Myopia
Conditions
Brief summary
Lens Fitting Evaluation of CooperVision MyDay™ Compared with 1-DAY ACUVUE® TruEye® and DAILIES TOTAL1®
Detailed description
The aim of this non-dispensing study is to evaluate the fitting performance of MyDay™ 8.4 base curve, especially for flatter corneas, and compared it with 1-DAY ACUVUE® TruEye® 9.0 base curve and DAILIES TOTAL1® 8.8 base curve in a range of spherical powers.
Interventions
Sponsors
CooperVision, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
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 soft spherical contact lens wearer * Has a contact lens spherical prescription between -4.00 to - 6.00 and higher than -7.00D (Diopters) (inclusive) * Has a BFS (Best Fit Sphere) that is higher than 8.2 measured and calculated by corneal topography * 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 * Is willing to comply with the visit schedule
Exclusion criteria
* Is not a habitual wearer of soft spherical contact lenses * Has a contact lens prescription outside the range of the available parameters of the study lenses * Has a contact lens 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 contact lens 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) 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: * Moderate to severe dry eye * 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 Overall - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Baseline | Lens fit evaluation overall for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline. (Optimal, Almost optimal, Border line to wear, Not acceptable (cannot wear)). |
| Corneal Staining Type - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Baseline | Corneal staining type (ocular response) for for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline. (Scale 0-4, 0.5 steps, 0=normal, 4=severe) C - central, N - nasal, T- temporal, S - superior, I - interior |
| Corneal Staining Extent - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Baseline | Corneal staining extent (ocular response) for for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline. (Scale 0-4, 0.5 steps, 0=normal, 4=severe) C - central, N - nasal, T- temporal, S - superior, I - interior |
| Corneal Staining Depth - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Baseline | Corneal staining depth for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group A assessed at baseline. (Scale 0-4, 0.5 steps, 0=normal, 4=severe) C - central, N - nasal, T- temporal, S - superior, I - interior |
| Corneal Shape Change - Tangential Radius - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | 6 hours | Corneal shape change for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group is assessed at 6 hours by the topographer measurement and functions (map function of Tangential Curvature Map) |
| Corneal Shape Change - Wavefront Error - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | 6 hours | Corneal shape change for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group is assessed at 6 hours by the topographer measurement and functions (Wavefront Error Map) |
| Lens Fit - Corneal Coverage - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Baseline | Lens fit evaluation for corneal coverage on insertion for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline with a 'yes' or 'no'. |
| Lens Fit - Horizontal Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Baseline | Lens fit evaluation of horizontal centration on insertion for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline. (Temporal, Little temporal, Centered, Little nasal, Nasal) |
| Lens Fit - Vertical Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Baseline | Lens fit evaluation of vertical centration on insertion for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline. (Up, Little up, Centered, Little low, Low) |
| Lens Fit - Post-blink Movement - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Baseline | Lens fit evaluation of post-blink movement on insertion for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline. (Tight, Little tight, Optimal, Little loose, Loose) |
| Lens Fit - Tightness on up Gaze Blink Lag - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Baseline | Lens fit evaluation of tightness on up gaze blink lag for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline (insertion). (Optimal, Acceptable, No lag, Falls from cornea) |
| Conjunctival Staining - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Baseline | Conjunctival staining for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline. (Scale 0-4, 0.5 steps 0=normal, 4=severe) N - nasal, T - temporal, S - superior, I - interior |
| Conjunctival Indentation - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Baseline | Conjunctival indentation for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline. (Scale 0-4, 0.5 steps 0=normal, 4=severe) N - nasal, T - temporal, S - superior, I - interior |
| Limbal Redness - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Baseline | Limbal redness for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline. (Scale 0-4, 0.5 steps 0=normal, 4=severe) N - nasal, T - temporal, S - superior, I - interior |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Itching Sensation on Insertion (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Baseline | Subjective ratings of itching sensation on insertion for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group is assessed at baseline. 4 point Likert scale (0=none, 1=mild, 2=moderate, 3=severe) |
| Itching Sensation on Removal (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | 6 hours | Subjective ratings of itching sensation on removal for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group is assessed at 6 hours. 4 point Likert scale (0=none, 1=mild, 2=moderate, 3=severe) |
| Red Eye (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | 6 hours | Subjective ratings of red eye on removal for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group is assessed at 6 hours. 4 point Likert scale (0=none, 1=mild, 2=moderate, 3=severe) |
| Dryness (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Baseline, 3 hours, 6 hours | Subjective ratings of dryness for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline, 3 hours, and 6 hours. (Scale 0-100, 0=cannot wear, 100= no dryness). |
| Comfort (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Baseline, 3 hours, 6 hours | Subjective ratings of comfort for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline, 3 hours, and 6 hours. (Scale 0-100, 0=cannot wear, 100= no lens feeling). |
| Handling (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Baseline and 6 hours | Subjective ratings of handling for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline (ease of insertion) and 6 hours (ease of removal). (Scale 0-100, 0=cannot handle at all, 100=no problem at all). |
| Vision (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Baseline, 3 hours, 6 hours | Subjective ratings of vision for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline, 3 hours, and 6 hours. (Scale 0-100, 0=cannot see due to blur vision, 100=clear vision without any blur image). |
| Overall Wearing Satisfaction (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | 6 hours | Subjective ratings of overall wearing satisfaction for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Scale 0-100, 0=very poor, 100=very satisfied). |
| Lens Preferences (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | 6 hours | Subjective ratings of lens preferences for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Which lens is preferred) |
| Pain and Foreign Body Sensation (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Baseline | Subjective ratings of pain and foreign body sensation for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group is assessed at baseline. 4 point Likert scale (0=none, 1=mild, 2=moderate, 3=severe) |
Countries
United States
Participant flow
Pre-assignment details
Two participants enrolled in the study did not meet inclusion criteria. One participant was disqualified due to high power. All three participants therefore discontinued before lens randomization.
Participants by arm
| Arm | Count |
|---|---|
| Overall Participant Flow Participants randomized wear the stenfilcon A and the delefilcon A contralaterally or the stenfilcon A and the narafilcon A contralaterally
stenfilcon A: contact lens
delefilcon A: contact lens
narafilcon A: contact lens | 19 |
| Total | 19 |
Baseline characteristics
| Characteristic | Overall Participant Flow |
|---|---|
| Age, Continuous | 22 years |
| Region of Enrollment United States | 19 participants |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 19 | 0 / 19 | 0 / 19 |
| serious Total, serious adverse events | 0 / 19 | 0 / 19 | 0 / 19 |
Outcome results
Primary
Conjunctival Indentation - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Conjunctival indentation for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Scale 0-4, 0.5 steps 0=normal, 4=severe) N - nasal, T - temporal, S - superior, I - interior
Time frame: 6 hours
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stenfilcon A (Delefilcon A Group) | Conjunctival Indentation - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | N | 0.05 units on a scale | Standard Deviation 0.16 |
| Stenfilcon A (Delefilcon A Group) | Conjunctival Indentation - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | T | 0.18 units on a scale | Standard Deviation 0.38 |
| Stenfilcon A (Delefilcon A Group) | Conjunctival Indentation - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | S | 0.11 units on a scale | Standard Deviation 0.32 |
| Stenfilcon A (Delefilcon A Group) | Conjunctival Indentation - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | I | 0.16 units on a scale | Standard Deviation 0.34 |
| Delefilcon A | Conjunctival Indentation - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | T | 0.05 units on a scale | Standard Deviation 0.16 |
| Delefilcon A | Conjunctival Indentation - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | S | 0.00 units on a scale | Standard Deviation 0 |
| Delefilcon A | Conjunctival Indentation - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | I | 0.11 units on a scale | Standard Deviation 0.27 |
| Delefilcon A | Conjunctival Indentation - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | N | 0.16 units on a scale | Standard Deviation 0.34 |
| Stenfilcon A (Narafilcon A Group) | Conjunctival Indentation - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | S | 0.21 units on a scale | Standard Deviation 0.45 |
| Stenfilcon A (Narafilcon A Group) | Conjunctival Indentation - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | T | 0.53 units on a scale | Standard Deviation 0.7 |
| Stenfilcon A (Narafilcon A Group) | Conjunctival Indentation - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | I | 0.21 units on a scale | Standard Deviation 0.35 |
| Stenfilcon A (Narafilcon A Group) | Conjunctival Indentation - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | N | 0.26 units on a scale | Standard Deviation 0.45 |
| Narafilcon A | Conjunctival Indentation - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | I | 0.13 units on a scale | Standard Deviation 0.33 |
| Narafilcon A | Conjunctival Indentation - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | T | 0.11 units on a scale | Standard Deviation 0.36 |
| Narafilcon A | Conjunctival Indentation - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | N | 0.08 units on a scale | Standard Deviation 0.34 |
| Narafilcon A | Conjunctival Indentation - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | S | 0.21 units on a scale | Standard Deviation 0.45 |
Primary
Conjunctival Indentation - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Conjunctival indentation for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline. (Scale 0-4, 0.5 steps 0=normal, 4=severe) N - nasal, T - temporal, S - superior, I - interior
Time frame: Baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stenfilcon A (Delefilcon A Group) | Conjunctival Indentation - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | N | 0.00 units on a scale | Standard Deviation 0 |
| Stenfilcon A (Delefilcon A Group) | Conjunctival Indentation - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | T | 0.00 units on a scale | Standard Deviation 0 |
| Stenfilcon A (Delefilcon A Group) | Conjunctival Indentation - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | S | 0.00 units on a scale | Standard Deviation 0 |
| Stenfilcon A (Delefilcon A Group) | Conjunctival Indentation - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | I | 0.00 units on a scale | Standard Deviation 0 |
| Delefilcon A | Conjunctival Indentation - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | T | 0.00 units on a scale | Standard Deviation 0 |
| Delefilcon A | Conjunctival Indentation - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | S | 0.00 units on a scale | Standard Deviation 0 |
