Astigmatism
Conditions
Brief summary
The aim of this study is to compare the clinical performance of the Biofinity Toric (comfilcon A) contact lens, versus Air Optix for Astigmatism (lotrafilcon B) over 1 month of daily wear.
Detailed description
Single masked, open label, randomized, bilateral, crossover study design comparing comfilcon A against lotrafilcon B lenses over 1 month of daily wear for each study lens. Each subject will be randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating the schedule for the second pair without a washout period.
Interventions
DEVICEcomfilcon A
test lens Pair(comfilcon A) or the control lens Pair(lotrafilcon B)
DEVICElotrafilcon B
test lens Pair(comfilcon A) or the control lens Pair(lotrafilcon B)
Sponsors
CooperVision, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
A person is eligible for inclusion in the study if he/she: * Is between 18 and 40 years of age (inclusive) * Has had a self-reported visual exam in the last two years * Is an adapted soft toric contact lens wearer * Has a contact lens spherical prescription between +6.00 to - 10.00 (inclusive) * Have no less than 0.75diopter (D) of astigmatism and no more than 2.25D in both eyes. * Can achieve best corrected spectacle distance visual acuity of 20/25 (0.10 logMAR) or better in each eye. * Can achieve a distance visual acuity of 20/30 (0.18 logMAR) or better in each eye with the study contact lenses. * Has clear corneas and no active ocular disease * Has read, understood and signed the information consent letter. * Patient contact lens refraction should fit within the available parameters of the study lenses. * Is willing to comply with the wear schedule (at least 5 days per week, \> 8 hours/day assuming there are no contraindications for doing so). * Is willing to comply with the visit schedule
Exclusion criteria
A person will be excluded from the study if he/she: * Has a contact lens prescription outside the range of the available parameters of the study lenses. * Has a spectacle cylinder less than -0.75D or more than -2.25 D 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 2-4) anterior segment abnormalities * Presence of ocular or systemic disease or need of medications which might interfere with contact lens wear. * Slit lamp findings that would contraindicate contact lens wear such as: * Pathological dry eye or associated findings * Pterygium, pinguecula, or corneal scars within the visual axis * Neovascularization \> 0.75 mm in from of the limbus * Giant papillary conjunctivitis (GCP) worse than grade 1 * Anterior uveitis or iritis (past or present) * Seborrheic eczema, Seborrheic conjunctivitis * History of corneal ulcers or fungal infections * Poor personal hygiene * Has a known history of corneal hypoesthesia (reduced corneal sensitivity) * Has aphakia, keratoconus or a highly irregular cornea. * Has Presbyopia or has dependence on spectacles for near work over the contact lenses. * Has undergone corneal refractive surgery. * Is participating in any other type of eye related clinical or research study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Stability | 2 weeks | Assessment of Lens Fit Performance for overall lens stability. Collected at 2 weeks for each lens. (Excellent or Good. |
| Lens Orientation Primary Gaze | Dispense | Assessment of Lens Fit Performance for lens orientation in primary position of gaze. Collected at dispense for each lens. (Degree of mislocation relative to lens axis mark.) |
| Lens Marking Visibility | Dispense | Assessment of Lens Fit Performance for lens marking visibility. Collected at dispense for each lens. (1-3, 1=excellent, 2=average, 3=poor) |
| Lens Stability on Blink | Dispense | Assessment of Lens Fit Performance for lens rotational stability on blink. Collected at dispense for each lens. (No rotation and 5-10 degrees rotation from axis location mark) |
| Lens Stability 5-10 Min | Dispense | Assessment of Lens Fit Performance for lens to stabilize in 5-10 min. Collected at dispense for each lens. (Varied less than 5 degrees from lens marking location between 5-10 min) |
| Lens Overall Stability | Dispense | Assessment of Lens Fit Performance for overall lens stability. Collected at dispense for each lens. (Excellent or Good) |
| Rotational Recovery 30/45 Deg | Dispense | Assessment of Lens Fit Performance for lens rotational recovery to original position. Collected at dispense for each lens. Assessed in degree of mislocation relative to original position after manual temporal rotation. (30 deg/10 blinks, 45 deg/60 sec) |
| Overall Fit Acceptance | Dispense | Assessment of Lens Fit Performance for overall lens fit acceptance. Collected at dispense for each lens. Rated perfect or not perfect based on lens fit alone. (0-4; 0=should not be worn, 3=not perfect but OK to dispense, 4=perfect) |
| Participants Use of Rewetting Drops | 2 Weeks | Proportion of subjects using rewetting drops. Collected at 2 weeks for each lens. (Yes, No) |
| Vision Quality Insertion, During Day, End Day, Night | 2 weeks | Participant rating of vision quality on insertion, during the day, end of day and night. Collected at 2 weeks wear for each lens. (0-100; 0=extremely poor vision totally blurred, 100=excellent vision totally sharp) |
| Vision Stability on Insertion, During Day, End Day | 2 weeks | Participant rating of vision stability on insertion, during the day, end of day. Collected at 2 weeks wear for each lens. (0-100; 0=totally unstable fluctuating/changing, 100=perfectly stable not fluctuating/changing) |
| Wavefront Aberrations Root Mean Square (RMS) (3mm) | 2 Weeks | Assessment of wavefront aberrations. Collected at 2 weeks for each lens. Wavefront measurement (3mm), Scale in microns (µm). |
| Wavefront Aberrations RMS (3mm) | 4 Weeks | Assessment of wavefront aberrations. Collected at 4 weeks for each lens. Wavefront measurement (3mm), Scale in microns (µm). |
| Wavefront Aberrations RMS (5mm) | 2 Weeks | Assessment of wavefront aberrations. Collected at 2 weeks for each lens. Wavefront measurement (5 mm), Scale in microns (µm). |
| Lens Surface Deposits | 2 weeks | Assessment of lens front surface deposits. Collected at 2 weeks wear for each lens. (Front surface deposits observed, 0-4, 0=clean, 4=deposits ≥0.5) |
| Overall Sensation of Smoothness | Baseline | Participant rating for overall sensation of smoothness. Collected at baseline for all habitual lenses. (5-point Likert Scale; Excellent, Good, Average, Below Average) |
| Comfort Satisfaction | Baseline | Participant rating for comfort satisfaction. Collected at baseline for all habitual lenses. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied) |
| Dryness Satisfaction | Baseline | Participant rating for dryness satisfaction. Collected at baseline for all habitual lenses. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied) |
| Daily and Comfortable Wearing Time | Baseline | Participant rating of lens Daily and Comfortable Wearing Time. Collected at baseline for all habitual lenses. (The hours of average comfortable wearing time and average daily wearing time.) |
| Comfort, Dryness, Handling, Lens Fit Stability, Vision Satisfaction | Baseline | Participant rating of lens Comfort, Dryness, Handling, Lens Fit Stability and Vision Satisfaction. Collected at baseline for all habitual lenses. (0-10; Comfort, Lens Fit and Satisfaction / 0=very poor,10=excellent; Dryness / 0=very dry, 10=no dryness; Handling / 0=very difficult, 10=very easy for handling) |
| Vision Quality Insertion, During Day, End Day | Baseline | Participant rating of vision quality on insertion, during the day, end of day. Collected at baseline for all habitual lenses. (0-100; 0=extremely poor vision totally blurred, 100=excellent vision totally sharp) |
| Vision Stability Insertion, During Day, End Day | Baseline | Participant rating of vision stability on insertion, during the day, end of day. Collected at baseline for all habitual lenses. (0-100; 0=totally unstable fluctuating/changing, 100=perfectly stable not fluctuating/changing) |
| Overall Sensation of Moistness | Baseline | Participant rating for overall sensation of moistness. Collected at baseline for all habitual lenses. (5-point Likert Scale; Excellent, Good, Average, Below Average) |
| Handling Satisfaction | Baseline | Participant rating for handling satisfaction. Collected at baseline for all habitual lenses. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied) |
| Lens Fit Satisfaction | Baseline | Participant rating for lens fit satisfaction. Collected at baseline for all habitual lenses. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied) |
| Vision Satisfaction | Baseline | Participant rating for vision satisfaction. Collected at baseline for all habitual lenses. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied) |
| Overall Satisfaction | Baseline | Participant rating for overall satisfaction. Collected at baseline for all habitual lenses. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied) |
| Comfort Upon Contact Lens Insertion | Dispense | Participant rating of comfort upon insertion. Collected at dispense for each lens. (0-10; 10=Can't Feel) |
| Vision Satisfaction Upon Contact Lens Insertion | Dispense | Participant rating of vision satisfaction upon insertion. Collected at dispense for each lens. (0-10; 10= Very Satisfied) |
| Vision Quality With Contact Lens Prescription | Dispense | Participant rating of Vision Quality with contact lens prescription. Collected at dispense for each lens. (0-100; 0=extremely poor vision totally blurred, 100=excellent vision totally sharp) |
| Vision Stability Upon Contact Lens Insertion | Dispense | Participant rating of vision stability on insertion. Collected at dispense for each lens. (0-100; 0=extremely poor vision totally blurred, 100=excellent vision totally sharp) |
| Visual Acuity logMAR | Dispense | Assessment of monocular and binocular high and low contrast visual acuity (VA). Collected at dispense for each lens. logMAR (VA). |
| Centration | Dispense | Assessment of Lens Fit Performance for centration. Collected at dispense for each lens. (Biomicroscopy; centered or slightly decentered) |
| Corneal Coverage | Dispense | Assessment of Lens Fit Performance for corneal coverage. Collected at dispense for each lens. Corneal coverage assessed in primary gaze: (yes=full corneal coverage at all times, no=incomplete corneal coverage) |
| Post Blink Movement | Dispense | Assessment of Lens Fit Performance for post blink movement. Collected at dispense for each lens. (0-4, 0.5 increments; 0=Insufficient, unacceptable movement, 4= Excessive, unacceptable movement) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bulbar Hyperaemia | Baseline | Assessment of ocular health. Collected at baseline after removal of habitual lenses. Proportion of eyes with grades 0-1 (No eyes graded \>1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe) |
| Lower Palpebral Hyperaemia | Baseline | Assessment of ocular health. Collected at baseline after removal of habitual lenses. Proportion of eyes with grades 0-1 (No eyes graded \>1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe) |
| Corneal Stromal Haze | Baseline | Assessment of ocular health. Collected at baseline after removal of habitual lenses. Proportion of eyes with grades 0-1 (No eyes graded \>1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe) |
| Corneal Neovascularization | Baseline | Investigators' objective assessment of ocular health. Collected at baseline after removal of habitual lenses. Proportion of eyes with grades 0-1 (No eyes graded \>1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe) |
| Corneal Infiltrates | Baseline | Assessment of ocular health. Collected at baseline after removal of habitual lenses. Proportion of eyes with grades 0-1 (No eyes graded \>1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe) |
| Participant Preference for Their Habitual Lenses or the First Study Lenses (Lotrafilcon B) | 2 weeks | Participant preference for their habitual lenses or the first study lenses during the last two weeks with regard to comfort, dryness, handling, vision, lens fit and overall. (Forced choice; habitual, study lenses) |
| Participant Preference for Their Habitual Lenses or the First Study Lenses (Comfilcon A) | 2 weeks | Participant preference for their habitual lenses or the first study lenses during the last two weeks with regard to comfort, dryness, handling, vision, lens fit and overall. (Forced choice; habitual, study lenses) |
| Participants Likelihood of Switching From Habitual Lenses to the Study Lenses | 4 weeks | Participants likelihood of switching from habitual lenses to either pair of the study lenses when asked; How likely are they to switch from their habitual lenses to either the first study lenses or the second study lenses? Collected at 4 weeks for each study pair. (4 point Likert scale; very likely, likely, unlikely, very unlikely) |
| Participants Likelihood of Continuing to Wear the Study Lenses. | 4 weeks | Participants likelihood of continuing to wear either of the pairs of study lenses when asked; How likely are they to continue to wearing either the first study lenses or the second study lenses? Collected at 4 weeks fore each study pair. (4 point Likert scale; very likely, likely, unlikely, very unlikely) |
| Participant Recommendation of a Study Lens to Friends, Family or Colleagues | 8 weeks | Percentage of participants that answer the question, What study lens they will most likely recommend to friends, family or colleagues? Collected at end of study. (Forced choice; First Study Lenses, Second Study Lenses) |
| Participant Likelihood of Recommending a Study Lens to Friends, Family or Colleagues. | 8 weeks | Percentage of participants that answer the question, How likely are they to recommend either the first pair of study lenses or the second pair of study lenses to friends, family or colleagues? Collected at study end. (4 point Likert scale; very likely, likely, unlikely, very unlikely) |
| Participant Preference for Their Habitual Lenses or Either of the Study Lenses | 8 weeks | Percentage of participants that answer the question, Which type of study lens they prefer with regard to comfort, dryness, handling, vision, lens fit and overall performance? Collected at study end. (Forced choice; habitual lenses, first study lenses, second study lenses) |
| Participant Preference for Either of the Study Lenses | 8 weeks | Percentage of participants that answer the question, Which type of study lens they prefer with regard to comfort, dryness, handling, vision, lens fit and overall performance? Collected at study end. (Forced choice; first study lenses, second study lenses, neither) |
| Limbal Hyperaemia | Baseline | Assessment of ocular health. Collected at baseline after removal of habitual lenses. Proportion of eyes with grades 0-1 (No eyes graded \>1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe) |
Countries
Spain
Participant flow
Recruitment details
Of the 60 subjects enrolled, 60 were fitted with the study lenses and completed the trial (i.e. no discontinuations).This study design considered a single-center, (Optometry Research Group), located at the University of Valencia Spain (target 60 subjects).
Pre-assignment details
All subjects were habitual lens wearers.
