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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| comfilcon A | Experimental | Each subject 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. |
|
| lotrafilcon B | Active Comparator | Each subject 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| comfilcon A | Device | test lens Pair(comfilcon A) or the control lens Pair(lotrafilcon B) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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.) | Baseline |
| 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) | Baseline |
| 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) | Baseline |
| 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) | Baseline |
| 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) | Baseline |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Baseline |
| Limbal Hyperaemia |
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Inclusion Criteria:
A person is eligible for inclusion in the study if he/she:
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:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Robert Montés-Mico, OD MPhil PhD | Optometry Research Group (GIO) - Optics Department, University of Valencia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Optometry Research Group (GIO) - Optics Department, University of Valencia | Valencia | Spain |
All subjects were habitual lens wearers.
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).
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| ID | Title | Description |
|---|---|---|
| FG000 | Comfilcon A Then Lotrafilcon B | All subjects were habitual lens wearers 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. |
| FG001 | Lotrafilcon B Then Comfilcon A | All subjects were habitual lens wearers 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The subject sample consisted of sixty (60) habitual toric contact lens wearers.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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.) | Posted | Mean | Standard Deviation | hours | Baseline |
|
|
From dispense up to one month for each pair of lenses.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Comfilcon A | All subjects were habitual lens wearers 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jose A. Vega Sr. Mgr. Global Medical Scientific Affairs | CooperVision | (925) 621-3761 | jvega2@coopervision.com |
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| ID | Term |
|---|---|
| D001251 | Astigmatism |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| lotrafilcon B | Device | test lens Pair(comfilcon A) or the control lens Pair(lotrafilcon B) |
|
|
| Baseline |
| 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) | Baseline |
| 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) | Baseline |
| 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) | Baseline |
| 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) | Baseline |
| 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) | Baseline |
| 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) | Baseline |
| Comfort Upon Contact Lens Insertion | Participant rating of comfort upon insertion. Collected at dispense for each lens. (0-10; 10=Can't Feel) | Dispense |
| Vision Satisfaction Upon Contact Lens Insertion | Participant rating of vision satisfaction upon insertion. Collected at dispense for each lens. (0-10; 10= Very Satisfied) | Dispense |
| 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) | Dispense |
| 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) | Dispense |
| Visual Acuity logMAR | Assessment of monocular and binocular high and low contrast visual acuity (VA). Collected at dispense for each lens. logMAR (VA). | Dispense |
| Centration | Assessment of Lens Fit Performance for centration. Collected at dispense for each lens. (Biomicroscopy; centered or slightly decentered) | Dispense |
| 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) | Dispense |
| 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) | Dispense |
| 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.) | Dispense |
| 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) | Dispense |
| 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) | Dispense |
| 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) | Dispense |
| Lens Overall Stability | Assessment of Lens Fit Performance for overall lens stability. Collected at dispense for each lens. (Excellent or Good) | Dispense |
| 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) | Dispense |
| 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) | Dispense |
| 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.) | 2 weeks |
| 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.) | 4 weeks |
| Participants Use of Rewetting Drops | Proportion of subjects using rewetting drops. Collected at 2 weeks for each lens. (Yes, No) | 2 Weeks |
| Participants Use of Rewetting Drops | Proportion of subjects using rewetting drops. Collected at 4 weeks for each lens. (Yes, No) | 4 Weeks |
| 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) | 2 weeks |
| 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) | 4 weeks |
| 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) | 2 weeks |
| 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) | 4 weeks |
| 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) | 2 weeks |
| 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) | 4 weeks |
| 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) | 2 weeks |
| 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) | 4 weeks |
| 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) | 2 weeks |
| 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) | 4 weeks |
| 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) | 2 weeks |
