizontal Centration | Nasal | 0 Eyes |
| Stenfilcon A (Group 1) | Lens Fit - Horizontal Centration | Central | 109 Eyes |
| Stenfilcon A (Group 1) | Lens Fit - Horizontal Centration | Temporal | 0 Eyes |
| Narafilcon A (Group 1) | Lens Fit - Horizontal Centration | Central | 104 Eyes |
| Narafilcon A (Group 1) | Lens Fit - Horizontal Centration | Little Nasal | 0 Eyes |
| Narafilcon A (Group 1) | Lens Fit - Horizontal Centration | Nasal | 0 Eyes |
| Narafilcon A (Group 1) | Lens Fit - Horizontal Centration | Little Temporal | 6 Eyes |
| Narafilcon A (Group 1) | Lens Fit - Horizontal Centration | Temporal | 0 Eyes |
| Stenfilcon A (Group 2) | Lens Fit - Horizontal Centration | Central | 102 Eyes |
| Stenfilcon A (Group 2) | Lens Fit - Horizontal Centration | Temporal | 0 Eyes |
| Stenfilcon A (Group 2) | Lens Fit - Horizontal Centration | Little Temporal | 0 Eyes |
| Stenfilcon A (Group 2) | Lens Fit - Horizontal Centration | Little Nasal | 0 Eyes |
| Stenfilcon A (Group 2) | Lens Fit - Horizontal Centration | Nasal | 0 Eyes |
| Delefilcon A (Group 2) | Lens Fit - Horizontal Centration | Little Nasal | 0 Eyes |
| Delefilcon A (Group 2) | Lens Fit - Horizontal Centration | Little Temporal | 2 Eyes |
| Delefilcon A (Group 2) | Lens Fit - Horizontal Centration | Temporal | 0 Eyes |
| Delefilcon A (Group 2) | Lens Fit - Horizontal Centration | Central | 100 Eyes |
| Delefilcon A (Group 2) | Lens Fit - Horizontal Centration | Nasal | 0 Eyes |
Secondary
Lens Fit Overall
Lens fit evaluation overall for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A is assessed at baseline. (Optimum, Good, Acceptable, Not acceptable (cannot wear))
Time frame: Baseline
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stenfilcon A (Group 1) | Lens Fit Overall | Optimum | 100 Eyes |
| Stenfilcon A (Group 1) | Lens Fit Overall | Good | 10 Eyes |
| Stenfilcon A (Group 1) | Lens Fit Overall | Acceptable | 0 Eyes |
| Stenfilcon A (Group 1) | Lens Fit Overall | Not Acceptable | 0 Eyes |
| Narafilcon A (Group 1) | Lens Fit Overall | Good | 26 Eyes |
| Narafilcon A (Group 1) | Lens Fit Overall | Acceptable | 3 Eyes |
| Narafilcon A (Group 1) | Lens Fit Overall | Not Acceptable | 0 Eyes |
| Narafilcon A (Group 1) | Lens Fit Overall | Optimum | 81 Eyes |
| Stenfilcon A (Group 2) | Lens Fit Overall | Acceptable | 2 Eyes |
| Stenfilcon A (Group 2) | Lens Fit Overall | Good | 4 Eyes |
| Stenfilcon A (Group 2) | Lens Fit Overall | Not Acceptable | 0 Eyes |
| Stenfilcon A (Group 2) | Lens Fit Overall | Optimum | 96 Eyes |
| Delefilcon A (Group 2) | Lens Fit Overall | Not Acceptable | 0 Eyes |
| Delefilcon A (Group 2) | Lens Fit Overall | Good | 12 Eyes |
| Delefilcon A (Group 2) | Lens Fit Overall | Optimum | 90 Eyes |
| Delefilcon A (Group 2) | Lens Fit Overall | Acceptable | 0 Eyes |
Secondary
Lens Fit Overall
Lens fit evaluation overall for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A is assessed at 1 week. (Optimum, Good, Acceptable, Not acceptable (cannot wear))
