Hyperopia, Myopia
Conditions
Brief summary
To obtain subjective and objective feedback on the clinical performance of Biofinity lenses after at least two weeks daily wear in existing contact lens wearers compared with their habitual lenses.
Interventions
DEVICEBiofinity XR
Sponsors
CooperVision, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Has had an oculo-visual examination in the last two years * Is at least 18 years of age and has full legal capacity to volunteer * Has read and understood the information consent letter * Is willing and able to follow instructions and maintain the appointment schedule * Is correctable to a visual acuity of 20/50 or better (in at least one eye) with their habitual vision correction * Currently wears soft contact lenses * They should require contact lens powers between -12.00 and -20.00D or between +8.00 and +15.00D * Has clear corneas and no active ocular disease * Demonstrates an acceptable fit with the study lenses.
Exclusion criteria
* Has any systemic disease affecting ocular health * Is taking medication, such as antihistamine eye drops, oral and ophthalmic betaadrenergic blockers (e.g. Propanolol, Timolol), anticholinergics, and any prescribed or over-the-counter eye medication, except artificial tears or eye lubricants * Have any active ocular disease and/or infection that would contraindicate contact lens wear. * Active ocular disease is defined as infection or inflammation which requires therapeutic treatment. Mild (i.e. not considered clinically relevant) lid abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and conjunctival staining and dry eye are not considered active ocular disease. Neovascularization and corneal scars are the result of previous hypoxia, infection or inflammation and are therefore not active. * Has worn gas permeable contact lenses within the last month. * Is aphakic * Has undergone corneal refractive surgery. * Is participating in any other type of clinical research study * Female who is currently pregnant or is breast-feeding.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Preference | Dispense | Subjective response of participant by questionnaire on a likert scale (Prefer New Lenses Strongly, Prefer New Lenses Slightly, No Preference - both acceptable/both unacceptable, Prefer My Own Lenses Slightly, Prefer My Own Lenses Strongly) Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit. |
| Hazing (Blurred Edges) | Baseline | Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extreame haze. Cannot be worn. 100=No hazing experienced at any time.) Obtained habitual lens history at baseline. |
| Vision Quality (During Day and at Night) | Baseline | Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extremely poor vision all the time. Cannot function; 100=Excellent vision all of the time.) Obtained habitual lens history at baseline. |
| Vision Quality (During Day) | Dispense | Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extremely poor vision all the time. Cannot function; 100=Excellent vision all of the time.) Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit. |
| Handling (Insertion, Removal, Overall) | Baseline | Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=cannot be worn,Causes pain; 100=Cannot be felt ever) Obtained habitual lens history at baseline. |
| Overall Satisfaction of Comfort, Vision, Handling | Dispense | Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extremely dissatisfied; 100=Extremely satisfied.) Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit. |
| Comfort Preference | Dispense | Subjective response of participant by questionnaire on a likert scale (Prefer New Lenses Strongly, Prefer New Lenses Slightly, No Preference - both acceptable/both unacceptable, Prefer My Own Lenses Slightly, Prefer My Own Lenses Strongly) Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit. |
| Vision Preference | Dispense | Subjective response of participant by questionnaire on a likert scale (Prefer New Lenses Strongly, Prefer New Lenses Slightly, No Preference - both acceptable/both unacceptable, Prefer My Own Lenses Slightly, Prefer My Own Lenses Strongly) Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit. |
| Handling Preference | 2 Weeks | Subjective response of participant by questionnaire on a likert scale (Prefer New Lenses Strongly, Prefer New Lenses Slightly, No Preference - both acceptable/both unacceptable, Prefer My Own Lenses Slightly, Prefer My Own Lenses Strongly) Obtained at 2 weeks. |
| Dryness (During Day and Dryness at Night) | Baseline | Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=cannot be worn, Extremely dry. 100=No dryness experienced at any time.) Obtained habitual lens history at baseline. |