Participants by arm
| Arm | Count |
|---|---|
| Comfilcon A Then Lotrafilcon B All subjects attended first visit with habitual lenses and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period. | 30 |
| Lotrafilcon B Then Comfilcon A All subjects attended first visit with habitual lenses and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period. | 30 |
| Total | 60 |
Baseline characteristics
| Characteristic | Comfilcon A Then Lotrafilcon B | Lotrafilcon B Then Comfilcon A | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 30 Participants | 30 Participants | 60 Participants |
| Region of Enrollment Spain | 30 participants | 30 participants | 60 participants |
| Sex: Female, Male Female | 16 Participants | 21 Participants | 37 Participants |
| Sex: Female, Male Male | 14 Participants | 9 Participants | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 60 | 0 / 60 |
| serious Total, serious adverse events | 0 / 60 | 0 / 60 |
Outcome results
Primary
Centration
Assessment of Lens Fit Performance for centration. Collected at 2 weeks for each lens. Proportion of contact lenses fitted where centration was centered or slightly decentered. (Biomicroscopy)
Time frame: 2 weeks
Population: All 60 subjects randomized to both sets of lenses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Study Group | Centration | centered | 94 percentage of lenses |
| Overall Study Group | Centration | slightly decentered | 6 percentage of lenses |
| Lotrafilcon B | Centration | centered | 78 percentage of lenses |
| Lotrafilcon B | Centration | slightly decentered | 22 percentage of lenses |
Primary
Centration
Assessment of Lens Fit Performance for centration. Collected at 4 weeks for each lens. Proportion of contact lenses fitted where centration was centered or slightly decentered. (Biomicroscopy)
Time frame: 4 weeks
Population: All 60 subjects randomized to both sets of lenses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Study Group | Centration | centered | 93 percentage of lenses |
| Overall Study Group | Centration | slightly decentered | 7 percentage of lenses |
| Lotrafilcon B | Centration | centered | 81 percentage of lenses |
| Lotrafilcon B | Centration | slightly decentered | 19 percentage of lenses |
Primary
Centration
Assessment of Lens Fit Performance for centration. Collected at dispense for each lens. (Biomicroscopy; centered or slightly decentered)
Time frame: Dispense
Population: All 60 subjects randomized to both sets of lenses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Study Group | Centration | centered | 94 percentage of lenses |
| Overall Study Group | Centration | slightly decentered | 6 percentage of lenses |
| Lotrafilcon B | Centration | centered | 79 percentage of lenses |
| Lotrafilcon B | Centration | slightly decentered | 21 percentage of lenses |
Primary
Comfort, Dryness, Handling, Lens Fit Stability, Vision Satisfaction
Participant rating of lens Comfort, Dryness, Handling, Lens Fit Stability and Vision Satisfaction. Collected at baseline for all habitual lenses. (0-10; Comfort, Lens Fit and Satisfaction / 0=very poor,10=excellent; Dryness / 0=very dry, 10=no dryness; Handling / 0=very difficult, 10=very easy for handling)
Time frame: Baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Overall Study Group | Comfort, Dryness, Handling, Lens Fit Stability, Vision Satisfaction | Comfort on Insertion | 8.0 units on a scale | Standard Deviation 1.3 |
| Overall Study Group | Comfort, Dryness, Handling, Lens Fit Stability, Vision Satisfaction | Comfort prior to Removal | 7.7 units on a scale | Standard Deviation 1.6 |
| Overall Study Group | Comfort, Dryness, Handling, Lens Fit Stability, Vision Satisfaction | Comfort Overall | 8.0 units on a scale | Standard Deviation 1.6 |
| Overall Study Group | Comfort, Dryness, Handling, Lens Fit Stability, Vision Satisfaction | Dryness during the Day | 8.0 units on a scale | Standard Deviation 1.6 |
| Overall Study Group | Comfort, Dryness, Handling, Lens Fit Stability, Vision Satisfaction | Dryness prior to Removal | 7.9 units on a scale | Standard Deviation 1.6 |
| Overall Study Group | Comfort, Dryness, Handling, Lens Fit Stability, Vision Satisfaction | Dryness Overall | 7.9 units on a scale | Standard Deviation 1.6 |
| Overall Study Group | Comfort, Dryness, Handling, Lens Fit Stability, Vision Satisfaction | Handling | 8.4 units on a scale | Standard Deviation 1.1 |
| Overall Study Group | Comfort, Dryness, Handling, Lens Fit Stability, Vision Satisfaction | Overall Lens Fit | 8.2 units on a scale | Standard Deviation 1.1 |
| Overall Study Group | Comfort, Dryness, Handling, Lens Fit Stability, Vision Satisfaction | Overall Vision Satisfaction | 8.1 units on a scale | Standard Deviation 1.2 |
Primary
Comfort, Dryness, Handling, Lens Fit Stability, Vision Satisfaction
Participant rating of lens Comfort, Dryness, Handling, Lens Fit Stability and Vision Satisfaction. Collected at 2 weeks wear for each lens. (0-10; Comfort, Lens Fit and Satisfaction / 0=very poor,10=excellent; Dryness / 0=very dry, 10=no dryness; Handling / 0=very difficult, 10=very easy for handling)
Time frame: 2 weeks
Population: All 60 subjects randomized to both sets of lenses.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Overall Study Group | Comfort, Dryness, Handling, Lens Fit Stability, Vision Satisfaction | Comfort prior to Removal | 8.7 units on a scale | Standard Deviation 1.1 |
| Overall Study Group | Comfort, Dryness, Handling, Lens Fit Stability, Vision Satisfaction | Dryness Overall | 8.7 units on a scale | Standard Deviation 1.3 |
| Overall Study Group | Comfort, Dryness, Handling, Lens Fit Stability, Vision Satisfaction | Dryness during the Day | 8.7 units on a scale | Standard Deviation 1.3 |
| Overall Study Group | Comfort, Dryness, Handling, Lens Fit Stability, Vision Satisfaction | Handling | 8.3 units on a scale | Standard Deviation 1.1 |
| Overall Study Group | Comfort, Dryness, Handling, Lens Fit Stability, Vision Satisfaction | Comfort Overall | 8.8 units on a scale | Standard Deviation 1.1 |
| Overall Study Group | Comfort, Dryness, Handling, Lens Fit Stability, Vision Satisfaction | Lens Fit Stability | 8.8 units on a scale | Standard Deviation 1.2 |
| Overall Study Group | Comfort, Dryness, Handling, Lens Fit Stability, Vision Satisfaction | Dryness prior to Removal | 8.6 units on a scale | Standard Deviation 1.5 |
| Overall Study Group | Comfort, Dryness, Handling, Lens Fit Stability, Vision Satisfaction | Vision Satisfaction | 8.7 units on a scale | Standard Deviation 1.1 |
| Overall Study Group | Comfort, Dryness, Handling, Lens Fit Stability, Vision Satisfaction | Comfort on Insertion | 8.7 units on a scale | Standard Deviation 1.1 |
| Lotrafilcon B | Comfort, Dryness, Handling, Lens Fit Stability, Vision Satisfaction | Vision Satisfaction | 8.0 units on a scale | Standard Deviation 1.5 |
| Lotrafilcon B | Comfort, Dryness, Handling, Lens Fit Stability, Vision Satisfaction | Comfort on Insertion | 7.7 units on a scale | Standard Deviation 1.3 |
| Lotrafilcon B | Comfort, Dryness, Handling, Lens Fit Stability, Vision Satisfaction | Comfort prior to Removal | 7.4 units on a scale | Standard Deviation 1.4 |
| Lotrafilcon B | Comfort, Dryness, Handling, Lens Fit Stability, Vision Satisfaction | Comfort Overall | 7.6 units on a scale | Standard Deviation 1.3 |
| Lotrafilcon B | Comfort, Dryness, Handling, Lens Fit Stability, Vision Satisfaction | Dryness during the Day | 7.6 units on a scale | Standard Deviation 1.4 |
| Lotrafilcon B | Comfort, Dryness, Handling, Lens Fit Stability, Vision Satisfaction | Dryness prior to Removal | 7.5 units on a scale | Standard Deviation 1.5 |
| Lotrafilcon B | Comfort, Dryness, Handling, Lens Fit Stability, Vision Satisfaction | Dryness Overall | 7.5 units on a scale | Standard Deviation 1.5 |
| Lotrafilcon B | Comfort, Dryness, Handling, Lens Fit Stability, Vision Satisfaction | Handling | 8.0 units on a scale | Standard Deviation 1.6 |
| Lotrafilcon B | Comfort, Dryness, Handling, Lens Fit Stability, Vision Satisfaction | Lens Fit Stability | 8.0 units on a scale | Standard Deviation 1.5 |
Primary
Comfort, Dryness, Handling, Lens Fit Stability, Vision Satisfaction
Participant rating of lens Comfort, Dryness, Handling, Lens Fit Stability and Vision Satisfaction. Collected at 4 weeks wear for each lens. (0-10; Comfort, Lens Fit and Satisfaction / 0=very poor,10=excellent; Dryness / 0=very dry, 10=no dryness; Handling / 0=very difficult, 10=very easy for handling)
Time frame: 4 weeks
Population: All 60 subjects randomized to both sets of lenses.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Overall Study Group | Comfort, Dryness, Handling, Lens Fit Stability, Vision Satisfaction | Comfort prior to Removal | 8.5 units on a scale | Standard Deviation 1.1 |
| Overall Study Group | Comfort, Dryness, Handling, Lens Fit Stability, Vision Satisfaction | Dryness Overall | 8.6 units on a scale | Standard Deviation 1.1 |
| Overall Study Group | Comfort, Dryness, Handling, Lens Fit Stability, Vision Satisfaction | Dryness during the Day | 8.5 units on a scale | Standard Deviation 1.1 |
| Overall Study Group | Comfort, Dryness, Handling, Lens Fit Stability, Vision Satisfaction | Handling | 8.2 units on a scale | Standard Deviation 1.1 |
| Overall Study Group | Comfort, Dryness, Handling, Lens Fit Stability, Vision Satisfaction | Comfort Overall | 8.6 units on a scale | Standard Deviation 1.1 |
| Overall Study Group | Comfort, Dryness, Handling, Lens Fit Stability, Vision Satisfaction | Lens Fit Stability | 8.6 units on a scale | Standard Deviation 1.1 |
| Overall Study Group | Comfort, Dryness, Handling, Lens Fit Stability, Vision Satisfaction | Dryness prior to Removal | 8.5 units on a scale | Standard Deviation 1.1 |
| Overall Study Group | Comfort, Dryness, Handling, Lens Fit Stability, Vision Satisfaction | Vision Satisfaction | 8.5 units on a scale | Standard Deviation 1 |
| Overall Study Group | Comfort, Dryness, Handling, Lens Fit Stability, Vision Satisfaction | Comfort on Insertion | 8.6 units on a scale | Standard Deviation 1 |
| Lotrafilcon B | Comfort, Dryness, Handling, Lens Fit Stability, Vision Satisfaction | Vision Satisfaction | 7.6 units on a scale | Standard Deviation 1.6 |
| Lotrafilcon B | Comfort, Dryness, Handling, Lens Fit Stability, Vision Satisfaction | Comfort on Insertion | 7.1 units on a scale | Standard Deviation 1.5 |
| Lotrafilcon B | Comfort, Dryness, Handling, Lens Fit Stability, Vision Satisfaction | Comfort prior to Removal | 6.7 units on a scale | Standard Deviation 1.6 |
| Lotrafilcon B | Comfort, Dryness, Handling, Lens Fit Stability, Vision Satisfaction | Comfort Overall | 6.9 units on a scale | Standard Deviation 1.6 |
| Lotrafilcon B | Comfort, Dryness, Handling, Lens Fit Stability, Vision Satisfaction | Dryness during the Day | 7.0 units on a scale | Standard Deviation 1.6 |
| Lotrafilcon B | Comfort, Dryness, Handling, Lens Fit Stability, Vision Satisfaction | Dryness prior to Removal | 7.0 units on a scale | Standard Deviation 1.5 |
| Lotrafilcon B | Comfort, Dryness, Handling, Lens Fit Stability, Vision Satisfaction | Dryness Overall | 7.0 units on a scale | Standard Deviation 1.6 |
| Lotrafilcon B | Comfort, Dryness, Handling, Lens Fit Stability, Vision Satisfaction | Handling | 7.8 units on a scale | Standard Deviation 1.7 |
| Lotrafilcon B | Comfort, Dryness, Handling, Lens Fit Stability, Vision Satisfaction | Lens Fit Stability | 7.6 units on a scale | Standard Deviation 1.6 |
Primary
Comfort Satisfaction
Participant rating for comfort satisfaction. Collected at 4 weeks wear for each lens. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)
Time frame: 4 weeks
Population: All 60 subjects randomized to both sets of lenses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Study Group | Comfort Satisfaction | Somewhat Dissatisfied | 5 percentage of participants |
| Overall Study Group | Comfort Satisfaction | Completely Satisfied | 72 percentage of participants |
| Overall Study Group | Comfort Satisfaction | Completely Dissatisfied | 0 percentage of participants |
| Overall Study Group | Comfort Satisfaction | Somewhat Satisfied | 23 percentage of participants |
| Lotrafilcon B | Comfort Satisfaction | Completely Dissatisfied | 10 percentage of participants |
| Lotrafilcon B | Comfort Satisfaction | Somewhat Satisfied | 37 percentage of participants |
| Lotrafilcon B | Comfort Satisfaction | Somewhat Dissatisfied | 27 percentage of participants |
| Lotrafilcon B | Comfort Satisfaction | Completely Satisfied | 27 percentage of participants |
Primary
Comfort Satisfaction
Participant rating for comfort satisfaction. Collected at 2 weeks wear for each lens. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)
Time frame: 2 weeks
Population: All 60 subjects randomized to both sets of lenses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Study Group | Comfort Satisfaction | Somewhat Satisfied | 23 percentage of participants |
| Overall Study Group | Comfort Satisfaction | Completely Satisfied | 72 percentage of participants |
| Overall Study Group | Comfort Satisfaction | Somewhat Dissatisfied | 5 percentage of participants |
| Overall Study Group | Comfort Satisfaction | Completely Dissatisfied | 0 percentage of participants |
| Lotrafilcon B | Comfort Satisfaction | Completely Dissatisfied | 2 percentage of participants |
| Lotrafilcon B | Comfort Satisfaction | Somewhat Dissatisfied | 28 percentage of participants |
| Lotrafilcon B | Comfort Satisfaction | Completely Satisfied | 25 percentage of participants |
| Lotrafilcon B | Comfort Satisfaction | Somewhat Satisfied | 45 percentage of participants |
Primary
Comfort Satisfaction
Participant rating for comfort satisfaction. Collected at baseline for all habitual lenses. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)
Time frame: Baseline
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Study Group | Comfort Satisfaction | Completely Satisfied | 37 percentage of participants |
| Overall Study Group | Comfort Satisfaction | Somewhat Satisfied | 55 percentage of participants |
| Overall Study Group | Comfort Satisfaction | Somewhat Dissatisfied | 7 percentage of participants |
| Overall Study Group | Comfort Satisfaction | Completely Dissatisfied | 2 percentage of participants |
Primary
Comfort Upon Contact Lens Insertion
Participant rating of comfort upon insertion. Collected at dispense for each lens. (0-10; 10=Can't Feel)
Time frame: Dispense
Population: All 60 subjects randomized to both sets of lenses.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Overall Study Group | Comfort Upon Contact Lens Insertion | 9.0 units on a scale | Standard Deviation 0.8 |
| Lotrafilcon B | Comfort Upon Contact Lens Insertion | 7.8 units on a scale | Standard Deviation 1.2 |
Primary
Corneal Coverage
Assessment of Lens Fit Performance for corneal coverage. Collected at 2 weks for each lens. Corneal coverage assessed in primary gaze: (yes=full corneal coverage at all times, no=incomplete corneal coverage)
Time frame: 2 weeks
Population: All 60 subjects randomized to both sets of lenses.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Overall Study Group | Corneal Coverage | 100 percentage of lenses |
| Lotrafilcon B | Corneal Coverage | 100 percentage of lenses |
Primary
Corneal Coverage
Assessment of Lens Fit Performance for corneal coverage. Collected at 4 weeks for each lens. Corneal coverage assessed in primary gaze: (yes=full corneal coverage at all times, no=incomplete corneal coverage)
Time frame: 4 weeks
Population: All 60 subjects randomized to both sets of lenses.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Overall Study Group | Corneal Coverage | 100 percentage of lenses |
| Lotrafilcon B | Corneal Coverage | 100 percentage of lenses |
Primary
Corneal Coverage
Assessment of Lens Fit Performance for corneal coverage. Collected at dispense for each lens. Corneal coverage assessed in primary gaze: (yes=full corneal coverage at all times, no=incomplete corneal coverage)
Time frame: Dispense
Population: All 60 subjects randomized to both sets of lenses.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Overall Study Group | Corneal Coverage | 100 percentage of lenses |
| Lotrafilcon B | Corneal Coverage | 100 percentage of lenses |
Primary
Daily and Comfortable Wearing Time
Participant rating of lens Daily and Comfortable Wearing Time. Collected at 2 weeks wear for each lens. (The hours of average comfortable wearing time and average daily wearing time.)