| Delefilcon A | Conjunctival Indentation - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | I | 0.00 units on a scale | Standard Deviation 0 |
| Delefilcon A | Conjunctival Indentation - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | N | 0.00 units on a scale | Standard Deviation 0 |
| Stenfilcon A (Narafilcon A Group) | Conjunctival Indentation - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | S | 0.00 units on a scale | Standard Deviation 0 |
| Stenfilcon A (Narafilcon A Group) | Conjunctival Indentation - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | T | 0.00 units on a scale | Standard Deviation 0 |
| Stenfilcon A (Narafilcon A Group) | Conjunctival Indentation - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | I | 0.00 units on a scale | Standard Deviation 0 |
| Stenfilcon A (Narafilcon A Group) | Conjunctival Indentation - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | N | 0.00 units on a scale | Standard Deviation 0 |
| Narafilcon A | Conjunctival Indentation - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | I | 0.08 units on a scale | Standard Deviation 0.34 |
| Narafilcon A | Conjunctival Indentation - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | T | 0.00 units on a scale | Standard Deviation 0 |
| Narafilcon A | Conjunctival Indentation - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | N | 0.08 units on a scale | Standard Deviation 0.34 |
| Narafilcon A | Conjunctival Indentation - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | S | 0.00 units on a scale | Standard Deviation 0 |
Primary
Conjunctival Staining - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Conjunctival staining for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline. (Scale 0-4, 0.5 steps 0=normal, 4=severe) N - nasal, T - temporal, S - superior, I - interior
Time frame: Baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stenfilcon A (Delefilcon A Group) | Conjunctival Staining - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | N | 0.42 units on a scale | Standard Deviation 0.48 |
| Stenfilcon A (Delefilcon A Group) | Conjunctival Staining - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | T | 0.39 units on a scale | Standard Deviation 0.43 |
| Stenfilcon A (Delefilcon A Group) | Conjunctival Staining - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | S | 0.13 units on a scale | Standard Deviation 0.23 |
| Stenfilcon A (Delefilcon A Group) | Conjunctival Staining - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | I | 0.26 units on a scale | Standard Deviation 0.26 |
| Delefilcon A | Conjunctival Staining - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | T | 0.34 units on a scale | Standard Deviation 0.5 |
| Delefilcon A | Conjunctival Staining - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | S | 0.16 units on a scale | Standard Deviation 0.24 |
| Delefilcon A | Conjunctival Staining - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | I | 0.18 units on a scale | Standard Deviation 0.34 |
| Delefilcon A | Conjunctival Staining - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | N | 0.53 units on a scale | Standard Deviation 0.51 |
| Stenfilcon A (Narafilcon A Group) | Conjunctival Staining - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | S | 0.21 units on a scale | Standard Deviation 0.3 |
| Stenfilcon A (Narafilcon A Group) | Conjunctival Staining - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | T | 0.34 units on a scale | Standard Deviation 0.37 |
| Stenfilcon A (Narafilcon A Group) | Conjunctival Staining - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | I | 0.24 units on a scale | Standard Deviation 0.35 |
| Stenfilcon A (Narafilcon A Group) | Conjunctival Staining - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | N | 0.68 units on a scale | Standard Deviation 0.53 |
| Narafilcon A | Conjunctival Staining - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | I | 0.34 units on a scale | Standard Deviation 0.37 |
| Narafilcon A | Conjunctival Staining - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | T | 0.45 units on a scale | Standard Deviation 0.44 |
| Narafilcon A | Conjunctival Staining - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | N | 0.47 units on a scale | Standard Deviation 0.49 |
| Narafilcon A | Conjunctival Staining - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | S | 0.21 units on a scale | Standard Deviation 0.3 |
Primary
Conjunctival Staining - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Conjunctival staining for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Scale 0-4, 0.5 steps 0=normal, 4=severe) N - nasal, T - temporal, S - superior, I - interior
Time frame: 6 hours
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stenfilcon A (Delefilcon A Group) | Conjunctival Staining - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | N | 0.97 units on a scale | Standard Deviation 0.49 |
| Stenfilcon A (Delefilcon A Group) | Conjunctival Staining - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | T | 1.11 units on a scale | Standard Deviation 0.74 |
| Stenfilcon A (Delefilcon A Group) | Conjunctival Staining - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | S | 0.26 units on a scale | Standard Deviation 0.45 |
| Stenfilcon A (Delefilcon A Group) | Conjunctival Staining - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | I | 0.53 units on a scale | Standard Deviation 0.56 |
| Delefilcon A | Conjunctival Staining - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | T | 0.47 units on a scale | Standard Deviation 0.46 |
| Delefilcon A | Conjunctival Staining - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | S | 0.24 units on a scale | Standard Deviation 0.31 |
| Delefilcon A | Conjunctival Staining - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | I | 0.63 units on a scale | Standard Deviation 0.6 |
| Delefilcon A | Conjunctival Staining - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | N | 0.79 units on a scale | Standard Deviation 0.54 |
| Stenfilcon A (Narafilcon A Group) | Conjunctival Staining - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | S | 0.45 units on a scale | Standard Deviation 0.6 |
| Stenfilcon A (Narafilcon A Group) | Conjunctival Staining - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | T | 1.39 units on a scale | Standard Deviation 0.89 |
| Stenfilcon A (Narafilcon A Group) | Conjunctival Staining - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | I | 0.87 units on a scale | Standard Deviation 0.6 |
| Stenfilcon A (Narafilcon A Group) | Conjunctival Staining - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | N | 1.00 units on a scale | Standard Deviation 0.75 |
| Narafilcon A | Conjunctival Staining - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | I | 1.24 units on a scale | Standard Deviation 1.03 |
| Narafilcon A | Conjunctival Staining - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | T | 0.97 units on a scale | Standard Deviation 0.68 |
| Narafilcon A | Conjunctival Staining - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | N | 1.29 units on a scale | Standard Deviation 0.87 |
| Narafilcon A | Conjunctival Staining - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | S | 0.61 units on a scale | Standard Deviation 1.04 |
Primary
Corneal Shape Change - Tangential Radius - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Corneal shape change for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group is assessed at 6 hours by the topographer measurement and functions (map function of Tangential Curvature Map)
Time frame: 6 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stenfilcon A (Delefilcon A Group) | Corneal Shape Change - Tangential Radius - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | -0.007 mm | Standard Deviation 0.036 |
| Delefilcon A | Corneal Shape Change - Tangential Radius - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | -0.004 mm | Standard Deviation 0.08 |
| Stenfilcon A (Narafilcon A Group) | Corneal Shape Change - Tangential Radius - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | 0.009 mm | Standard Deviation 0.035 |
| Narafilcon A | Corneal Shape Change - Tangential Radius - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | 0.017 mm | Standard Deviation 0.027 |
Primary
Corneal Shape Change - Wavefront Error - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Corneal shape change for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group is assessed at 6 hours by the topographer measurement and functions (Wavefront Error Map)
Time frame: 6 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stenfilcon A (Delefilcon A Group) | Corneal Shape Change - Wavefront Error - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | 0.004 microns | Standard Deviation 0.022 |
| Delefilcon A | Corneal Shape Change - Wavefront Error - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | -0.006 microns | Standard Deviation 0.149 |
| Stenfilcon A (Narafilcon A Group) | Corneal Shape Change - Wavefront Error - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | -0.006 microns | Standard Deviation 0.024 |
| Narafilcon A | Corneal Shape Change - Wavefront Error - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | 0.004 microns | Standard Deviation 0.019 |
Primary
Corneal Staining Depth - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Corneal staining depth (ocular response) for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Scale 0-4, 0.5 steps, 0=normal, 4=severe) C - central, N - nasal, T- temporal, S - superior, I - interior
Time frame: 6 hours
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stenfilcon A (Delefilcon A Group) | Corneal Staining Depth - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | S | 0.53 units on a scale | Standard Deviation 0.51 |
| Stenfilcon A (Delefilcon A Group) | Corneal Staining Depth - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | N | 0.05 units on a scale | Standard Deviation 0.23 |
| Stenfilcon A (Delefilcon A Group) | Corneal Staining Depth - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | I | 0.26 units on a scale | Standard Deviation 0.45 |
| Stenfilcon A (Delefilcon A Group) | Corneal Staining Depth - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | T | 0.05 units on a scale | Standard Deviation 0.23 |
| Stenfilcon A (Delefilcon A Group) | Corneal Staining Depth - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | C | 0.00 units on a scale | Standard Deviation 0 |
| Delefilcon A | Corneal Staining Depth - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | T | 0.00 units on a scale | Standard Deviation 0 |
| Delefilcon A | Corneal Staining Depth - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | S | 0.55 units on a scale | Standard Deviation 0.69 |
| Delefilcon A | Corneal Staining Depth - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | I | 0.26 units on a scale | Standard Deviation 0.45 |
| Delefilcon A | Corneal Staining Depth - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | N | 0.05 units on a scale | Standard Deviation 0.33 |
| Delefilcon A | Corneal Staining Depth - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | C | 0.05 units on a scale | Standard Deviation 0.23 |
| Stenfilcon A (Narafilcon A Group) | Corneal Staining Depth - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | T | 0.16 units on a scale | Standard Deviation 0.37 |
| Stenfilcon A (Narafilcon A Group) | Corneal Staining Depth - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | C | 0.00 units on a scale | Standard Deviation 0 |
| Stenfilcon A (Narafilcon A Group) | Corneal Staining Depth - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | N | 0.05 units on a scale | Standard Deviation 0.23 |
| Stenfilcon A (Narafilcon A Group) | Corneal Staining Depth - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | S | 0.58 units on a scale | Standard Deviation 0.51 |
| Stenfilcon A (Narafilcon A Group) | Corneal Staining Depth - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | I | 0.47 units on a scale | Standard Deviation 0.51 |
| Narafilcon A | Corneal Staining Depth - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | S | 0.42 units on a scale | Standard Deviation 0.51 |
| Narafilcon A | Corneal Staining Depth - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | N | 0.32 units on a scale | Standard Deviation 0.48 |
| Narafilcon A | Corneal Staining Depth - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | C | 0.05 units on a scale | Standard Deviation 0.23 |
| Narafilcon A | Corneal Staining Depth - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | T | 0.11 units on a scale | Standard Deviation 0.32 |
| Narafilcon A | Corneal Staining Depth - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | I | 0.53 units on a scale | Standard Deviation 0.51 |
Primary
Corneal Staining Depth - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Corneal staining depth for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group A assessed at baseline. (Scale 0-4, 0.5 steps, 0=normal, 4=severe) C - central, N - nasal, T- temporal, S - superior, I - interior