| Dryness (During Day) | Dispense | Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=cannot be worn, Extremely dry. 100=No dryness experienced at any time.) Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit. |
| Comfort (Insertion, End of Day, Overall) | Baseline | Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=cannot be worn,Causes pain; 100=Cannot be felt ever) Obtained habitual lens history at baseline. |
| Comfort (Insertion) | Dispense | Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=cannot be worn,Causes pain; 100=Cannot be felt ever) Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit. |
| Ghosting (Multiple Images) | Baseline | Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extreame ghosting. Cannot be worn. 100=No ghosting ever.) Obtained habitual lens history at baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lens Movement | Dispense | Objective measurement by investigator of overall post-blink lens movement. (Average Grade; Graded 0-4; 0=exceptionally tight, 2=optimal, 4=exceptionally loose) Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit. |
| Lens Centration - Habitual Lenses | Baseline | Objective measurement by investigator. (Assessed as optimum, slightly decentered, extremely decentered) Obtained for habitual lenses at baseline. |
| Lens Centration | Dispense | Objective measurement by investigator. (Assessed as optimum, slightly decentered, extremely decentered) Obtained at baseline at dispense. |
| Lens Movement - Habitual Lenses | Baseline | Objective measurement by investigator of overall post-blink lens movement. (Average Grade; Graded 0-4; 0=exceptionally tight, 2=optimal, 4=exceptionally loose) Obtained for habitual lenses at baseline. |
| Visual Acuity | Baseline | Objective measurement by investigator of monocular high and low contrast logMar visual acuity. Visual Acuity High-Contrast (VA HC), Visual Acuity Low-Contrast (VA LC), Visual Acuity High-Contrast OU (VA HC OU), Visual Acuity Low-Contrast OU (VA LC OU). Obtained for habitual lenses at baseline. |
| Anterior Ocular Physiological Response | Baseline | Ocular response assessed with the slit lamp using a Visual Analog Scale (0-4, 0=none, 4=severe). Obtained for habitual lenses at baseline. |
| Average Wearing Time | Baseline | Participant response when asked, Number of hours worn today? (hours per day) Obtained for habitual lens at baseline. |
| Overall Fit Acceptance | Baseline | Objective measurement by investigator of overall fit acceptance. (scale 0-4; 0=very poor, 4=very good) Obtained for habitual lenses at baseline. |
Countries
Canada, United States
Participant flow
Recruitment details
Study included 2 visits screening and fitting. Up to 50 existing lens wearers prescriptions from +20 to -20D spheres fitted. Participants evaluated at baseline/screening and lens dispensing visit with at least 1 other visit occurring at minium of 2 weeks lens wear.
Participants by arm
| Arm | Count |
|---|---|
| Comfilcon A Participants dispensed Biofinity XR lenses over two weeks of lens wear
Biofinity XR / comfilcon A | 19 |
| Total | 19 |
Baseline characteristics
| Characteristic | Comfilcon A |
|---|---|
| Age, Continuous | 43 years STANDARD_DEVIATION 17 |
| Region of Enrollment Canada | 4 participants |
| Region of Enrollment United States | 15 participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 19 |
| serious Total, serious adverse events | 0 / 19 |
Outcome results
Primary
Comfort (Insertion)
Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=cannot be worn,Causes pain; 100=Cannot be felt ever) Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.
Time frame: Dispense
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Comfilcon A | Comfort (Insertion) | 89 units on a scale | Standard Deviation 9 |
Primary
Comfort (Insertion, End of Day, Overall)
Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=cannot be worn,Causes pain; 100=Cannot be felt ever) Obtained habitual lens history at baseline.
Time frame: Baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Comfilcon A | Comfort (Insertion, End of Day, Overall) | Comfort | 86 units on a scale | Standard Deviation 8 |
| Comfilcon A | Comfort (Insertion, End of Day, Overall) | Comfort at End of Day | 62 units on a scale | Standard Deviation 18 |
| Comfilcon A | Comfort (Insertion, End of Day, Overall) | Overall Comfort | 83 units on a scale | Standard Deviation 15 |
Primary
Comfort (Insertion, End of Day, Overall)
Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=cannot be worn,Causes pain; 100=Cannot be felt ever) Obtained at 2 weeks.