Time frame: 2 weeks
Population: All 60 subjects randomized to both sets of lenses.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Overall Study Group | Daily and Comfortable Wearing Time | average comfortable wearing time | 9.8 hours | Standard Deviation 2.3 |
| Overall Study Group | Daily and Comfortable Wearing Time | average daily wearing time | 10.1 hours | Standard Deviation 2 |
| Lotrafilcon B | Daily and Comfortable Wearing Time | average daily wearing time | 10.1 hours | Standard Deviation 1.8 |
| Lotrafilcon B | Daily and Comfortable Wearing Time | average comfortable wearing time | 8.3 hours | Standard Deviation 3 |
Primary
Daily and Comfortable Wearing Time
Participant rating of lens Daily and Comfortable Wearing Time. Collected at baseline for all habitual lenses. (The hours of average comfortable wearing time and average daily wearing time.)
Time frame: Baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Overall Study Group | Daily and Comfortable Wearing Time | Average comfortable wearing time | 8.8 hours | Standard Deviation 2.5 |
| Overall Study Group | Daily and Comfortable Wearing Time | Average daily wearing time | 9.2 hours | Standard Deviation 2.6 |
Primary
Daily and Comfortable Wearing Time
Participant rating of lens Daily and Comfortable Wearing Time. Collected at 4 weeks wear for each lens. (The hours of average comfortable wearing time and average daily wearing time.)
Time frame: 4 weeks
Population: All 60 subjects randomized to both sets of lenses.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Overall Study Group | Daily and Comfortable Wearing Time | average comfortable wearing time | 9.5 hours | Standard Deviation 2.1 |
| Overall Study Group | Daily and Comfortable Wearing Time | average daily wearing time | 9.9 hours | Standard Deviation 1.7 |
| Lotrafilcon B | Daily and Comfortable Wearing Time | average comfortable wearing time | 7.8 hours | Standard Deviation 2.8 |
| Lotrafilcon B | Daily and Comfortable Wearing Time | average daily wearing time | 9.8 hours | Standard Deviation 1.7 |
Primary
Dryness Satisfaction
Participant rating for dryness satisfaction. Collected at baseline for all habitual lenses. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)
Time frame: Baseline
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Study Group | Dryness Satisfaction | Completely Satisfied | 33 percentage of participants |
| Overall Study Group | Dryness Satisfaction | Somewhat Satisfied | 53 percentage of participants |
| Overall Study Group | Dryness Satisfaction | Somewhat Dissatisfied | 12 percentage of participants |
| Overall Study Group | Dryness Satisfaction | Completely Dissatisfied | 2 percentage of participants |
Primary
Dryness Satisfaction
Participant rating for dryness satisfaction. Collected at 4 weeks wear for each lens. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)
Time frame: 4 weeks
Population: All 60 subjects randomized to both sets of lenses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Study Group | Dryness Satisfaction | Completely Satisfied | 77 percentage of participants |
| Overall Study Group | Dryness Satisfaction | Somewhat Satisfied | 13 percentage of participants |
| Overall Study Group | Dryness Satisfaction | Somewhat Dissatisfied | 10 percentage of participants |
| Overall Study Group | Dryness Satisfaction | Completely Dissatisfied | 0 percentage of participants |
| Lotrafilcon B | Dryness Satisfaction | Completely Dissatisfied | 10 percentage of participants |
| Lotrafilcon B | Dryness Satisfaction | Completely Satisfied | 23 percentage of participants |
| Lotrafilcon B | Dryness Satisfaction | Somewhat Dissatisfied | 32 percentage of participants |
| Lotrafilcon B | Dryness Satisfaction | Somewhat Satisfied | 35 percentage of participants |
Primary
Dryness Satisfaction
Participant rating for dryness satisfaction. Collected at 2 weeks wear for each lens. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)
Time frame: 2 weeks
Population: All 60 subjects randomized to both sets of lenses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Study Group | Dryness Satisfaction | Completely Satisfied | 73 percentage of participants |
| Overall Study Group | Dryness Satisfaction | Somewhat Satisfied | 27 percentage of participants |
| Overall Study Group | Dryness Satisfaction | Somewhat Dissatisfied | 0 percentage of participants |
| Overall Study Group | Dryness Satisfaction | Completely Dissatisfied | 0 percentage of participants |
| Lotrafilcon B | Dryness Satisfaction | Completely Dissatisfied | 1.7 percentage of participants |
| Lotrafilcon B | Dryness Satisfaction | Completely Satisfied | 32 percentage of participants |
| Lotrafilcon B | Dryness Satisfaction | Somewhat Dissatisfied | 25 percentage of participants |
| Lotrafilcon B | Dryness Satisfaction | Somewhat Satisfied | 42 percentage of participants |
Primary
Handling Satisfaction
Participant rating for handling satisfaction. Collected at baseline for all habitual lenses. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)
Time frame: Baseline
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Study Group | Handling Satisfaction | Completely Satisfied | 57 percentage of participants |
| Overall Study Group | Handling Satisfaction | Somewhat Satisfied | 37 percentage of participants |
| Overall Study Group | Handling Satisfaction | Somewhat Dissatisfied | 5 percentage of participants |
| Overall Study Group | Handling Satisfaction | Completely Dissatisfied | 2 percentage of participants |
Primary
Handling Satisfaction
Participant rating for handling satisfaction. Collected at 4 weeks wear for each lens. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)
Time frame: 4 weeks
Population: All 60 subjects randomized to both sets of lenses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Study Group | Handling Satisfaction | Completely Satisfied | 42 percentage of participants |
| Overall Study Group | Handling Satisfaction | Somewhat Satisfied | 48 percentage of participants |
| Overall Study Group | Handling Satisfaction | Somewhat Dissatisfied | 10 percentage of participants |
| Overall Study Group | Handling Satisfaction | Completely Dissatisfied | 0 percentage of participants |
| Lotrafilcon B | Handling Satisfaction | Completely Dissatisfied | 0 percentage of participants |
| Lotrafilcon B | Handling Satisfaction | Completely Satisfied | 40 percentage of participants |
| Lotrafilcon B | Handling Satisfaction | Somewhat Dissatisfied | 12 percentage of participants |
| Lotrafilcon B | Handling Satisfaction | Somewhat Satisfied | 48 percentage of participants |
Primary
Handling Satisfaction
Participant rating for handling satisfaction. Collected at 2 weeks wear for each lens. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)
Time frame: 2 weeks
Population: All 60 subjects randomized to both sets of lenses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Study Group | Handling Satisfaction | Completely Satisfied | 47 percentage of participants |
| Overall Study Group | Handling Satisfaction | Somewhat Dissatisfied | 12 percentage of participants |
| Overall Study Group | Handling Satisfaction | Somewhat Satisfied | 42 percentage of participants |
| Overall Study Group | Handling Satisfaction | Completely Dissatisfied | 0 percentage of participants |
| Lotrafilcon B | Handling Satisfaction | Somewhat Satisfied | 43 percentage of participants |
| Lotrafilcon B | Handling Satisfaction | Completely Satisfied | 45 percentage of participants |
| Lotrafilcon B | Handling Satisfaction | Completely Dissatisfied | 1.7 percentage of participants |
| Lotrafilcon B | Handling Satisfaction | Somewhat Dissatisfied | 10 percentage of participants |
Primary
Lens Fit Satisfaction
Participant rating for lens fit satisfaction. Collected at 2 weeks wear for each lens. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)
Time frame: 2 weeks
Population: All 60 subjects randomized to both sets of lenses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Study Group | Lens Fit Satisfaction | Completely Satisfied | 70 percentage of participants |
| Overall Study Group | Lens Fit Satisfaction | Somewhat Satisfied | 27 percentage of participants |
| Overall Study Group | Lens Fit Satisfaction | Somewhat Dissatisfied | 3 percentage of participants |
| Overall Study Group | Lens Fit Satisfaction | Completely Dissatisfied | 0 percentage of participants |
| Lotrafilcon B | Lens Fit Satisfaction | Completely Dissatisfied | 2 percentage of participants |
| Lotrafilcon B | Lens Fit Satisfaction | Completely Satisfied | 45 percentage of participants |
| Lotrafilcon B | Lens Fit Satisfaction | Somewhat Dissatisfied | 7 percentage of participants |
| Lotrafilcon B | Lens Fit Satisfaction | Somewhat Satisfied | 47 percentage of participants |
Primary
Lens Fit Satisfaction
Participant rating for lens fit satisfaction. Collected at baseline for all habitual lenses. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)
Time frame: Baseline
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Study Group | Lens Fit Satisfaction | Completely Satisfied | 42 percentage of participants |
| Overall Study Group | Lens Fit Satisfaction | Somewhat Satisfied | 50 percentage of participants |
| Overall Study Group | Lens Fit Satisfaction | Somewhat Dissatisfied | 8 percentage of participants |
| Overall Study Group | Lens Fit Satisfaction | Completely Dissatisfied | 0 percentage of participants |
Primary
Lens Fit Satisfaction
Participant rating for lens fit satisfaction. Collected at 4 weeks wear for each lens. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)
Time frame: 4 weeks
Population: All 60 subjects randomized to both sets of lenses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Study Group | Lens Fit Satisfaction | Completely Satisfied | 70 percentage of participants |
| Overall Study Group | Lens Fit Satisfaction | Somewhat Dissatisfied | 5 percentage of participants |
| Overall Study Group | Lens Fit Satisfaction | Completely Dissatisfied | 0 percentage of participants |
| Overall Study Group | Lens Fit Satisfaction | Somewhat Satisfied | 25 percentage of participants |
| Lotrafilcon B | Lens Fit Satisfaction | Completely Dissatisfied | 0 percentage of participants |
| Lotrafilcon B | Lens Fit Satisfaction | Completely Satisfied | 35 percentage of participants |
| Lotrafilcon B | Lens Fit Satisfaction | Somewhat Satisfied | 55 percentage of participants |
| Lotrafilcon B | Lens Fit Satisfaction | Somewhat Dissatisfied | 10 percentage of participants |
Primary
Lens Marking Visibility
Assessment of Lens Fit Performance for lens marking visibility. Collected at dispense for each lens. (1-3, 1=excellent, 2=average, 3=poor)
Time frame: Dispense
Population: All 60 subjects randomized to both sets of lenses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Study Group | Lens Marking Visibility | Excellent | 89 percentage of lenses |
| Overall Study Group | Lens Marking Visibility | Average | 11 percentage of lenses |
| Overall Study Group | Lens Marking Visibility | Poor | 0 percentage of lenses |
| Lotrafilcon B | Lens Marking Visibility | Excellent | 42 percentage of lenses |
| Lotrafilcon B | Lens Marking Visibility | Average | 42 percentage of lenses |
| Lotrafilcon B | Lens Marking Visibility | Poor | 16 percentage of lenses |
Primary
Lens Marking Visibility
Assessment of Lens Fit Performance for lens marking visibility. Collected at 2 weeks for each lens. (1-3, 1=excellent, 2=average, 3=poor)
Time frame: 2 weeks
Population: All 60 subjects randomized to both sets of lenses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Study Group | Lens Marking Visibility | Excellent | 88 percentage of lenses |
| Overall Study Group | Lens Marking Visibility | Average | 12 percentage of lenses |
| Overall Study Group | Lens Marking Visibility | Poor | 0 percentage of lenses |
| Lotrafilcon B | Lens Marking Visibility | Excellent | 27 percentage of lenses |
| Lotrafilcon B | Lens Marking Visibility | Average | 49 percentage of lenses |
| Lotrafilcon B | Lens Marking Visibility | Poor | 24 percentage of lenses |
Primary
Lens Marking Visibility
Assessment of Lens Fit Performance for lens marking visibility. Collected at 4 weeks for each lens. (1-3, 1=excellent, 2=average, 3=poor)
Time frame: 4 weeks
Population: All 60 subjects randomized to both sets of lenses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Study Group | Lens Marking Visibility | Excellent | 84 percentage of lenses |
| Overall Study Group | Lens Marking Visibility | Average | 16 percentage of lenses |
| Overall Study Group | Lens Marking Visibility | Poor | 0 percentage of lenses |
| Lotrafilcon B | Lens Marking Visibility | Excellent | 20 percentage of lenses |
| Lotrafilcon B | Lens Marking Visibility | Average | 50 percentage of lenses |
| Lotrafilcon B | Lens Marking Visibility | Poor | 30 percentage of lenses |
Primary
Lens Orientation Primary Gaze
Assessment of Lens Fit Performance for lens orientation in primary position of gaze. Collected at dispense for each lens. (Degree of mislocation relative to lens axis mark.)
Time frame: Dispense
Population: All 60 subjects randomized to both sets of lenses.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Overall Study Group | Lens Orientation Primary Gaze | 0.71 degrees | Standard Deviation 1.75 |
| Lotrafilcon B | Lens Orientation Primary Gaze | 1.06 degrees | Standard Deviation 1.9 |
Primary
Lens Orientation Primary Gaze
Assessment of Lens Fit Performance for lens orientation in primary position of gaze. Assessed at 2 weeks wear for each lens. (Degree of mislocation relative to lens axis mark.)
Time frame: 2 weeks
Population: All 60 subjects randomized to both sets of lenses.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Overall Study Group | Lens Orientation Primary Gaze | 0.67 degrees | Standard Deviation 1.71 |
| Lotrafilcon B | Lens Orientation Primary Gaze | 1.17 degrees | Standard Deviation 2.22 |
Primary
Lens Orientation Primary Gaze
Assessment of Lens Fit Performance for lens orientation in primary position of gaze. Assessed at 4 weeks wear for each lens. (Degree of mislocation relative to lens axis mark.)
Time frame: 4 weeks
Population: All 60 subjects randomized to both sets of lenses.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Overall Study Group | Lens Orientation Primary Gaze | 0.87 degrees | Standard Deviation 2.01 |
| Lotrafilcon B | Lens Orientation Primary Gaze | 1.08 degrees | Standard Deviation 2.17 |
Primary
Lens Overall Stability
Assessment of Lens Fit Performance for overall lens stability. Collected at dispense for each lens. (Excellent or Good)
Time frame: Dispense
Population: All 60 subjects randomized to both sets of lenses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Study Group | Lens Overall Stability | Excellent | 80 percentage of lenses |
| Overall Study Group | Lens Overall Stability | Good | 20 percentage of lenses |
| Lotrafilcon B | Lens Overall Stability | Excellent | 50 percentage of lenses |
| Lotrafilcon B | Lens Overall Stability | Good | 50 percentage of lenses |
Primary
Lens Stability 5-10 Min
Assessment of Lens Fit Performance for lens to stabilize in 5-10 min. Collected at 4 weeks for each lens. Varied less than 5 degrees from lens marking location between 5-10 min.