Time frame: Baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stenfilcon A (Delefilcon A Group) | Corneal Staining Depth - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | S | 0.37 units on a scale | Standard Deviation 0.5 |
| Stenfilcon A (Delefilcon A Group) | Corneal Staining Depth - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | N | 0.26 units on a scale | Standard Deviation 0.45 |
| Stenfilcon A (Delefilcon A Group) | Corneal Staining Depth - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | I | 0.26 units on a scale | Standard Deviation 0.45 |
| Stenfilcon A (Delefilcon A Group) | Corneal Staining Depth - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | T | 0.26 units on a scale | Standard Deviation 0.45 |
| Stenfilcon A (Delefilcon A Group) | Corneal Staining Depth - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | C | 0.11 units on a scale | Standard Deviation 0.32 |
| Delefilcon A | Corneal Staining Depth - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | T | 0.26 units on a scale | Standard Deviation 0.45 |
| Delefilcon A | Corneal Staining Depth - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | S | 0.26 units on a scale | Standard Deviation 0.45 |
| Delefilcon A | Corneal Staining Depth - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | I | 0.32 units on a scale | Standard Deviation 0.48 |
| Delefilcon A | Corneal Staining Depth - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | N | 0.34 units on a scale | Standard Deviation 0.53 |
| Delefilcon A | Corneal Staining Depth - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | C | 0.05 units on a scale | Standard Deviation 0.23 |
| Stenfilcon A (Narafilcon A Group) | Corneal Staining Depth - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | T | 0.21 units on a scale | Standard Deviation 0.42 |
| Stenfilcon A (Narafilcon A Group) | Corneal Staining Depth - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | C | 0.05 units on a scale | Standard Deviation 0.23 |
| Stenfilcon A (Narafilcon A Group) | Corneal Staining Depth - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | N | 0.37 units on a scale | Standard Deviation 0.5 |
| Stenfilcon A (Narafilcon A Group) | Corneal Staining Depth - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | S | 0.42 units on a scale | Standard Deviation 0.51 |
| Stenfilcon A (Narafilcon A Group) | Corneal Staining Depth - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | I | 0.42 units on a scale | Standard Deviation 0.51 |
| Narafilcon A | Corneal Staining Depth - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | S | 0.47 units on a scale | Standard Deviation 0.51 |
| Narafilcon A | Corneal Staining Depth - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | N | 0.26 units on a scale | Standard Deviation 0.45 |
| Narafilcon A | Corneal Staining Depth - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | C | 0.00 units on a scale | Standard Deviation 0 |
| Narafilcon A | Corneal Staining Depth - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | T | 0.26 units on a scale | Standard Deviation 0.45 |
| Narafilcon A | Corneal Staining Depth - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | I | 0.42 units on a scale | Standard Deviation 0.51 |
Primary
Corneal Staining Extent - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Corneal staining extent (ocular response) for for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline. (Scale 0-4, 0.5 steps, 0=normal, 4=severe) C - central, N - nasal, T- temporal, S - superior, I - interior
Time frame: Baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stenfilcon A (Delefilcon A Group) | Corneal Staining Extent - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | S | 0.18 units on a scale | Standard Deviation 0.25 |
| Stenfilcon A (Delefilcon A Group) | Corneal Staining Extent - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | N | 0.24 units on a scale | Standard Deviation 0.51 |
| Stenfilcon A (Delefilcon A Group) | Corneal Staining Extent - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | I | 0.24 units on a scale | Standard Deviation 0.45 |
| Stenfilcon A (Delefilcon A Group) | Corneal Staining Extent - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | T | 0.13 units on a scale | Standard Deviation 0.23 |
| Stenfilcon A (Delefilcon A Group) | Corneal Staining Extent - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | C | 0.13 units on a scale | Standard Deviation 0.47 |
| Delefilcon A | Corneal Staining Extent - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | T | 0.18 units on a scale | Standard Deviation 0.42 |
| Delefilcon A | Corneal Staining Extent - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | S | 0.16 units on a scale | Standard Deviation 0.29 |
| Delefilcon A | Corneal Staining Extent - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | I | 0.32 units on a scale | Standard Deviation 0.71 |
| Delefilcon A | Corneal Staining Extent - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | N | 0.34 units on a scale | Standard Deviation 0.53 |
| Delefilcon A | Corneal Staining Extent - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | C | 0.03 units on a scale | Standard Deviation 0.11 |
| Stenfilcon A (Narafilcon A Group) | Corneal Staining Extent - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | T | 0.18 units on a scale | Standard Deviation 0.42 |
| Stenfilcon A (Narafilcon A Group) | Corneal Staining Extent - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | C | 0.03 units on a scale | Standard Deviation 0.11 |
| Stenfilcon A (Narafilcon A Group) | Corneal Staining Extent - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | N | 0.32 units on a scale | Standard Deviation 0.53 |
| Stenfilcon A (Narafilcon A Group) | Corneal Staining Extent - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | S | 0.24 units on a scale | Standard Deviation 0.31 |
| Stenfilcon A (Narafilcon A Group) | Corneal Staining Extent - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | I | 0.37 units on a scale | Standard Deviation 0.55 |
| Narafilcon A | Corneal Staining Extent - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | S | 0.32 units on a scale | Standard Deviation 0.42 |
| Narafilcon A | Corneal Staining Extent - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | N | 0.24 units on a scale | Standard Deviation 0.45 |
| Narafilcon A | Corneal Staining Extent - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | C | 0.00 units on a scale | Standard Deviation 0 |
| Narafilcon A | Corneal Staining Extent - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | T | 0.24 units on a scale | Standard Deviation 0.42 |
| Narafilcon A | Corneal Staining Extent - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | I | 0.34 units on a scale | Standard Deviation 0.47 |
Primary
Corneal Staining Extent - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Corneal staining extent (ocular response) for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Scale 0-4, 0.5 steps, 0=normal, 4=severe) C - central, N - nasal, T- temporal, S - superior, I - interior
Time frame: 6 hours
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stenfilcon A (Delefilcon A Group) | Corneal Staining Extent - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | S | 0.29 units on a scale | Standard Deviation 0.3 |
| Stenfilcon A (Delefilcon A Group) | Corneal Staining Extent - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | N | 0.11 units on a scale | Standard Deviation 0.46 |
| Stenfilcon A (Delefilcon A Group) | Corneal Staining Extent - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | I | 0.18 units on a scale | Standard Deviation 0.34 |
| Stenfilcon A (Delefilcon A Group) | Corneal Staining Extent - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | T | 0.03 units on a scale | Standard Deviation 0.11 |
| Stenfilcon A (Delefilcon A Group) | Corneal Staining Extent - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | C | 0.00 units on a scale | Standard Deviation 0 |
| Delefilcon A | Corneal Staining Extent - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | T | 0.00 units on a scale | Standard Deviation 0 |
| Delefilcon A | Corneal Staining Extent - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | S | 0.29 units on a scale | Standard Deviation 0.3 |
| Delefilcon A | Corneal Staining Extent - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | I | 0.16 units on a scale | Standard Deviation 0.29 |
| Delefilcon A | Corneal Staining Extent - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | N | 0.03 units on a scale | Standard Deviation 0.11 |
| Delefilcon A | Corneal Staining Extent - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | C | 0.03 units on a scale | Standard Deviation 0.11 |
| Stenfilcon A (Narafilcon A Group) | Corneal Staining Extent - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | T | 0.09 units on a scale | Standard Deviation 0.19 |
| Stenfilcon A (Narafilcon A Group) | Corneal Staining Extent - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | C | 0.00 units on a scale | Standard Deviation 0 |
| Stenfilcon A (Narafilcon A Group) | Corneal Staining Extent - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | N | 0.03 units on a scale | Standard Deviation 0.11 |
| Stenfilcon A (Narafilcon A Group) | Corneal Staining Extent - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | S | 0.37 units on a scale | Standard Deviation 0.37 |
| Stenfilcon A (Narafilcon A Group) | Corneal Staining Extent - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | I | 0.37 units on a scale | Standard Deviation 0.52 |
| Narafilcon A | Corneal Staining Extent - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | S | 0.29 units on a scale | Standard Deviation 0.42 |
| Narafilcon A | Corneal Staining Extent - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | N | 0.24 units on a scale | Standard Deviation 0.39 |
| Narafilcon A | Corneal Staining Extent - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | C | 0.05 units on a scale | Standard Deviation 0.23 |
| Narafilcon A | Corneal Staining Extent - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | T | 0.11 units on a scale | Standard Deviation 0.32 |
| Narafilcon A | Corneal Staining Extent - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | I | 0.39 units on a scale | Standard Deviation 0.43 |
Primary
Corneal Staining Type - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Corneal staining type (ocular response) for for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Scale 0-4, 0.5 steps, 0=normal, 4=severe) C - central, N - nasal, T- temporal, S - superior, I - interior
Time frame: 6 hours
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stenfilcon A (Delefilcon A Group) | Corneal Staining Type - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | N | 0.05 units on a scale | Standard Deviation 0.23 |
| Stenfilcon A (Delefilcon A Group) | Corneal Staining Type - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | I | 0.26 units on a scale | Standard Deviation 0.51 |
| Stenfilcon A (Delefilcon A Group) | Corneal Staining Type - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | T | 0.18 units on a scale | Standard Deviation 0.8 |
| Stenfilcon A (Delefilcon A Group) | Corneal Staining Type - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | S | 0.53 units on a scale | Standard Deviation 0.59 |
| Stenfilcon A (Delefilcon A Group) | Corneal Staining Type - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | C | 0.00 units on a scale | Standard Deviation 0 |
| Delefilcon A | Corneal Staining Type - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | T | 0.00 units on a scale | Standard Deviation 0 |
| Delefilcon A | Corneal Staining Type - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | C | 0.08 units on a scale | Standard Deviation 0.34 |
| Delefilcon A | Corneal Staining Type - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | N | 0.08 units on a scale | Standard Deviation 0.34 |
| Delefilcon A | Corneal Staining Type - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | S | 0.74 units on a scale | Standard Deviation 1.01 |
| Delefilcon A | Corneal Staining Type - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | I | 0.39 units on a scale | Standard Deviation 0.86 |
| Stenfilcon A (Narafilcon A Group) | Corneal Staining Type - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | N | 0.08 units on a scale | Standard Deviation 0.34 |
| Stenfilcon A (Narafilcon A Group) | Corneal Staining Type - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | T | 0.21 units on a scale | Standard Deviation 0.54 |
| Stenfilcon A (Narafilcon A Group) | Corneal Staining Type - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | I | 0.71 units on a scale | Standard Deviation 0.93 |
| Stenfilcon A (Narafilcon A Group) | Corneal Staining Type - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | S | 0.76 units on a scale | Standard Deviation 0.84 |
| Stenfilcon A (Narafilcon A Group) | Corneal Staining Type - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | C | 0.00 units on a scale | Standard Deviation 0 |