Time frame: 2 Weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Comfilcon A | Comfort (Insertion, End of Day, Overall) | Comfort | 89 units on a scale | Standard Deviation 11 |
| Comfilcon A | Comfort (Insertion, End of Day, Overall) | Comfort at End of Day | 76 units on a scale | Standard Deviation 22 |
| Comfilcon A | Comfort (Insertion, End of Day, Overall) | Overall Comfort | 86 units on a scale | Standard Deviation 17 |
Primary
Comfort Preference
Subjective response of participant by questionnaire on a likert scale (Prefer New Lenses Strongly, Prefer New Lenses Slightly, No Preference - both acceptable/both unacceptable, Prefer My Own Lenses Slightly, Prefer My Own Lenses Strongly) Obtained at 2 weeks.
Time frame: 2 Weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Comfilcon A | Comfort Preference | comfilcon A lenses | 42 percentage of participants |
| Comfilcon A | Comfort Preference | habitual lenses | 26 percentage of participants |
| Comfilcon A | Comfort Preference | no preference | 32 percentage of participants |
Primary
Comfort Preference
Subjective response of participant by questionnaire on a likert scale (Prefer New Lenses Strongly, Prefer New Lenses Slightly, No Preference - both acceptable/both unacceptable, Prefer My Own Lenses Slightly, Prefer My Own Lenses Strongly) Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.
Time frame: Dispense
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Comfilcon A | Comfort Preference | comfilcon A lenses | 47 percentage of participants |
| Comfilcon A | Comfort Preference | habitual lenses | 16 percentage of participants |
| Comfilcon A | Comfort Preference | no preference | 37 percentage of participants |
Primary
Dryness (During Day)
Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=cannot be worn, Extremely dry. 100=No dryness experienced at any time.) Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.
Time frame: Dispense
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Comfilcon A | Dryness (During Day) | 92 units on a scale | Standard Deviation 10 |
Primary
Dryness (During Day and Dryness at Night)
Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=cannot be worn, Extremely dry. 100=No dryness experienced at any time.) Obtained at two weeks.
Time frame: 2 Weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Comfilcon A | Dryness (During Day and Dryness at Night) | Dryness | 87 units on a scale | Standard Deviation 12 |
| Comfilcon A | Dryness (During Day and Dryness at Night) | Dryness at End of Day | 76 units on a scale | Standard Deviation 24 |
Primary
Dryness (During Day and Dryness at Night)
Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=cannot be worn, Extremely dry. 100=No dryness experienced at any time.) Obtained habitual lens history at baseline.
Time frame: Baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Comfilcon A | Dryness (During Day and Dryness at Night) | Dryness at End of Day | 53 units on a scale | Standard Deviation 25 |
| Comfilcon A | Dryness (During Day and Dryness at Night) | Dryness During Day | 69 units on a scale | Standard Deviation 17 |
Primary
Ghosting (Multiple Images)
Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extreme ghosting. Cannot be worn. 100=No ghosting ever.) Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.
Time frame: Dispense
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Comfilcon A | Ghosting (Multiple Images) | 93 units on a scale | Standard Deviation 15 |
Primary
Ghosting (Multiple Images)
Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extreame ghosting. Cannot be worn. 100=No ghosting ever.) Obtained habitual lens history at baseline.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Comfilcon A | Ghosting (Multiple Images) | 90 units on a scale | Standard Deviation 12 |
Primary
Ghosting (Multiple Images)
Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extreme ghosting. Cannot be worn. 100=No ghosting ever.) Obtained at 2 weeks.
Time frame: 2 Weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Comfilcon A | Ghosting (Multiple Images) | 92 units on a scale | Standard Deviation 15 |
Primary
Handling (Insertion, Removal, Overall)
Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=cannot be worn,Causes pain; 100=Cannot be felt ever) Obtained habitual lens history at baseline.
