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Open label, 1-week daily disposable, dispensing study
Evaluate the clinical performance of habitual wearers of FILCON IV 1 sphere lenses when refitted with ocufilcon D asphere for 1 week of daily disposable wear.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| filcon IV 1 and ocufilcon D | Experimental | Habitual wearers of filcon IV 1 sphere lenses refitted with asphere ocufilcon D lenses. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| filcon IV 1 | Device | contact lens |
| |
| ocufilcon D |
| Measure | Description | Time Frame |
|---|---|---|
| Lens Fit, Centration - Filcon IV 1 and Ocufilcon D | Lens fit, centration for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale: optimum, decentration acceptable, and decentration unacceptable | Baseline and 1 Week |
| Lens Fit, Post-blink Movement - Filcon IV 1 and Ocufilcon D | Lens fit, post-blink movement for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. (Scale 0-4, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement). | Baseline and 1 Week |
| Lens Fit, Lens Tightness - Filcon IV 1 and Ocufilcon D | Lens fit, lens tightness for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale 0%-100% continuous scale 0% - Falls from cornea without lid support 50% - Optimum 100% - No movement | Baseline and 1 Week |
| Lens Fit, Overall Fit Acceptance - Filcon IV 1 and Ocufilcon D | Lens fit, overall fit acceptance for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale 0-4, 0=Should not be worn, 4=Perfect. | Baseline and 1 Week |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Acuity - Filcon IV 1 and Ocufilcon D | Visual acuity for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week using logMAR chart (a logMAR of 0.0=20/20 in Snellen notation and negative values indicate better visual acuity). | Baseline and 1 Week |
| Comfort (Subjective Ratings) - Filcon IV 1 and Ocufilcon D |
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Inclusion Criteria:
Exclusion Criteria:
Is not a habitual wearer of Avaira sphere lenses
Has a CL prescription outside the range of the available parameters of the study lenses.
Has a spectacle cylinder ≥1.00D of cylinder in either eye.
Has a history of not achieving comfortable CL 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 | 46100 | Spain |
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| ID | Title | Description |
|---|---|---|
| FG000 | Overall Participants | Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses. filcon IV 1: contact lens ocufilcon D: contact lens |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Participants | Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses. filcon IV 1: contact lens ocufilcon D: contact lens |
| 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 | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Visual Acuity - Filcon IV 1 and Ocufilcon D | Visual acuity for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week using logMAR chart (a logMAR of 0.0=20/20 in Snellen notation and negative values indicate better visual acuity). | Posted | Mean | Standard Deviation | LogMAR | Baseline and 1 Week |
|
From dispense up to one week for each study 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 | Overall Participants | Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses. filcon IV 1: contact lens ocufilcon D: contact lens |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jose A. Vega, OD, Sr. Manager Global Medical Scientific Affairs | Coopervision | (925) 621-3761 | javega@coopervision.com |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| D006956 | Hyperopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| Device |
contact lens |
|
Subjective ratings for comfort for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. (Scale 0-10, 0=could feel, 10=cannot feel). |
| Baseline and 1 Week |
| Dryness (Subjective Ratings) - Filcon IV 1 and Ocufilcon D | Subjective ratings of dryness for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. (Scale 0-10, 0=dryness, 10=no dryness). | Baseline and 1 Week |
| Handling (Subjective Ratings) - Filcon IV 1 and Ocufilcon D | Subjective ratings of handling for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. (Scale 0-10, 0=very difficult to handle, 10=very easy to handle). | Baseline and 1 Week |
| Vision Satisfaction (Subjective Ratings) - Filcon IV 1 and Ocufilcon D | Subjective ratings of vision satisfaction for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. (Scale 0-10, 0=dissatisfied, 10=very satisfied). | Baseline and 1 Week |
| Lens Preference (Subjective Ratings) - Filcon IV 1 and Ocufilcon D | Subjective ratings of participant's lens preference for either filcon IV 1 or ocufilcon D on comfort, dryness, handling, vision, and overall. Forced choice: filcon IV 1 or ocufilcon D. | 1 Week |
| Lens Satisfaction, Comfort - Filcon IV 1 and Ocufilcon D | Lens satisfaction of comfort for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale 1-4, 1=completely satisfied, 4=completely dissatisfied. | Baseline and 1 Week |
| Lens Satisfaction, Dryness - Filcon IV 1 and Ocufilcon D | Lens satisfaction of dryness for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale 1-4, 1=completely satisfied, 4=completely dissatisfied. | Baseline and 1 Week |
| Lens Satisfaction, Handling - Filcon IV 1 and Ocufilcon D | Lens satisfaction of handling forfilcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale 1-4, 1=completely satisfied, 4=completely dissatisfied. | Baseline and 1 Week |