| Narafilcon A | Corneal Staining Type - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | N | 0.71 units on a scale | Standard Deviation 1.25 |
| Narafilcon A | Corneal Staining Type - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | S | 0.47 units on a scale | Standard Deviation 0.66 |
| Narafilcon A | Corneal Staining Type - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | T | 0.18 units on a scale | Standard Deviation 0.61 |
| Narafilcon A | Corneal Staining Type - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | C | 0.03 units on a scale | Standard Deviation 0.11 |
| Narafilcon A | Corneal Staining Type - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | I | 0.61 units on a scale | Standard Deviation 0.68 |
Primary
Corneal Staining Type - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Corneal staining type (ocular response) for for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline. (Scale 0-4, 0.5 steps, 0=normal, 4=severe) C - central, N - nasal, T- temporal, S - superior, I - interior
Time frame: Baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stenfilcon A (Delefilcon A Group) | Corneal Staining Type - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | T | 0.24 units on a scale | Standard Deviation 0.45 |
| Stenfilcon A (Delefilcon A Group) | Corneal Staining Type - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | N | 0.34 units on a scale | Standard Deviation 0.6 |
| Stenfilcon A (Delefilcon A Group) | Corneal Staining Type - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | C | 0.16 units on a scale | Standard Deviation 0.47 |
| Stenfilcon A (Delefilcon A Group) | Corneal Staining Type - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | I | 0.26 units on a scale | Standard Deviation 0.48 |
| Stenfilcon A (Delefilcon A Group) | Corneal Staining Type - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | S | 0.45 units on a scale | Standard Deviation 0.64 |
| Delefilcon A | Corneal Staining Type - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | T | 0.34 units on a scale | Standard Deviation 0.62 |
| Delefilcon A | Corneal Staining Type - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | C | 0.05 units on a scale | Standard Deviation 0.23 |
| Delefilcon A | Corneal Staining Type - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | N | 0.55 units on a scale | Standard Deviation 0.86 |
| Delefilcon A | Corneal Staining Type - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | S | 0.29 units on a scale | Standard Deviation 0.51 |
| Delefilcon A | Corneal Staining Type - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | I | 0.37 units on a scale | Standard Deviation 0.6 |
| Stenfilcon A (Narafilcon A Group) | Corneal Staining Type - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | C | 0.08 units on a scale | Standard Deviation 0.34 |
| Stenfilcon A (Narafilcon A Group) | Corneal Staining Type - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | T | 0.21 units on a scale | Standard Deviation 0.45 |
| Stenfilcon A (Narafilcon A Group) | Corneal Staining Type - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | I | 0.55 units on a scale | Standard Deviation 0.76 |
| Stenfilcon A (Narafilcon A Group) | Corneal Staining Type - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | N | 0.53 units on a scale | Standard Deviation 0.77 |
| Stenfilcon A (Narafilcon A Group) | Corneal Staining Type - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | S | 0.45 units on a scale | Standard Deviation 0.55 |
| Narafilcon A | Corneal Staining Type - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | N | 0.37 units on a scale | Standard Deviation 0.7 |
| Narafilcon A | Corneal Staining Type - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | T | 0.32 units on a scale | Standard Deviation 0.56 |
| Narafilcon A | Corneal Staining Type - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | S | 0.45 units on a scale | Standard Deviation 0.5 |
| Narafilcon A | Corneal Staining Type - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | I | 0.53 units on a scale | Standard Deviation 0.74 |
| Narafilcon A | Corneal Staining Type - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | C | 0.00 units on a scale | Standard Deviation 0 |
Primary
Lens Fit - Corneal Coverage - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Lens fit evaluation for corneal coverage on insertion for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline with a 'yes' or 'no'.
Time frame: Baseline
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stenfilcon A (Delefilcon A Group) | Lens Fit - Corneal Coverage - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | No | 0 participants |
| Stenfilcon A (Delefilcon A Group) | Lens Fit - Corneal Coverage - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Yes | 19 participants |
| Delefilcon A | Lens Fit - Corneal Coverage - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Yes | 19 participants |
| Delefilcon A | Lens Fit - Corneal Coverage - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | No | 0 participants |
| Stenfilcon A (Narafilcon A Group) | Lens Fit - Corneal Coverage - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | No | 0 participants |
| Stenfilcon A (Narafilcon A Group) | Lens Fit - Corneal Coverage - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Yes | 19 participants |
| Narafilcon A | Lens Fit - Corneal Coverage - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | No | 0 participants |
| Narafilcon A | Lens Fit - Corneal Coverage - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Yes | 19 participants |
Primary
Lens Fit - Corneal Coverage - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Lens fit evaluation for corneal coverage on removal for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours with a 'yes' or 'no'.
Time frame: 6 hours
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stenfilcon A (Delefilcon A Group) | Lens Fit - Corneal Coverage - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Yes | 19 participants |
| Stenfilcon A (Delefilcon A Group) | Lens Fit - Corneal Coverage - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | No | 0 participants |
| Delefilcon A | Lens Fit - Corneal Coverage - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | No | 0 participants |
| Delefilcon A | Lens Fit - Corneal Coverage - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Yes | 19 participants |
| Stenfilcon A (Narafilcon A Group) | Lens Fit - Corneal Coverage - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Yes | 19 participants |
| Stenfilcon A (Narafilcon A Group) | Lens Fit - Corneal Coverage - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | No | 0 participants |
| Narafilcon A | Lens Fit - Corneal Coverage - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Yes | 18 participants |
| Narafilcon A | Lens Fit - Corneal Coverage - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | No | 1 participants |
Primary
Lens Fit - Horizontal Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Lens fit evaluation of horizontal centration on removal for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Temporal, Little temporal, Centered, Little nasal, Nasal)
Time frame: 6 hours
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stenfilcon A (Delefilcon A Group) | Lens Fit - Horizontal Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Little loose | 0 participants |
| Stenfilcon A (Delefilcon A Group) | Lens Fit - Horizontal Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Little temporal | 2 participants |
| Stenfilcon A (Delefilcon A Group) | Lens Fit - Horizontal Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Loose | 0 participants |
| Stenfilcon A (Delefilcon A Group) | Lens Fit - Horizontal Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Centered | 17 participants |
| Stenfilcon A (Delefilcon A Group) | Lens Fit - Horizontal Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Temporal | 0 participants |
| Delefilcon A | Lens Fit - Horizontal Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Centered | 18 participants |
| Delefilcon A | Lens Fit - Horizontal Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Little loose | 0 participants |
| Delefilcon A | Lens Fit - Horizontal Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Loose | 0 participants |
| Delefilcon A | Lens Fit - Horizontal Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Little temporal | 1 participants |
| Delefilcon A | Lens Fit - Horizontal Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Temporal | 0 participants |
| Stenfilcon A (Narafilcon A Group) | Lens Fit - Horizontal Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Centered | 19 participants |
| Stenfilcon A (Narafilcon A Group) | Lens Fit - Horizontal Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Temporal | 0 participants |
| Stenfilcon A (Narafilcon A Group) | Lens Fit - Horizontal Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Little temporal | 0 participants |
| Stenfilcon A (Narafilcon A Group) | Lens Fit - Horizontal Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Little loose | 0 participants |
| Stenfilcon A (Narafilcon A Group) | Lens Fit - Horizontal Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Loose | 0 participants |
| Narafilcon A | Lens Fit - Horizontal Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Little loose | 0 participants |
| Narafilcon A | Lens Fit - Horizontal Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Little temporal | 3 participants |
| Narafilcon A | Lens Fit - Horizontal Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Temporal | 2 participants |
| Narafilcon A | Lens Fit - Horizontal Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Centered | 14 participants |
| Narafilcon A | Lens Fit - Horizontal Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Loose | 0 participants |
Primary
Lens Fit - Horizontal Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Lens fit evaluation of horizontal centration on insertion for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline. (Temporal, Little temporal, Centered, Little nasal, Nasal)
Time frame: Baseline
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stenfilcon A (Delefilcon A Group) | Lens Fit - Horizontal Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Little loose | 0 participants |
| Stenfilcon A (Delefilcon A Group) | Lens Fit - Horizontal Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Little temporal | 2 participants |
| Stenfilcon A (Delefilcon A Group) | Lens Fit - Horizontal Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Loose | 0 participants |
| Stenfilcon A (Delefilcon A Group) | Lens Fit - Horizontal Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Centered | 17 participants |
| Stenfilcon A (Delefilcon A Group) | Lens Fit - Horizontal Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Temporal | 0 participants |
| Delefilcon A | Lens Fit - Horizontal Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Centered | 19 participants |
| Delefilcon A | Lens Fit - Horizontal Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Little loose | 0 participants |
| Delefilcon A | Lens Fit - Horizontal Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Loose | 0 participants |
| Delefilcon A | Lens Fit - Horizontal Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Little temporal | 0 participants |
| Delefilcon A | Lens Fit - Horizontal Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Temporal | 0 participants |
| Stenfilcon A (Narafilcon A Group) | Lens Fit - Horizontal Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Centered | 19 participants |
| Stenfilcon A (Narafilcon A Group) | Lens Fit - Horizontal Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Temporal | 0 participants |
| Stenfilcon A (Narafilcon A Group) | Lens Fit - Horizontal Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Little temporal | 0 participants |
| Stenfilcon A (Narafilcon A Group) | Lens Fit - Horizontal Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Little loose | 0 participants |
| Stenfilcon A (Narafilcon A Group) | Lens Fit - Horizontal Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Loose | 0 participants |
| Narafilcon A | Lens Fit - Horizontal Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Little loose | 0 participants |
| Narafilcon A | Lens Fit - Horizontal Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Little temporal | 4 participants |
| Narafilcon A | Lens Fit - Horizontal Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Temporal | 2 participants |
| Narafilcon A | Lens Fit - Horizontal Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Centered | 13 participants |
| Narafilcon A | Lens Fit - Horizontal Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Loose | 0 participants |
Primary
Lens Fit Overall - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Lens fit evaluation overall for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Optimal, Almost optimal, Border line to wear, Not acceptable (cannot wear)).