| 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) | 4 weeks |
| 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) | 2 weeks |
| 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) | 4 weeks |
| 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) | 2 weeks |
| 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) | 4 weeks |
| 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) | 2 weeks |
| 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) | 4 weeks |
| 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) | 2 weeks |
| 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) | 4 weeks |
| 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) | 2 weeks |
| 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) | 4 weeks |
| 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). | 2 Weeks |
| Wavefront Aberrations RMS (3mm) | Assessment of wavefront aberrations. Collected at 4 weeks for each lens. Wavefront measurement (3mm), Scale in microns (µm). | 4 Weeks |
| Wavefront Aberrations RMS (5mm) | Assessment of wavefront aberrations. Collected at 2 weeks for each lens. Wavefront measurement (5 mm), Scale in microns (µm). | 2 Weeks |
| Wavefront Aberrations RMS (5mm) | Assessment of wavefront aberrations. Collected at 4 weeks for each lens. Wavefront measurement (5 mm), Scale in microns (µm). | 4 Weeks |
| 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) | 2 Weeks |
| 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) | 4 Weeks |
| 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.) | 2 weeks |
| 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.) | 4 weeks |
| 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) | 2 weeks |
| 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) | 4 weeks |
| 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) | 2 weeks |
| 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) | 4 weeks |
| 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) | 2 weeks |
| 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) | 4 weeks |
| 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) | 2 weeks |
| 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) | 4 weeks |
| 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) | 2 weeks |
| 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) | 4 weeks |
| 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) | 2 weeks |
| 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) | 4 weeks |
| 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) | 2 weeks |
| 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) | 4 weeks |
| 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. | 2 weeks |
| 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. | 4 weeks |
| Overall Stability | Assessment of Lens Fit Performance for overall lens stability. Collected at 2 weeks for each lens. (Excellent or Good. | 2 weeks |
| Overall Stability | Assessment of Lens Fit Performance for overall lens stability. Collected at 4 weeks for each lens. (Excellent or Good. | 4 weeks |
| 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) | 2 weeks |
| 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) | 4 weeks |
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) |
| 2 weeks |
| 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) | 4 weeks |
| 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) | Baseline |
| 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) | 2 weeks |
| 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) | 4 weeks |
| 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) | Baseline |
| 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) | 2 weeks |
| 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) | 4 weeks |
| 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) | Baseline |
| 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) | 2 weeks |
| 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) | 4 weeks |
| 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) | Baseline |
| 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) | 2 weeks |
| 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) | 4 weeks |
| 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) | Baseline |
| 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) | 2 weeks |
| 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) | 4 weeks |
| 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) | 2 weeks |
| 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) | 2 weeks |
| 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) | 4 weeks |
| 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) | 4 weeks |
| 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) | 4 weeks |
| 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) | 4 weeks |
| 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) | 8 weeks |
| 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) | 8 weeks |
| 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) | 8 weeks |
| 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) | 8 weeks |
| 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. |
| BG002 | Total | Total of all reporting groups |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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) | Posted | Number | percentage of eyes | Baseline | Eyes | Eyes |
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| 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) | Posted | Mean | Standard Deviation | units on a scale | Baseline |
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| 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) | Posted | Mean | Standard Deviation | units on a scale | Baseline |
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| 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) | Posted | Mean | Standard Deviation | units on a scale | Baseline |
