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To evaluate the comparative clinical performance of the fanfilcon A silicone hydrogel lens used in daily wear and to compare this with competitive hydrogel lens products.
This 8-week, subject-masked, bilateral, two-part, cross-over evaluation will compare the clinical performance of fanfilcon A silicone hydrogel contact lens and competitive hydrogel contact lenses when worn daily. Lenses will be replaced either on a 2-weekly or 4-weekly basis, depending on control lens group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ocufilcon D control lens, then fanfilcon A test lens | Experimental | Participants will wear the ocufilcon D control lens for 4 weeks, then crossover to fanfilcon A test lens for 4 weeks of daily wear. |
|
| etafilcon A controls, then fanfilcon A test lens | Experimental | Participants will wear the etafilcon D control lens for 2 weeks, then crossover to fanfilcon A test lens for 2 weeks of daily wear. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fanfilcon A test lens | Device | Silicone hydrogel contact lens |
|
| Measure | Description | Time Frame |
|---|---|---|
| Subjective Overall Comfort Rating | Subjective overall comfort rating was assessed on a 0-10 subjective scale, 0=extremely uncomfortable, 10=can't feel lenses | Two weeks |
| Subjective Overall Comfort Rating | Subjective overall comfort rating was assessed on a 0-10 subjective scale, 0=extremely uncomfortable, 10=can't feel lenses | Four weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Average Wearing Time | Average wearing time - measured by time of day using 24-hour clock, to the nearest 10 minutes | Two weeks |
| Average Wearing Time | Average wearing time - measured by time of day using 24-hour clock, to the nearest 10 minutes |
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Inclusion Criteria:
Be a currently adapted soft contact lens wearer (>1 month of lens wear).
Be at least 18 years of age.
Refractive astigmatism <1.00D in both eyes.
Have clear corneas and be free of any anterior segment disorders.
Be correctable through spherocylindrical refraction to 20/25 or better in each eye.
Contact lens sphere requirement between -1.00D and -6.00D (inclusive).
Require visual correction in both eyes (monovision allowed, no monofit).
Have normal eyes with no evidence of abnormality or disease. For the purposes of this study a normal eye is defined as one having:
Own a mobile phone and be able to respond to SMS survey during the period 8am-8pm.
Willing to comply with the wear and study visit schedule.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David C Ardaya, OD | Golden Optometric Group | Principal Investigator |
| William J Bogus, OD | Office of William J. Bogus, O.D. | Principal Investigator |
| Bryan E Frazier, OD | Frazier Vision, Inc | Principal Investigator |
| Wayne Golden, OD | Golden Vision | Principal Investigator |
| Andrew J Sacco, OD | Sacco Eye Group | Principal Investigator |
| Christopher Pearson, OD | Omega Vision Center PA (DBA Sabal Eye Care) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Golden Optometric Group | Whittier | California | 90606 | United States | ||
| Omega Vision Center PA (DBA Sabal Eye Care) |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ocufilcon D Control Lens, Then Fanfilcon A Test Lens | Participants will wear the ocufilcon D control lens for 4 weeks, then crossover to fanfilcon A test lens for 4 weeks of daily wear. ocufilcon D control lens: hydrogel contact lens fanfilcon A test lens: Silicone hydrogel contact lens |
| FG001 | Etafilcon A Controls, Then Fanfilcon A Test Lens | Participants will wear the etafilcon D control lens for 2 weeks, then crossover to fanfilcon A test lens for 2 weeks of daily wear. etafilcon A control lens: hydrogel contact lens fanfilcon A test lens: Silicone hydrogel contact lens |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention |
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| ||||||||||||||||||
| Second Intervention |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ocufilcon D Control Lens, Then Fanfilcon A Test Lens | Participants will wear the ocufilcon D control lens for 4 weeks, then crossover to fanfilcon A test lens for 4 weeks of daily wear. ocufilcon D control lens: hydrogel contact lens fanfilcon A test lens: Silicone hydrogel contact lens |
| BG001 |
| 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 | Subjective Overall Comfort Rating | Subjective overall comfort rating was assessed on a 0-10 subjective scale, 0=extremely uncomfortable, 10=can't feel lenses | Posted | Mean | Standard Deviation | units on a scale | Two weeks |
|
From dispense up to 4 weeks for ocufilcon D and fanfilcon A - Group A, from dispense up to 2 weeks for etafilcon A and fanfilcon A - Group B. A total of 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 | Ocufilcon D - Group A | Subjects were randomized to wear ocufilcon D control lens for four weeks. Ocufilcon D - hydrogel contact lens |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| headache | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jose A. Vega, O.D., MSc, FAAO | CooperVision, Inc. | 925-621-3761 | 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 | Mar 22, 2019 | Sep 11, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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Subjects will be masked to lens type. Investigators will be unmasked.