Time frame: 4 weeks
Population: All 60 subjects randomized to both sets of lenses.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Overall Study Group | Lens Stability 5-10 Min | 100 percentage of lenses |
| Lotrafilcon B | Lens Stability 5-10 Min | 100 percentage of lenses |
Primary
Lens Stability 5-10 Min
Assessment of Lens Fit Performance for lens to stabilize in 5-10 min. Collected at dispense for each lens. (Varied less than 5 degrees from lens marking location between 5-10 min)
Time frame: Dispense
Population: All 60 subjects randomized to both sets of lenses.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Overall Study Group | Lens Stability 5-10 Min | 100 percentage of lenses |
| Lotrafilcon B | Lens Stability 5-10 Min | 100 percentage of lenses |
Primary
Lens Stability 5-10 Min
Assessment of Lens Fit Performance for lens to stabilize in 5-10 min. Collected at 2 weeks for each lens. Varied less than 5 degrees from lens marking location between 5-10 min.
Time frame: 2 weeks
Population: All 60 subjects randomized to both sets of lenses.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Overall Study Group | Lens Stability 5-10 Min | 100 percentage of lenses |
| Lotrafilcon B | Lens Stability 5-10 Min | 100 percentage of lenses |
Primary
Lens Stability on Blink
Assessment of Lens Fit Performance for lens rotational stability on blink. Collected at dispense for each lens. (No rotation and 5-10 degrees rotation from axis location mark)
Time frame: Dispense
Population: All 60 subjects randomized to both sets of lenses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Study Group | Lens Stability on Blink | No rotation | 100 percentage of lenses |
| Overall Study Group | Lens Stability on Blink | 5-10 degrees | 0 percentage of lenses |
| Lotrafilcon B | Lens Stability on Blink | No rotation | 98 percentage of lenses |
| Lotrafilcon B | Lens Stability on Blink | 5-10 degrees | 2 percentage of lenses |
Primary
Lens Stability on Blink
Assessment of Lens Fit Performance for lens rotational stability on blink. Collected at 2 weeks for each lens. (No rotation and 5-10 degrees rotation from axis location mark)
Time frame: 2 weeks
Population: All 60 subjects randomized to both sets of lenses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Study Group | Lens Stability on Blink | No rotation | 98 percentage of lenses |
| Overall Study Group | Lens Stability on Blink | 5-10 degrees | 2 percentage of lenses |
| Lotrafilcon B | Lens Stability on Blink | No rotation | 99 percentage of lenses |
| Lotrafilcon B | Lens Stability on Blink | 5-10 degrees | 1 percentage of lenses |
Primary
Lens Stability on Blink
Assessment of Lens Fit Performance for lens rotational stability on blink. Collected at 4 weeks for each lens. (No rotation and 5-10 degrees rotation from axis location mark)
Time frame: 4 weeks
Population: All 60 subjects randomized to both sets of lenses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Study Group | Lens Stability on Blink | No rotation | 100 percentage of lenses |
| Overall Study Group | Lens Stability on Blink | 5-10 degrees | 0 percentage of lenses |
| Lotrafilcon B | Lens Stability on Blink | No rotation | 99 percentage of lenses |
| Lotrafilcon B | Lens Stability on Blink | 5-10 degrees | 1 percentage of lenses |
Primary
Lens Surface Deposits
Assessment of lens front surface deposits. Collected at 2 weeks wear for each lens. (Front surface deposits observed, 0-4, 0=clean, 4=deposits ≥0.5)
Time frame: 2 weeks
Population: All 60 subjects randomized to both sets of lenses.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Overall Study Group | Lens Surface Deposits | 0.26 units on a scale | Standard Deviation 0.31 |
| Lotrafilcon B | Lens Surface Deposits | 0.41 units on a scale | Standard Deviation 0.36 |
Primary
Lens Surface Deposits
Assessment of lens front surface deposits. Collected at 4 weeks wear for each lens. (Front surface deposits observed, 0-4, 0=clean, 4=deposits ≥0.5)
Time frame: 4 weeks
Population: All 60 subjects randomized to both sets of lenses.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Overall Study Group | Lens Surface Deposits | 0.41 units on a scale | Standard Deviation 0.34 |
| Lotrafilcon B | Lens Surface Deposits | 0.71 units on a scale | Standard Deviation 0.41 |
Primary
Overall Fit Acceptance
Assessment of Lens Fit Performance for overall lens fit acceptance. Collected at 2 weeks for each lens. Rated perfect or not perfect based on lens fit alone. (0-4; 0=should not be worn, 3=not perfect but OK to dispense, 4=perfect)
Time frame: 2 weeks
Population: All 60 subjects randomized to both sets of lenses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Study Group | Overall Fit Acceptance | Perfect | 76 percentage of lenses |
| Overall Study Group | Overall Fit Acceptance | Not Perfect | 24 percentage of lenses |
| Lotrafilcon B | Overall Fit Acceptance | Perfect | 49 percentage of lenses |
| Lotrafilcon B | Overall Fit Acceptance | Not Perfect | 51 percentage of lenses |
Primary
Overall Fit Acceptance
Assessment of Lens Fit Performance for overall lens fit acceptance. Collected at dispense for each lens. Rated perfect or not perfect based on lens fit alone. (0-4; 0=should not be worn, 3=not perfect but OK to dispense, 4=perfect)
Time frame: Dispense
Population: All 60 subjects randomized to both sets of lenses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Study Group | Overall Fit Acceptance | Perfect | 82 percentage of lenses fitted |
| Overall Study Group | Overall Fit Acceptance | Not Perfect | 18 percentage of lenses fitted |
| Lotrafilcon B | Overall Fit Acceptance | Perfect | 57 percentage of lenses fitted |
| Lotrafilcon B | Overall Fit Acceptance | Not Perfect | 43 percentage of lenses fitted |
Primary
Overall Fit Acceptance
Assessment of Lens Fit Performance for overall lens fit acceptance. Collected at 4 weeks for each lens. Rated perfect or not perfect based on lens fit alone. (0-4; 0=should not be worn, 3=not perfect but OK to dispense, 4=perfect)
Time frame: 4 weeks
Population: All 60 subjects randomized to both sets of lenses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Study Group | Overall Fit Acceptance | Perfect | 73 percentage of lenses |
| Overall Study Group | Overall Fit Acceptance | Not Perfect | 27 percentage of lenses |
| Lotrafilcon B | Overall Fit Acceptance | Perfect | 44 percentage of lenses |
| Lotrafilcon B | Overall Fit Acceptance | Not Perfect | 56 percentage of lenses |
Primary
Overall Satisfaction
Participant rating for overall satisfaction. Collected at 2 weeks wear for each lens. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)
Time frame: 2 weeks
Population: All 60 subjects randomized to both sets of lenses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Study Group | Overall Satisfaction | Completely Satisfied | 68 percentage of participants |
| Overall Study Group | Overall Satisfaction | Somewhat Satisfied | 30 percentage of participants |
| Overall Study Group | Overall Satisfaction | Somewhat Dissatisfied | 2 percentage of participants |
| Overall Study Group | Overall Satisfaction | Completely Dissatisfied | 0 percentage of participants |
| Lotrafilcon B | Overall Satisfaction | Completely Dissatisfied | 2 percentage of participants |
| Lotrafilcon B | Overall Satisfaction | Completely Satisfied | 30 percentage of participants |
| Lotrafilcon B | Overall Satisfaction | Somewhat Dissatisfied | 23 percentage of participants |
| Lotrafilcon B | Overall Satisfaction | Somewhat Satisfied | 45 percentage of participants |
Primary
Overall Satisfaction
Participant rating for overall satisfaction. Collected at baseline for all habitual lenses. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)
Time frame: Baseline
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Study Group | Overall Satisfaction | Completely Satisfied | 40 percentage of participants |
| Overall Study Group | Overall Satisfaction | Somewhat Satisfied | 53 percentage of participants |
| Overall Study Group | Overall Satisfaction | Somewhat Dissatisfied | 7 percentage of participants |
| Overall Study Group | Overall Satisfaction | Completely Dissatisfied | 0 percentage of participants |
Primary
Overall Satisfaction
Participant rating for overall satisfaction. Collected at 4 weeks wear for each lens. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)
Time frame: 4 weeks
Population: All 60 subjects randomized to both sets of lenses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Study Group | Overall Satisfaction | Completely Satisfied | 65 percentage of participants |
| Overall Study Group | Overall Satisfaction | Somewhat Satisfied | 28 percentage of participants |
| Overall Study Group | Overall Satisfaction | Somewhat Dissatisfied | 7 percentage of participants |
| Overall Study Group | Overall Satisfaction | Completely Dissatisfied | 0 percentage of participants |
| Lotrafilcon B | Overall Satisfaction | Completely Dissatisfied | 7 percentage of participants |
| Lotrafilcon B | Overall Satisfaction | Completely Satisfied | 22 percentage of participants |
| Lotrafilcon B | Overall Satisfaction | Somewhat Dissatisfied | 27 percentage of participants |
| Lotrafilcon B | Overall Satisfaction | Somewhat Satisfied | 45 percentage of participants |
Primary
Overall Sensation of Moistness
Participant rating for overall sensation of moistness. Collected at 4 weeks wear for each lens. (5-point Likert Scale; Excellent, Good, Average, Below Average, Poor)
Time frame: 4 weeks
Population: All 60 subjects randomized to both sets of lenses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Study Group | Overall Sensation of Moistness | Good | 27 percentage of participants |
| Overall Study Group | Overall Sensation of Moistness | Below Average | 2 percentage of participants |
| Overall Study Group | Overall Sensation of Moistness | Average | 12 percentage of participants |
| Overall Study Group | Overall Sensation of Moistness | Poor | 0 percentage of participants |
| Overall Study Group | Overall Sensation of Moistness | Excellent | 60 percentage of participants |
| Lotrafilcon B | Overall Sensation of Moistness | Poor | 3 percentage of participants |
| Lotrafilcon B | Overall Sensation of Moistness | Excellent | 18 percentage of participants |
| Lotrafilcon B | Overall Sensation of Moistness | Good | 23 percentage of participants |
| Lotrafilcon B | Overall Sensation of Moistness | Average | 30 percentage of participants |
| Lotrafilcon B | Overall Sensation of Moistness | Below Average | 25 percentage of participants |
Primary
Overall Sensation of Moistness
Participant rating for overall sensation of moistness. Collected at 2 weeks wear for each lens. (5-point Likert Scale; Excellent, Good, Average, Below Average, Poor)
Time frame: 2 weeks
Population: All 60 subjects randomized to both sets of lenses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Study Group | Overall Sensation of Moistness | Good | 30 percentage of participants |
| Overall Study Group | Overall Sensation of Moistness | Below Average | 0 percentage of participants |
| Overall Study Group | Overall Sensation of Moistness | Average | 13 percentage of participants |
| Overall Study Group | Overall Sensation of Moistness | Poor | 0 percentage of participants |
| Overall Study Group | Overall Sensation of Moistness | Excellent | 57 percentage of participants |
| Lotrafilcon B | Overall Sensation of Moistness | Poor | 5 percentage of participants |
| Lotrafilcon B | Overall Sensation of Moistness | Excellent | 20 percentage of participants |
| Lotrafilcon B | Overall Sensation of Moistness | Good | 30 percentage of participants |
| Lotrafilcon B | Overall Sensation of Moistness | Average | 33 percentage of participants |
| Lotrafilcon B | Overall Sensation of Moistness | Below Average | 12 percentage of participants |
Primary
Overall Sensation of Moistness
Participant rating for overall sensation of moistness. Collected at baseline for all habitual lenses. (5-point Likert Scale; Excellent, Good, Average, Below Average)
Time frame: Baseline
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Study Group | Overall Sensation of Moistness | Good | 25 percentage of subjects |
| Overall Study Group | Overall Sensation of Moistness | Average | 50 percentage of subjects |
| Overall Study Group | Overall Sensation of Moistness | Below Average | 0 percentage of subjects |
| Overall Study Group | Overall Sensation of Moistness | Excellent | 23 percentage of subjects |
| Overall Study Group | Overall Sensation of Moistness | Poor | 2 percentage of subjects |
Primary
Overall Sensation of Smoothness
Participant rating for overall sensation of smoothness. Collected at 4 weeks wear for each lens. (5-point Likert Scale; Excellent, Good, Average, Below Average, Poor)
Time frame: 4 weeks
Population: All 60 subjects randomized to both sets of lenses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Study Group | Overall Sensation of Smoothness | Good | 42 percentage of participants |
| Overall Study Group | Overall Sensation of Smoothness | Below Average | 2 percentage of participants |
| Overall Study Group | Overall Sensation of Smoothness | Average | 10 percentage of participants |
| Overall Study Group | Overall Sensation of Smoothness | Poor | 0 percentage of participants |
| Overall Study Group | Overall Sensation of Smoothness | Excellent | 47 percentage of participants |
| Lotrafilcon B | Overall Sensation of Smoothness | Poor | 3 percentage of participants |
| Lotrafilcon B | Overall Sensation of Smoothness | Excellent | 13 percentage of participants |
| Lotrafilcon B | Overall Sensation of Smoothness | Good | 38 percentage of participants |
| Lotrafilcon B | Overall Sensation of Smoothness | Average | 28 percentage of participants |
| Lotrafilcon B | Overall Sensation of Smoothness | Below Average | 17 percentage of participants |
Primary
Overall Sensation of Smoothness
Participant rating for overall sensation of smoothness. Collected at 2 weeks wear for each lens. (5-point Likert Scale; Excellent, Good, Average, Below Average, Poor)
Time frame: 2 weeks
Population: All 60 subjects randomized to both sets of lenses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Study Group | Overall Sensation of Smoothness | Good | 38 percentage of participants |
| Overall Study Group | Overall Sensation of Smoothness | Below Average | 0 percentage of participants |
| Overall Study Group | Overall Sensation of Smoothness | Average | 13 percentage of participants |
| Overall Study Group | Overall Sensation of Smoothness | Poor | 0 percentage of participants |
| Overall Study Group | Overall Sensation of Smoothness | Excellent | 48 percentage of participants |
| Lotrafilcon B | Overall Sensation of Smoothness | Poor | 2 percentage of participants |
| Lotrafilcon B | Overall Sensation of Smoothness | Excellent | 27 percentage of participants |
| Lotrafilcon B | Overall Sensation of Smoothness | Good | 30 percentage of participants |
| Lotrafilcon B | Overall Sensation of Smoothness | Average | 30 percentage of participants |
| Lotrafilcon B | Overall Sensation of Smoothness | Below Average | 12 percentage of participants |
Primary
Overall Sensation of Smoothness
Participant rating for overall sensation of smoothness. Collected at baseline for all habitual lenses. (5-point Likert Scale; Excellent, Good, Average, Below Average)
Time frame: Baseline
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Study Group | Overall Sensation of Smoothness | Excellent | 27 percentage of participants |
| Overall Study Group | Overall Sensation of Smoothness | Good | 33 percentage of participants |
| Overall Study Group | Overall Sensation of Smoothness | Average | 40 percentage of participants |
| Overall Study Group | Overall Sensation of Smoothness | Below Average | 0 percentage of participants |
| Overall Study Group | Overall Sensation of Smoothness | Poor | 0 percentage of participants |
Primary
Overall Stability
Assessment of Lens Fit Performance for overall lens stability. Collected at 2 weeks for each lens. (Excellent or Good.