Time frame: 6 hours
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stenfilcon A (Delefilcon A Group) | Lens Fit Overall - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Optimal | 18 participants |
| Stenfilcon A (Delefilcon A Group) | Lens Fit Overall - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Almost optimal | 1 participants |
| Stenfilcon A (Delefilcon A Group) | Lens Fit Overall - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Border line to wear | 0 participants |
| Stenfilcon A (Delefilcon A Group) | Lens Fit Overall - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Not acceptable (cannot wear) | 0 participants |
| Delefilcon A | Lens Fit Overall - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Almost optimal | 1 participants |
| Delefilcon A | Lens Fit Overall - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Border line to wear | 0 participants |
| Delefilcon A | Lens Fit Overall - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Not acceptable (cannot wear) | 0 participants |
| Delefilcon A | Lens Fit Overall - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Optimal | 18 participants |
| Stenfilcon A (Narafilcon A Group) | Lens Fit Overall - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Border line to wear | 0 participants |
| Stenfilcon A (Narafilcon A Group) | Lens Fit Overall - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Almost optimal | 0 participants |
| Stenfilcon A (Narafilcon A Group) | Lens Fit Overall - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Not acceptable (cannot wear) | 0 participants |
| Stenfilcon A (Narafilcon A Group) | Lens Fit Overall - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Optimal | 19 participants |
| Narafilcon A | Lens Fit Overall - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Not acceptable (cannot wear) | 0 participants |
| Narafilcon A | Lens Fit Overall - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Almost optimal | 4 participants |
| Narafilcon A | Lens Fit Overall - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Optimal | 13 participants |
| Narafilcon A | Lens Fit Overall - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Border line to wear | 2 participants |
Primary
Lens Fit Overall - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Lens fit evaluation overall for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline. (Optimal, Almost optimal, Border line to wear, Not acceptable (cannot wear)).
Time frame: Baseline
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stenfilcon A (Delefilcon A Group) | Lens Fit Overall - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Optimal | 15 participants |
| Stenfilcon A (Delefilcon A Group) | Lens Fit Overall - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Almost optimal | 4 participants |
| Stenfilcon A (Delefilcon A Group) | Lens Fit Overall - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Border line to wear | 0 participants |
| Stenfilcon A (Delefilcon A Group) | Lens Fit Overall - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Not acceptable (cannot wear) | 0 participants |
| Delefilcon A | Lens Fit Overall - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Almost optimal | 1 participants |
| Delefilcon A | Lens Fit Overall - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Border line to wear | 0 participants |
| Delefilcon A | Lens Fit Overall - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Not acceptable (cannot wear) | 0 participants |
| Delefilcon A | Lens Fit Overall - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Optimal | 18 participants |
| Stenfilcon A (Narafilcon A Group) | Lens Fit Overall - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Border line to wear | 0 participants |
| Stenfilcon A (Narafilcon A Group) | Lens Fit Overall - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Almost optimal | 1 participants |
| Stenfilcon A (Narafilcon A Group) | Lens Fit Overall - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Not acceptable (cannot wear) | 0 participants |
| Stenfilcon A (Narafilcon A Group) | Lens Fit Overall - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Optimal | 18 participants |
| Narafilcon A | Lens Fit Overall - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Not acceptable (cannot wear) | 0 participants |
| Narafilcon A | Lens Fit Overall - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Almost optimal | 5 participants |
| Narafilcon A | Lens Fit Overall - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Optimal | 13 participants |
| Narafilcon A | Lens Fit Overall - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Border line to wear | 1 participants |
Primary
Lens Fit - Post-blink Movement - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Lens fit evaluation of post-blink movement on removal for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Tight, Little tight, Optimal, Little loose, Loose)
Time frame: 6 hours
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stenfilcon A (Delefilcon A Group) | Lens Fit - Post-blink Movement - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Little loose | 2 participants |
| Stenfilcon A (Delefilcon A Group) | Lens Fit - Post-blink Movement - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Little tight | 0 participants |
| Stenfilcon A (Delefilcon A Group) | Lens Fit - Post-blink Movement - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Loose | 0 participants |
| Stenfilcon A (Delefilcon A Group) | Lens Fit - Post-blink Movement - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Optimal | 17 participants |
| Stenfilcon A (Delefilcon A Group) | Lens Fit - Post-blink Movement - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Tight | 0 participants |
| Delefilcon A | Lens Fit - Post-blink Movement - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Optimal | 18 participants |
| Delefilcon A | Lens Fit - Post-blink Movement - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Little loose | 1 participants |
| Delefilcon A | Lens Fit - Post-blink Movement - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Loose | 0 participants |
| Delefilcon A | Lens Fit - Post-blink Movement - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Little tight | 0 participants |
| Delefilcon A | Lens Fit - Post-blink Movement - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Tight | 0 participants |
| Stenfilcon A (Narafilcon A Group) | Lens Fit - Post-blink Movement - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Optimal | 18 participants |
| Stenfilcon A (Narafilcon A Group) | Lens Fit - Post-blink Movement - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Tight | 0 participants |
| Stenfilcon A (Narafilcon A Group) | Lens Fit - Post-blink Movement - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Little tight | 0 participants |
| Stenfilcon A (Narafilcon A Group) | Lens Fit - Post-blink Movement - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Little loose | 1 participants |
| Stenfilcon A (Narafilcon A Group) | Lens Fit - Post-blink Movement - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Loose | 0 participants |
| Narafilcon A | Lens Fit - Post-blink Movement - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Little loose | 0 participants |
| Narafilcon A | Lens Fit - Post-blink Movement - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Little tight | 0 participants |
| Narafilcon A | Lens Fit - Post-blink Movement - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Tight | 0 participants |
| Narafilcon A | Lens Fit - Post-blink Movement - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Optimal | 19 participants |
| Narafilcon A | Lens Fit - Post-blink Movement - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Loose | 0 participants |
Primary
Lens Fit - Post-blink Movement - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Lens fit evaluation of post-blink movement on insertion for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline. (Tight, Little tight, Optimal, Little loose, Loose)
Time frame: Baseline
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stenfilcon A (Delefilcon A Group) | Lens Fit - Post-blink Movement - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Little loose | 0 participants |
| Stenfilcon A (Delefilcon A Group) | Lens Fit - Post-blink Movement - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Little tight | 0 participants |
| Stenfilcon A (Delefilcon A Group) | Lens Fit - Post-blink Movement - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Loose | 1 participants |
| Stenfilcon A (Delefilcon A Group) | Lens Fit - Post-blink Movement - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Optimal | 18 participants |
| Stenfilcon A (Delefilcon A Group) | Lens Fit - Post-blink Movement - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Tight | 0 participants |
| Delefilcon A | Lens Fit - Post-blink Movement - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Optimal | 18 participants |
| Delefilcon A | Lens Fit - Post-blink Movement - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Little loose | 1 participants |
| Delefilcon A | Lens Fit - Post-blink Movement - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Loose | 0 participants |
| Delefilcon A | Lens Fit - Post-blink Movement - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Little tight | 0 participants |
| Delefilcon A | Lens Fit - Post-blink Movement - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Tight | 0 participants |
| Stenfilcon A (Narafilcon A Group) | Lens Fit - Post-blink Movement - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Optimal | 18 participants |
| Stenfilcon A (Narafilcon A Group) | Lens Fit - Post-blink Movement - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Tight | 0 participants |
| Stenfilcon A (Narafilcon A Group) | Lens Fit - Post-blink Movement - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Little tight | 0 participants |
| Stenfilcon A (Narafilcon A Group) | Lens Fit - Post-blink Movement - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Little loose | 0 participants |
| Stenfilcon A (Narafilcon A Group) | Lens Fit - Post-blink Movement - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Loose | 1 participants |
| Narafilcon A | Lens Fit - Post-blink Movement - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Little loose | 0 participants |
| Narafilcon A | Lens Fit - Post-blink Movement - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Little tight | 0 participants |
| Narafilcon A | Lens Fit - Post-blink Movement - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Tight | 0 participants |
| Narafilcon A | Lens Fit - Post-blink Movement - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Optimal | 19 participants |
| Narafilcon A | Lens Fit - Post-blink Movement - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Loose | 0 participants |
Primary
Lens Fit - Tightness on up Gaze Blink Lag - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Lens fit evaluation of tightness on up gaze blink lag for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours on removal. (Optimal, Acceptable, No lag, Falls from cornea)
Time frame: 6 hours
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stenfilcon A (Delefilcon A Group) | Lens Fit - Tightness on up Gaze Blink Lag - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | No lag | 0 participants |
| Stenfilcon A (Delefilcon A Group) | Lens Fit - Tightness on up Gaze Blink Lag - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Acceptable | 3 participants |
| Stenfilcon A (Delefilcon A Group) | Lens Fit - Tightness on up Gaze Blink Lag - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Optimal | 16 participants |
| Stenfilcon A (Delefilcon A Group) | Lens Fit - Tightness on up Gaze Blink Lag - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Falls from cornea | 0 participants |
| Delefilcon A | Lens Fit - Tightness on up Gaze Blink Lag - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Acceptable | 2 participants |
| Delefilcon A | Lens Fit - Tightness on up Gaze Blink Lag - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Optimal | 17 participants |
| Delefilcon A | Lens Fit - Tightness on up Gaze Blink Lag - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | No lag | 0 participants |
| Delefilcon A | Lens Fit - Tightness on up Gaze Blink Lag - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Falls from cornea | 0 participants |
| Stenfilcon A (Narafilcon A Group) | Lens Fit - Tightness on up Gaze Blink Lag - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Optimal | 17 participants |
| Stenfilcon A (Narafilcon A Group) | Lens Fit - Tightness on up Gaze Blink Lag - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Falls from cornea | 0 participants |
| Stenfilcon A (Narafilcon A Group) | Lens Fit - Tightness on up Gaze Blink Lag - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | No lag | 0 participants |
| Stenfilcon A (Narafilcon A Group) | Lens Fit - Tightness on up Gaze Blink Lag - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Acceptable | 2 participants |
| Narafilcon A | Lens Fit - Tightness on up Gaze Blink Lag - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Acceptable | 4 participants |
