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The aim of this prospective study is to evaluate the clinical performance of habitual wearers of methafilcon A aspheric lenses after a refit with fanfilcon A sphere lenses for 4 weeks of daily wear.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| methalfilcon A contact lenses / fanfilcon A contact lenses | Experimental | All subjects will first wear methafilcon A contact lenses for four (4) weeks of daily wear, then be refitted with fanfilcon A toric contact lenses for four (4) weeks of daily wear. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| methafilcon A contact lenses | Device | Bilateral daily wear of methafilcon A contact lenses |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Lens Centration Assessment by the Investigator - Methafilcon A Contact Lenses | Lens centration assessment using 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable). | Baseline |
| Percentage of Participants With Lens Centration Assessment by the Investigator - Methafilcon A Contact Lenses | Lens centration assessment using 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable). | 4 weeks |
| Percentage of Participants With Lens Centration Assessment by the Investigator - Fanfilcon A Contact Lenses | Lens centration assessment using 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable). | Baseline |
| Percentage of Participants With Lens Centration Assessment by the Investigator - Fanfilcon A Contact Lenses | Lens centration assessment using 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable). | 2 weeks |
| Percentage of Participants With Lens Centration Assessment by the Investigator - Fanfilcon A Contact Lenses | Lens centration assessment using 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable). | 4 weeks |
| Percentage of Participants With Corneal Coverage Assessment by the Investigator - Methafilcon A Contact Lenses | Corneal coverage is collected on a YES/NO response. Yes - lens covers the cornea, No - lens does not cover the cornea |
| Measure | Description | Time Frame |
|---|---|---|
| Average Daily Wearing Time - Methafilcon A Contact Lenses | Average daily wearing time response by the subject | 4 weeks |
| Average Daily Wearing Time - Fanfilcon A Contact Lenses | Average daily wearing time response by the subject. |
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Inclusion Criteria:
Exclusion Criteria:
Has a Contact Lens (CL) prescription outside the range of the available parameters of the study lenses
Has a spectacle cylinder of ≥ 1.00D (Diopter) in either eye
Has a history of not achieving comfortable Contact Lens (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:
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| Name | Affiliation | Role |
|---|---|---|
| Ruben Velazquez, MSc FIACLE | School of Optometry, National Autonomous University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Optometry Clinic, National Autonomous University | Mexico City | Mexico |
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42 subjects were enrolled but three subjects did not satisfy the minimum number of days / hours of wear during the study and excluded from all the analysis.
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| ID | Title | Description |
|---|---|---|
| FG000 | Methalfilcon A Contact Lenses / Fanfilcon A Contact Lenses | All subjects will first wear methafilcon A contact lenses for four (4) weeks of daily wear, then be refitted with fanfilcon A toric contact lenses for four (4) weeks of daily wear. methafilcon A contact lenses: Bilateral daily wear of methafilcon A contact lenses fanfilcon A contact lenses: Bilateral daily wear of fanfilcon A contact lenses |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study | Total Participants |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Lens Centration Assessment by the Investigator - Methafilcon A Contact Lenses | Lens centration assessment using 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable). | Posted | Number | percentage of participants | Baseline |
|
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From baseline up to 8 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 | Methafilcon A | All subjects will wear methafilcon A contact lenses for four (4) weeks of daily wear, then be refitted with fanfilcon A toric contact lenses for four (4) weeks of daily wear. methafilcon A contact lenses: Bilateral daily wear of methafilcon A contact lenses |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jose A. Vega, O.D, MSc., FAAO | CooperVision. Inc | 9256213761 | javega@coopervision.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 10, 2018 | May 29, 2020 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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Study lenses will be transferred, by an assistant, out of their packaging to unmarked new contact lens cases filled with unpreserved sterile saline just prior to dispensing to maintain subject masking of the study lenses
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| fanfilcon A contact lenses | Device | Bilateral daily wear of fanfilcon A contact lenses |
|
| Baseline |
