Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The aim of this prospective study is to evaluate the clinical performance of habitual wearers of methafilcon A toric lenses after a refit with fanfilcon A toric lenses for 1-month of daily wear.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| methafilcon A toric / fanfilcon A toric contact lenses | Experimental | All subjects will first wear methafilcon A toric contact lenses for four (4) weeks of daily wear, then refitted with fanfilcon A toric contact lenses for four (4) weeks of daily wear. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| methafilcon A toric contact lenses | Device | Bilateral daily wear of methafilcon A toric contact lenses |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Lens Centration Assessment by the Investigator - Methafilcon A Toric Contact Lenses | Lens centration was assessed on a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable). | Baseline |
| Number of Participants With Lens Centration Assessment by the Investigator - Methafilcon A Toric Contact Lenses | Lens centration was assessed on a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable). | 4 weeks |
| Number of Participants With Lens Centration Assessment by the Investigator - Fanfilcon A Toric Contact Lenses | Lens centration was assessed on a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable). | Baseline |
| Number of Participants With Lens Centration Assessment by the Investigator - Fanfilcon A Toric Contact Lenses | Lens centration was assessed on a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable). | 2 weeks |
| Number of Participants With Lens Centration Assessment by the Investigator - Fanfilcon A Toric Contact Lenses | Lens centration was assessed on a 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 Toric Contact Lenses | Corneal coverage was 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 Toric Contact Lenses | Average daily wearing time response by the subject | 4 weeks |
| Average Daily Wearing Time - Fanfilcon A Toric Contact Lenses | Average daily wearing time response by the subject |
Not provided
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 less than -0.75D or more than -2.50 D of cylinder 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:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Methafilcon A / Fanfilcon A Contact Lenses | All subjects will first wear methafilcon A contact lenses for four (4) weeks of daily wear, then refitted with fanfilcon A 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 | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Methafilcon A |
|
| ||||||||||||||||||
| Fanfilcon A |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study | Total Participants |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Number of Participants With Lens Centration Assessment by the Investigator - Methafilcon A Toric Contact Lenses | Lens centration was assessed on a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable). | Posted | Count of Participants | Participants | Baseline |
|
|
From baseline up to 8 weeks
Not provided
Not provided
| 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 Toric Contact Lenses | All subjects will first wear methafilcon A toric contact lenses for four (4) weeks of daily wear, then refitted with fanfilcon A toric contact lenses for four (4) weeks of daily wear. methafilcon A toric contact lenses: Bilateral daily wear of methafilcon A toric contact lenses |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jose A. Vega, O.D, MSc., FAAO | CooperVision. Inc | 9256213761 | javega@coopervision.com |
Not provided
| 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 21, 2018 | May 26, 2020 | Prot_SAP_001.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
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
Not provided
| fanfilcon A toric contact lenses | Device | Bilateral daily wear of fanfilcon A toric contact lenses |
|
| Baseline |