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| 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) | Posted | Number | percentage of subjects | Baseline |
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| 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) | Posted | Number | percentage of participants | Baseline |
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| 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) | Posted | Number | percentage of participants | Baseline |
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| 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) | Posted | Number | percentage of participants | Baseline |
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| 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) | Posted | Number | percentage of participants | Baseline |
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| 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) | Posted | Number | percentage of participants | Baseline |
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| 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) | Posted | Number | percentage of participants | Baseline |
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| 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) | Posted | Number | percentage of participants | Baseline |
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| Primary | Comfort Upon Contact Lens Insertion | Participant rating of comfort upon insertion. Collected at dispense for each lens. (0-10; 10=Can't Feel) | All 60 subjects randomized to both sets of lenses. | Posted | Mean | Standard Deviation | units on a scale | Dispense |
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| 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) | All 60 subjects randomized to both sets of lenses. | Posted | Mean | Standard Deviation | units on a scale | Dispense |
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| 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) | All 60 subjects randomized to both sets of lenses. | Posted | Mean | Standard Deviation | units on a scale | Dispense |
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| 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) | All 60 subjects randomized to both sets of lenses. | Posted | Mean | Standard Deviation | units on a scale | Dispense |
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| Primary | Visual Acuity logMAR | Assessment of monocular and binocular high and low contrast visual acuity (VA). Collected at dispense for each lens. logMAR (VA). | All 60 subjects randomized to both sets of lenses. | Posted | Log Mean | Standard Deviation | logMAR | Dispense | Eyes | Eyes |
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| Primary | Centration | Assessment of Lens Fit Performance for centration. Collected at dispense for each lens. (Biomicroscopy; centered or slightly decentered) | All 60 subjects randomized to both sets of lenses. | Posted | Number | percentage of lenses | Dispense | lenses | lenses |
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| 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) | All 60 subjects randomized to both sets of lenses. | Posted | Number | percentage of lenses | Dispense | Lenses | Lenses |
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| 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) | All 60 subjects randomized to both sets of lenses. | Posted | Mean | Standard Deviation | units on a scale | Dispense | Lenses | Lenses |
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| 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.) | All 60 subjects randomized to both sets of lenses. | Posted | Mean | Standard Deviation | degrees | Dispense | Lenses | Lenses |
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| 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) | All 60 subjects randomized to both sets of lenses. | Posted | Number | percentage of lenses | Dispense | Lenses | Lenses |
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| 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) | All 60 subjects randomized to both sets of lenses. | Posted | Number | percentage of lenses | Dispense | Lenses | Lenses |
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| 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) | All 60 subjects randomized to both sets of lenses. | Posted | Number | percentage of lenses | Dispense | Lenses | Lenses |
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| Primary | Lens Overall Stability | Assessment of Lens Fit Performance for overall lens stability. Collected at dispense for each lens. (Excellent or Good) | All 60 subjects randomized to both sets of lenses. | Posted | Number | percentage of lenses | Dispense | Lenses | Lenses |
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| 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) | All 60 subjects randomized to both sets of lenses. | Posted | Mean | Standard Deviation | degrees | Dispense | Lenses | Lenses |
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| 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) | All 60 subjects randomized to both sets of lenses. | Posted | Number | percentage of lenses fitted | Dispense | Lenses | Lenses |
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| 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.) | All 60 subjects randomized to both sets of lenses. | Posted | Mean | Standard Deviation | hours | 2 weeks |
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| 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.) | All 60 subjects randomized to both sets of lenses. | Posted | Mean | Standard Deviation | hours | 4 weeks |
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| Primary | Participants Use of Rewetting Drops | Proportion of subjects using rewetting drops. Collected at 2 weeks for each lens. (Yes, No) | All 60 subjects randomized to both sets of lenses. | Posted | Number | percentage of participants | 2 Weeks |