| Lens Satisfaction, Vision - Filcon IV 1 and Ocufilcon D | Lens satisfaction of vision for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale 1-4, 1=completely satisfied, 4=completely dissatisfied. | Baseline and 1 Week |
| Lens Satisfaction, Overall - Filcon IV 1 and Ocufilcon D | Lens satisfaction overall for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale 1-4, 1=completely satisfied, 4=completely dissatisfied. | Baseline and 1 Week |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Secondary | Comfort (Subjective Ratings) - Filcon IV 1 and Ocufilcon D | Subjective ratings for comfort for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. (Scale 0-10, 0=could feel, 10=cannot feel). | Posted | Mean | Standard Deviation | units on a scale | Baseline and 1 Week |
|
|
|
| Primary | Lens Fit, Centration - Filcon IV 1 and Ocufilcon D | Lens fit, centration for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale: optimum, decentration acceptable, and decentration unacceptable | Posted | Number | percentage of eyes | Baseline and 1 Week |
|
|
|
| Primary | Lens Fit, Post-blink Movement - Filcon IV 1 and Ocufilcon D | Lens fit, post-blink movement for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. (Scale 0-4, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement). | Posted | Number | percentage of eyes | Baseline and 1 Week |
|
|
|
| Primary | Lens Fit, Lens Tightness - Filcon IV 1 and Ocufilcon D | Lens fit, lens tightness for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale 0%-100% continuous scale 0% - Falls from cornea without lid support 50% - Optimum 100% - No movement | Posted | Mean | Standard Deviation | percentage of mean lens tightness | Baseline and 1 Week |
|
|
|
| Primary | Lens Fit, Overall Fit Acceptance - Filcon IV 1 and Ocufilcon D | Lens fit, overall fit acceptance for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale 0-4, 0=Should not be worn, 4=Perfect. | Posted | Number | percentage of eyes | Baseline and 1 Week |
|
|
|
| Secondary | Dryness (Subjective Ratings) - Filcon IV 1 and Ocufilcon D | Subjective ratings of dryness for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. (Scale 0-10, 0=dryness, 10=no dryness). | Posted | Mean | Standard Deviation | units on a scale | Baseline and 1 Week |
|
|
|
| Secondary | Handling (Subjective Ratings) - Filcon IV 1 and Ocufilcon D | Subjective ratings of handling for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. (Scale 0-10, 0=very difficult to handle, 10=very easy to handle). | Posted | Mean | Standard Deviation | units on a scale | Baseline and 1 Week |
|
|
|
| Secondary | Vision Satisfaction (Subjective Ratings) - Filcon IV 1 and Ocufilcon D | Subjective ratings of vision satisfaction for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. (Scale 0-10, 0=dissatisfied, 10=very satisfied). | Posted | Mean | Standard Deviation | units on a scale | Baseline and 1 Week |
|
|
|
| Secondary | Lens Preference (Subjective Ratings) - Filcon IV 1 and Ocufilcon D | Subjective ratings of participant's lens preference for either filcon IV 1 or ocufilcon D on comfort, dryness, handling, vision, and overall. Forced choice: filcon IV 1 or ocufilcon D. | Posted | Number | percentage of participants | 1 Week |
|
|
|
| Secondary | Lens Satisfaction, Comfort - Filcon IV 1 and Ocufilcon D | Lens satisfaction of comfort for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale 1-4, 1=completely satisfied, 4=completely dissatisfied. | Posted | Number | percentage of participants | Baseline and 1 Week |
|
|
|
| Secondary | Lens Satisfaction, Dryness - Filcon IV 1 and Ocufilcon D | Lens satisfaction of dryness for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale 1-4, 1=completely satisfied, 4=completely dissatisfied. | Posted | Number | percentage of participants | Baseline and 1 Week |
|
|
|
| Secondary | Lens Satisfaction, Handling - Filcon IV 1 and Ocufilcon D | Lens satisfaction of handling forfilcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale 1-4, 1=completely satisfied, 4=completely dissatisfied. | Posted | Number | percentage of participants | Baseline and 1 Week |
|
|
|
| Secondary | Lens Satisfaction, Vision - Filcon IV 1 and Ocufilcon D | Lens satisfaction of vision for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale 1-4, 1=completely satisfied, 4=completely dissatisfied. | Posted | Number | percentage of participants | Baseline and 1 Week |
|
|
|
| Secondary | Lens Satisfaction, Overall - Filcon IV 1 and Ocufilcon D | Lens satisfaction overall for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale 1-4, 1=completely satisfied, 4=completely dissatisfied. | Posted | Number | percentage of participants | Baseline and 1 Week |
|
|
|
| 0 |
| 40 |
| 0 |
| 40 |
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between the Principal Investigator and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
| Comfort overall |
|
| Decentration acceptable |
|
| Decentration unacceptable |
|
| 1=Minimal, but acceptable movement |
|
| 2=Optimal movement |
|
| 3=Moderate, but acceptable movement |
|
| 4=Excessive, unacceptable movement |
|
| Borderline but acceptable |
|
| Min. acceptable |
|
| Not perfect but OK |
|
| Perfect |
|
| Overall dryness |
|
| Handling |
|
| Vision |
|
| Overall |
|
| Somewhat Dissatisfied |
|
| Completely Dissatisfied |
|
| Somewhat Dissatisfied |
|
| Completely Dissatisfied |
|
| Somewhat Dissatisfied |
|
| Completely Dissatisfied |
|
| Somewhat Dissatisfied |
|
| Completely Dissatisfied |
|
| Somewhat Dissatisfied |
|
| Completely Dissatisfied |
|