| Narafilcon A | Lens Fit - Tightness on up Gaze Blink Lag - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Falls from cornea | 2 participants |
| Narafilcon A | Lens Fit - Tightness on up Gaze Blink Lag - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Optimal | 13 participants |
| Narafilcon A | Lens Fit - Tightness on up Gaze Blink Lag - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | No lag | 0 participants |
Primary
Lens Fit - Tightness on up Gaze Blink Lag - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Lens fit evaluation of tightness on up gaze blink lag for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline (insertion). (Optimal, Acceptable, No lag, Falls from cornea)
Time frame: Baseline
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stenfilcon A (Delefilcon A Group) | Lens Fit - Tightness on up Gaze Blink Lag - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Optimal | 12 participants |
| Stenfilcon A (Delefilcon A Group) | Lens Fit - Tightness on up Gaze Blink Lag - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Acceptable | 6 participants |
| Stenfilcon A (Delefilcon A Group) | Lens Fit - Tightness on up Gaze Blink Lag - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | No lag | 0 participants |
| Stenfilcon A (Delefilcon A Group) | Lens Fit - Tightness on up Gaze Blink Lag - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Falls from cornea | 1 participants |
| Delefilcon A | Lens Fit - Tightness on up Gaze Blink Lag - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Acceptable | 5 participants |
| Delefilcon A | Lens Fit - Tightness on up Gaze Blink Lag - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | No lag | 0 participants |
| Delefilcon A | Lens Fit - Tightness on up Gaze Blink Lag - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Falls from cornea | 0 participants |
| Delefilcon A | Lens Fit - Tightness on up Gaze Blink Lag - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Optimal | 14 participants |
| Stenfilcon A (Narafilcon A Group) | Lens Fit - Tightness on up Gaze Blink Lag - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | No lag | 0 participants |
| Stenfilcon A (Narafilcon A Group) | Lens Fit - Tightness on up Gaze Blink Lag - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Acceptable | 3 participants |
| Stenfilcon A (Narafilcon A Group) | Lens Fit - Tightness on up Gaze Blink Lag - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Falls from cornea | 0 participants |
| Stenfilcon A (Narafilcon A Group) | Lens Fit - Tightness on up Gaze Blink Lag - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Optimal | 16 participants |
| Narafilcon A | Lens Fit - Tightness on up Gaze Blink Lag - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Falls from cornea | 3 participants |
| Narafilcon A | Lens Fit - Tightness on up Gaze Blink Lag - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Acceptable | 5 participants |
| Narafilcon A | Lens Fit - Tightness on up Gaze Blink Lag - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Optimal | 11 participants |
| Narafilcon A | Lens Fit - Tightness on up Gaze Blink Lag - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | No lag | 0 participants |
Primary
Lens Fit - Vertical Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Lens fit evaluation of vertical centration on removal for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Up, Little up, Centered, Little low, Low)
Time frame: 6 hours
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stenfilcon A (Delefilcon A Group) | Lens Fit - Vertical Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Little low | 0 participants |
| Stenfilcon A (Delefilcon A Group) | Lens Fit - Vertical Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Little Up | 0 participants |
| Stenfilcon A (Delefilcon A Group) | Lens Fit - Vertical Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Low | 1 participants |
| Stenfilcon A (Delefilcon A Group) | Lens Fit - Vertical Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Centered | 18 participants |
| Stenfilcon A (Delefilcon A Group) | Lens Fit - Vertical Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Up | 0 participants |
| Delefilcon A | Lens Fit - Vertical Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Centered | 18 participants |
| Delefilcon A | Lens Fit - Vertical Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Little low | 1 participants |
| Delefilcon A | Lens Fit - Vertical Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Low | 0 participants |
| Delefilcon A | Lens Fit - Vertical Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Little Up | 0 participants |
| Delefilcon A | Lens Fit - Vertical Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Up | 0 participants |
| Stenfilcon A (Narafilcon A Group) | Lens Fit - Vertical Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Centered | 18 participants |
| Stenfilcon A (Narafilcon A Group) | Lens Fit - Vertical Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Up | 0 participants |
| Stenfilcon A (Narafilcon A Group) | Lens Fit - Vertical Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Little Up | 0 participants |
| Stenfilcon A (Narafilcon A Group) | Lens Fit - Vertical Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Little low | 1 participants |
| Stenfilcon A (Narafilcon A Group) | Lens Fit - Vertical Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Low | 0 participants |
| Narafilcon A | Lens Fit - Vertical Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Little low | 3 participants |
| Narafilcon A | Lens Fit - Vertical Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Little Up | 0 participants |
| Narafilcon A | Lens Fit - Vertical Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Up | 0 participants |
| Narafilcon A | Lens Fit - Vertical Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Centered | 10 participants |
| Narafilcon A | Lens Fit - Vertical Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Low | 6 participants |
Primary
Lens Fit - Vertical Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Lens fit evaluation of vertical centration on insertion for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline. (Up, Little up, Centered, Little low, Low)
Time frame: Baseline
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stenfilcon A (Delefilcon A Group) | Lens Fit - Vertical Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Little low | 3 participants |
| Stenfilcon A (Delefilcon A Group) | Lens Fit - Vertical Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Little Up | 0 participants |
| Stenfilcon A (Delefilcon A Group) | Lens Fit - Vertical Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Low | 1 participants |
| Stenfilcon A (Delefilcon A Group) | Lens Fit - Vertical Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Centered | 15 participants |
| Stenfilcon A (Delefilcon A Group) | Lens Fit - Vertical Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Up | 0 participants |
| Delefilcon A | Lens Fit - Vertical Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Centered | 16 participants |
| Delefilcon A | Lens Fit - Vertical Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Little low | 3 participants |
| Delefilcon A | Lens Fit - Vertical Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Low | 0 participants |
| Delefilcon A | Lens Fit - Vertical Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Little Up | 0 participants |
| Delefilcon A | Lens Fit - Vertical Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Up | 0 participants |
| Stenfilcon A (Narafilcon A Group) | Lens Fit - Vertical Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Centered | 17 participants |
| Stenfilcon A (Narafilcon A Group) | Lens Fit - Vertical Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Up | 0 participants |
| Stenfilcon A (Narafilcon A Group) | Lens Fit - Vertical Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Little Up | 0 participants |
| Stenfilcon A (Narafilcon A Group) | Lens Fit - Vertical Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Little low | 2 participants |
| Stenfilcon A (Narafilcon A Group) | Lens Fit - Vertical Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Low | 0 participants |
| Narafilcon A | Lens Fit - Vertical Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Little low | 6 participants |
| Narafilcon A | Lens Fit - Vertical Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Little Up | 1 participants |
| Narafilcon A | Lens Fit - Vertical Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Up | 0 participants |
| Narafilcon A | Lens Fit - Vertical Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Centered | 10 participants |
| Narafilcon A | Lens Fit - Vertical Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Low | 2 participants |
Primary
Limbal Redness - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Limbal redness for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline. (Scale 0-4, 0.5 steps 0=normal, 4=severe) N - nasal, T - temporal, S - superior, I - interior
Time frame: Baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stenfilcon A (Delefilcon A Group) | Limbal Redness - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | N | 0.97 units on a scale | Standard Deviation 0.49 |
| Stenfilcon A (Delefilcon A Group) | Limbal Redness - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | T | 0.74 units on a scale | Standard Deviation 0.35 |
| Stenfilcon A (Delefilcon A Group) | Limbal Redness - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | S | 0.82 units on a scale | Standard Deviation 0.45 |
| Stenfilcon A (Delefilcon A Group) | Limbal Redness - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | I | 0.68 units on a scale | Standard Deviation 0.45 |
| Delefilcon A | Limbal Redness - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | T | 0.89 units on a scale | Standard Deviation 0.59 |
| Delefilcon A | Limbal Redness - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | S | 0.84 units on a scale | Standard Deviation 0.5 |
| Delefilcon A | Limbal Redness - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | I | 0.63 units on a scale | Standard Deviation 0.47 |
| Delefilcon A | Limbal Redness - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | N | 1.05 units on a scale | Standard Deviation 0.44 |
| Stenfilcon A (Narafilcon A Group) | Limbal Redness - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | S | 0.79 units on a scale | Standard Deviation 0.67 |
| Stenfilcon A (Narafilcon A Group) | Limbal Redness - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | T | 0.79 units on a scale | Standard Deviation 0.67 |
| Stenfilcon A (Narafilcon A Group) | Limbal Redness - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | I | 0.66 units on a scale | Standard Deviation 0.41 |
| Stenfilcon A (Narafilcon A Group) | Limbal Redness - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | N | 0.97 units on a scale | Standard Deviation 0.46 |
| Narafilcon A | Limbal Redness - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | I | 0.71 units on a scale | Standard Deviation 0.51 |
| Narafilcon A | Limbal Redness - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | T | 0.97 units on a scale | Standard Deviation 0.7 |
| Narafilcon A | Limbal Redness - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | N | 1.11 units on a scale | Standard Deviation 0.7 |
| Narafilcon A | Limbal Redness - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | S | 0.76 units on a scale | Standard Deviation 0.63 |
Primary
Limbal Redness - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Limbal redness for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Scale 0-4, 0.5 steps 0=normal, 4=severe) N - nasal, T - temporal, S - superior, I - interior
Time frame: 6 hours
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stenfilcon A (Delefilcon A Group) | Limbal Redness - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | N | 1.08 units on a scale | Standard Deviation 0.63 |
| Stenfilcon A (Delefilcon A Group) | Limbal Redness - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | T | 1.00 units on a scale | Standard Deviation 0.44 |
| Stenfilcon A (Delefilcon A Group) | Limbal Redness - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | S | 0.89 units on a scale | Standard Deviation 0.52 |
| Stenfilcon A (Delefilcon A Group) | Limbal Redness - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | I | 0.89 units on a scale | Standard Deviation 0.49 |
| Delefilcon A | Limbal Redness - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | T | 1.03 units on a scale | Standard Deviation 0.49 |
| Delefilcon A | Limbal Redness - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | S | 0.84 units on a scale | Standard Deviation 0.44 |
| Delefilcon A | Limbal Redness - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | I | 0.84 units on a scale | Standard Deviation 0.41 |
| Delefilcon A | Limbal Redness - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | N | 1.03 units on a scale | Standard Deviation 0.35 |
| Stenfilcon A (Narafilcon A Group) | Limbal Redness - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | S | 0.84 units on a scale | Standard Deviation 0.55 |