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| Primary | Participants Use of Rewetting Drops | Proportion of subjects using rewetting drops. Collected at 4 weeks for each lens. (Yes, No) | All 60 subjects randomized to both sets of lenses. | Posted | Number | percentage of participants | 4 Weeks |
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| 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) | All 60 subjects randomized to both sets of lenses. | Posted | Mean | Standard Deviation | units on a scale | 2 weeks |
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| 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) | All 60 subjects randomized to both sets of lenses. | Posted | Mean | Standard Deviation | units on a scale | 4 weeks |
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| 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) | All 60 subjects randomized to both sets of lenses. | Posted | Mean | Standard Deviation | units on a scale | 2 weeks |
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| 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) | All 60 subjects randomized to both sets of lenses. | Posted | Mean | Standard Deviation | units on a scale | 4 weeks |
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| 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) | All 60 subjects randomized to both sets of lenses. | Posted | Mean | Standard Deviation | units on a scale | 2 weeks |
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| 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) | All 60 subjects randomized to both sets of lenses. | Posted | Mean | Standard Deviation | units on a scale | 4 weeks |
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| 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) | All 60 subjects randomized to both sets of lenses. | Posted | Number | percentage of participants | 2 weeks |
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| 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) | All 60 subjects randomized to both sets of lenses. | Posted | Number | percentage of participants | 4 weeks |
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| 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) | All 60 subjects randomized to both sets of lenses. | Posted | Number | percentage of participants | 2 weeks |
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| 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) | All 60 subjects randomized to both sets of lenses. | Posted | Number | percentage of participants | 4 weeks |
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| 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) | All 60 subjects randomized to both sets of lenses. | Posted | Number | percentage of participants | 2 weeks |
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| 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) | All 60 subjects randomized to both sets of lenses. | Posted | Number | percentage of participants | 4 weeks |
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| 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) | All 60 subjects randomized to both sets of lenses. | Posted | Number | percentage of participants | 2 weeks |
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| 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) | All 60 subjects randomized to both sets of lenses. | Posted | Number | percentage of participants | 4 weeks |
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| 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) | All 60 subjects randomized to both sets of lenses. | Posted | Number | percentage of participants | 2 weeks |
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| 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) | All 60 subjects randomized to both sets of lenses. | Posted | Number | percentage of participants | 4 weeks |
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| 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) | All 60 subjects randomized to both sets of lenses. | Posted | Number | percentage of participants | 2 weeks |
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| 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) | All 60 subjects randomized to both sets of lenses. | Posted | Number | percentage of participants | 4 weeks |
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| 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) | All 60 subjects randomized to both sets of lenses. | Posted | Number | percentage of participants | 2 weeks |
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| 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) | All 60 subjects randomized to both sets of lenses. | Posted | Number | percentage of participants | 4 weeks |
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| 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) | All 60 subjects randomized to both sets of lenses. | Posted | Number | percentage of participants | 2 weeks |
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| 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) | All 60 subjects randomized to both sets of lenses. | Posted | Number | percentage of participants | 4 weeks |
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| 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). | All 60 subjects randomized to both sets of lenses. | Posted | Mean | Standard Deviation | microns | 2 Weeks | Lenses | Lenses |
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| Primary | Wavefront Aberrations RMS (3mm) | Assessment of wavefront aberrations. Collected at 4 weeks for each lens. Wavefront measurement (3mm), Scale in microns (µm). | All 60 subjects randomized to both sets of lenses. | Posted | Mean | Standard Deviation | microns | 4 Weeks | Lenses | Lenses |