| Percentage of Participants With Corneal Coverage Assessment by the Investigator - Methafilcon A Toric Contact Lenses | Corneal coverage was 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 Toric Contact Lenses | Corneal coverage was 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 Toric Contact Lenses | Corneal coverage was 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 Toric Contact Lenses | Corneal coverage was 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 Toric Contact Lenses | Post-blink movement was assessed on a 0-4 scale (where: 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 Toric Contact Lenses | Post-blink movement was assessed on a 0-4 scale (where: 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 Toric Contact Lenses | Post-blink movement was assessed on a 0-4 scale (where: 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 Toric Contact Lenses | Post-blink movement was assessed on a 0-4 scale (where: 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 Toric Contact Lenses | Post-blink movement was assessed on a 0-4 scale (where: 0=Insufficient, unacceptable movement,1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement). | 4 weeks |
| Lens Orientation in Primary Position of Gaze Assessment by the Investigator - Methalfilcon A Toric Contact Lenses | Lens orientation was assessed in 5-degree steps with the slit lamp by measuring the amount of mislocation of the axis mark on the lens relative to the 6 o'clock position. | Baseline |
| Lens Orientation in Primary Position of Gaze Assessment by the Investigator - Methalfilcon A Toric Contact Lenses | Lens orientation was assessed in 5-degree steps with the slit lamp by measuring the amount of mislocation of the axis mark on the lens relative to the 6 o'clock position. | 4 weeks |
| Lens Orientation in Primary Position of Gaze Assessment by the Investigator - Fanfilcon A Toric Contact Lenses | Lens orientation was assessed in 5-degree steps with the slit lamp by measuring the amount of mislocation of the axis mark on the lens relative to the 6 o'clock position. | Baseline |
| Lens Orientation in Primary Position of Gaze Assessment by the Investigator - Fanfilcon A Toric Contact Lenses | Lens orientation was assessed in 5-degree steps with the slit lamp by measuring the amount of mislocation of the axis mark on the lens relative to the 6 o'clock position. | 2 weeks |
| Lens Orientation in Primary Position of Gaze Assessment by the Investigator - Fanfilcon A Toric Contact Lenses | Lens orientation was assessed in 5-degree steps with the slit lamp by measuring the amount of mislocation of the axis mark on the lens relative to the 6 o'clock position. | 4 weeks |
| Rotational Recovery Assessment by the Investigator - Methafilcon A Toric Contact Lenses | Lens rotational recovery was assessed in 5-degree steps 1 minute after the lens was manually rotated 45degrees temporally from the primary gaze position | Baseline |
| Rotational Recovery Assessment by the Investigator - Methafilcon A Toric Contact Lenses | Lens rotational recovery was assessed in 5-degree steps 1 minute after the lens was manually rotated 45degrees temporally from the primary gaze position | 4 weeks |
| Rotational Recovery Assessment by the Investigator - Fanfilcon A Toric Contact Lenses | Lens rotational recovery was assessed in 5-degree steps 1 minute after the lens was manually rotated 45degrees temporally from the primary gaze position | Baseline |
| Rotational Recovery Assessment by the Investigator - Fanfilcon A Toric Contact Lenses | Lens rotational recovery was assessed in 5-degree steps 1 minute after the lens was manually rotated 45degrees temporally from the primary gaze position | 2 weeks |
| Rotational Recovery Assessment by the Investigator - Fanfilcon A Toric Contact Lenses | Lens rotational recovery was assessed in 5-degree steps 1 minute after the lens was manually rotated 45degrees temporally from the primary gaze position | 4 weeks |
| Overall Stability Assessment by the Investigator - Methafilcon A Toric Contact Lenses | Overall lens stability was assessed using a 0 - 4 scale (where 0 = very poor stability, and 4 = excellent stability). | Baseline |
| Overall Stability Assessment by the Investigator - Methafilcon A Toric Contact Lenses | Overall lens stability was assessed using a 0 - 4 scale (where 0 = very poor stability, and 4 = excellent stability). | 4 weeks |
| Overall Stability Assessment by the Investigator - Fanfilcon A Toric Contact Lenses | Overall lens stability was assessed using a 0 - 4 scale (where 0 = very poor stability, and 4 = excellent stability). | Baseline |