Time frame: 2 weeks
Population: All 60 subjects randomized to both sets of lenses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Study Group | Overall Stability | Excellent | 74 percentage of lenses |
| Overall Study Group | Overall Stability | Good | 26 percentage of lenses |
| Lotrafilcon B | Overall Stability | Excellent | 38 percentage of lenses |
| Lotrafilcon B | Overall Stability | Good | 62 percentage of lenses |
Primary
Overall Stability
Assessment of Lens Fit Performance for overall lens stability. Collected at 4 weeks for each lens. (Excellent or Good.
Time frame: 4 weeks
Population: All 60 subjects randomized to both sets of lenses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Study Group | Overall Stability | Excellent | 72 percentage of lenses |
| Overall Study Group | Overall Stability | Good | 28 percentage of lenses |
| Lotrafilcon B | Overall Stability | Excellent | 36 percentage of lenses |
| Lotrafilcon B | Overall Stability | Good | 64 percentage of lenses |
Primary
Participants Use of Rewetting Drops
Proportion of subjects using rewetting drops. Collected at 4 weeks for each lens. (Yes, No)
Time frame: 4 Weeks
Population: All 60 subjects randomized to both sets of lenses.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Overall Study Group | Participants Use of Rewetting Drops | 15 percentage of participants |
| Lotrafilcon B | Participants Use of Rewetting Drops | 58 percentage of participants |
Primary
Participants Use of Rewetting Drops
Proportion of subjects using rewetting drops. Collected at 2 weeks for each lens. (Yes, No)
Time frame: 2 Weeks
Population: All 60 subjects randomized to both sets of lenses.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Overall Study Group | Participants Use of Rewetting Drops | 7 percentage of participants |
| Lotrafilcon B | Participants Use of Rewetting Drops | 50 percentage of participants |
Primary
Post Blink Movement
Assessment of Lens Fit Performance for post blink movement. Collected at dispense for each lens. (0-4, 0.5 increments; 0=Insufficient, unacceptable movement, 4= Excessive, unacceptable movement)
Time frame: Dispense
Population: All 60 subjects randomized to both sets of lenses.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Overall Study Group | Post Blink Movement | 0.09 units on a scale | Standard Deviation 0.3 |
| Lotrafilcon B | Post Blink Movement | 0.19 units on a scale | Standard Deviation 0.42 |
Primary
Post Blink Movement
Assessment of Lens Fit Performance for post blink movement. Collected at 4 weeks for each lens. (0-4, 0.5 increments; 0=Insufficient, unacceptable movement, 4= Excessive, unacceptable movement)
Time frame: 4 weeks
Population: All 60 subjects randomized to both sets of lenses.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Overall Study Group | Post Blink Movement | 0.01 units on a scale | Standard Deviation 0.09 |
| Lotrafilcon B | Post Blink Movement | 0.05 units on a scale | Standard Deviation 0.22 |
Primary
Post Blink Movement
Assessment of Lens Fit Performance for post blink movement. Collected at 2 weeks for each lens. (0-4, 0.5 increments; 0=Insufficient, unacceptable movement, 4= Excessive, unacceptable movement)
Time frame: 2 weeks
Population: All 60 subjects randomized to both sets of lenses.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Overall Study Group | Post Blink Movement | 0 units on a scale | Standard Deviation 0 |
| Lotrafilcon B | Post Blink Movement | 0.05 units on a scale | Standard Deviation 0.22 |
Primary
Rotational Recovery 30/45 Deg
Assessment of Lens Fit Performance for lens rotational recovery to original position. Collected at dispense for each lens. Assessed in degree of mislocation relative to original position after manual temporal rotation. (30 deg/10 blinks, 45 deg/60 sec)
Time frame: Dispense
Population: All 60 subjects randomized to both sets of lenses.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Overall Study Group | Rotational Recovery 30/45 Deg | 30 deg/ 10 blinks | 0.542 degrees | Standard Deviation 1.56 |
| Overall Study Group | Rotational Recovery 30/45 Deg | 45 deg/ 60 sec | 0.625 degrees | Standard Deviation 1.66 |
| Lotrafilcon B | Rotational Recovery 30/45 Deg | 45 deg/ 60 sec | 0.875 degrees | Standard Deviation 2.01 |
| Lotrafilcon B | Rotational Recovery 30/45 Deg | 30 deg/ 10 blinks | 0.833 degrees | Standard Deviation 1.98 |
Primary
Rotational Recovery 30/45 Deg
Assessment of Lens Fit Performance for lens rotational recovery to original position. Collected at 2 weeks wear for each lens. Assessed in degree of mislocation relative to original position after manual temporal rotation. (30 deg/10 blinks, 45 deg/60 sec)
Time frame: 2 weeks
Population: All 60 subjects randomized to both sets of lenses.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Overall Study Group | Rotational Recovery 30/45 Deg | 30 deg/ 10 blinks | 0.25 degrees | Standard Deviation 1.09 |
| Overall Study Group | Rotational Recovery 30/45 Deg | 45 deg/ 60 sec | 0.58 degrees | Standard Deviation 1.61 |
| Lotrafilcon B | Rotational Recovery 30/45 Deg | 30 deg/ 10 blinks | 0.83 degrees | Standard Deviation 1.98 |
| Lotrafilcon B | Rotational Recovery 30/45 Deg | 45 deg/ 60 sec | 0.96 degrees | Standard Deviation 2.08 |
Primary
Rotational Recovery 30/45 Deg
Assessment of Lens Fit Performance for lens rotational recovery to original position. Collected at 2 weeks wear for each lens. Assessed in degree of mislocation relative to original position after manual temporal rotation. (30 deg/10 blinks, 45 deg/60 sec)
Time frame: 4 weeks
Population: All 60 subjects randomized to both sets of lenses.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Overall Study Group | Rotational Recovery 30/45 Deg | 30 deg/ 10 blinks | 0.33 degrees | Standard Deviation 1.25 |
| Overall Study Group | Rotational Recovery 30/45 Deg | 45 deg/ 60 sec | 0.45 degrees | Standard Deviation 1.45 |
| Lotrafilcon B | Rotational Recovery 30/45 Deg | 30 deg/ 10 blinks | 0.66 degrees | Standard Deviation 1.82 |
| Lotrafilcon B | Rotational Recovery 30/45 Deg | 45 deg/ 60 sec | 0.63 degrees | Standard Deviation 1.78 |
Primary
Vision Quality Insertion, During Day, End Day
Participant rating of vision quality on insertion, during the day, end of day. Collected at baseline for all habitual lenses. (0-100; 0=extremely poor vision totally blurred, 100=excellent vision totally sharp)
Time frame: Baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Overall Study Group | Vision Quality Insertion, During Day, End Day | On Insertion | 78.5 units on a scale | Standard Deviation 12.4 |
| Overall Study Group | Vision Quality Insertion, During Day, End Day | During the Day | 82.7 units on a scale | Standard Deviation 13.2 |
| Overall Study Group | Vision Quality Insertion, During Day, End Day | End of Day | 80.2 units on a scale | Standard Deviation 14.3 |
Primary
Vision Quality Insertion, During Day, End Day, Night
Participant rating of vision quality on insertion, during the day, end of day and night. Collected at 4 weeks wear for each lens. (0-100; 0=extremely poor vision totally blurred, 100=excellent vision totally sharp)
Time frame: 4 weeks
Population: All 60 subjects randomized to both sets of lenses.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Overall Study Group | Vision Quality Insertion, During Day, End Day, Night | On Insertion | 85 units on a scale | Standard Deviation 10 |
| Overall Study Group | Vision Quality Insertion, During Day, End Day, Night | During the Day | 88 units on a scale | Standard Deviation 10 |
| Overall Study Group | Vision Quality Insertion, During Day, End Day, Night | End of Day | 86 units on a scale | Standard Deviation 11 |
| Overall Study Group | Vision Quality Insertion, During Day, End Day, Night | Night | 83 units on a scale | Standard Deviation 10 |
| Lotrafilcon B | Vision Quality Insertion, During Day, End Day, Night | Night | 76 units on a scale | Standard Deviation 12 |
| Lotrafilcon B | Vision Quality Insertion, During Day, End Day, Night | On Insertion | 79 units on a scale | Standard Deviation 11 |
| Lotrafilcon B | Vision Quality Insertion, During Day, End Day, Night | End of Day | 80 units on a scale | Standard Deviation 13 |
| Lotrafilcon B | Vision Quality Insertion, During Day, End Day, Night | During the Day | 82 units on a scale | Standard Deviation 13 |
Primary
Vision Quality Insertion, During Day, End Day, Night
Participant rating of vision quality on insertion, during the day, end of day and night. Collected at 2 weeks wear for each lens. (0-100; 0=extremely poor vision totally blurred, 100=excellent vision totally sharp)
Time frame: 2 weeks
Population: All 60 subjects randomized to both sets of lenses.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Overall Study Group | Vision Quality Insertion, During Day, End Day, Night | On Insertion | 88 units on a scale | Standard Deviation 8 |
| Overall Study Group | Vision Quality Insertion, During Day, End Day, Night | During the Day | 89 units on a scale | Standard Deviation 9 |
| Overall Study Group | Vision Quality Insertion, During Day, End Day, Night | End of Day | 87 units on a scale | Standard Deviation 9 |
| Overall Study Group | Vision Quality Insertion, During Day, End Day, Night | Night | 84 units on a scale | Standard Deviation 9 |
| Lotrafilcon B | Vision Quality Insertion, During Day, End Day, Night | Night | 80 units on a scale | Standard Deviation 12 |
| Lotrafilcon B | Vision Quality Insertion, During Day, End Day, Night | On Insertion | 84 units on a scale | Standard Deviation 9 |
| Lotrafilcon B | Vision Quality Insertion, During Day, End Day, Night | End of Day | 83 units on a scale | Standard Deviation 11 |
| Lotrafilcon B | Vision Quality Insertion, During Day, End Day, Night | During the Day | 85 units on a scale | Standard Deviation 10 |
Primary
Vision Quality With Contact Lens Prescription
Participant rating of Vision Quality with contact lens prescription. Collected at dispense for each lens. (0-100; 0=extremely poor vision totally blurred, 100=excellent vision totally sharp)
Time frame: Dispense
Population: All 60 subjects randomized to both sets of lenses.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Overall Study Group | Vision Quality With Contact Lens Prescription | 88 units on a scale | Standard Deviation 9.3 |
| Lotrafilcon B | Vision Quality With Contact Lens Prescription | 82 units on a scale | Standard Deviation 11.9 |
Primary
Vision Satisfaction
Participant rating for vision satisfaction. Collected at 4 weeks wear for each lens. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)
Time frame: 4 weeks
Population: All 60 subjects randomized to both sets of lenses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Study Group | Vision Satisfaction | Completely Satisfied | 63 percentage of participants |
| Overall Study Group | Vision Satisfaction | Somewhat Satisfied | 32 percentage of participants |
| Overall Study Group | Vision Satisfaction | Somewhat Dissatisfied | 5 percentage of participants |
| Overall Study Group | Vision Satisfaction | Completely Dissatisfied | 0 percentage of participants |
| Lotrafilcon B | Vision Satisfaction | Completely Dissatisfied | 0 percentage of participants |
| Lotrafilcon B | Vision Satisfaction | Completely Satisfied | 35 percentage of participants |
| Lotrafilcon B | Vision Satisfaction | Somewhat Dissatisfied | 12 percentage of participants |
| Lotrafilcon B | Vision Satisfaction | Somewhat Satisfied | 53 percentage of participants |
Primary
Vision Satisfaction
Participant rating for vision satisfaction. Collected at baseline for all habitual lenses. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)
Time frame: Baseline
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Study Group | Vision Satisfaction | Completely Satisfied | 48 percentage of participants |
| Overall Study Group | Vision Satisfaction | Somewhat Satisfied | 45 percentage of participants |
| Overall Study Group | Vision Satisfaction | Somewhat Dissatisfied | 7 percentage of participants |
| Overall Study Group | Vision Satisfaction | Completely Dissatisfied | 0 percentage of participants |
Primary
Vision Satisfaction
Participant rating for vision satisfaction. Collected at 2 weeks wear for each lens. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)
Time frame: 2 weeks
Population: All 60 subjects randomized to both sets of lenses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Study Group | Vision Satisfaction | Completely Satisfied | 70 percentage of participants |
| Overall Study Group | Vision Satisfaction | Somewhat Satisfied | 30 percentage of participants |
| Overall Study Group | Vision Satisfaction | Somewhat Dissatisfied | 0 percentage of participants |
| Overall Study Group | Vision Satisfaction | Completely Dissatisfied | 0 percentage of participants |
| Lotrafilcon B | Vision Satisfaction | Completely Dissatisfied | 2 percentage of participants |
| Lotrafilcon B | Vision Satisfaction | Completely Satisfied | 43 percentage of participants |
| Lotrafilcon B | Vision Satisfaction | Somewhat Dissatisfied | 7 percentage of participants |
| Lotrafilcon B | Vision Satisfaction | Somewhat Satisfied | 48 percentage of participants |
Primary
Vision Satisfaction Upon Contact Lens Insertion
Participant rating of vision satisfaction upon insertion. Collected at dispense for each lens. (0-10; 10= Very Satisfied)
Time frame: Dispense
Population: All 60 subjects randomized to both sets of lenses.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Overall Study Group | Vision Satisfaction Upon Contact Lens Insertion | 8.8 units on a scale | Standard Deviation 1.1 |
| Lotrafilcon B | Vision Satisfaction Upon Contact Lens Insertion | 8.2 units on a scale | Standard Deviation 1.3 |
Primary
Vision Stability Insertion, During Day, End Day
Participant rating of vision stability on insertion, during the day, end of day. Collected at baseline for all habitual lenses. (0-100; 0=totally unstable fluctuating/changing, 100=perfectly stable not fluctuating/changing)
Time frame: Baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Overall Study Group | Vision Stability Insertion, During Day, End Day | On Insertion | 78.5 units on a scale | Standard Deviation 12 |
| Overall Study Group | Vision Stability Insertion, During Day, End Day | During the Day | 83.8 units on a scale | Standard Deviation 13.4 |
| Overall Study Group | Vision Stability Insertion, During Day, End Day | End of Day | 82.9 units on a scale | Standard Deviation 13.3 |
Primary
Vision Stability on Insertion, During Day, End Day
Participant rating of vision stability on insertion, during the day, end of day. Collected at 2 weeks wear for each lens. (0-100; 0=totally unstable fluctuating/changing, 100=perfectly stable not fluctuating/changing)
Time frame: 2 weeks
Population: All 60 subjects randomized to both sets of lenses.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Overall Study Group | Vision Stability on Insertion, During Day, End Day | On Insertion | 87 units on a scale | Standard Deviation 9 |
| Overall Study Group | Vision Stability on Insertion, During Day, End Day | During the Day | 91 units on a scale | Standard Deviation 9 |
| Overall Study Group | Vision Stability on Insertion, During Day, End Day | End of Day | 89 units on a scale | Standard Deviation 10 |
| Lotrafilcon B | Vision Stability on Insertion, During Day, End Day | On Insertion | 83 units on a scale | Standard Deviation 11 |
| Lotrafilcon B | Vision Stability on Insertion, During Day, End Day | During the Day | 85 units on a scale | Standard Deviation 13 |
| Lotrafilcon B | Vision Stability on Insertion, During Day, End Day | End of Day | 84 units on a scale | Standard Deviation 12 |
Primary
Vision Stability on Insertion, During Day, End Day
Participant rating of vision stability on insertion, during the day, end of day. Collected at 4 weeks wear for each lens. (0-100; 0=totally unstable fluctuating/changing, 100=perfectly stable not fluctuating/changing)
Time frame: 4 weeks
Population: All 60 subjects randomized to both sets of lenses.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Overall Study Group | Vision Stability on Insertion, During Day, End Day | On Insertion | 85 units on a scale | Standard Deviation 10 |
| Overall Study Group | Vision Stability on Insertion, During Day, End Day | During the Day | 87 units on a scale | Standard Deviation 11 |
| Overall Study Group | Vision Stability on Insertion, During Day, End Day | End of Day | 86 units on a scale | Standard Deviation 9 |
| Lotrafilcon B | Vision Stability on Insertion, During Day, End Day | End of Day | 80 units on a scale | Standard Deviation 13 |
| Lotrafilcon B | Vision Stability on Insertion, During Day, End Day | On Insertion | 80 units on a scale | Standard Deviation 13 |
| Lotrafilcon B | Vision Stability on Insertion, During Day, End Day | During the Day | 82 units on a scale | Standard Deviation 14 |
Primary
Vision Stability Upon Contact Lens Insertion
Participant rating of vision stability on insertion. Collected at dispense for each lens. (0-100; 0=extremely poor vision totally blurred, 100=excellent vision totally sharp)
Time frame: Dispense
Population: All 60 subjects randomized to both sets of lenses.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Overall Study Group | Vision Stability Upon Contact Lens Insertion | 87 units on a scale | Standard Deviation 11.9 |
| Lotrafilcon B | Vision Stability Upon Contact Lens Insertion | 82 units on a scale | Standard Deviation 11.7 |
Primary
Visual Acuity logMAR
Assessment of monocular and binocular high and low contrast visual acuity (VA). Collected at 2 weeks for each lens. logMAR (VA). Monocular High Contrast Visual Acuity (MHCVA), Monocular Low Contrast Visual Acuity (MLCVA), Binocular High Contrast Visual Acuity (BHCVA), Binocular Low Contrast Visual Acuity (BLCVA)
Time frame: 2 Weeks
Population: All 60 subjects randomized to both sets of lenses.