| Percentage of Participants With Corneal Coverage Assessment by the Investigator - Methafilcon A Contact Lenses | Corneal coverage is collected on a YES/NO response. Yes - lens covers the cornea, No - lens does not cover the cornea | 4 weeks |
| Percentage of Participants With Corneal Coverage Assessment by the Investigator - Fanfilcon A Contact Lenses | Corneal coverage is collected on a YES/NO response. Yes - lens covers the cornea, No - lens does not cover the cornea | Baseline |
| Percentage of Participants With Corneal Coverage Assessment by the Investigator - Fanfilcon A Contact Lenses | Corneal coverage is collected on a YES/NO response. Yes - lens covers the cornea, No - lens does not cover the cornea | 2 weeks |
| Percentage of Participants With Corneal Coverage Assessment by the Investigator - Fanfilcon A Contact Lenses | Corneal coverage is collected on a YES/NO response. Yes - lens covers the cornea, No - lens does not cover the cornea | 4 weeks |
| Post-blink Movement Assessment by the Investigator - Methafilcon A Contact Lenses | Post-blink movement, was rated at each visit using a 0-4 scale (0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement). | Baseline |
| Post-blink Movement Assessment by the Investigator - Methafilcon A Contact Lenses | Post-blink movement, was rated at each visit using a 0-4 scale (0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement). | 4 weeks |
| Post-blink Movement Assessment by the Investigator - Fanfilcon A Contact Lenses | Post-blink movement, was rated at each visit using a 0-4 scale (0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement). | Baseline |
| Post-blink Movement Assessment by the Investigator - Fanfilcon A Contact Lenses | Post-blink movement, was rated at each visit using a 0-4 scale (0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement). | 2 weeks |
| Post-blink Movement Assessment by the Investigator - Fanfilcon A Contact Lenses | Post-blink movement, was rated at each visit using a 0-4 scale (0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement). | 4 weeks |
| Lens Tightness Assessment by the Investigator - Methafilcon A Contact Lenses | Lens tightness was assessed using the push-up test and a 0 - 100% continuous scale (where 0% =falls from cornea without lid support, 50% = optimum and 100%=no movement). | Baseline |
| Lens Tightness Assessment by the Investigator - Methafilcon A Contact Lenses | Lens tightness was assessed using the push-up test and a 0 - 100% continuous scale (where 0% =falls from cornea without lid support, 50% = optimum and 100%=no movement). | 4 weeks |
| Lens Tightness Assessment by the Investigator - Fanfilcon A Contact Lenses | Lens tightness was assessed using the push-up test and a 0 - 100% continuous scale (where 0% =falls from cornea without lid support, 50% = optimum and 100%=no movement). | Baseline |
| Lens Tightness Assessment by the Investigator - Fanfilcon A Contact Lenses | Lens tightness was assessed using the push-up test and a 0 - 100% continuous scale (where 0% =falls from cornea without lid support, 50% = optimum and 100%=no movement). | 2 weeks |
| Lens Tightness Assessment by the Investigator - Fanfilcon A Contact Lenses | Lens tightness was assessed using the push-up test and a 0 - 100% continuous scale (where 0% =falls from cornea without lid support, 50% = optimum and 100%=no movement). | 4 weeks |
| Overall Lens Fit Acceptance by the Investigator - Methafilcon A Contact Lenses | Lens fit acceptance was evaluated using a 0 - 4 scale 0=Should not be worn, 1=Borderline but unacceptable, 2=Minimal acceptable, early review, 3=Not perfect but okay to dispense, 4=perfect | Baseline |
| Overall Lens Fit Acceptance by the Investigator - Methafilcon A Contact Lenses | Lens fit acceptance was evaluated using a 0 - 4 scale 0=Should not be worn, 1=Borderline but unacceptable, 2=Minimal acceptable, early review, 3=Not perfect but okay to dispense, 4=perfect | 4 weeks |
| Overall Lens Fit Acceptance by the Investigator - Fanfilcon A Contact Lenses | Lens fit acceptance was evaluated using a 0 - 4 scale 0=Should not be worn, 1=Borderline but unacceptable, 2=Minimal acceptable, early review, 3=Not perfect but okay to dispense, 4=perfect | Baseline |
| Overall Lens Fit Acceptance by the Investigator - Fanfilcon A Contact Lenses | Lens fit acceptance was evaluated using a 0 - 4 scale 0=Should not be worn, 1=Borderline but unacceptable, 2=Minimal acceptable, early review, 3=Not perfect but okay to dispense, 4=perfect | 2 weeks |
| Overall Lens Fit Acceptance by the Investigator - Fanfilcon A Contact Lenses | Lens fit acceptance was evaluated using a 0 - 4 scale 0=Should not be worn, 1=Borderline but unacceptable, 2=Minimal acceptable, early review, 3=Not perfect but okay to dispense, 4=perfect | 4 weeks |
| 2 weeks |
| Average Daily Wearing Time - Fanfilcon A Contact Lenses | Average daily wearing time response by the subject | 4 weeks |
| Average Comfortable Wearing Time - Methafilcon A Contact Lenses | Average comfortable wearing time - response by the subject | 4 weeks |
| Average Comfortable Wearing Time - Fanfilcon A Contact Lenses | Average comfortable wearing time - response by the subject | 2 weeks |