| Overall Stability Assessment by the Investigator - Fanfilcon A Toric Contact Lenses | Overall lens stability was assessed using a 0 - 4 scale (where 0 = very poor stability, and 4 = excellent stability). | 2 weeks |
| Overall Stability Assessment by the Investigator - Fanfilcon A Toric Contact Lenses | Overall lens stability was assessed using a 0 - 4 scale (where 0 = very poor stability, and 4 = excellent stability). | 4 weeks |
| Overall Lens Fit Acceptance by the Investigator - Methafilcon A Toric Contact Lenses | Overall lens fit acceptance assessed using grade (0-4) 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 Toric Contact Lenses | Overall lens fit acceptance assessed using grade (0-4) 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 Toric Contact Lenses | Overall lens fit acceptance assessed using grade (0-4) 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 Toric Contact Lenses | Overall lens fit acceptance assessed using grade (0-4) 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 Toric Contact Lenses | Overall lens fit acceptance assessed using grade (0-4) 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 Toric Contact Lenses | Average daily wearing time response by the subject | 4 weeks |
| Average Comfortable Wearing Time - Methafilcon A Toric Contact Lenses | Average comfortable wearing time - response by the subject | 4 weeks |
| Average Comfortable Wearing Time - Fanfilcon A Toric Contact Lenses | Average comfortable wearing time - response by the subject | 2 weeks |
| Average Comfortable Wearing Time - Fanfilcon A Toric Contact Lenses | Average comfortable wearing time - response by the subject | 4 weeks |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Primary | Number of Participants With Lens Centration Assessment by the Investigator - Methafilcon A Toric Contact Lenses | Lens centration was assessed on a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable). | Posted | Count of Participants | Participants | 4 weeks |
|
|
|
| Primary | Number of Participants With Lens Centration Assessment by the Investigator - Fanfilcon A Toric Contact Lenses | Lens centration was assessed on a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable). | Posted | Count of Participants | Participants | Baseline |
|
|
|
| Primary | Number of Participants With Lens Centration Assessment by the Investigator - Fanfilcon A Toric Contact Lenses | Lens centration was assessed on a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable). | Posted | Count of Participants | Participants | 2 weeks |
|
|
|
| Primary | Number of Participants With Lens Centration Assessment by the Investigator - Fanfilcon A Toric Contact Lenses | Lens centration was assessed on a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable). | Posted | Count of Participants | Participants | 4 weeks |
|
|
|
| Primary | Percentage of Participants With Corneal Coverage Assessment by the Investigator - Methafilcon A Toric Contact Lenses | Corneal coverage was collected on a YES/NO response. Yes - lens covers the cornea, No - lens does not cover the cornea | Posted | Number | percentage of participants | Baseline |
|
|
|
| Primary | Percentage of Participants With Corneal Coverage Assessment by the Investigator - Methafilcon A Toric Contact Lenses | Corneal coverage was 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 |
|
|
|
| Primary | Percentage of Participants With Corneal Coverage Assessment by the Investigator - Fanfilcon A Toric Contact Lenses | Corneal coverage was collected on a YES/NO response. Yes - lens covers the cornea, No - lens does not cover the cornea | Posted | Number | percentage of participants | Baseline |
|
|
|
| Primary | Percentage of Participants With Corneal Coverage Assessment by the Investigator - Fanfilcon A Toric Contact Lenses | Corneal coverage was 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 |
|
|
|
| Primary | Percentage of Participants With Corneal Coverage Assessment by the Investigator - Fanfilcon A Toric Contact Lenses | Corneal coverage was 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 |
|
|
|
| Primary | Post-blink Movement Assessment by the Investigator - Methafilcon A Toric Contact Lenses | Post-blink movement was assessed on a 0-4 scale (where: 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 |