| Arm | Measure | Group | Value (LOG_MEAN) | Dispersion |
|---|---|---|---|---|
| Overall Study Group | Visual Acuity logMAR | MHCVA (both eyes Average) | -0.01 logMAR | Standard Deviation 0.05 |
| Overall Study Group | Visual Acuity logMAR | MLCVA (both eyes Average) | 0.19 logMAR | Standard Deviation 0.05 |
| Overall Study Group | Visual Acuity logMAR | BHCVA | -0.04 logMAR | Standard Deviation 0.05 |
| Overall Study Group | Visual Acuity logMAR | BLCVA | 0.17 logMAR | Standard Deviation 0.05 |
| Lotrafilcon B | Visual Acuity logMAR | BLCVA | 0.18 logMAR | Standard Deviation 0.05 |
| Lotrafilcon B | Visual Acuity logMAR | MHCVA (both eyes Average) | -0.01 logMAR | Standard Deviation 0.05 |
| Lotrafilcon B | Visual Acuity logMAR | BHCVA | -0.03 logMAR | Standard Deviation 0.05 |
| Lotrafilcon B | Visual Acuity logMAR | MLCVA (both eyes Average) | 0.19 logMAR | Standard Deviation 0.05 |
Primary
Visual Acuity logMAR
Assessment of monocular and binocular high and low contrast visual acuity (VA). Collected at 4 weeks for each lens. logMAR (VA). Monocular High Contrast Visual Acuity (MHCVA), Monocular Low Contrast Visual Acuity (MLCVA), Binocular High Contrast Visual Acuity (BHCVA), Binocular Low Contrast Visual Acuity (BLCVA)
Time frame: 4 Weeks
Population: All 60 subjects randomized to both sets of lenses.
| Arm | Measure | Group | Value (LOG_MEAN) | Dispersion |
|---|---|---|---|---|
| Overall Study Group | Visual Acuity logMAR | MHCVA (both eyes Average) | -0.01 logMAR | Standard Deviation 0.05 |
| Overall Study Group | Visual Acuity logMAR | MLCVA (both eyes Average) | 0.19 logMAR | Standard Deviation 0.05 |
| Overall Study Group | Visual Acuity logMAR | BHCVA | -0.03 logMAR | Standard Deviation 0.05 |
| Overall Study Group | Visual Acuity logMAR | BLCVA | 0.18 logMAR | Standard Deviation 0.05 |
| Lotrafilcon B | Visual Acuity logMAR | BLCVA | 0.18 logMAR | Standard Deviation 0.05 |
| Lotrafilcon B | Visual Acuity logMAR | MHCVA (both eyes Average) | -0.01 logMAR | Standard Deviation 0.05 |
| Lotrafilcon B | Visual Acuity logMAR | BHCVA | -0.03 logMAR | Standard Deviation 0.05 |
| Lotrafilcon B | Visual Acuity logMAR | MLCVA (both eyes Average) | 0.19 logMAR | Standard Deviation 0.05 |
Primary
Visual Acuity logMAR
Assessment of monocular and binocular high and low contrast visual acuity (VA). Collected at dispense for each lens. logMAR (VA).
Time frame: Dispense
Population: All 60 subjects randomized to both sets of lenses.
| Arm | Measure | Group | Value (LOG_MEAN) | Dispersion |
|---|---|---|---|---|
| Overall Study Group | Visual Acuity logMAR | MHCVA (OU Average) | -0.02 logMAR | Standard Deviation 0.05 |
| Overall Study Group | Visual Acuity logMAR | MLCVA (OU Average) | 0.18 logMAR | Standard Deviation 0.05 |
| Overall Study Group | Visual Acuity logMAR | BHCVA | -0.04 logMAR | Standard Deviation 0.06 |
| Overall Study Group | Visual Acuity logMAR | BLCVA | 0.17 logMAR | Standard Deviation 0.07 |
| Lotrafilcon B | Visual Acuity logMAR | BLCVA | 0.18 logMAR | Standard Deviation 0.05 |
| Lotrafilcon B | Visual Acuity logMAR | MHCVA (OU Average) | -0.01 logMAR | Standard Deviation 0.06 |
| Lotrafilcon B | Visual Acuity logMAR | BHCVA | -0.02 logMAR | Standard Deviation 0.05 |
| Lotrafilcon B | Visual Acuity logMAR | MLCVA (OU Average) | 0.19 logMAR | Standard Deviation 0.07 |
Primary
Wavefront Aberrations RMS (3mm)
Assessment of wavefront aberrations. Collected at 4 weeks for each lens. Wavefront measurement (3mm), Scale in microns (µm).
Time frame: 4 Weeks
Population: All 60 subjects randomized to both sets of lenses.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Overall Study Group | Wavefront Aberrations RMS (3mm) | HOA | 0.071 microns | Standard Deviation 0.052 |
| Overall Study Group | Wavefront Aberrations RMS (3mm) | Third Order | 0.047 microns | Standard Deviation 0.051 |
| Overall Study Group | Wavefront Aberrations RMS (3mm) | Fourth Order | 0.033 microns | Standard Deviation 0.061 |
| Lotrafilcon B | Wavefront Aberrations RMS (3mm) | HOA | 0.075 microns | Standard Deviation 0.063 |
| Lotrafilcon B | Wavefront Aberrations RMS (3mm) | Third Order | 0.05 microns | Standard Deviation 0.048 |
| Lotrafilcon B | Wavefront Aberrations RMS (3mm) | Fourth Order | 0.03 microns | Standard Deviation 0.059 |
Primary
Wavefront Aberrations RMS (5mm)
Assessment of wavefront aberrations. Collected at 4 weeks for each lens. Wavefront measurement (5 mm), Scale in microns (µm).
Time frame: 4 Weeks
Population: All 60 subjects randomized to both sets of lenses.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Overall Study Group | Wavefront Aberrations RMS (5mm) | HOA | 0.261 microns | Standard Deviation 0.065 |
| Overall Study Group | Wavefront Aberrations RMS (5mm) | Third Order | 0.161 microns | Standard Deviation 0.042 |
| Overall Study Group | Wavefront Aberrations RMS (5mm) | Fourth Order | 0.075 microns | Standard Deviation 0.0291 |
| Lotrafilcon B | Wavefront Aberrations RMS (5mm) | HOA | 0.287 microns | Standard Deviation 0.075 |
| Lotrafilcon B | Wavefront Aberrations RMS (5mm) | Third Order | 0.167 microns | Standard Deviation 0.055 |
| Lotrafilcon B | Wavefront Aberrations RMS (5mm) | Fourth Order | 0.081 microns | Standard Deviation 0.034 |
Primary
Wavefront Aberrations RMS (5mm)
Assessment of wavefront aberrations. Collected at 2 weeks for each lens. Wavefront measurement (5 mm), Scale in microns (µm).
Time frame: 2 Weeks
Population: All 60 subjects randomized to both sets of lenses.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Overall Study Group | Wavefront Aberrations RMS (5mm) | HOA | 0.214 microns | Standard Deviation 0.052 |
| Overall Study Group | Wavefront Aberrations RMS (5mm) | Third Order | 0.156 microns | Standard Deviation 0.041 |
| Overall Study Group | Wavefront Aberrations RMS (5mm) | Fourth Order | 0.071 microns | Standard Deviation 0.031 |
| Lotrafilcon B | Wavefront Aberrations RMS (5mm) | HOA | 0.223 microns | Standard Deviation 0.063 |
| Lotrafilcon B | Wavefront Aberrations RMS (5mm) | Third Order | 0.161 microns | Standard Deviation 0.052 |
| Lotrafilcon B | Wavefront Aberrations RMS (5mm) | Fourth Order | 0.075 microns | Standard Deviation 0.032 |
Primary
Wavefront Aberrations Root Mean Square (RMS) (3mm)
Assessment of wavefront aberrations. Collected at 2 weeks for each lens. Wavefront measurement (3mm), Scale in microns (µm).