| Average Comfortable Wearing Time - Fanfilcon A Contact Lenses | Average comfortable wearing time - response by the subject | 4 weeks |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Primary | Percentage of Participants With Lens Centration Assessment by the Investigator - Methafilcon A Contact Lenses | Lens centration assessment using 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable). | Posted | Number | percentage of participants | 4 weeks |
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| Primary | Percentage of Participants With Lens Centration Assessment by the Investigator - Fanfilcon A Contact Lenses | Lens centration assessment using 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable). | Posted | Number | percentage of participants | Baseline |
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| Primary | Percentage of Participants With Lens Centration Assessment by the Investigator - Fanfilcon A Contact Lenses | Lens centration assessment using 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable). | Posted | Number | percentage of participants | 2 weeks |
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| Primary | Percentage of Participants With Lens Centration Assessment by the Investigator - Fanfilcon A Contact Lenses | Lens centration assessment using 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable). | Posted | Number | percentage of participants | 4 weeks |
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| Primary | Percentage of Participants With Corneal Coverage Assessment by the Investigator - Methafilcon A Contact Lenses | Corneal coverage is collected on a YES/NO response. Yes - lens covers the cornea, No - lens does not cover the cornea | Posted | Number | percentage of participants | Baseline |
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| Primary | Percentage of Participants With Corneal Coverage Assessment by the Investigator - Methafilcon A Contact Lenses | Corneal coverage is collected on a YES/NO response. Yes - lens covers the cornea, No - lens does not cover the cornea | Posted | Number | percentage of participants | 4 weeks |
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| Primary | Percentage of Participants With Corneal Coverage Assessment by the Investigator - Fanfilcon A Contact Lenses | Corneal coverage is collected on a YES/NO response. Yes - lens covers the cornea, No - lens does not cover the cornea | Posted | Number | percentage of participants | Baseline |
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| Primary | Percentage of Participants With Corneal Coverage Assessment by the Investigator - Fanfilcon A Contact Lenses | Corneal coverage is collected on a YES/NO response. Yes - lens covers the cornea, No - lens does not cover the cornea | Posted | Number | percentage of participants | 2 weeks |
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| Primary | Percentage of Participants With Corneal Coverage Assessment by the Investigator - Fanfilcon A Contact Lenses | Corneal coverage is collected on a YES/NO response. Yes - lens covers the cornea, No - lens does not cover the cornea | Posted | Number | percentage of participants | 4 weeks |
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| Primary | Post-blink Movement Assessment by the Investigator - Methafilcon A Contact Lenses | Post-blink movement, was rated at each visit using a 0-4 scale (0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement). | Posted | Mean | Standard Deviation | units on a scale | Baseline |
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| Primary | Post-blink Movement Assessment by the Investigator - Methafilcon A Contact Lenses | Post-blink movement, was rated at each visit using a 0-4 scale (0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement). | Posted | Mean | Standard Deviation | units on a scale | 4 weeks |
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| Primary | Post-blink Movement Assessment by the Investigator - Fanfilcon A Contact Lenses | Post-blink movement, was rated at each visit using a 0-4 scale (0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement). | Posted | Mean | Standard Deviation | units on a scale | Baseline |
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| Primary | Post-blink Movement Assessment by the Investigator - Fanfilcon A Contact Lenses | Post-blink movement, was rated at each visit using a 0-4 scale (0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement). | Posted | Mean | Standard Deviation | units on a scale | 2 weeks |
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| Primary | Post-blink Movement Assessment by the Investigator - Fanfilcon A Contact Lenses | Post-blink movement, was rated at each visit using a 0-4 scale (0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement). | Posted | Mean | Standard Deviation | units on a scale | 4 weeks |
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| Primary | Lens Tightness Assessment by the Investigator - Methafilcon A Contact Lenses | Lens tightness was assessed using the push-up test and a 0 - 100% continuous scale (where 0% =falls from cornea without lid support, 50% = optimum and 100%=no movement). | Posted | Mean | Standard Deviation | units on a scale | Baseline |