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| Primary | Wavefront Aberrations RMS (5mm) | Assessment of wavefront aberrations. Collected at 2 weeks for each lens. Wavefront measurement (5 mm), Scale in microns (µm). | All 60 subjects randomized to both sets of lenses. | Posted | Mean | Standard Deviation | microns | 2 Weeks | Lenses | Lenses |
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| Primary | Wavefront Aberrations RMS (5mm) | Assessment of wavefront aberrations. Collected at 4 weeks for each lens. Wavefront measurement (5 mm), Scale in microns (µm). | All 60 subjects randomized to both sets of lenses. | Posted | Mean | Standard Deviation | microns | 4 Weeks | Eyes | Eyes |
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| 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) | All 60 subjects randomized to both sets of lenses. | Posted | Log Mean | Standard Deviation | logMAR | 2 Weeks |
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| 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) | All 60 subjects randomized to both sets of lenses. | Posted | Log Mean | Standard Deviation | logMAR | 4 Weeks |
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| 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.) | All 60 subjects randomized to both sets of lenses. | Posted | Mean | Standard Deviation | degrees | 2 weeks | Lenses | Lenses |
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| 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.) | All 60 subjects randomized to both sets of lenses. | Posted | Mean | Standard Deviation | degrees | 4 weeks | lenses | lenses |
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| 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) | All 60 subjects randomized to both sets of lenses. | Posted | Mean | Standard Deviation | degrees | 2 weeks | Lenses | Lenses |
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| 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) | All 60 subjects randomized to both sets of lenses. | Posted | Mean | Standard Deviation | degrees | 4 weeks | Lenses | Lenses |
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| 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) | All 60 subjects randomized to both sets of lenses. | Posted | Mean | Standard Deviation | units on a scale | 2 weeks | lenses | lenses |
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| 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) | All 60 subjects randomized to both sets of lenses. | Posted | Mean | Standard Deviation | units on a scale | 4 weeks | lenses | lenses |
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| 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) | All 60 subjects randomized to both sets of lenses. | Posted | Number | percentage of lenses | 2 weeks | lenses | lenses |
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| 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) | All 60 subjects randomized to both sets of lenses. | Posted | Number | percentage of lenses | 4 weeks | lenses | lenses |
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| 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) | All 60 subjects randomized to both sets of lenses. | Posted | Number | percentage of lenses | 2 weeks | lenses | lenses |
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| 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) | All 60 subjects randomized to both sets of lenses. | Posted | Number | percentage of lenses | 4 weeks | lenses | lenses |
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| 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) | All 60 subjects randomized to both sets of lenses. | Posted | Mean | Standard Deviation | units on a scale | 2 weeks | Lenses | Lenses |
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| 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) | All 60 subjects randomized to both sets of lenses. | Posted | Mean | Standard Deviation | units on a scale | 4 weeks | Lenses | Lenses |
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| 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) | All 60 subjects randomized to both sets of lenses. | Posted | Number | percentage of lenses | 2 weeks | lenses | lenses |
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| 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) | All 60 subjects randomized to both sets of lenses. | Posted | Number | percentage of lenses | 4 weeks | lenses | lenses |
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| 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) | All 60 subjects randomized to both sets of lenses. | Posted | Number | percentage of lenses | 2 weeks | lenses | lenses |
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| 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) | All 60 subjects randomized to both sets of lenses. | Posted | Number | percentage of lenses | 4 weeks | lenses | lenses |
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| 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. | All 60 subjects randomized to both sets of lenses. | Posted | Number | percentage of lenses | 2 weeks | Lenses | Lenses |
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| 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. | All 60 subjects randomized to both sets of lenses. | Posted | Number | percentage of lenses | 4 weeks | Lenses | Lenses |
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| 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) | All 60 subjects randomized to both sets of lenses. | Posted | Number | percentage of eyes | 2 weeks | Eyes | Eyes |