Time frame: 1 week
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stenfilcon A (Group 1) | Lens Fit Overall | Not Acceptable | 0 Eyes |
| Stenfilcon A (Group 1) | Lens Fit Overall | Acceptable | 0 Eyes |
| Stenfilcon A (Group 1) | Lens Fit Overall | Good | 8 Eyes |
| Stenfilcon A (Group 1) | Lens Fit Overall | Optimum | 102 Eyes |
| Narafilcon A (Group 1) | Lens Fit Overall | Optimum | 75 Eyes |
| Narafilcon A (Group 1) | Lens Fit Overall | Acceptable | 3 Eyes |
| Narafilcon A (Group 1) | Lens Fit Overall | Good | 30 Eyes |
| Narafilcon A (Group 1) | Lens Fit Overall | Not Acceptable | 2 Eyes |
| Stenfilcon A (Group 2) | Lens Fit Overall | Not Acceptable | 0 Eyes |
| Stenfilcon A (Group 2) | Lens Fit Overall | Optimum | 98 Eyes |
| Stenfilcon A (Group 2) | Lens Fit Overall | Good | 2 Eyes |
| Stenfilcon A (Group 2) | Lens Fit Overall | Acceptable | 2 Eyes |
| Delefilcon A (Group 2) | Lens Fit Overall | Not Acceptable | 0 Eyes |
| Delefilcon A (Group 2) | Lens Fit Overall | Optimum | 95 Eyes |
| Delefilcon A (Group 2) | Lens Fit Overall | Acceptable | 0 Eyes |
| Delefilcon A (Group 2) | Lens Fit Overall | Good | 7 Eyes |
Secondary
Lens Fit - Post-blink Movement
Lens fit evaluation of post-blink movement for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A is assessed at baseline. (Tight, Little tight, Optimal, Little loose, Loose)
Time frame: Baseline
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stenfilcon A (Group 1) | Lens Fit - Post-blink Movement | Little Loose | 6 Eyes |
| Stenfilcon A (Group 1) | Lens Fit - Post-blink Movement | Tight | 0 Eyes |
| Stenfilcon A (Group 1) | Lens Fit - Post-blink Movement | Loose | 0 Eyes |
| Stenfilcon A (Group 1) | Lens Fit - Post-blink Movement | Optimum | 104 Eyes |
| Stenfilcon A (Group 1) | Lens Fit - Post-blink Movement | Little Tight | 0 Eyes |
| Narafilcon A (Group 1) | Lens Fit - Post-blink Movement | Optimum | 94 Eyes |
| Narafilcon A (Group 1) | Lens Fit - Post-blink Movement | Little Loose | 10 Eyes |
| Narafilcon A (Group 1) | Lens Fit - Post-blink Movement | Little Tight | 6 Eyes |
| Narafilcon A (Group 1) | Lens Fit - Post-blink Movement | Loose | 0 Eyes |
| Narafilcon A (Group 1) | Lens Fit - Post-blink Movement | Tight | 0 Eyes |
| Stenfilcon A (Group 2) | Lens Fit - Post-blink Movement | Optimum | 96 Eyes |
| Stenfilcon A (Group 2) | Lens Fit - Post-blink Movement | Tight | 0 Eyes |
| Stenfilcon A (Group 2) | Lens Fit - Post-blink Movement | Little Tight | 2 Eyes |
| Stenfilcon A (Group 2) | Lens Fit - Post-blink Movement | Little Loose | 4 Eyes |
| Stenfilcon A (Group 2) | Lens Fit - Post-blink Movement | Loose | 0 Eyes |
| Delefilcon A (Group 2) | Lens Fit - Post-blink Movement | Little Loose | 1 Eyes |
| Delefilcon A (Group 2) | Lens Fit - Post-blink Movement | Little Tight | 4 Eyes |
| Delefilcon A (Group 2) | Lens Fit - Post-blink Movement | Tight | 0 Eyes |
| Delefilcon A (Group 2) | Lens Fit - Post-blink Movement | Optimum | 97 Eyes |