Time frame: 2 Weeks
Population: All 60 subjects randomized to both sets of lenses.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Overall Study Group | Wavefront Aberrations Root Mean Square (RMS) (3mm) | HOA | 0.065 microns | Standard Deviation 0.061 |
| Overall Study Group | Wavefront Aberrations Root Mean Square (RMS) (3mm) | Third Order | 0.043 microns | Standard Deviation 0.054 |
| Overall Study Group | Wavefront Aberrations Root Mean Square (RMS) (3mm) | Fourth Order | 0.034 microns | Standard Deviation 0.049 |
| Lotrafilcon B | Wavefront Aberrations Root Mean Square (RMS) (3mm) | Third Order | 0.046 microns | Standard Deviation 0.041 |
| Lotrafilcon B | Wavefront Aberrations Root Mean Square (RMS) (3mm) | HOA | 0.07 microns | Standard Deviation 0.066 |
| Lotrafilcon B | Wavefront Aberrations Root Mean Square (RMS) (3mm) | Fourth Order | 0.029 microns | Standard Deviation 0.051 |
Secondary
Bulbar Hyperaemia
Assessment of ocular health. Collected at 4 weeks after removal of lenses. Proportion of eyes with grades 0-1 (No eyes graded \>1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)
Time frame: 4 weeks
Population: All 60 subjects randomized to both sets of lenses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Study Group | Bulbar Hyperaemia | Grade 0 | 100 percentage of eyes |
| Overall Study Group | Bulbar Hyperaemia | Grade 1/2 | 0 percentage of eyes |
| Overall Study Group | Bulbar Hyperaemia | Grade 1 | 0 percentage of eyes |
| Lotrafilcon B | Bulbar Hyperaemia | Grade 1 | 0 percentage of eyes |
| Lotrafilcon B | Bulbar Hyperaemia | Grade 0 | 94 percentage of eyes |
| Lotrafilcon B | Bulbar Hyperaemia | Grade 1/2 | 6 percentage of eyes |
Secondary
Bulbar Hyperaemia
Assessment of ocular health. Collected at baseline after removal of habitual lenses. Proportion of eyes with grades 0-1 (No eyes graded \>1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)
Time frame: Baseline
Population: All 60 subjects randomized to both sets of lenses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Study Group | Bulbar Hyperaemia | Grade 1/2 | 1.6 percentage of eyes |
| Overall Study Group | Bulbar Hyperaemia | Grade 0 | 98.4 percentage of eyes |
| Overall Study Group | Bulbar Hyperaemia | Grade 1 | 0.0 percentage of eyes |
Secondary
Bulbar Hyperaemia
Assessment of ocular health. Collected at 2 weeks after removal of lenses. Proportion of eyes with grades 0-1 (No eyes graded \>1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)
Time frame: 2 weeks
Population: All 60 subjects randomized to both sets of lenses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Study Group | Bulbar Hyperaemia | Grade 0 | 100 percentage of eyes |
| Overall Study Group | Bulbar Hyperaemia | Grade 1/2 | 0 percentage of eyes |
| Overall Study Group | Bulbar Hyperaemia | Grade 1 | 0 percentage of eyes |
| Lotrafilcon B | Bulbar Hyperaemia | Grade 0 | 95 percentage of eyes |
| Lotrafilcon B | Bulbar Hyperaemia | Grade 1/2 | 5 percentage of eyes |
| Lotrafilcon B | Bulbar Hyperaemia | Grade 1 | 0 percentage of eyes |
Secondary
Corneal Infiltrates
Assessment of ocular health. Collected at 2 weeks after removal of lenses. Proportion of eyes with grades 0-1 (No eyes graded \>1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)
Time frame: 2 weeks
Population: All 60 subjects randomized to both sets of lenses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Study Group | Corneal Infiltrates | Grade 0 | 100 percentage of eyes |
| Overall Study Group | Corneal Infiltrates | Grade 1/2 | 0 percentage of eyes |
| Overall Study Group | Corneal Infiltrates | Grade 1 | 0 percentage of eyes |
| Lotrafilcon B | Corneal Infiltrates | Grade 0 | 100 percentage of eyes |
| Lotrafilcon B | Corneal Infiltrates | Grade 1/2 | 0 percentage of eyes |
| Lotrafilcon B | Corneal Infiltrates | Grade 1 | 0 percentage of eyes |
Secondary
Corneal Infiltrates
Assessment of ocular health. Collected at 4 weeks after removal of lenses. Proportion of eyes with grades 0-1 (No eyes graded \>1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)
Time frame: 4 weeks
Population: All 60 subjects randomized to both sets of lenses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Study Group | Corneal Infiltrates | Grade 0 | 100 percentage of eyes |
| Overall Study Group | Corneal Infiltrates | Grade 1/2 | 0 percentage of eyes |
| Overall Study Group | Corneal Infiltrates | Grade 1 | 0 percentage of eyes |
| Lotrafilcon B | Corneal Infiltrates | Grade 0 | 100 percentage of eyes |
| Lotrafilcon B | Corneal Infiltrates | Grade 1/2 | 0 percentage of eyes |
| Lotrafilcon B | Corneal Infiltrates | Grade 1 | 0 percentage of eyes |
Secondary
Corneal Infiltrates
Assessment of ocular health. Collected at baseline after removal of habitual lenses. Proportion of eyes with grades 0-1 (No eyes graded \>1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)
Time frame: Baseline
Population: All 60 subjects randomized to both sets of lenses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Study Group | Corneal Infiltrates | Grade 0 | 100 percentage of eyes |
| Overall Study Group | Corneal Infiltrates | Grade 1/2 | 0.0 percentage of eyes |
| Overall Study Group | Corneal Infiltrates | Grade 1 | 0.0 percentage of eyes |
Secondary
Corneal Neovascularization
Investigators' objective assessment of ocular health. Collected at baseline after removal of habitual lenses. Proportion of eyes with grades 0-1 (No eyes graded \>1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)
Time frame: Baseline
Population: All 60 subjects randomized to both sets of lenses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Study Group | Corneal Neovascularization | Grade 0 | 96.7 percentage of eyes |
| Overall Study Group | Corneal Neovascularization | Grade 1/2 | 3.3 percentage of eyes |
| Overall Study Group | Corneal Neovascularization | Grade 1 | 0.0 percentage of eyes |
Secondary
Corneal Neovascularization
Assessment of ocular health. Collected at 2 weeks after removal of lenses. Proportion of eyes with grades 0-1 (No eyes graded \>1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)
Time frame: 2 weeks
Population: All 60 subjects randomized to both sets of lenses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Study Group | Corneal Neovascularization | Grade 0 | 100 percentage of eyes |
| Overall Study Group | Corneal Neovascularization | Grade 1/2 | 0 percentage of eyes |
| Overall Study Group | Corneal Neovascularization | Grade 1 | 0 percentage of eyes |
| Lotrafilcon B | Corneal Neovascularization | Grade 0 | 96 percentage of eyes |
| Lotrafilcon B | Corneal Neovascularization | Grade 1/2 | 4 percentage of eyes |
| Lotrafilcon B | Corneal Neovascularization | Grade 1 | 0 percentage of eyes |
Secondary
Corneal Neovascularization
Assessment of ocular health. Collected at 4 weeks after removal of lenses. Proportion of eyes with grades 0-1 (No eyes graded \>1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)
Time frame: 4 weeks
Population: All 60 subjects randomized to both sets of lenses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Study Group | Corneal Neovascularization | Grade 0 | 100 percentage of eyes |
| Overall Study Group | Corneal Neovascularization | Grade 1/2 | 0 percentage of eyes |
| Overall Study Group | Corneal Neovascularization | Grade 1 | 0 percentage of eyes |
| Lotrafilcon B | Corneal Neovascularization | Grade 0 | 97 percentage of eyes |
| Lotrafilcon B | Corneal Neovascularization | Grade 1/2 | 3 percentage of eyes |
| Lotrafilcon B | Corneal Neovascularization | Grade 1 | 0 percentage of eyes |
Secondary
Corneal Stromal Haze
Assessment of ocular health. Collected at baseline after removal of habitual lenses. Proportion of eyes with grades 0-1 (No eyes graded \>1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)
Time frame: Baseline
Population: All 60 subjects randomized to both sets of lenses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Study Group | Corneal Stromal Haze | Grade 0 | 100 percentage of eyes |
| Overall Study Group | Corneal Stromal Haze | Grade 1/2 | 0.0 percentage of eyes |
| Overall Study Group | Corneal Stromal Haze | Grade 1 | 0.0 percentage of eyes |
Secondary
Corneal Stromal Haze
Assessment of ocular health. Collected at 2 weeks after removal of lenses. Proportion of eyes with grades 0-1 (No eyes graded \>1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)
Time frame: 2 weeks
Population: All 60 subjects randomized to both sets of lenses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Study Group | Corneal Stromal Haze | Grade 0 | 100 percentage of eyes |
| Overall Study Group | Corneal Stromal Haze | Grade 1/2 | 0 percentage of eyes |
| Overall Study Group | Corneal Stromal Haze | Grade 1 | 0 percentage of eyes |
| Lotrafilcon B | Corneal Stromal Haze | Grade 0 | 100 percentage of eyes |
| Lotrafilcon B | Corneal Stromal Haze | Grade 1/2 | 0 percentage of eyes |
| Lotrafilcon B | Corneal Stromal Haze | Grade 1 | 0 percentage of eyes |
Secondary
Corneal Stromal Haze
Assessment of ocular health. Collected at 4 weeks after removal of lenses. Proportion of eyes with grades 0-1 (No eyes graded \>1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)
Time frame: 4 weeks
Population: All 60 subjects randomized to both sets of lenses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Study Group | Corneal Stromal Haze | Grade 0 | 100 percentage of eyes |
| Overall Study Group | Corneal Stromal Haze | Grade 1/2 | 0 percentage of eyes |
| Overall Study Group | Corneal Stromal Haze | Grade 1 | 0 percentage of eyes |
| Lotrafilcon B | Corneal Stromal Haze | Grade 0 | 100 percentage of eyes |
| Lotrafilcon B | Corneal Stromal Haze | Grade 1/2 | 0 percentage of eyes |
| Lotrafilcon B | Corneal Stromal Haze | Grade 1 | 0 percentage of eyes |
Secondary
Limbal Hyperaemia
Assessment of ocular health. Collected at 2 weeks after removal of lenses. Proportion of eyes with grades 0-1 (No eyes graded \>1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)
Time frame: 2 weeks
Population: All 60 subjects randomized to both sets of lenses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Study Group | Limbal Hyperaemia | Grade 1 | 0 percentage of eyes |
| Overall Study Group | Limbal Hyperaemia | Grade 0 | 99 percentage of eyes |
| Overall Study Group | Limbal Hyperaemia | Grade 1/2 | 1 percentage of eyes |
| Lotrafilcon B | Limbal Hyperaemia | Grade 1 | 0 percentage of eyes |
| Lotrafilcon B | Limbal Hyperaemia | Grade 0 | 100 percentage of eyes |
| Lotrafilcon B | Limbal Hyperaemia | Grade 1/2 | 0 percentage of eyes |
Secondary
Limbal Hyperaemia
Assessment of ocular health. Collected at 4 weeks after removal of lenses. Proportion of eyes with grades 0-1 (No eyes graded \>1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)
Time frame: 4 weeks
Population: All 60 subjects randomized to both sets of lenses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Study Group | Limbal Hyperaemia | Grade 0 | 98 percentage of eyes |
| Overall Study Group | Limbal Hyperaemia | Grade 1/2 | 2 percentage of eyes |
| Overall Study Group | Limbal Hyperaemia | Grade 1 | 0 percentage of eyes |
| Lotrafilcon B | Limbal Hyperaemia | Grade 0 | 98 percentage of eyes |
| Lotrafilcon B | Limbal Hyperaemia | Grade 1/2 | 2 percentage of eyes |
| Lotrafilcon B | Limbal Hyperaemia | Grade 1 | 0 percentage of eyes |
Secondary
Limbal Hyperaemia
Assessment of ocular health. Collected at baseline after removal of habitual lenses. Proportion of eyes with grades 0-1 (No eyes graded \>1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)
Time frame: Baseline
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Study Group | Limbal Hyperaemia | Grade 0 | 97.5 percentage of eyes |
| Overall Study Group | Limbal Hyperaemia | Grade 1/2 | 2.5 percentage of eyes |
| Overall Study Group | Limbal Hyperaemia | Grade 1 | 0.0 percentage of eyes |
Secondary
Lower Palpebral Hyperaemia
Assessment of ocular health. Collected at 4 weeks after removal of lenses. Proportion of eyes with grades 0-1 (No eyes graded \>1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)
Time frame: 4 weeks
Population: All 60 subjects randomized to both sets of lenses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Study Group | Lower Palpebral Hyperaemia | Grade 1/2 | 7 percentage of eyes |
| Overall Study Group | Lower Palpebral Hyperaemia | Grade 0 | 93 percentage of eyes |
| Overall Study Group | Lower Palpebral Hyperaemia | Grade 1 | 0 percentage of eyes |
| Lotrafilcon B | Lower Palpebral Hyperaemia | Grade 1/2 | 20 percentage of eyes |
| Lotrafilcon B | Lower Palpebral Hyperaemia | Grade 0 | 78 percentage of eyes |
| Lotrafilcon B | Lower Palpebral Hyperaemia | Grade 1 | 2 percentage of eyes |
Secondary
Lower Palpebral Hyperaemia
Assessment of ocular health. Collected at baseline after removal of habitual lenses. Proportion of eyes with grades 0-1 (No eyes graded \>1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)
Time frame: Baseline
Population: All 60 subjects randomized to both sets of lenses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Study Group | Lower Palpebral Hyperaemia | Grade 0 | 92.5 percentage of eyes |
| Overall Study Group | Lower Palpebral Hyperaemia | Grade 1/2 | 7.5 percentage of eyes |
| Overall Study Group | Lower Palpebral Hyperaemia | Grade 1 | 0.0 percentage of eyes |
Secondary
Lower Palpebral Hyperaemia
Assessment of ocular health. Collected at 2 weeks after removal of lenses. Proportion of eyes with grades 0-1 (No eyes graded \>1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)
Time frame: 2 weeks
Population: All 60 subjects randomized to both sets of lenses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Study Group | Lower Palpebral Hyperaemia | Grade 0 | 96 percentage of eyes |
| Overall Study Group | Lower Palpebral Hyperaemia | Grade 1/2 | 4 percentage of eyes |
| Overall Study Group | Lower Palpebral Hyperaemia | Grade 1 | 0 percentage of eyes |
| Lotrafilcon B | Lower Palpebral Hyperaemia | Grade 0 | 82 percentage of eyes |
| Lotrafilcon B | Lower Palpebral Hyperaemia | Grade 1/2 | 18 percentage of eyes |
| Lotrafilcon B | Lower Palpebral Hyperaemia | Grade 1 | 0 percentage of eyes |
Secondary
Participant Likelihood of Recommending a Study Lens to Friends, Family or Colleagues.