| Stenfilcon A (Narafilcon A Group) | Limbal Redness - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | T | 1.16 units on a scale | Standard Deviation 0.55 |
| Stenfilcon A (Narafilcon A Group) | Limbal Redness - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | I | 0.95 units on a scale | Standard Deviation 0.64 |
| Stenfilcon A (Narafilcon A Group) | Limbal Redness - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | N | 1.05 units on a scale | Standard Deviation 0.5 |
| Narafilcon A | Limbal Redness - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | I | 0.95 units on a scale | Standard Deviation 0.44 |
| Narafilcon A | Limbal Redness - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | T | 1.13 units on a scale | Standard Deviation 0.64 |
| Narafilcon A | Limbal Redness - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | N | 1.34 units on a scale | Standard Deviation 0.76 |
| Narafilcon A | Limbal Redness - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | S | 0.84 units on a scale | Standard Deviation 0.5 |
Secondary
Comfort (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Subjective ratings of comfort for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline, 3 hours, and 6 hours. (Scale 0-100, 0=cannot wear, 100= no lens feeling).
Time frame: Baseline, 3 hours, 6 hours
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stenfilcon A (Delefilcon A Group) | Comfort (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Baseline | 90.0 units on a scale | Standard Deviation 11.8 |
| Stenfilcon A (Delefilcon A Group) | Comfort (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | 6 hours | 86.1 units on a scale | Standard Deviation 16.8 |
| Stenfilcon A (Delefilcon A Group) | Comfort (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | 3 hours | 90.0 units on a scale | Standard Deviation 16.3 |
| Delefilcon A | Comfort (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Baseline | 92.7 units on a scale | Standard Deviation 8.2 |
| Delefilcon A | Comfort (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | 6 hours | 88.4 units on a scale | Standard Deviation 14.4 |
| Delefilcon A | Comfort (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | 3 hours | 88.4 units on a scale | Standard Deviation 17.2 |
| Stenfilcon A (Narafilcon A Group) | Comfort (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | 3 hours | 90.2 units on a scale | Standard Deviation 12.5 |
| Stenfilcon A (Narafilcon A Group) | Comfort (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Baseline | 84.3 units on a scale | Standard Deviation 20.6 |
| Stenfilcon A (Narafilcon A Group) | Comfort (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | 6 hours | 88.1 units on a scale | Standard Deviation 13.9 |
| Narafilcon A | Comfort (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Baseline | 84.6 units on a scale | Standard Deviation 14.4 |
| Narafilcon A | Comfort (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | 6 hours | 85.6 units on a scale | Standard Deviation 17.8 |
| Narafilcon A | Comfort (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | 3 hours | 86.1 units on a scale | Standard Deviation 17.7 |
Secondary
Dryness (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Subjective ratings of dryness for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline, 3 hours, and 6 hours. (Scale 0-100, 0=cannot wear, 100= no dryness).
Time frame: Baseline, 3 hours, 6 hours
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stenfilcon A (Delefilcon A Group) | Dryness (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Baseline | 91.3 units on a scale | Standard Deviation 13.7 |
| Stenfilcon A (Delefilcon A Group) | Dryness (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | 6 hours | 88.7 units on a scale | Standard Deviation 15.1 |
| Stenfilcon A (Delefilcon A Group) | Dryness (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | 3 hours | 87.8 units on a scale | Standard Deviation 12.6 |
| Delefilcon A | Dryness (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Baseline | 92.5 units on a scale | Standard Deviation 14.2 |
| Delefilcon A | Dryness (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | 6 hours | 88.6 units on a scale | Standard Deviation 14.9 |
| Delefilcon A | Dryness (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | 3 hours | 87.2 units on a scale | Standard Deviation 16 |
| Stenfilcon A (Narafilcon A Group) | Dryness (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | 3 hours | 89.7 units on a scale | Standard Deviation 15.2 |
| Stenfilcon A (Narafilcon A Group) | Dryness (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Baseline | 93.0 units on a scale | Standard Deviation 8.1 |
| Stenfilcon A (Narafilcon A Group) | Dryness (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | 6 hours | 85.4 units on a scale | Standard Deviation 16.5 |
| Narafilcon A | Dryness (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Baseline | 90.2 units on a scale | Standard Deviation 11.5 |
| Narafilcon A | Dryness (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | 6 hours | 84.6 units on a scale | Standard Deviation 120.3 |
| Narafilcon A | Dryness (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | 3 hours | 87.2 units on a scale | Standard Deviation 19 |
Secondary
Handling (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Subjective ratings of handling for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline (ease of insertion) and 6 hours (ease of removal). (Scale 0-100, 0=cannot handle at all, 100=no problem at all).
Time frame: Baseline and 6 hours
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stenfilcon A (Delefilcon A Group) | Handling (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Baseline (insertion) | 95.8 units on a scale | Standard Deviation 5.3 |
| Stenfilcon A (Delefilcon A Group) | Handling (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | 6 hours (removal) | 81.6 units on a scale | Standard Deviation 27.7 |
| Delefilcon A | Handling (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | 6 hours (removal) | 86.4 units on a scale | Standard Deviation 22.5 |
| Delefilcon A | Handling (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Baseline (insertion) | 93.0 units on a scale | Standard Deviation 9.4 |
| Stenfilcon A (Narafilcon A Group) | Handling (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Baseline (insertion) | 90.9 units on a scale | Standard Deviation 10.8 |
| Stenfilcon A (Narafilcon A Group) | Handling (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | 6 hours (removal) | 88.3 units on a scale | Standard Deviation 21 |
| Narafilcon A | Handling (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Baseline (insertion) | 91.3 units on a scale | Standard Deviation 12.8 |
| Narafilcon A | Handling (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | 6 hours (removal) | 93.2 units on a scale | Standard Deviation 19.1 |
Secondary
Itching Sensation on Insertion (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Subjective ratings of itching sensation on insertion for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group is assessed at baseline. 4 point Likert scale (0=none, 1=mild, 2=moderate, 3=severe)
Time frame: Baseline
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stenfilcon A (Delefilcon A Group) | Itching Sensation on Insertion (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | None | 15 participants |
| Stenfilcon A (Delefilcon A Group) | Itching Sensation on Insertion (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Mild | 4 participants |
| Stenfilcon A (Delefilcon A Group) | Itching Sensation on Insertion (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Moderate | 0 participants |
| Stenfilcon A (Delefilcon A Group) | Itching Sensation on Insertion (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Severe | 0 participants |
| Delefilcon A | Itching Sensation on Insertion (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Severe | 0 participants |
| Delefilcon A | Itching Sensation on Insertion (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Moderate | 0 participants |
| Delefilcon A | Itching Sensation on Insertion (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Mild | 2 participants |
| Delefilcon A | Itching Sensation on Insertion (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | None | 17 participants |
| Stenfilcon A (Narafilcon A Group) | Itching Sensation on Insertion (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Moderate | 0 participants |
| Stenfilcon A (Narafilcon A Group) | Itching Sensation on Insertion (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Severe | 0 participants |
| Stenfilcon A (Narafilcon A Group) | Itching Sensation on Insertion (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Mild | 1 participants |
| Stenfilcon A (Narafilcon A Group) | Itching Sensation on Insertion (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | None | 18 participants |
| Narafilcon A | Itching Sensation on Insertion (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Mild | 3 participants |
| Narafilcon A | Itching Sensation on Insertion (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | None | 16 participants |
| Narafilcon A | Itching Sensation on Insertion (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Severe | 0 participants |
| Narafilcon A | Itching Sensation on Insertion (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Moderate | 0 participants |
Secondary
Itching Sensation on Removal (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Subjective ratings of itching sensation on removal for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group is assessed at 6 hours. 4 point Likert scale (0=none, 1=mild, 2=moderate, 3=severe)
Time frame: 6 hours
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stenfilcon A (Delefilcon A Group) | Itching Sensation on Removal (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | None | 15 participants |
| Stenfilcon A (Delefilcon A Group) | Itching Sensation on Removal (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Mild | 4 participants |
| Stenfilcon A (Delefilcon A Group) | Itching Sensation on Removal (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Moderate | 0 participants |
| Stenfilcon A (Delefilcon A Group) | Itching Sensation on Removal (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Severe | 0 participants |
| Delefilcon A | Itching Sensation on Removal (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Mild | 3 participants |
| Delefilcon A | Itching Sensation on Removal (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Moderate | 0 participants |
| Delefilcon A | Itching Sensation on Removal (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Severe | 0 participants |
| Delefilcon A | Itching Sensation on Removal (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | None | 16 participants |
| Stenfilcon A (Narafilcon A Group) | Itching Sensation on Removal (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Moderate | 1 participants |
| Stenfilcon A (Narafilcon A Group) | Itching Sensation on Removal (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Mild | 3 participants |
| Stenfilcon A (Narafilcon A Group) | Itching Sensation on Removal (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Severe | 0 participants |
| Stenfilcon A (Narafilcon A Group) | Itching Sensation on Removal (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | None | 15 participants |
| Narafilcon A | Itching Sensation on Removal (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Severe | 0 participants |
| Narafilcon A | Itching Sensation on Removal (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Mild | 4 participants |
| Narafilcon A | Itching Sensation on Removal (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | None | 14 participants |
| Narafilcon A | Itching Sensation on Removal (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Moderate | 1 participants |
Secondary
Lens Preferences (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Subjective ratings of lens preferences for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Which lens is preferred)
Time frame: 6 hours
Population: Preference is missing for 1 participant in the stenfilcon A/delefilcon A group whom did not answer preference question of which lens is preferred.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Stenfilcon A (Delefilcon A Group) | Lens Preferences (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | 7 participants |
| Delefilcon A | Lens Preferences (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | 11 participants |
| Stenfilcon A (Narafilcon A Group) | Lens Preferences (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | 15 participants |
| Narafilcon A | Lens Preferences (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | 4 participants |
Secondary
Overall Wearing Satisfaction (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Subjective ratings of overall wearing satisfaction for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Scale 0-100, 0=very poor, 100=very satisfied).