| Delefilcon A (Group 2) | Lens Fit - Post-blink Movement | Loose | 0 Eyes |
Secondary
Lens Fit - Post-blink Movement
Lens fit evaluation of post-blink movement for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A is assessed at 1 week. (Tight, Little tight, Optimal, Little loose, Loose)
Time frame: 1 week
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stenfilcon A (Group 1) | Lens Fit - Post-blink Movement | Little Loose | 3 Eyes |
| Stenfilcon A (Group 1) | Lens Fit - Post-blink Movement | Little Tight | 0 Eyes |
| Stenfilcon A (Group 1) | Lens Fit - Post-blink Movement | Loose | 0 Eyes |
| Stenfilcon A (Group 1) | Lens Fit - Post-blink Movement | Optimum | 107 Eyes |
| Stenfilcon A (Group 1) | Lens Fit - Post-blink Movement | Tight | 0 Eyes |
| Narafilcon A (Group 1) | Lens Fit - Post-blink Movement | Optimum | 92 Eyes |
| Narafilcon A (Group 1) | Lens Fit - Post-blink Movement | Little Loose | 5 Eyes |
| Narafilcon A (Group 1) | Lens Fit - Post-blink Movement | Loose | 1 Eyes |
| Narafilcon A (Group 1) | Lens Fit - Post-blink Movement | Little Tight | 10 Eyes |
| Narafilcon A (Group 1) | Lens Fit - Post-blink Movement | Tight | 2 Eyes |
| Stenfilcon A (Group 2) | Lens Fit - Post-blink Movement | Optimum | 97 Eyes |
| Stenfilcon A (Group 2) | Lens Fit - Post-blink Movement | Tight | 0 Eyes |
| Stenfilcon A (Group 2) | Lens Fit - Post-blink Movement | Little Tight | 1 Eyes |
| Stenfilcon A (Group 2) | Lens Fit - Post-blink Movement | Little Loose | 4 Eyes |
| Stenfilcon A (Group 2) | Lens Fit - Post-blink Movement | Loose | 0 Eyes |
| Delefilcon A (Group 2) | Lens Fit - Post-blink Movement | Little Loose | 0 Eyes |
| Delefilcon A (Group 2) | Lens Fit - Post-blink Movement | Little Tight | 5 Eyes |
| Delefilcon A (Group 2) | Lens Fit - Post-blink Movement | Tight | 0 Eyes |
| Delefilcon A (Group 2) | Lens Fit - Post-blink Movement | Optimum | 97 Eyes |
| Delefilcon A (Group 2) | Lens Fit - Post-blink Movement | Loose | 0 Eyes |
Secondary
Lens Fit - Vertical Centration
Lens fit evaluation of vertical centration for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A is assessed at baseline. (Upper, Little upper, Centered, Little lower, Lower)
Time frame: Baseline
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stenfilcon A (Group 1) | Lens Fit - Vertical Centration | Little Lower | 4 Eyes |
| Stenfilcon A (Group 1) | Lens Fit - Vertical Centration | Little Upper | 2 Eyes |
| Stenfilcon A (Group 1) | Lens Fit - Vertical Centration | Lower | 0 Eyes |
| Stenfilcon A (Group 1) | Lens Fit - Vertical Centration | Central | 104 Eyes |
| Stenfilcon A (Group 1) | Lens Fit - Vertical Centration | Upper | 0 Eyes |
| Narafilcon A (Group 1) | Lens Fit - Vertical Centration | Central | 86 Eyes |
| Narafilcon A (Group 1) | Lens Fit - Vertical Centration | Little Lower | 8 Eyes |
| Narafilcon A (Group 1) | Lens Fit - Vertical Centration | Lower | 0 Eyes |
| Narafilcon A (Group 1) | Lens Fit - Vertical Centration | Little Upper | 16 Eyes |