Percentage of participants that answer the question, How likely are they to recommend either the first pair of study lenses or the second pair of study lenses to friends, family or colleagues? Collected at study end. (4 point Likert scale; very likely, likely, unlikely, very unlikely)
Time frame: 8 weeks
Population: All 60 subjects randomized to both sets of lenses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Study Group | Participant Likelihood of Recommending a Study Lens to Friends, Family or Colleagues. | Unlikely | 11 percentage of participants |
| Overall Study Group | Participant Likelihood of Recommending a Study Lens to Friends, Family or Colleagues. | Very Likely | 52 percentage of participants |
| Overall Study Group | Participant Likelihood of Recommending a Study Lens to Friends, Family or Colleagues. | Very Unlikely | 2 percentage of participants |
| Overall Study Group | Participant Likelihood of Recommending a Study Lens to Friends, Family or Colleagues. | Likely | 35 percentage of participants |
| Lotrafilcon B | Participant Likelihood of Recommending a Study Lens to Friends, Family or Colleagues. | Very Unlikely | 10 percentage of participants |
| Lotrafilcon B | Participant Likelihood of Recommending a Study Lens to Friends, Family or Colleagues. | Likely | 40 percentage of participants |
| Lotrafilcon B | Participant Likelihood of Recommending a Study Lens to Friends, Family or Colleagues. | Unlikely | 35 percentage of participants |
| Lotrafilcon B | Participant Likelihood of Recommending a Study Lens to Friends, Family or Colleagues. | Very Likely | 15 percentage of participants |
Secondary
Participant Preference for Either of the Study Lenses
Percentage of participants that answer the question, Which type of study lens they prefer with regard to comfort, dryness, handling, vision, lens fit and overall performance? Collected at study end. (Forced choice; first study lenses, second study lenses, neither)
Time frame: 8 weeks
Population: All 60 subjects wore habitual lenses prior to randomization of study lenses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Study Group | Participant Preference for Either of the Study Lenses | Overall | 78 percentage of participants |
| Overall Study Group | Participant Preference for Either of the Study Lenses | Dryness | 80 percentage of participants |
| Overall Study Group | Participant Preference for Either of the Study Lenses | Lens Fit | 58 percentage of participants |
| Overall Study Group | Participant Preference for Either of the Study Lenses | Vision | 70 percentage of participants |
| Overall Study Group | Participant Preference for Either of the Study Lenses | Handling | 40 percentage of participants |
| Overall Study Group | Participant Preference for Either of the Study Lenses | Comfort | 80 percentage of participants |
| Lotrafilcon B | Participant Preference for Either of the Study Lenses | Handling | 55 percentage of participants |
| Lotrafilcon B | Participant Preference for Either of the Study Lenses | Vision | 28 percentage of participants |
| Lotrafilcon B | Participant Preference for Either of the Study Lenses | Comfort | 20 percentage of participants |
| Lotrafilcon B | Participant Preference for Either of the Study Lenses | Overall | 22 percentage of participants |
| Lotrafilcon B | Participant Preference for Either of the Study Lenses | Lens Fit | 38 percentage of participants |
| Lotrafilcon B | Participant Preference for Either of the Study Lenses | Dryness | 20 percentage of participants |
| Habitual | Participant Preference for Either of the Study Lenses | Overall | 0 percentage of participants |
| Habitual | Participant Preference for Either of the Study Lenses | Lens Fit | 4 percentage of participants |
| Habitual | Participant Preference for Either of the Study Lenses | Comfort | 0 percentage of participants |
| Habitual | Participant Preference for Either of the Study Lenses | Dryness | 0 percentage of participants |
| Habitual | Participant Preference for Either of the Study Lenses | Handling | 5 percentage of participants |
| Habitual | Participant Preference for Either of the Study Lenses | Vision | 2 percentage of participants |
Secondary
Participant Preference for Their Habitual Lenses or Either of the Study Lenses
Percentage of participants that answer the question, Which type of study lens they prefer with regard to comfort, dryness, handling, vision, lens fit and overall performance? Collected at study end. (Forced choice; habitual lenses, first study lenses, second study lenses)
Time frame: 8 weeks
Population: All 60 subjects wore habitual lenses prior to randomization of study lenses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Study Group | Participant Preference for Their Habitual Lenses or Either of the Study Lenses | Handling | 27 percentage of participants |
| Overall Study Group | Participant Preference for Their Habitual Lenses or Either of the Study Lenses | Comfort | 72 percentage of participants |
| Overall Study Group | Participant Preference for Their Habitual Lenses or Either of the Study Lenses | Lens Fit | 47 percentage of participants |
| Overall Study Group | Participant Preference for Their Habitual Lenses or Either of the Study Lenses | Overall | 65 percentage of participants |
| Overall Study Group | Participant Preference for Their Habitual Lenses or Either of the Study Lenses | Vision | 60 percentage of participants |
| Overall Study Group | Participant Preference for Their Habitual Lenses or Either of the Study Lenses | Dryness | 68 percentage of participants |
| Lotrafilcon B | Participant Preference for Their Habitual Lenses or Either of the Study Lenses | Dryness | 17 percentage of participants |
| Lotrafilcon B | Participant Preference for Their Habitual Lenses or Either of the Study Lenses | Comfort | 15 percentage of participants |
| Lotrafilcon B | Participant Preference for Their Habitual Lenses or Either of the Study Lenses | Handling | 42 percentage of participants |
| Lotrafilcon B | Participant Preference for Their Habitual Lenses or Either of the Study Lenses | Lens Fit | 42 percentage of participants |
| Lotrafilcon B | Participant Preference for Their Habitual Lenses or Either of the Study Lenses | Vision | 30 percentage of participants |
| Lotrafilcon B | Participant Preference for Their Habitual Lenses or Either of the Study Lenses | Overall | 23 percentage of participants |
| Habitual | Participant Preference for Their Habitual Lenses or Either of the Study Lenses | Comfort | 13 percentage of participants |
| Habitual | Participant Preference for Their Habitual Lenses or Either of the Study Lenses | Overall | 12 percentage of participants |
| Habitual | Participant Preference for Their Habitual Lenses or Either of the Study Lenses | Vision | 10 percentage of participants |
| Habitual | Participant Preference for Their Habitual Lenses or Either of the Study Lenses | Handling | 31 percentage of participants |
| Habitual | Participant Preference for Their Habitual Lenses or Either of the Study Lenses | Dryness | 15 percentage of participants |
| Habitual | Participant Preference for Their Habitual Lenses or Either of the Study Lenses | Lens Fit | 11 percentage of participants |
Secondary
Participant Preference for Their Habitual Lenses or the First Study Lenses (Comfilcon A)
Participant preference for their habitual lenses or the first study lenses during the last two weeks with regard to comfort, dryness, handling, vision, lens fit and overall. (Forced choice; habitual, study lenses)
Time frame: 2 weeks
Population: All 60 subjects were habitual lense wearers and randomized to both sets of study lenses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Study Group | Participant Preference for Their Habitual Lenses or the First Study Lenses (Comfilcon A) | Dryness | 18 percentage of patients |
| Overall Study Group | Participant Preference for Their Habitual Lenses or the First Study Lenses (Comfilcon A) | Vision | 25 percentage of patients |
| Overall Study Group | Participant Preference for Their Habitual Lenses or the First Study Lenses (Comfilcon A) | Comfort | 20 percentage of patients |
| Overall Study Group | Participant Preference for Their Habitual Lenses or the First Study Lenses (Comfilcon A) | Handling | 55 percentage of patients |
| Overall Study Group | Participant Preference for Their Habitual Lenses or the First Study Lenses (Comfilcon A) | Overall | 25 percentage of patients |
| Overall Study Group | Participant Preference for Their Habitual Lenses or the First Study Lenses (Comfilcon A) | Lens Fit | 30 percentage of patients |
| Lotrafilcon B | Participant Preference for Their Habitual Lenses or the First Study Lenses (Comfilcon A) | Overall | 75 percentage of patients |
| Lotrafilcon B | Participant Preference for Their Habitual Lenses or the First Study Lenses (Comfilcon A) | Comfort | 80 percentage of patients |
| Lotrafilcon B | Participant Preference for Their Habitual Lenses or the First Study Lenses (Comfilcon A) | Dryness | 82 percentage of patients |
| Lotrafilcon B | Participant Preference for Their Habitual Lenses or the First Study Lenses (Comfilcon A) | Handling | 45 percentage of patients |
| Lotrafilcon B | Participant Preference for Their Habitual Lenses or the First Study Lenses (Comfilcon A) | Vision | 75 percentage of patients |
| Lotrafilcon B | Participant Preference for Their Habitual Lenses or the First Study Lenses (Comfilcon A) | Lens Fit | 70 percentage of patients |
Secondary
Participant Preference for Their Habitual Lenses or the First Study Lenses (Comfilcon A)
Participant preference for their habitual lenses or the first study lenses during the last four weeks with regard to comfort, dryness, handling, vision, lens fit and overall. (Forced choice; habitual, study lenses)
Time frame: 4 weeks
Population: All 60 subjects were habitual lense wearers and randomized to both sets of study lenses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Study Group | Participant Preference for Their Habitual Lenses or the First Study Lenses (Comfilcon A) | Comfort | 20 percentage of participants |
| Overall Study Group | Participant Preference for Their Habitual Lenses or the First Study Lenses (Comfilcon A) | Handling | 52 percentage of participants |
| Overall Study Group | Participant Preference for Their Habitual Lenses or the First Study Lenses (Comfilcon A) | Overall | 23 percentage of participants |
| Overall Study Group | Participant Preference for Their Habitual Lenses or the First Study Lenses (Comfilcon A) | Vision | 27 percentage of participants |
| Overall Study Group | Participant Preference for Their Habitual Lenses or the First Study Lenses (Comfilcon A) | Dryness | 22 percentage of participants |
| Overall Study Group | Participant Preference for Their Habitual Lenses or the First Study Lenses (Comfilcon A) | Lens Fit | 27 percentage of participants |
| Lotrafilcon B | Participant Preference for Their Habitual Lenses or the First Study Lenses (Comfilcon A) | Dryness | 78 percentage of participants |
| Lotrafilcon B | Participant Preference for Their Habitual Lenses or the First Study Lenses (Comfilcon A) | Overall | 77 percentage of participants |
| Lotrafilcon B | Participant Preference for Their Habitual Lenses or the First Study Lenses (Comfilcon A) | Comfort | 80 percentage of participants |
| Lotrafilcon B | Participant Preference for Their Habitual Lenses or the First Study Lenses (Comfilcon A) | Lens Fit | 73 percentage of participants |
| Lotrafilcon B | Participant Preference for Their Habitual Lenses or the First Study Lenses (Comfilcon A) | Handling | 48 percentage of participants |
| Lotrafilcon B | Participant Preference for Their Habitual Lenses or the First Study Lenses (Comfilcon A) | Vision | 73 percentage of participants |
Secondary
Participant Preference for Their Habitual Lenses or the First Study Lenses (Lotrafilcon B)
Participant preference for their habitual lenses or the first study lenses during the last four weeks with regard to comfort, dryness, handling, vision, lens fit and overall. (Forced choice; habitual, study lenses)
Time frame: 4 weeks
Population: All 60 subjects were habitual lense wearers and randomized to both sets of study lenses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Study Group | Participant Preference for Their Habitual Lenses or the First Study Lenses (Lotrafilcon B) | Vision | 45 percentage of participants |
| Overall Study Group | Participant Preference for Their Habitual Lenses or the First Study Lenses (Lotrafilcon B) | Dryness | 58 percentage of participants |
| Overall Study Group | Participant Preference for Their Habitual Lenses or the First Study Lenses (Lotrafilcon B) | Lens Fit | 52 percentage of participants |
| Overall Study Group | Participant Preference for Their Habitual Lenses or the First Study Lenses (Lotrafilcon B) | Comfort | 62 percentage of participants |
| Overall Study Group | Participant Preference for Their Habitual Lenses or the First Study Lenses (Lotrafilcon B) | Overall | 55 percentage of participants |
| Overall Study Group | Participant Preference for Their Habitual Lenses or the First Study Lenses (Lotrafilcon B) | Handling | 57 percentage of participants |
| Lotrafilcon B | Participant Preference for Their Habitual Lenses or the First Study Lenses (Lotrafilcon B) | Overall | 45 percentage of participants |
| Lotrafilcon B | Participant Preference for Their Habitual Lenses or the First Study Lenses (Lotrafilcon B) | Comfort | 38 percentage of participants |
| Lotrafilcon B | Participant Preference for Their Habitual Lenses or the First Study Lenses (Lotrafilcon B) | Dryness | 42 percentage of participants |
| Lotrafilcon B | Participant Preference for Their Habitual Lenses or the First Study Lenses (Lotrafilcon B) | Vision | 55 percentage of participants |
| Lotrafilcon B | Participant Preference for Their Habitual Lenses or the First Study Lenses (Lotrafilcon B) | Lens Fit | 48 percentage of participants |
| Lotrafilcon B | Participant Preference for Their Habitual Lenses or the First Study Lenses (Lotrafilcon B) | Handling | 43 percentage of participants |
Secondary
Participant Preference for Their Habitual Lenses or the First Study Lenses (Lotrafilcon B)
Participant preference for their habitual lenses or the first study lenses during the last two weeks with regard to comfort, dryness, handling, vision, lens fit and overall. (Forced choice; habitual, study lenses)
Time frame: 2 weeks
Population: All 60 subjects were habitual lense wearers and randomized to both sets of study lenses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Study Group | Participant Preference for Their Habitual Lenses or the First Study Lenses (Lotrafilcon B) | Comfort | 55 percentage of patients |
| Overall Study Group | Participant Preference for Their Habitual Lenses or the First Study Lenses (Lotrafilcon B) | Dryness | 57 percentage of patients |
| Overall Study Group | Participant Preference for Their Habitual Lenses or the First Study Lenses (Lotrafilcon B) | Handling | 55 percentage of patients |
| Overall Study Group | Participant Preference for Their Habitual Lenses or the First Study Lenses (Lotrafilcon B) | Vision | 47 percentage of patients |
| Overall Study Group | Participant Preference for Their Habitual Lenses or the First Study Lenses (Lotrafilcon B) | Lens Fit | 43 percentage of patients |
| Overall Study Group | Participant Preference for Their Habitual Lenses or the First Study Lenses (Lotrafilcon B) | Overall | 53 percentage of patients |
| Lotrafilcon B | Participant Preference for Their Habitual Lenses or the First Study Lenses (Lotrafilcon B) | Lens Fit | 57 percentage of patients |
| Lotrafilcon B | Participant Preference for Their Habitual Lenses or the First Study Lenses (Lotrafilcon B) | Comfort | 45 percentage of patients |
| Lotrafilcon B | Participant Preference for Their Habitual Lenses or the First Study Lenses (Lotrafilcon B) | Vision | 53 percentage of patients |
| Lotrafilcon B | Participant Preference for Their Habitual Lenses or the First Study Lenses (Lotrafilcon B) | Dryness | 43 percentage of patients |
| Lotrafilcon B | Participant Preference for Their Habitual Lenses or the First Study Lenses (Lotrafilcon B) | Overall | 47 percentage of patients |
| Lotrafilcon B | Participant Preference for Their Habitual Lenses or the First Study Lenses (Lotrafilcon B) | Handling | 45 percentage of patients |
Secondary
Participant Recommendation of a Study Lens to Friends, Family or Colleagues
Percentage of participants that answer the question, What study lens they will most likely recommend to friends, family or colleagues? Collected at end of study. (Forced choice; First Study Lenses, Second Study Lenses)
Time frame: 8 weeks
Population: All 60 subjects randomized to both sets of lenses.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Overall Study Group | Participant Recommendation of a Study Lens to Friends, Family or Colleagues | 77 percentage of participants |
| Lotrafilcon B | Participant Recommendation of a Study Lens to Friends, Family or Colleagues | 23 percentage of participants |
Secondary
Participants Likelihood of Continuing to Wear the Study Lenses.
Participants likelihood of continuing to wear either of the pairs of study lenses when asked; How likely are they to continue to wearing either the first study lenses or the second study lenses? Collected at 4 weeks fore each study pair. (4 point Likert scale; very likely, likely, unlikely, very unlikely)
Time frame: 4 weeks
Population: All 60 subjects randomized to both sets of lenses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Study Group | Participants Likelihood of Continuing to Wear the Study Lenses. | Very Likely | 45 percentage of participants |
| Overall Study Group | Participants Likelihood of Continuing to Wear the Study Lenses. | Likely | 32 percentage of participants |
| Overall Study Group | Participants Likelihood of Continuing to Wear the Study Lenses. | Unlikely | 22 percentage of participants |
| Overall Study Group | Participants Likelihood of Continuing to Wear the Study Lenses. | Very Unlikely | 2 percentage of participants |
| Lotrafilcon B | Participants Likelihood of Continuing to Wear the Study Lenses. | Very Unlikely | 17 percentage of participants |
| Lotrafilcon B | Participants Likelihood of Continuing to Wear the Study Lenses. | Very Likely | 12 percentage of participants |
| Lotrafilcon B | Participants Likelihood of Continuing to Wear the Study Lenses. | Unlikely | 42 percentage of participants |
| Lotrafilcon B | Participants Likelihood of Continuing to Wear the Study Lenses. | Likely | 30 percentage of participants |
Secondary
Participants Likelihood of Switching From Habitual Lenses to the Study Lenses
Participants likelihood of switching from habitual lenses to either pair of the study lenses when asked; How likely are they to switch from their habitual lenses to either the first study lenses or the second study lenses? Collected at 4 weeks for each study pair. (4 point Likert scale; very likely, likely, unlikely, very unlikely)
Time frame: 4 weeks
Population: All 60 subjects randomized to both sets of lenses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Study Group | Participants Likelihood of Switching From Habitual Lenses to the Study Lenses | Very Likely | 45 percentage of particpants |
| Overall Study Group | Participants Likelihood of Switching From Habitual Lenses to the Study Lenses | Likely | 32 percentage of particpants |
| Overall Study Group | Participants Likelihood of Switching From Habitual Lenses to the Study Lenses | Unlikely | 22 percentage of particpants |
| Overall Study Group | Participants Likelihood of Switching From Habitual Lenses to the Study Lenses | Very Unlikely | 2 percentage of particpants |
| Lotrafilcon B | Participants Likelihood of Switching From Habitual Lenses to the Study Lenses | Very Unlikely | 17 percentage of particpants |
| Lotrafilcon B | Participants Likelihood of Switching From Habitual Lenses to the Study Lenses | Very Likely | 10 percentage of particpants |
| Lotrafilcon B | Participants Likelihood of Switching From Habitual Lenses to the Study Lenses | Unlikely | 42 percentage of particpants |
| Lotrafilcon B | Participants Likelihood of Switching From Habitual Lenses to the Study Lenses | Likely | 32 percentage of particpants |