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| 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) | All 60 subjects randomized to both sets of lenses. | Posted | Number | percentage of eyes | 4 weeks | Eyes | 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) | All 60 subjects randomized to both sets of lenses. | Posted | Number | percentage of eyes | Baseline | Eyes | 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) | All 60 subjects randomized to both sets of lenses. | Posted | Number | percentage of eyes | 2 weeks | Eyes | Eyes |
|
|
|
| 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) | All 60 subjects randomized to both sets of lenses. | Posted | Number | percentage of eyes | 4 weeks | Eyes | 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) | All 60 subjects randomized to both sets of lenses. | Posted | Number | percentage of eyes | Baseline | Eyes | 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) | All 60 subjects randomized to both sets of lenses. | Posted | Number | percentage of eyes | 2 weeks | Eyes | 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) | All 60 subjects randomized to both sets of lenses. | Posted | Number | percentage of eyes | 4 weeks | Eyes | 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) | All 60 subjects randomized to both sets of lenses. | Posted | Number | percentage of eyes | Baseline | Eyes | 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) | All 60 subjects randomized to both sets of lenses. | Posted | Number | percentage of eyes | 2 weeks | Eyes | 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) | All 60 subjects randomized to both sets of lenses. | Posted | Number | percentage of eyes | 4 weeks | Eyes | 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) | All 60 subjects randomized to both sets of lenses. | Posted | Number | percentage of eyes | Baseline | Eyes | 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) | All 60 subjects randomized to both sets of lenses. | Posted | Number | percentage of eyes | 2 weeks | Eyes | 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) | All 60 subjects randomized to both sets of lenses. | Posted | Number | percentage of eyes | 4 weeks | Eyes | Eyes |
|
|
|
| Primary | Overall Stability | Assessment of Lens Fit Performance for overall lens stability. Collected at 2 weeks for each lens. (Excellent or Good. | All 60 subjects randomized to both sets of lenses. | Posted | Number | percentage of lenses | 2 weeks | Lenses | Lenses |
|
|
|
| Primary | Overall Stability | Assessment of Lens Fit Performance for overall lens stability. Collected at 4 weeks for each lens. (Excellent or Good. | All 60 subjects randomized to both sets of lenses. | Posted | Number | percentage of lenses | 4 weeks | Lenses | Lenses |
|
|
|
| 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) | All 60 subjects randomized to both sets of lenses. | Posted | Number | percentage of lenses | 2 weeks | Lenses | Lenses |
|
|
|
| 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) | All 60 subjects randomized to both sets of lenses. | Posted | Number | percentage of lenses | 4 weeks | Lenses | Lenses |
|
|
|
| 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) | All 60 subjects randomized to both sets of lenses. | Posted | Number | percentage of eyes | Baseline | Eyes | 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) | All 60 subjects randomized to both sets of lenses. | Posted | Number | percentage of eyes | 2 weeks | Eyes | 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) | All 60 subjects randomized to both sets of lenses. | Posted | Number | percentage of eyes | 4 weeks | Eyes | Eyes |
|
|
|
| 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) | All 60 subjects were habitual lense wearers and randomized to both sets of study lenses. | Posted | Number | percentage of patients | 2 weeks |
|
|
|
| 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) | All 60 subjects were habitual lense wearers and randomized to both sets of study lenses. | Posted | Number | percentage of patients | 2 weeks |
|
|
|
| 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) | All 60 subjects were habitual lense wearers and randomized to both sets of study lenses. | Posted | Number | percentage of participants | 4 weeks |
|
|
|
| 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) | All 60 subjects were habitual lense wearers and randomized to both sets of study lenses. | Posted | Number | percentage of participants | 4 weeks |
|
|
|
| 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) | All 60 subjects randomized to both sets of lenses. | Posted | Number | percentage of particpants | 4 weeks |
|
|
|
| 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) | All 60 subjects randomized to both sets of lenses. | Posted | Number | percentage of participants | 4 weeks |
|
|
|
| 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) | All 60 subjects randomized to both sets of lenses. | Posted | Number | percentage of participants | 8 weeks |
|
|
|
| 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) | All 60 subjects randomized to both sets of lenses. | Posted | Number | percentage of participants | 8 weeks |
|
|
|
| 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) | All 60 subjects wore habitual lenses prior to randomization of study lenses. | Posted | Number | percentage of participants | 8 weeks |
|
|
|
| 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) | All 60 subjects wore habitual lenses prior to randomization of study lenses. | Posted | Number | percentage of participants | 8 weeks |
|
|
|
| 0 |
| 60 |
| 0 |
| 60 |
| EG001 | Lotrafilcon B | All subjects were habitual lens wearers 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.) | 0 | 60 | 0 | 60 |
The investigators will not be permitted to publish or present at scientific meetings results obtained from the clinical study without prior written consent from the sponsor.