|
|
|
| Primary | Post-blink Movement Assessment by the Investigator - Methafilcon A Toric Contact Lenses | Post-blink movement was assessed on a 0-4 scale (where: 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 |
|
|
|
| Primary | Post-blink Movement Assessment by the Investigator - Fanfilcon A Toric Contact Lenses | Post-blink movement was assessed on a 0-4 scale (where: 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 |
|
|
|
| Primary | Post-blink Movement Assessment by the Investigator - Fanfilcon A Toric Contact Lenses | Post-blink movement was assessed on a 0-4 scale (where: 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 |
|
|
|
| Primary | Post-blink Movement Assessment by the Investigator - Fanfilcon A Toric Contact Lenses | Post-blink movement was assessed on a 0-4 scale (where: 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 |
|
|
|
| Primary | Lens Orientation in Primary Position of Gaze Assessment by the Investigator - Methalfilcon A Toric Contact Lenses | Lens orientation was assessed in 5-degree steps with the slit lamp by measuring the amount of mislocation of the axis mark on the lens relative to the 6 o'clock position. | Posted | Mean | Standard Deviation | Degrees | Baseline |
|
|
|
| Primary | Lens Orientation in Primary Position of Gaze Assessment by the Investigator - Methalfilcon A Toric Contact Lenses | Lens orientation was assessed in 5-degree steps with the slit lamp by measuring the amount of mislocation of the axis mark on the lens relative to the 6 o'clock position. | Posted | Mean | Standard Deviation | Degrees | 4 weeks |
|
|
|
| Primary | Lens Orientation in Primary Position of Gaze Assessment by the Investigator - Fanfilcon A Toric Contact Lenses | Lens orientation was assessed in 5-degree steps with the slit lamp by measuring the amount of mislocation of the axis mark on the lens relative to the 6 o'clock position. | Posted | Mean | Standard Deviation | Degrees | Baseline |
|
|
|
| Primary | Lens Orientation in Primary Position of Gaze Assessment by the Investigator - Fanfilcon A Toric Contact Lenses | Lens orientation was assessed in 5-degree steps with the slit lamp by measuring the amount of mislocation of the axis mark on the lens relative to the 6 o'clock position. | Posted | Mean | Standard Deviation | Degrees | 2 weeks |
|
|
|
| Primary | Lens Orientation in Primary Position of Gaze Assessment by the Investigator - Fanfilcon A Toric Contact Lenses | Lens orientation was assessed in 5-degree steps with the slit lamp by measuring the amount of mislocation of the axis mark on the lens relative to the 6 o'clock position. | Posted | Mean | Standard Deviation | Degrees | 4 weeks |
|
|
|
| Primary | Rotational Recovery Assessment by the Investigator - Methafilcon A Toric Contact Lenses | Lens rotational recovery was assessed in 5-degree steps 1 minute after the lens was manually rotated 45degrees temporally from the primary gaze position | Posted | Mean | Standard Deviation | Degrees | Baseline |
|
|
|
| Primary | Rotational Recovery Assessment by the Investigator - Methafilcon A Toric Contact Lenses | Lens rotational recovery was assessed in 5-degree steps 1 minute after the lens was manually rotated 45degrees temporally from the primary gaze position | Posted | Mean | Standard Deviation | Degrees | 4 weeks |
|
|
|
| Primary | Rotational Recovery Assessment by the Investigator - Fanfilcon A Toric Contact Lenses | Lens rotational recovery was assessed in 5-degree steps 1 minute after the lens was manually rotated 45degrees temporally from the primary gaze position | Posted | Mean | Standard Deviation | Degrees | Baseline |
|
|
|
| Primary | Rotational Recovery Assessment by the Investigator - Fanfilcon A Toric Contact Lenses | Lens rotational recovery was assessed in 5-degree steps 1 minute after the lens was manually rotated 45degrees temporally from the primary gaze position | Posted | Mean | Standard Deviation | Degrees | 2 weeks |
|
|
|
| Primary | Rotational Recovery Assessment by the Investigator - Fanfilcon A Toric Contact Lenses | Lens rotational recovery was assessed in 5-degree steps 1 minute after the lens was manually rotated 45degrees temporally from the primary gaze position | Posted | Mean | Standard Deviation | Degrees | 4 weeks |