|
| ocufilcon D control lens | Device | hydrogel contact lens |
|
|
| etafilcon A control lens | Device | hydrogel contact lens |
|
|
| Four weeks |
| Average Comfortable Wearing Time | Average comfortable wearing time was assessed by time of day when first aware of lenses using 24-hour clock, to the nearest 10 minutes. | Two weeks |
| Average Comfortable Wearing Time | Average comfortable wearing time was assessed by time of day when first aware of lenses using 24-hour clock, to the nearest 10 minutes. | Four weeks |
| Lens Centration | Lens centration will be recorded in the scale of 0 to 2 (0=centered - optimal, 1 = decentered slightly, 2 = substantially decentered (>0.5mm)). | Baseline (after 15 minutes) |
| Lens Centration | Lens centration will be recorded in the scale of 0 to 2 (0=centered - optimal, 1 = decentered slightly, 2 = substantially decentered (>0.5mm)). | Two weeks |
| Lens Centration | Lens centration will be recorded in the scale of 0 to 2 (0=centered - optimal, 1 = decentered slightly, 2 = substantially decentered (>0.5mm)). | Four weeks |
| Corneal Coverage | Corneal coverage (yes=full corneal coverage all times / no=incomplete corneal coverage) | Baseline (after 15 minutes of lens dispense) |
| Corneal Coverage | Corneal coverage (yes=full corneal coverage all times / no=incomplete corneal coverage) | Two weeks |
| Corneal Coverage | Corneal coverage (yes=full corneal coverage all times / no=incomplete corneal coverage) | Four weeks |
| Post-Blink Movement | Post-blink movement measured by scale 0-4 (0=insufficient, 1=minimal, unacceptable movement, 2=optimal movement, 3=moderate, but acceptable movement, 4=excessive, unacceptable movement) | Baseline (after 15 minutes of lens dispense) |
| Post-Blink Movement | Post-blink movement measured by scale 0-4 (0=insufficient, 1=minimal, unacceptable movement, 2=optimal movement, 3=moderate, but acceptable movement, 4=excessive, unacceptable movement) | Two weeks |
| Post-Blink Movement | Post-blink movement measured by scale 0-4 (0=insufficient, 1=minimal, unacceptable movement, 2=optimal movement, 3=moderate, but acceptable movement, 4=excessive, unacceptable movement) | Four weeks |
| Lens Tightness - Push-up Test | Lens tightness - push-up test 0-100% continuous scale (100%=movement, 50%=optimum, 0%=Falls from cornea without lid support) | Baseline (after 15 minutes of lens dispense) |
| Lens Tightness - Push-up Test | Lens tightness - push-up test 0-100% continuous scale (100%=movement, 50%=optimum, 0%=Falls from cornea without lid support) | Two weeks |
| Lens Tightness - Push-up Test | Lens tightness - push-up test 0-100% continuous scale (100%=movement, 50%=optimum, 0%=Falls from cornea without lid support) | Four weeks |
| Overall Lens Fit Acceptance | Overall lens fit acceptance - Graded on a scale of 0-4 (0=should not be worn, 1=borderline but not acceptable, 2=minimal acceptable, 3=not perfect but OK to dispense, 4=perfect) | Baseline (after 15 minutes of lens dispense) |
| Overall Lens Fit Acceptance | Overall lens fit acceptance - Graded on a scale of 0-4 (0=should not be worn, 1=borderline but not acceptable, 2=minimal acceptable, 3=not perfect but OK to dispense, 4=perfect) | Two weeks |
| Overall Lens Fit Acceptance | Overall lens fit acceptance - Graded on a scale of 0-4 (0=should not be worn, 1=borderline but not acceptable, 2=minimal acceptable, 3=not perfect but OK to dispense, 4=perfect) | Four weeks |
| Rating of Lens Surface Wettability | Lens surface wettability rated on the appearance on the lens surface (0-4 scale, 0=Very poor: immediately displaying non-wetting areas on lens surface, 4=Excellent: appearance of a healthy cornea with very long drying time). | Baseline (after 15 minutes of lens dispense) |
| Rating of Lens Surface Wettability | Lens surface wettability rated on the appearance on the lens surface (0-4 scale, 0=Very poor: immediately displaying non-wetting areas on lens surface, 4=Excellent: appearance of a healthy cornea with very long drying time). | Two weeks |
| Rating of Lens Surface Wettability | Lens surface wettability rated on the appearance on the lens surface (0-4 scale, 0=Very poor: immediately displaying non-wetting areas on lens surface, 4=Excellent: appearance of a healthy cornea with very long drying time). | Four weeks |
| Presence of Film Deposits | Presence of film deposits on front surface of the lens graded 0-4 (0=No film, 1=Slight film visible only under magnification, 2=Moderate film only under magnification, 3=Moderate film visible to the naked eye, 4=heavy film visible to the naked eye). | Two weeks |
| Presence of Film Deposits | Presence of film deposits on front surface of the lens graded 0-4 (0=No film, 1=Slight film visible only under magnification, 2=Moderate film only under magnification, 3=Moderate film visible to the naked eye, 4=heavy film visible to the naked eye). | Four weeks |
| Number of White Spot Deposits | Number of white spot deposits assessed using slit lamp with white light, low medium magnification | Two weeks |
| Number of White Spot Deposits | Number of white spot deposits assessed using slit lamp with white light, low medium magnification | Four weeks |