Time frame: Baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Comfilcon A | Handling (Insertion, Removal, Overall) | Ease of Insertion | 93 units on a scale | Standard Deviation 10 |
| Comfilcon A | Handling (Insertion, Removal, Overall) | Ease of Removal | 87 units on a scale | Standard Deviation 13 |
| Comfilcon A | Handling (Insertion, Removal, Overall) | Ease of Handling Overall | 91 units on a scale | Standard Deviation 12 |
Primary
Handling (Insertion, Removal, Overall)
Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=cannot be worn,Causes pain; 100=Cannot be felt ever) Obtained at 2 weeks.
Time frame: 2 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Comfilcon A | Handling (Insertion, Removal, Overall) | Ease of Insertion | 94 units on a scale | Standard Deviation 7 |
| Comfilcon A | Handling (Insertion, Removal, Overall) | Ease of Removal | 83 units on a scale | Standard Deviation 19 |
| Comfilcon A | Handling (Insertion, Removal, Overall) | Ease of Handling Overall | 89 units on a scale | Standard Deviation 13 |
Primary
Handling Preference
Subjective response of participant by questionnaire on a likert scale (Prefer New Lenses Strongly, Prefer New Lenses Slightly, No Preference - both acceptable/both unacceptable, Prefer My Own Lenses Slightly, Prefer My Own Lenses Strongly) Obtained at 2 weeks.
Time frame: 2 Weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Comfilcon A | Handling Preference | comfilcon A lenses | 32 percentage of participants |
| Comfilcon A | Handling Preference | habitual lenses | 32 percentage of participants |
| Comfilcon A | Handling Preference | no preference | 37 percentage of participants |
Primary
Hazing (Blurred Edges)
Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extreme haze. Cannot be worn. 100=No hazing experienced at any time.) Obtained at 2 weeks.
Time frame: 2 Weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Comfilcon A | Hazing (Blurred Edges) | 92 units on a scale | Standard Deviation 14 |
Primary
Hazing (Blurred Edges)
Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extreame haze. Cannot be worn. 100=No hazing experienced at any time.) Obtained habitual lens history at baseline.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Comfilcon A | Hazing (Blurred Edges) | 79 units on a scale | Standard Deviation 24 |
Primary
Overall Preference
Subjective response of participant by questionnaire on a likert scale (Prefer New Lenses Strongly, Prefer New Lenses Slightly, No Preference - both acceptable/both unacceptable, Prefer My Own Lenses Slightly, Prefer My Own Lenses Strongly) Obtained at 2 weeks.
Time frame: 2 Weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Comfilcon A | Overall Preference | no preference | 16 percentage of participants |
| Comfilcon A | Overall Preference | comfilcon A lenses | 63 percentage of participants |
| Comfilcon A | Overall Preference | habitual lenses | 21 percentage of participants |
Primary
Overall Preference
Subjective response of participant by questionnaire on a likert scale (Prefer New Lenses Strongly, Prefer New Lenses Slightly, No Preference - both acceptable/both unacceptable, Prefer My Own Lenses Slightly, Prefer My Own Lenses Strongly) Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.
Time frame: Dispense
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Comfilcon A | Overall Preference | comfilcon A lenses | 37 percentage of participants |
| Comfilcon A | Overall Preference | habitual lenses | 5 percentage of participants |
| Comfilcon A | Overall Preference | no preference | 58 percentage of participants |
Primary
Overall Satisfaction of Comfort, Vision, Handling
Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extremely dissatisfied; 100=Extremely satisfied.) Obtained habitual lens history at baseline.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Comfilcon A | Overall Satisfaction of Comfort, Vision, Handling | 82 units on a scale | Standard Deviation 15 |
Primary
Overall Satisfaction of Comfort, Vision, Handling
Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extremely dissatisfied; 100=Extremely satisfied.) Obtained at baseline at 2 weeks.
Time frame: 2 Weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Comfilcon A | Overall Satisfaction of Comfort, Vision, Handling | 87 units on a scale | Standard Deviation 15 |
Primary
Overall Satisfaction of Comfort, Vision, Handling
Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extremely dissatisfied; 100=Extremely satisfied.) Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.