|
|
|
| Primary | Overall Stability Assessment by the Investigator - Methafilcon A Toric Contact Lenses | Overall lens stability was assessed using a 0 - 4 scale (where 0 = very poor stability, and 4 = excellent stability). | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
|
|
| Primary | Overall Stability Assessment by the Investigator - Methafilcon A Toric Contact Lenses | Overall lens stability was assessed using a 0 - 4 scale (where 0 = very poor stability, and 4 = excellent stability). | Posted | Mean | Standard Deviation | units on a scale | 4 weeks |
|
|
|
| Primary | Overall Stability Assessment by the Investigator - Fanfilcon A Toric Contact Lenses | Overall lens stability was assessed using a 0 - 4 scale (where 0 = very poor stability, and 4 = excellent stability). | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
|
|
| Primary | Overall Stability Assessment by the Investigator - Fanfilcon A Toric Contact Lenses | Overall lens stability was assessed using a 0 - 4 scale (where 0 = very poor stability, and 4 = excellent stability). | Posted | Mean | Standard Deviation | units on a scale | 2 weeks |
|
|
|
| Primary | Overall Stability Assessment by the Investigator - Fanfilcon A Toric Contact Lenses | Overall lens stability was assessed using a 0 - 4 scale (where 0 = very poor stability, and 4 = excellent stability). | Posted | Mean | Standard Deviation | units on a scale | 4 weeks |
|
|
|
| Primary | Overall Lens Fit Acceptance by the Investigator - Methafilcon A Toric Contact Lenses | Overall lens fit acceptance assessed using grade (0-4) 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 |
|
|
|
| Primary | Overall Lens Fit Acceptance by the Investigator - Methafilcon A Toric Contact Lenses | Overall lens fit acceptance assessed using grade (0-4) 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 |
|
|
|
| Primary | Overall Lens Fit Acceptance by the Investigator - Fanfilcon A Toric Contact Lenses | Overall lens fit acceptance assessed using grade (0-4) 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 |
|
|
|
| Primary | Overall Lens Fit Acceptance by the Investigator - Fanfilcon A Toric Contact Lenses | Overall lens fit acceptance assessed using grade (0-4) 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 |
|
|
|
| Primary | Overall Lens Fit Acceptance by the Investigator - Fanfilcon A Toric Contact Lenses | Overall lens fit acceptance assessed using grade (0-4) 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 |
|
|
|
| Secondary | Average Daily Wearing Time - Methafilcon A Toric Contact Lenses | Average daily wearing time response by the subject | Posted | Mean | Standard Deviation | hours / day | 4 weeks |
|
|
|
| Secondary | Average Daily Wearing Time - Fanfilcon A Toric Contact Lenses | Average daily wearing time response by the subject | Posted | Mean | Standard Deviation | hours/day | 2 weeks |
|
|
|
| Secondary | Average Daily Wearing Time - Fanfilcon A Toric Contact Lenses | Average daily wearing time response by the subject | Posted | Mean | Standard Deviation | hours/day | 4 weeks |
|
|
|
| Secondary | Average Comfortable Wearing Time - Methafilcon A Toric Contact Lenses | Average comfortable wearing time - response by the subject | Posted | Mean | Standard Deviation | hours/day | 4 weeks |
|
|
|
| Secondary | Average Comfortable Wearing Time - Fanfilcon A Toric Contact Lenses | Average comfortable wearing time - response by the subject | Posted | Mean | Standard Deviation | hours/day | 2 weeks |
|
|
|
| Secondary | Average Comfortable Wearing Time - Fanfilcon A Toric Contact Lenses | Average comfortable wearing time - response by the subject | Posted | Mean | Standard Deviation | hours/day | 4 weeks |
|
|
|
| 0 |
| 43 |
| 0 |
| 43 |
| 0 |
| 43 |
| EG001 | Fanfilcon A Toric Contact Lenses | All subjects will first wear methafilcon A toric contact lenses for four (4) weeks of daily wear, then refitted with fanfilcon A toric contact lenses for four (4) weeks of daily wear. fanfilcon A toric contact lenses: Bilateral daily wear of fanfilcon A toric contact lenses | 0 | 42 | 0 | 42 | 0 | 42 |
Not provided
Not provided
| Title | Measurements |
|---|
|
| Title |
|---|
| Measurements |
|---|
|
| Title |
|---|
| Measurements |
|---|
|
| Title |
|---|
| Measurements |
|---|
|