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| Primary | Lens Tightness Assessment by the Investigator - Methafilcon A Contact Lenses | Lens tightness was assessed using the push-up test and a 0 - 100% continuous scale (where 0% =falls from cornea without lid support, 50% = optimum and 100%=no movement). | Posted | Mean | Standard Deviation | units on a scale | 4 weeks |
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| Primary | Lens Tightness Assessment by the Investigator - Fanfilcon A Contact Lenses | Lens tightness was assessed using the push-up test and a 0 - 100% continuous scale (where 0% =falls from cornea without lid support, 50% = optimum and 100%=no movement). | Posted | Mean | Standard Deviation | units on a scale | Baseline |
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| Primary | Lens Tightness Assessment by the Investigator - Fanfilcon A Contact Lenses | Lens tightness was assessed using the push-up test and a 0 - 100% continuous scale (where 0% =falls from cornea without lid support, 50% = optimum and 100%=no movement). | Posted | Mean | Standard Deviation | units on a scale | 2 weeks |
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| Primary | Lens Tightness Assessment by the Investigator - Fanfilcon A Contact Lenses | Lens tightness was assessed using the push-up test and a 0 - 100% continuous scale (where 0% =falls from cornea without lid support, 50% = optimum and 100%=no movement). | Posted | Mean | Standard Deviation | units on a scale | 4 weeks |
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| Primary | Overall Lens Fit Acceptance by the Investigator - Methafilcon A Contact Lenses | Lens fit acceptance was evaluated using a 0 - 4 scale 0=Should not be worn, 1=Borderline but unacceptable, 2=Minimal acceptable, early review, 3=Not perfect but okay to dispense, 4=perfect | Posted | Mean | Standard Deviation | units on a scale | Baseline |
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| Primary | Overall Lens Fit Acceptance by the Investigator - Methafilcon A Contact Lenses | Lens fit acceptance was evaluated using a 0 - 4 scale 0=Should not be worn, 1=Borderline but unacceptable, 2=Minimal acceptable, early review, 3=Not perfect but okay to dispense, 4=perfect | Posted | Mean | Standard Deviation | units on a scale | 4 weeks |
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| Primary | Overall Lens Fit Acceptance by the Investigator - Fanfilcon A Contact Lenses | Lens fit acceptance was evaluated using a 0 - 4 scale 0=Should not be worn, 1=Borderline but unacceptable, 2=Minimal acceptable, early review, 3=Not perfect but okay to dispense, 4=perfect | Posted | Mean | Standard Deviation | units on a scale | Baseline |
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| Primary | Overall Lens Fit Acceptance by the Investigator - Fanfilcon A Contact Lenses | Lens fit acceptance was evaluated using a 0 - 4 scale 0=Should not be worn, 1=Borderline but unacceptable, 2=Minimal acceptable, early review, 3=Not perfect but okay to dispense, 4=perfect | Posted | Mean | Standard Deviation | units on a scale | 2 weeks |
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| Primary | Overall Lens Fit Acceptance by the Investigator - Fanfilcon A Contact Lenses | Lens fit acceptance was evaluated using a 0 - 4 scale 0=Should not be worn, 1=Borderline but unacceptable, 2=Minimal acceptable, early review, 3=Not perfect but okay to dispense, 4=perfect | Posted | Mean | Standard Deviation | units on a scale | 4 weeks |
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| Secondary | Average Daily Wearing Time - Methafilcon A Contact Lenses | Average daily wearing time response by the subject | Posted | Mean | Standard Deviation | hours / day | 4 weeks |
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| Secondary | Average Daily Wearing Time - Fanfilcon A Contact Lenses | Average daily wearing time response by the subject. | Posted | Mean | Standard Deviation | hours / day | 2 weeks |
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| Secondary | Average Daily Wearing Time - Fanfilcon A Contact Lenses | Average daily wearing time response by the subject | Posted | Mean | Standard Deviation | hours / day | 4 weeks |
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| Secondary | Average Comfortable Wearing Time - Methafilcon A Contact Lenses | Average comfortable wearing time - response by the subject | Posted | Mean | Standard Deviation | hours / day | 4 weeks |
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| Secondary | Average Comfortable Wearing Time - Fanfilcon A Contact Lenses | Average comfortable wearing time - response by the subject | Posted | Mean | Standard Deviation | hours / day | 2 weeks |
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| Secondary | Average Comfortable Wearing Time - Fanfilcon A Contact Lenses | Average comfortable wearing time - response by the subject | Posted | Mean | Standard Deviation | hours / day | 4 weeks |
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| EG001 | Fanfilcon A | All subjects will wear methafilcon A contact lenses for four (4) weeks of daily wear, then be refitted with fanfilcon A toric contact lenses for four (4) weeks of daily wear. fanfilcon A contact lenses: Bilateral daily wear of fanfilcon A | 0 | 39 | 0 | 39 | 0 | 39 |
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