Time frame: Dispense
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Comfilcon A | Overall Satisfaction of Comfort, Vision, Handling | 90 units on a scale | Standard Deviation 8 |
Primary
Vision Preference
Subjective response of participant by questionnaire on a likert scale (Prefer New Lenses Strongly, Prefer New Lenses Slightly, No Preference - both acceptable/both unacceptable, Prefer My Own Lenses Slightly, Prefer My Own Lenses Strongly) Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.
Time frame: Dispense
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Comfilcon A | Vision Preference | comfilcon A lenses | 42 percentage of participants |
| Comfilcon A | Vision Preference | habitual lenses | 0 percentage of participants |
| Comfilcon A | Vision Preference | no preference | 58 percentage of participants |
Primary
Vision Preference
Subjective response of participant by questionnaire on a likert scale (Prefer New Lenses Strongly, Prefer New Lenses Slightly, No Preference - both acceptable/both unacceptable, Prefer My Own Lenses Slightly, Prefer My Own Lenses Strongly) Obtained at 2 weeks.
Time frame: 2 Weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Comfilcon A | Vision Preference | comfilcon A lenses | 53 percentage of participants |
| Comfilcon A | Vision Preference | habitual lenses | 31 percentage of participants |
| Comfilcon A | Vision Preference | no preference | 16 percentage of participants |
Primary
Vision Quality (During Day)
Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extremely poor vision all the time. Cannot function; 100=Excellent vision all of the time.) Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.
Time frame: Dispense
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Comfilcon A | Vision Quality (During Day) | 87 units on a scale | Standard Deviation 15 |
Primary
Vision Quality (During Day and at Night)
Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extremely poor vision all the time. Cannot function; 100=Excellent vision all of the time.) Obtained habitual lens history at baseline.
Time frame: Baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Comfilcon A | Vision Quality (During Day and at Night) | Vision During the Day | 78 units on a scale | Standard Deviation 17 |
| Comfilcon A | Vision Quality (During Day and at Night) | Vision at Night | 62 units on a scale | Standard Deviation 22 |
Primary
Vision Quality (During Day and at Night)
Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extremely poor vision all the time. Cannot function; 100=Excellent vision all of the time.) Obtained at 2 weeks.
Time frame: 2 Weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Comfilcon A | Vision Quality (During Day and at Night) | Vision During the Day | 86 units on a scale | Standard Deviation 16 |
| Comfilcon A | Vision Quality (During Day and at Night) | Vision at Night | 78 units on a scale | Standard Deviation 22 |
Secondary
Anterior Ocular Physiological Response
Ocular response assessed with the slit lamp using a Visual Analog Scale (0-4, 0=none, 4=severe). Obtained at 2 weeks.
Time frame: 2 Weeks
Population: Overall Conjunctival Staining (n=16), Overall Palpebral Papillae (n=8) Missing data as not all sites collected this data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Comfilcon A | Anterior Ocular Physiological Response | Overall Redness Bulbar | 1.00 units on a scale | Standard Deviation 0.69 |
| Comfilcon A | Anterior Ocular Physiological Response | Overall Redness Limbal | 0.74 units on a scale | Standard Deviation 0.81 |
| Comfilcon A | Anterior Ocular Physiological Response | Overall Corneal Staining Type | 0.47 units on a scale | Standard Deviation 0.61 |
| Comfilcon A | Anterior Ocular Physiological Response | Corneal Staining Extent (n=19) | 0.45 units on a scale | Standard Deviation 0.6 |
| Comfilcon A | Anterior Ocular Physiological Response | Conjunctival Staining (n=16) | 0.94 units on a scale | Standard Deviation 0.96 |
| Comfilcon A | Anterior Ocular Physiological Response | Overall Palpebral Injection | 0.9 units on a scale | Standard Deviation 0.61 |
| Comfilcon A | Anterior Ocular Physiological Response | Overall Palpebral Papillae (n=8) | 0.7 units on a scale | Standard Deviation 0.65 |
Secondary
Anterior Ocular Physiological Response
Ocular response assessed with the slit lamp using a Visual Analog Scale (0-4, 0=none, 4=severe). Obtained for habitual lenses at baseline.
