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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Biofinity XR | Experimental | Participants dispensed Biofinity XR lenses over two weeks of lens wear |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biofinity XR | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline |
| 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. | Dispense |
| 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. | 2 Weeks |
| 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. | Baseline |
| 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. | Dispense |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Lens Centration - Habitual Lenses | Objective measurement by investigator. (Assessed as optimum, slightly decentered, extremely decentered) Obtained for habitual lenses at baseline. | Baseline |
| Lens Centration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lyndon Jones | CCLR, University of Waterloo | Principal Investigator |
| Meng Lin | CRC, University of California Berkeley | Principal Investigator |
| Jan Bergmanson | TERTC, University of Houston | Principal Investigator |
| Pete Kollbaum | CORL, Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UC Berkeley Clinica Research Center | Berkeley | California | 94720-2020 | United States | ||
| CORL, Indiana University School of Optometry |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Comfilcon A | Participants dispensed Biofinity XR lenses over two weeks of lens wear Biofinity XR / comfilcon A |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Comfilcon A | Participants dispensed Biofinity XR lenses over two weeks of lens wear Biofinity XR / comfilcon A |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
|
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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 | Participants dispensed Biofinity XR lenses over two weeks of lens wear Biofinity XR / comfilcon A |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Cheryl McKinnon | CooperVision | 925-251-2034 | cmckinnon@coopervision.com |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| D006956 | Hyperopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| 2 Weeks |
| 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. | Baseline |
| 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. | Dispense |
| 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. | 2 Weeks |
| 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. | Baseline |
| 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. | 2 Weeks |
| 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. | Baseline |
| 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. | Dispense |
| 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. | 2 Weeks |
| 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. | Baseline |
| 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. | 2 weeks |
| 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. | Dispense |
| 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. | Baseline |
| 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. | 2 Weeks |
| 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. | Dispense |
| 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. | 2 Weeks |
| 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. | Dispense |
| 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. | 2 Weeks |
| 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. | 2 Weeks |
| 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. | Dispense |
| 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. | 2 Weeks |
Objective measurement by investigator. (Assessed as optimum, slightly decentered, extremely decentered) Obtained at baseline at dispense.
| Dispense |
| Lens Centration | Objective measurement by investigator. (Assessed as optimum, slightly decentered, extremely decentered) Obtained at 2 weeks. | 2 Weeks |
| 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. | Baseline |
| 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. | Dispense |
| 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. | 2 Weeks |
| 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. | Baseline |
| 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. | Dispense |
| Overall Fit Acceptance | Objective measurement by investigator of overall fit acceptance. (scale 0-4; 0=very poor, 4=very good) Obtained at 2 weeks. | 2 Weeks |
| 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. | Baseline |
| 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. | Dispense |
| 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. | 2 Weeks |
| 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. | Baseline |
| 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. | 2 Weeks |
| Average Wearing Time | Participant response when asked, "Number of hours worn today?" (hours per day) Obtained for habitual lens at baseline. | Baseline |
| Average Wearing Time | Participant response when asked, "Number of hours worn today?" (hours per day) Obtained at 2 weeks. | 2 Weeks |
| Indianapolis |
| Indiana |
| 46266-6057 |
| United States |
| TERTC, University of Houston | Houston | Texas | 77204-2020 | United States |
| CCLR, University of Waterloo | Waterloo | Ontario | N2L 3G1 | Canada |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | Lens Centration - Habitual Lenses | Objective measurement by investigator. (Assessed as optimum, slightly decentered, extremely decentered) Obtained for habitual lenses at baseline. | Posted | Number | percentage of lenses | Baseline | Lenses | Lenses |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | Dispense |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | 2 Weeks |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | Dispense |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | 2 Weeks |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | Dispense |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | 2 Weeks |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | 2 Weeks |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | Dispense |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | 2 Weeks |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | 2 weeks |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | Dispense |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | 2 Weeks |
|
|
|
| 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. | Posted | Number | percentage of participants | Dispense |
|
|
|
| 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. | Posted | Number | percentage of participants | 2 Weeks |
|
|
|
| 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. | Posted | Number | percentage of participants | Dispense |
|
|
|
| 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. | Posted | Number | percentage of participants | 2 Weeks |
|
|
|
| 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. | Posted | Number | percentage of participants | 2 Weeks |
|
|
|
| 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. | Posted | Number | percentage of participants | Dispense |
|
|
|
| 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. | Posted | Number | percentage of participants | 2 Weeks |
|
|
|
| Secondary | Lens Centration | Objective measurement by investigator. (Assessed as optimum, slightly decentered, extremely decentered) Obtained at baseline at dispense. | Posted | Number | percentage of lenses | Dispense | Lenses | Lenses |
|
|
|
| Secondary | Lens Centration | Objective measurement by investigator. (Assessed as optimum, slightly decentered, extremely decentered) Obtained at 2 weeks. | Posted | Number | percentage of lenses | 2 Weeks | Lenses | Lenses |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline | Lenses | 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 dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit. | Posted | Mean | Standard Deviation | units on a scale | Dispense | Lenses | 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. | Posted | Mean | Standard Deviation | units on a scale | 2 Weeks | Lenses | Lenses |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline | Lenses | Lenses |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | Dispense | Lenses | Lenses |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | 2 Weeks | Lenses | Lenses |
|
|
|
| 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. | Posted | Mean | Standard Deviation | logMar | Baseline |
|
|
|
| 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. | Posted | Mean | Standard Deviation | logMar | Dispense |
|
|
|
| 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. | Posted | Mean | Standard Deviation | logMar | 2 Weeks |
|
|
|
| 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. | Overall Conjunctival Staining (n=16), Overall Palpebral Papillae (n=8) Missing data as not all sites collected this data. | Posted | Mean | Standard Deviation | units on a scale | Baseline | Eyes | Eyes |
|
|
|
| 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. | Overall Conjunctival Staining (n=16), Overall Palpebral Papillae (n=8) Missing data as not all sites collected this data. | Posted | Mean | Standard Deviation | units on a scale | 2 Weeks | Eyes | Eyes |
|
|
|
| Secondary | Average Wearing Time | Participant response when asked, "Number of hours worn today?" (hours per day) Obtained for habitual lens at baseline. | Posted | Mean | Standard Deviation | hours | Baseline |
|
|
|
| Secondary | Average Wearing Time | Participant response when asked, "Number of hours worn today?" (hours per day) Obtained at 2 weeks. | Posted | Mean | Standard Deviation | hours | 2 Weeks |
|
|
|
| 0 |
| 19 |
| 0 |
| 19 |
All information gathered during this study is proprietary and should be made available only to those directly involved in the study. Information and reports arising from this project are the property of the sponsor.
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|---|
| Measurements |
|---|
|
| VA LC (OU) |
|
| Title | Measurements |
|---|---|
|
| Corneal Staining Extent (n=19) |
|
| Conjunctival Staining (n=16) |
|
| Overall Palpebral Injection |
|
| Overall Palpebral Papillae (n=8) |
|
| Title | Measurements |
|---|---|
|
| Corneal Staining Extent (n=19) |
|
| Conjunctival Staining (n=16) |
|
| Overall Palpebral Injection |
|
| Overall Palpebral Papillae (n=8) |
|