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The aim of this dispensing study is to evaluate the clinical performance of habitual wearers of enfilcon A lenses following a refit with fanfilcon A lenses over 4 weeks of daily wear.
This is a 30 subject, prospective, dispensing, bilateral wear, subject-masked study, reviewing the refit characteristics in a group of enfilcon A wearers switched to the fanfilcon A lens. Subject's habitual enfilcon A lenses will be evaluated at the first vist and then re-fitted with a pair of fanfilcon A lenses for 4 weeks of daily wear. After the dispensing visit, subjects will return for evaluations at 1 week, 2 weeks, and 4 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| enfilcon A (habitual) | No Intervention | Participants are habitual wearers of enfilcon A lens and refitted with fanfilcon A lens. | |
| fanfilcon A (test) | Experimental | Participants are habitual wearers of enfilcon A lens and refitted with fanfilcon A lens. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fanfilcon A (test) | Device | contact lens |
|
| Measure | Description | Time Frame |
|---|---|---|
| Lens Fit - Centration | Lens fit evaluation of centration for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. Scale: optimum, decentration acceptable, decentration unacceptable. | Baseline, 1 week, 2 weeks, and 4 weeks |
| Lens Fit - Post-blink Movement | Lens fit evaluation of post-blink movement for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. Scale 0-5 Likert scale, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement. | Baseline, 1 week, 2 weeks, and 4 weeks |
| Lens Tightness on Push-up | Lens fit evaluation of tightness on push-up test for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. Scale: 0%-100%, 0%=Falls from cornea without lid support, 50%=Optimum, 100%=No movement. | Baseline, 1 week, 2 weeks, and 4 weeks |
| Overall Fit Acceptance | Overall fit acceptance for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. Scale 0-4, 0=Should not be worn, 1=Borderline but unacceptable, 2=Minimum acceptable, early review, 3=Not perfect but okay to dispense, 4=Perfect. | Baseline, 1 week, 2 weeks, and 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Comfort | Subjective rating of overall comfort for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. Scale 0-10, 0=could feel, 10=cannot feel. | Baseline, 1 week, 2 weeks, and 4 weeks |
| Dryness Overall |
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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:
Is not a habitual wearer of enfilcon A lenses
Has a CL (Contact Lens) 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 3-4) 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, O.D., PhD | Optometry Research Group (GIO) 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 | Participants are habitual wearers of enfilcon A lens and refitted with fanfilcon A lens. fanfilcon A (test): contact lens |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
34 subjects completed the study and included in the baseline analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Participants | Participants are habitual wearers of enfilcon A lens and refitted with fanfilcon A lens. fanfilcon A (test): 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 | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Lens Fit - Centration | Lens fit evaluation of centration for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. Scale: optimum, decentration acceptable, decentration unacceptable. | Posted | Number | percentage of eyes | Baseline, 1 week, 2 weeks, and 4 weeks |
|
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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 | Participants are habitual wearers of enfilcon A lens and refitted with fanfilcon A lens. fanfilcon A (test): contact lens |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Manager Global Medical Scientific Affairs | CooperVision Inc. | 925 621-3761 | javega@coopervision.com |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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Subjective rating of overall dryness for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. Scale 0-10, 0=very dry, 10=no dryness. |
| Baseline, 1 week, 2 weeks, and 4 weeks |
| Handling | Subjective rating of handling for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. Scale 0-10, 0=very difficult to handle, 10=very easy to handle. | Baseline, 1 week, 2 weeks, and 4 weeks |
| Overall Vision Satisfaction | Subjective rating of overall vision satisfaction for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. Scale 0-10, 0=very dissatisfied, 10=very satisfied. | Baseline, 1 week, 2 weeks, and 4 weeks |
| Overall Satisfaction | Subjective rating of overall satisfaction for enfilcon A habitual lens (control) at baseline and fanfilcon A lens (test) at 1 week, 2 weeks, and 4 weeks. Scale 1-4, 1=completely satisfied, 2=somewhat satisfied, 3=somewhat dissatisfied, 4=completely dissatisfied. | Baseline, 1 week, 2 weeks, and 4 weeks |