Time frame: Baseline
Population: Overall Conjunctival Staining (n=16), Overall Palpebral Papillae (n=8) Missing data as not all sites collected this data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Comfilcon A | Anterior Ocular Physiological Response | Overall Redness Bulbar | 1.13 units on a scale | Standard Deviation 0.64 |
| Comfilcon A | Anterior Ocular Physiological Response | Overall Redness Limbal | 0.84 units on a scale | Standard Deviation 0.78 |
| Comfilcon A | Anterior Ocular Physiological Response | Overall Corneal Staining Type | 0.68 units on a scale | Standard Deviation 0.53 |
| Comfilcon A | Anterior Ocular Physiological Response | Corneal Staining Extent (n=19) | 0.66 units on a scale | Standard Deviation 0.58 |
| Comfilcon A | Anterior Ocular Physiological Response | Conjunctival Staining (n=16) | 0.31 units on a scale | Standard Deviation 0.55 |
| Comfilcon A | Anterior Ocular Physiological Response | Overall Palpebral Injection | 0.8 units on a scale | Standard Deviation 0.69 |
| Comfilcon A | Anterior Ocular Physiological Response | Overall Palpebral Papillae (n=8) | 0.3 units on a scale | Standard Deviation 0.51 |
Secondary
Average Wearing Time
Participant response when asked, Number of hours worn today? (hours per day) Obtained at 2 weeks.
Time frame: 2 Weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Comfilcon A | Average Wearing Time | 12.5 hours | Standard Deviation 2.8 |
Secondary
Average Wearing Time
Participant response when asked, Number of hours worn today? (hours per day) Obtained for habitual lens at baseline.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Comfilcon A | Average Wearing Time | 13 hours | Standard Deviation 3.6 |
Secondary
Lens Centration
Objective measurement by investigator. (Assessed as optimum, slightly decentered, extremely decentered) Obtained at 2 weeks.
Time frame: 2 Weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Comfilcon A | Lens Centration | optimum | 63 percentage of lenses |
| Comfilcon A | Lens Centration | slightly decentered | 32 percentage of lenses |
| Comfilcon A | Lens Centration | extremely decentered | 5 percentage of lenses |
Secondary
Lens Centration
Objective measurement by investigator. (Assessed as optimum, slightly decentered, extremely decentered) Obtained at baseline at dispense.
Time frame: Dispense
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Comfilcon A | Lens Centration | optimum | 63 percentage of lenses |
| Comfilcon A | Lens Centration | slightly decentered | 26 percentage of lenses |
| Comfilcon A | Lens Centration | extremely decentered | 10 percentage of lenses |
Secondary
Lens Centration - Habitual Lenses
Objective measurement by investigator. (Assessed as optimum, slightly decentered, extremely decentered) Obtained for habitual lenses at baseline.
Time frame: Baseline
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Comfilcon A | Lens Centration - Habitual Lenses | optimum | 53 percentage of lenses |
| Comfilcon A | Lens Centration - Habitual Lenses | slightly decentered | 37 percentage of lenses |
| Comfilcon A | Lens Centration - Habitual Lenses | extremely decentered | 11 percentage of lenses |
Secondary
Lens Movement
Objective measurement by investigator of overall post-blink lens movement. (Average Grade; Graded 0-4; 0=exceptionally tight, 2=optimal, 4=exceptionally loose) Obtained at 2 weeks wear.
Time frame: 2 Weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Comfilcon A | Lens Movement | 2.45 units on a scale | Standard Deviation 0.6 |
Secondary
Lens Movement
Objective measurement by investigator of overall post-blink lens movement. (Average Grade; Graded 0-4; 0=exceptionally tight, 2=optimal, 4=exceptionally loose) Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.