Time frame: 6 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stenfilcon A (Delefilcon A Group) | Overall Wearing Satisfaction (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | 86.5 units on a scale | Standard Deviation 17.4 |
| Delefilcon A | Overall Wearing Satisfaction (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | 88.6 units on a scale | Standard Deviation 14.4 |
| Stenfilcon A (Narafilcon A Group) | Overall Wearing Satisfaction (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | 86.8 units on a scale | Standard Deviation 13.4 |
| Narafilcon A | Overall Wearing Satisfaction (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | 83.4 units on a scale | Standard Deviation 17.5 |
Secondary
Pain and Foreign Body Sensation (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Subjective ratings of pain and foreign body sensation for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group is assessed at 6 hours. 4 point Likert scale (0=none, 1=mild, 2=moderate, 3=severe)
Time frame: 6 hours
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stenfilcon A (Delefilcon A Group) | Pain and Foreign Body Sensation (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | None | 15 participants |
| Stenfilcon A (Delefilcon A Group) | Pain and Foreign Body Sensation (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Mild | 2 participants |
| Stenfilcon A (Delefilcon A Group) | Pain and Foreign Body Sensation (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Moderate | 2 participants |
| Stenfilcon A (Delefilcon A Group) | Pain and Foreign Body Sensation (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Severe | 0 participants |
| Delefilcon A | Pain and Foreign Body Sensation (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Mild | 3 participants |
| Delefilcon A | Pain and Foreign Body Sensation (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Moderate | 1 participants |
| Delefilcon A | Pain and Foreign Body Sensation (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Severe | 0 participants |
| Delefilcon A | Pain and Foreign Body Sensation (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | None | 15 participants |
| Stenfilcon A (Narafilcon A Group) | Pain and Foreign Body Sensation (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Moderate | 0 participants |
| Stenfilcon A (Narafilcon A Group) | Pain and Foreign Body Sensation (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Mild | 6 participants |
| Stenfilcon A (Narafilcon A Group) | Pain and Foreign Body Sensation (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Severe | 0 participants |
| Stenfilcon A (Narafilcon A Group) | Pain and Foreign Body Sensation (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | None | 13 participants |
| Narafilcon A | Pain and Foreign Body Sensation (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Severe | 0 participants |
| Narafilcon A | Pain and Foreign Body Sensation (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Mild | 7 participants |
| Narafilcon A | Pain and Foreign Body Sensation (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | None | 11 participants |
| Narafilcon A | Pain and Foreign Body Sensation (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Moderate | 1 participants |
Secondary
Pain and Foreign Body Sensation (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Subjective ratings of pain and foreign body sensation for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group is assessed at baseline. 4 point Likert scale (0=none, 1=mild, 2=moderate, 3=severe)
Time frame: Baseline
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stenfilcon A (Delefilcon A Group) | Pain and Foreign Body Sensation (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | None | 18 participants |
| Stenfilcon A (Delefilcon A Group) | Pain and Foreign Body Sensation (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Mild | 1 participants |
| Stenfilcon A (Delefilcon A Group) | Pain and Foreign Body Sensation (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Moderate | 0 participants |
| Stenfilcon A (Delefilcon A Group) | Pain and Foreign Body Sensation (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Severe | 0 participants |
| Delefilcon A | Pain and Foreign Body Sensation (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Mild | 3 participants |
| Delefilcon A | Pain and Foreign Body Sensation (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Moderate | 0 participants |
| Delefilcon A | Pain and Foreign Body Sensation (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Severe | 0 participants |
| Delefilcon A | Pain and Foreign Body Sensation (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | None | 16 participants |
| Stenfilcon A (Narafilcon A Group) | Pain and Foreign Body Sensation (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Moderate | 2 participants |
| Stenfilcon A (Narafilcon A Group) | Pain and Foreign Body Sensation (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Mild | 5 participants |
| Stenfilcon A (Narafilcon A Group) | Pain and Foreign Body Sensation (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Severe | 0 participants |
| Stenfilcon A (Narafilcon A Group) | Pain and Foreign Body Sensation (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | None | 12 participants |
| Narafilcon A | Pain and Foreign Body Sensation (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Severe | 1 participants |
| Narafilcon A | Pain and Foreign Body Sensation (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Mild | 8 participants |
| Narafilcon A | Pain and Foreign Body Sensation (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | None | 9 participants |
| Narafilcon A | Pain and Foreign Body Sensation (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Moderate | 1 participants |
Secondary
Red Eye (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Subjective ratings of red eye on removal for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group is assessed at 6 hours. 4 point Likert scale (0=none, 1=mild, 2=moderate, 3=severe)
Time frame: 6 hours
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stenfilcon A (Delefilcon A Group) | Red Eye (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | None | 19 participants |
| Stenfilcon A (Delefilcon A Group) | Red Eye (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Mild | 0 participants |
| Stenfilcon A (Delefilcon A Group) | Red Eye (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Moderate | 0 participants |
| Stenfilcon A (Delefilcon A Group) | Red Eye (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Severe | 0 participants |
| Delefilcon A | Red Eye (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Mild | 0 participants |
| Delefilcon A | Red Eye (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Moderate | 0 participants |
| Delefilcon A | Red Eye (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Severe | 0 participants |
| Delefilcon A | Red Eye (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | None | 19 participants |
| Stenfilcon A (Narafilcon A Group) | Red Eye (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Moderate | 0 participants |
| Stenfilcon A (Narafilcon A Group) | Red Eye (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Mild | 2 participants |
| Stenfilcon A (Narafilcon A Group) | Red Eye (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Severe | 0 participants |
| Stenfilcon A (Narafilcon A Group) | Red Eye (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | None | 17 participants |
| Narafilcon A | Red Eye (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Severe | 0 participants |
| Narafilcon A | Red Eye (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Mild | 3 participants |
| Narafilcon A | Red Eye (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | None | 16 participants |
| Narafilcon A | Red Eye (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Moderate | 0 participants |
Secondary
Vision (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Subjective ratings of vision for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline, 3 hours, and 6 hours. (Scale 0-100, 0=cannot see due to blur vision, 100=clear vision without any blur image).
Time frame: Baseline, 3 hours, 6 hours
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stenfilcon A (Delefilcon A Group) | Vision (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | 3 hours | 93.5 units on a scale | Standard Deviation 11.4 |
| Stenfilcon A (Delefilcon A Group) | Vision (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | 6 hours | 93.0 units on a scale | Standard Deviation 8.1 |
| Stenfilcon A (Delefilcon A Group) | Vision (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Baseline | 90.0 units on a scale | Standard Deviation 13.6 |
| Delefilcon A | Vision (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Baseline | 94.1 units on a scale | Standard Deviation 6.9 |
| Delefilcon A | Vision (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | 3 hours | 96.8 units on a scale | Standard Deviation 3.9 |
| Delefilcon A | Vision (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | 6 hours | 93.9 units on a scale | Standard Deviation 9.5 |
| Stenfilcon A (Narafilcon A Group) | Vision (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | 3 hours | 93.2 units on a scale | Standard Deviation 10 |
| Stenfilcon A (Narafilcon A Group) | Vision (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Baseline | 86.5 units on a scale | Standard Deviation 19.1 |
| Stenfilcon A (Narafilcon A Group) | Vision (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | 6 hours | 92.4 units on a scale | Standard Deviation 7 |
| Narafilcon A | Vision (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | Baseline | 90.6 units on a scale | Standard Deviation 7.7 |
| Narafilcon A | Vision (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | 6 hours | 90.5 units on a scale | Standard Deviation 9.7 |
| Narafilcon A | Vision (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A | 3 hours | 90.3 units on a scale | Standard Deviation 13 |