| Title | Measurements |
|---|
|
| Title | Measurements |
|---|---|
|
| Dryness during the Day |
|
| Dryness prior to Removal |
|
| Dryness Overall |
|
| Handling |
|
| Overall Lens Fit |
|
| Overall Vision Satisfaction |
|
|
| Title |
|---|
| Measurements |
|---|
|
| Below Average |
|
| Poor |
|
| Below Average |
|
| Poor |
|
| Completely Dissatisfied |
|
| Completely Dissatisfied |
|
| Completely Dissatisfied |
|
| Completely Dissatisfied |
|
| Completely Dissatisfied |
|
| Completely Dissatisfied |
|
| BHCVA |
|
| BLCVA |
|
| Poor |
|
| Comfort Overall |
|
| Dryness during the Day |
|
| Dryness prior to Removal |
|
| Dryness Overall |
|
| Handling |
|
| Lens Fit Stability |
|
| Vision Satisfaction |
|
| Comfort Overall |
|
| Dryness during the Day |
|
| Dryness prior to Removal |
|
| Dryness Overall |
|
| Handling |
|
| Lens Fit Stability |
|
| Vision Satisfaction |
|
| End of Day |
|
| Night |
|
| End of Day |
|
| Night |
|
| End of Day |
|
| End of Day |
|
| Average |
|
| Below Average |
|
| Poor |
|
| Average |
|
| Below Average |
|
| Poor |
|
| Average |
|
| Below Average |
|
| Poor |
|
| Average |
|
| Below Average |
|
| Poor |
|
| Somewhat Dissatisfied |
|
| Completely Dissatisfied |
|
| Somewhat Dissatisfied |
|
| Completely Dissatisfied |
|
| Somewhat Dissatisfied |
|
| Completely Dissatisfied |
|
| Somewhat Dissatisfied |
|
| Completely Dissatisfied |
|
| Somewhat Dissatisfied |
|
| Completely Dissatisfied |
|
| Somewhat Dissatisfied |
|
| Completely Dissatisfied |
|
| Somewhat Dissatisfied |
|
| Completely Dissatisfied |
|
| Somewhat Dissatisfied |
|
| Completely Dissatisfied |
|
| Somewhat Dissatisfied |
|
| Completely Dissatisfied |
|
| Somewhat Dissatisfied |
|
| Completely Dissatisfied |
|
| Somewhat Dissatisfied |
|
| Completely Dissatisfied |
|
| Somewhat Dissatisfied |
|
| Completely Dissatisfied |
|
| Fourth Order |
|
| Fourth Order |
|
| Fourth Order |
|
| Fourth Order |
|
| BHCVA |
|
| BLCVA |
|
| BHCVA |
|
| BLCVA |
|
| Poor |
|
| Poor |
|
| Grade 1 |
|
| Grade 1 |
|
| Title | Measurements |
|---|
|
| Grade 1 |
|
| Grade 1 |
|
| Title | Measurements |
|---|
|
| Grade 1 |
|
| Grade 1 |
|
| Title | Measurements |
|---|
|
| Grade 1 |
|
| Grade 1 |
|
| Title | Measurements |
|---|
|
| Grade 1 |
|
| Grade 1 |
|
| Title | Measurements |
|---|
|
| Grade 1 |
|
| Grade 1 |
|
| Handling |
|
| Vision |
|
| Lens Fit |
|
| Overall |
|
| Handling |
|
| Vision |
|
| Lens Fit |
|
| Overall |
|
| Handling |
|
| Vision |
|
| Lens Fit |
|
| Overall |
|
| Handling |
|
| Vision |
|
| Lens Fit |
|
| Overall |
|
| Unlikely |
|
| Very Unlikely |
|
| Unlikely |
|
| Very Unlikely |
|
| Unlikely |
|
| Very Unlikely |
|
| Title | Measurements |
|---|---|
|
| Handling |
|
| Lens Fit |
|
| Vision |
|
| Overall |
|
| Title | Measurements |
|---|---|
|
| Handling |
|
| Lens Fit |
|
| Vision |
|
| Overall |
|