| Lens Preference Overall | Subject's overall preference for one of two contact lenses. Forced choice: enfilcon A habitual lens (control) or fanfilcon A lens (test). | 1 week, 2 weeks, and 4 weeks |
| Wearing Times | Average wearing time and comfortable wearing times for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks measured by hours. | Baseline, 1 week, 2 weeks, and 4 weeks |
| Conjunctival Staining | Conjunctival staining for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. (Scale 0-4, 0.5 steps 0=normal, 4=severe). | Baseline, 1 week, 2 weeks, and 4 weeks |
| Corneal Staining | Corneal staining for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. Scale 0-4, 0.5 steps 0=normal, 4=severe. | Baseline, 1 week, 2 weeks, and 4 weeks |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
fanfilcon A lens (test) |
| OG003 | Fanfilcon A: 4 Weeks | fanfilcon A lens (test) |
|
|
| Primary | Lens Fit - Post-blink Movement | Lens fit evaluation of post-blink movement for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. Scale 0-5 Likert scale, 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, 1 week, 2 weeks, and 4 weeks |
|
|
|
| Primary | Lens Tightness on Push-up | Lens fit evaluation of tightness on push-up test for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. Scale: 0%-100%, 0%=Falls from cornea without lid support, 50%=Optimum, 100%=No movement. | Posted | Mean | Standard Deviation | percentage of lens tightness | Baseline, 1 week, 2 weeks, and 4 weeks |
|
|
|
| Primary | Overall Fit Acceptance | Overall fit acceptance for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. Scale 0-4, 0=Should not be worn, 1=Borderline but unacceptable, 2=Minimum acceptable, early review, 3=Not perfect but okay to dispense, 4=Perfect. | Posted | Number | percentage of eyes | Baseline, 1 week, 2 weeks, and 4 weeks |
|
|
|
| Secondary | Overall Comfort | Subjective rating of overall comfort for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. Scale 0-10, 0=could feel, 10=cannot feel. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 1 week, 2 weeks, and 4 weeks |
|
|
|
| Secondary | Dryness Overall | Subjective rating of overall dryness for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. Scale 0-10, 0=very dry, 10=no dryness. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 1 week, 2 weeks, and 4 weeks |
|
|
|
| Secondary | Handling | Subjective rating of handling for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. Scale 0-10, 0=very difficult to handle, 10=very easy to handle. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 1 week, 2 weeks, and 4 weeks |
|
|
|
| Secondary | Overall Vision Satisfaction | Subjective rating of overall vision satisfaction for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. Scale 0-10, 0=very dissatisfied, 10=very satisfied. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 1 week, 2 weeks, and 4 weeks |
|
|
|
| Secondary | Overall Satisfaction | Subjective rating of overall satisfaction for enfilcon A habitual lens (control) at baseline and fanfilcon A lens (test) at 1 week, 2 weeks, and 4 weeks. Scale 1-4, 1=completely satisfied, 2=somewhat satisfied, 3=somewhat dissatisfied, 4=completely dissatisfied. | One participant withdrew from the study after week 1. | Posted | Number | percentage of subjects | Baseline, 1 week, 2 weeks, and 4 weeks |
|
|
|
| Secondary | Lens Preference Overall | Subject's overall preference for one of two contact lenses. Forced choice: enfilcon A habitual lens (control) or fanfilcon A lens (test). | One participant withdrew from the study after week 1. | Posted | Number | percentage of subjects | 1 week, 2 weeks, and 4 weeks |
|
|
|
| Secondary | Wearing Times | Average wearing time and comfortable wearing times for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks measured by hours. | Posted | Mean | Standard Deviation | hours | Baseline, 1 week, 2 weeks, and 4 weeks |
|
|
|
| Secondary | Conjunctival Staining | Conjunctival staining for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. (Scale 0-4, 0.5 steps 0=normal, 4=severe). | Posted | Number | percentage of eyes | Baseline, 1 week, 2 weeks, and 4 weeks |
|
|
|
| Secondary | Corneal Staining | Corneal staining for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. Scale 0-4, 0.5 steps 0=normal, 4=severe. | Posted | Number | percentage of eyes | Baseline, 1 week, 2 weeks, and 4 weeks |
|
|
|
| 0 |
| 35 |
| 0 |
| 35 |
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| Minimal, but acceptable movement |
|
| Optimal movement |
|
| Moderate, but acceptable movement |
|
| Excessive, unacceptable movement |
|
| Borderline but unacceptable |
|
| Minimum acceptable |
|
| Not perfect but okay |
|
| Perfect |
|
|
| 1 week - fanfilcon A lens (test) |
|
|
| 2 weeks - fanfilcon A lens (test) |
|
|
| 4 weeks - fanfilcon A lens (test) |
|
|
| 2 weeks |
|
|
| 4 weeks |
|
|
| Comfortable wearing time |
|
| 0.5 |
|
| 1.0 |
|
| 1.5 |
|
| 2.0 |
|
| 2.5 |
|
| 3.0 |
|
| 3.5 |
|
| 4.0 |
|
| 0.5 |
|
| 1.0 |
|
| 1.5 |
|
| 2.0 |
|
| 2.5 |
|
| 3.0 |
|
| 3.5 |
|
| 4.0 |
|