Time frame: Dispense
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Comfilcon A | Lens Movement | 2.39 units on a scale | Standard Deviation 0.52 |
Secondary
Lens Movement - Habitual Lenses
Objective measurement by investigator of overall post-blink lens movement. (Average Grade; Graded 0-4; 0=exceptionally tight, 2=optimal, 4=exceptionally loose) Obtained for habitual lenses at baseline.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Comfilcon A | Lens Movement - Habitual Lenses | 2.47 units on a scale | Standard Deviation 0.92 |
Secondary
Overall Fit Acceptance
Objective measurement by investigator of overall fit acceptance. (scale 0-4; 0=very poor, 4=very good) Obtained at 2 weeks.
Time frame: 2 Weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Comfilcon A | Overall Fit Acceptance | 3.45 units on a scale | Standard Deviation 0.394 |
Secondary
Overall Fit Acceptance
Objective measurement by investigator of overall fit acceptance. (scale 0-4; 0=very poor, 4=very good) Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.
Time frame: Dispense
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Comfilcon A | Overall Fit Acceptance | 3.47 units on a scale | Standard Deviation 0.51 |
Secondary
Overall Fit Acceptance
Objective measurement by investigator of overall fit acceptance. (scale 0-4; 0=very poor, 4=very good) Obtained for habitual lenses at baseline.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Comfilcon A | Overall Fit Acceptance | 3.33 units on a scale | Standard Deviation 0.59 |
Secondary
Visual Acuity
Objective measurement by investigator of monocular high and low contrast logMar visual acuity. Visual Acuity High-Contrast (VA HC), Visual Acuity Low-Contrast (VA LC), Visual Acuity High-Contrast OU (VA HC OU), Visual Acuity Low-Contrast OU (VA LC OU). Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.
Time frame: Dispense
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Comfilcon A | Visual Acuity | VA HC | 0.10 logMar | Standard Deviation 0.15 |
| Comfilcon A | Visual Acuity | VA LC | 0.18 logMar | Standard Deviation 0.16 |
| Comfilcon A | Visual Acuity | VA HC (OU) | 0.03 logMar | Standard Deviation 0.13 |
| Comfilcon A | Visual Acuity | VA LC (OU) | 0.11 logMar | Standard Deviation 0.14 |
Secondary
Visual Acuity
Objective measurement by investigator of monocular high and low contrast logMar visual acuity. Visual Acuity High-Contrast (VA HC), Visual Acuity Low-Contrast (VA LC), Visual Acuity High-Contrast OU (VA HC OU), Visual Acuity Low-Contrast OU (VA LC OU). Obtained at 2 weeks.
Time frame: 2 Weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Comfilcon A | Visual Acuity | VA HC | 0.11 logMar | Standard Deviation 0.11 |
| Comfilcon A | Visual Acuity | VA LC | 0.18 logMar | Standard Deviation 0.15 |
| Comfilcon A | Visual Acuity | VA HC (OU) | 0.02 logMar | Standard Deviation 0.12 |
| Comfilcon A | Visual Acuity | VA LC (OU) | 0.11 logMar | Standard Deviation 0.14 |
Secondary
Visual Acuity
Objective measurement by investigator of monocular high and low contrast logMar visual acuity. Visual Acuity High-Contrast (VA HC), Visual Acuity Low-Contrast (VA LC), Visual Acuity High-Contrast OU (VA HC OU), Visual Acuity Low-Contrast OU (VA LC OU). Obtained for habitual lenses at baseline.
Time frame: Baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Comfilcon A | Visual Acuity | VA HC | 0.16 logMar | Standard Deviation 0.12 |
| Comfilcon A | Visual Acuity | VA LC | 0.22 logMar | Standard Deviation 0.14 |
| Comfilcon A | Visual Acuity | VA HC (OU) | 0.04 logMar | Standard Deviation 0.13 |
| Comfilcon A | Visual Acuity | VA LC (OU) | 0.15 logMar | Standard Deviation 0.15 |