| Narafilcon A (Group 1) | Lens Fit - Vertical Centration | Upper | 0 Eyes |
| Stenfilcon A (Group 2) | Lens Fit - Vertical Centration | Central | 100 Eyes |
| Stenfilcon A (Group 2) | Lens Fit - Vertical Centration | Upper | 0 Eyes |
| Stenfilcon A (Group 2) | Lens Fit - Vertical Centration | Little Upper | 0 Eyes |
| Stenfilcon A (Group 2) | Lens Fit - Vertical Centration | Little Lower | 2 Eyes |
| Stenfilcon A (Group 2) | Lens Fit - Vertical Centration | Lower | 0 Eyes |
| Delefilcon A (Group 2) | Lens Fit - Vertical Centration | Little Lower | 2 Eyes |
| Delefilcon A (Group 2) | Lens Fit - Vertical Centration | Little Upper | 4 Eyes |
| Delefilcon A (Group 2) | Lens Fit - Vertical Centration | Upper | 0 Eyes |
| Delefilcon A (Group 2) | Lens Fit - Vertical Centration | Central | 96 Eyes |
| Delefilcon A (Group 2) | Lens Fit - Vertical Centration | Lower | 0 Eyes |
Secondary
Lens Fit - Vertical Centration
Lens fit evaluation of vertical centration for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A is assessed at 1 week. (Upper, Little upper, Centered, Little lower, Lower)
Time frame: 1 week
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stenfilcon A (Group 1) | Lens Fit - Vertical Centration | Little Lower | 3 Eyes |
| Stenfilcon A (Group 1) | Lens Fit - Vertical Centration | Little Upper | 0 Eyes |
| Stenfilcon A (Group 1) | Lens Fit - Vertical Centration | Lower | 0 Eyes |
| Stenfilcon A (Group 1) | Lens Fit - Vertical Centration | Central | 107 Eyes |
| Stenfilcon A (Group 1) | Lens Fit - Vertical Centration | Upper | 0 Eyes |
| Narafilcon A (Group 1) | Lens Fit - Vertical Centration | Central | 90 Eyes |
| Narafilcon A (Group 1) | Lens Fit - Vertical Centration | Little Lower | 13 Eyes |
| Narafilcon A (Group 1) | Lens Fit - Vertical Centration | Lower | 0 Eyes |
| Narafilcon A (Group 1) | Lens Fit - Vertical Centration | Little Upper | 7 Eyes |
| Narafilcon A (Group 1) | Lens Fit - Vertical Centration | Upper | 0 Eyes |
| Stenfilcon A (Group 2) | Lens Fit - Vertical Centration | Central | 102 Eyes |
| Stenfilcon A (Group 2) | Lens Fit - Vertical Centration | Upper | 0 Eyes |
| Stenfilcon A (Group 2) | Lens Fit - Vertical Centration | Little Upper | 0 Eyes |
| Stenfilcon A (Group 2) | Lens Fit - Vertical Centration | Little Lower | 0 Eyes |
| Stenfilcon A (Group 2) | Lens Fit - Vertical Centration | Lower | 0 Eyes |
| Delefilcon A (Group 2) | Lens Fit - Vertical Centration | Little Lower | 0 Eyes |
| Delefilcon A (Group 2) | Lens Fit - Vertical Centration | Little Upper | 4 Eyes |
| Delefilcon A (Group 2) | Lens Fit - Vertical Centration | Upper | 0 Eyes |
| Delefilcon A (Group 2) | Lens Fit - Vertical Centration | Central | 98 Eyes |
| Delefilcon A (Group 2) | Lens Fit - Vertical Centration | Lower | 0 Eyes |
Secondary
Limbal Redness
Limbal redness for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A is assessed at 1 week. (Grading scale 0-4, 0.5 steps 0=Normal, 1=Trace 2=MIld, 3=Moderate 4=Severe)
Time frame: 1 week
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stenfilcon A (Group 1) | Limbal Redness | Trace | 0 Eyes |
| Stenfilcon A (Group 1) | Limbal Redness | Normal | 110 Eyes |
| Stenfilcon A (Group 1) | Limbal Redness | Mild | 0 Eyes |
| Stenfilcon A (Group 1) | Limbal Redness | Moderate | 0 Eyes |
| Stenfilcon A (Group 1) | Limbal Redness | Severe | 0 Eyes |
| Narafilcon A (Group 1) | Limbal Redness | Mild | 0 Eyes |
| Narafilcon A (Group 1) | Limbal Redness | Normal | 106 Eyes |
| Narafilcon A (Group 1) | Limbal Redness | Trace | 4 Eyes |
| Narafilcon A (Group 1) | Limbal Redness | Moderate | 0 Eyes |
| Narafilcon A (Group 1) | Limbal Redness | Severe | 0 Eyes |
| Stenfilcon A (Group 2) | Limbal Redness | Trace | 0 Eyes |
| Stenfilcon A (Group 2) | Limbal Redness | Mild | 0 Eyes |
| Stenfilcon A (Group 2) | Limbal Redness | Normal | 102 Eyes |
| Stenfilcon A (Group 2) | Limbal Redness | Severe | 0 Eyes |
| Stenfilcon A (Group 2) | Limbal Redness | Moderate | 0 Eyes |
| Delefilcon A (Group 2) | Limbal Redness | Normal | 99 Eyes |
| Delefilcon A (Group 2) | Limbal Redness | Moderate | 0 Eyes |
| Delefilcon A (Group 2) | Limbal Redness | Mild | 0 Eyes |
| Delefilcon A (Group 2) | Limbal Redness | Severe | 0 Eyes |
| Delefilcon A (Group 2) | Limbal Redness | Trace | 3 Eyes |
Secondary
Papillary Conjunctivitis
Papillary conjunctivitis for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A is assessed at 1 week. (Grading scale 0-4, 0.5 steps 0=Normal, 1=Trace 2=MIld, 3=Moderate 4=Severe)
Time frame: 1 week
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stenfilcon A (Group 1) | Papillary Conjunctivitis | Moderate | 0 Eyes |
| Stenfilcon A (Group 1) | Papillary Conjunctivitis | Trace | 0 Eyes |
| Stenfilcon A (Group 1) | Papillary Conjunctivitis | Severe | 0 Eyes |
| Stenfilcon A (Group 1) | Papillary Conjunctivitis | Mild | 0 Eyes |
| Stenfilcon A (Group 1) | Papillary Conjunctivitis | Normal | 110 Eyes |
| Narafilcon A (Group 1) | Papillary Conjunctivitis | Mild | 0 Eyes |
| Narafilcon A (Group 1) | Papillary Conjunctivitis | Moderate | 0 Eyes |
| Narafilcon A (Group 1) | Papillary Conjunctivitis | Severe | 0 Eyes |
| Narafilcon A (Group 1) | Papillary Conjunctivitis | Trace | 0 Eyes |
| Narafilcon A (Group 1) | Papillary Conjunctivitis | Normal | 110 Eyes |
| Stenfilcon A (Group 2) | Papillary Conjunctivitis | Mild | 0 Eyes |
| Stenfilcon A (Group 2) | Papillary Conjunctivitis | Normal | 102 Eyes |
| Stenfilcon A (Group 2) | Papillary Conjunctivitis | Trace | 0 Eyes |
| Stenfilcon A (Group 2) | Papillary Conjunctivitis | Moderate | 0 Eyes |
| Stenfilcon A (Group 2) | Papillary Conjunctivitis | Severe | 0 Eyes |
| Delefilcon A (Group 2) | Papillary Conjunctivitis | Moderate | 0 Eyes |
| Delefilcon A (Group 2) | Papillary Conjunctivitis | Trace | 0 Eyes |
| Delefilcon A (Group 2) | Papillary Conjunctivitis | Normal | 102 Eyes |
| Delefilcon A (Group 2) | Papillary Conjunctivitis | Mild | 0 Eyes |
| Delefilcon A (Group 2) | Papillary Conjunctivitis | Severe | 0 Eyes |