| Primary Gaze Lag | Primary gaze lag measured by scale 0-4 (0=insufficient, 1=minimal, unacceptable movement, 2=optimal movement, 3=moderate, but acceptable movement, 4=excessive, unacceptable movement) | Baseline (after 15 minutes of lens dispense) |
| Primary Gaze Lag | Primary gaze lag measured by scale 0-4 (0=insufficient, 1=minimal, unacceptable movement, 2=optimal movement, 3=moderate, but acceptable movement, 4=excessive, unacceptable movement) | Two weeks |
| Primary Gaze Lag | Primary gaze lag measured by scale 0-4 (0=insufficient, 1=minimal, unacceptable movement, 2=optimal movement, 3=moderate, but acceptable movement, 4=excessive, unacceptable movement) | Four weeks |
| Comfort Throughout the Day | Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses | Day 3 - 8:00am |
| Comfort Throughout the Day | Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses | Day 3 - 12:00pm |
| Comfort Throughout the Day | Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses | Day 3 - 4:00pm |
| Comfort Throughout the Day | Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses | Day 3 - 8:00pm |
| Comfort Throughout the Day | Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses | Day 7 - 8:00am |
| Comfort Throughout the Day | Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses | Day 7 - 12:00pm |
| Comfort Throughout the Day | Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses | Day 7 - 4:00pm |
| Comfort Throughout the Day | Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses | Day 7 - 8:00pm |
| Comfort Throughout the Day | Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses | Day 12 - 8:00am |
| Comfort Throughout the Day | Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses | Day 12 - 12:00pm |
| Comfort Throughout the Day | Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses | Day 12 - 4:00pm |
| Comfort Throughout the Day | Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses | Day 12 - 8:00pm |
| Comfort Throughout the Day | Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses | Day 26 - 8:00am |
| Comfort Throughout the Day | Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses | Day 26 - 12:00pm |
| Comfort Throughout the Day | Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses | Day 26 - 4:00pm |
| Comfort Throughout the Day | Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses | Day 26 - 8:00pm |
| Longwood |
| Florida |
| 32779 |
| United States |
| Golden Vision | Sarasota | Florida | 34232 | United States |
| Sacco Eye Group | Vestal | New York | 13850 | United States |
| Frazier Vision, Inc | Tyler | Texas | 75703 | United States |
| Office of William J. Bogus, O.D. | Salt Lake City | Utah | 84106 | United States |
| NOT COMPLETED |
|
|
| Etafilcon A Controls, Then Fanfilcon A Test Lens |
Participants will wear the etafilcon D control lens for 2 weeks, then crossover to fanfilcon A test lens for 2 weeks of daily wear. etafilcon A control lens: hydrogel contact lens fanfilcon A test lens: Silicone hydrogel contact lens |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Subjects were randomized to wear etafilcon A control lens for two weeks. Etafilcon A - hydrogel contact lens |
| OG003 | Fanfilcon A - Group B | Subjects were randomized to wear fanfilcon A test lens for two weeks. Fanfilcon A - SiHy contact lens |
|
|
| Primary | Subjective Overall Comfort Rating | Subjective overall comfort rating was assessed on a 0-10 subjective scale, 0=extremely uncomfortable, 10=can't feel lenses | Posted | Mean | Standard Deviation | units on a scale | Four weeks |
|
|
|
| Secondary | Average Wearing Time | Average wearing time - measured by time of day using 24-hour clock, to the nearest 10 minutes | Posted | Mean | Standard Deviation | hours/day | Two weeks |
|
|
|
| Secondary | Average Wearing Time | Average wearing time - measured by time of day using 24-hour clock, to the nearest 10 minutes | Posted | Mean | Standard Deviation | hours/day | Four weeks |
|
|
|
| Secondary | Average Comfortable Wearing Time | Average comfortable wearing time was assessed by time of day when first aware of lenses using 24-hour clock, to the nearest 10 minutes. | Posted | Mean | Standard Deviation | hours/day | Two weeks |
|
|
|
| Secondary | Average Comfortable Wearing Time | Average comfortable wearing time was assessed by time of day when first aware of lenses using 24-hour clock, to the nearest 10 minutes. | Posted | Mean | Standard Deviation | hours/day | Four weeks |
|
|
|
| Secondary | Lens Centration | Lens centration will be recorded in the scale of 0 to 2 (0=centered - optimal, 1 = decentered slightly, 2 = substantially decentered (>0.5mm)). | Posted | Number | percentage of eyes | Baseline (after 15 minutes) | eyes | eyes |
|
|
|
| Secondary | Lens Centration | Lens centration will be recorded in the scale of 0 to 2 (0=centered - optimal, 1 = decentered slightly, 2 = substantially decentered (>0.5mm)). | Posted | Number | percentage of eyes | Two weeks | eyes | eyes |
|
|
|
| Secondary | Lens Centration | Lens centration will be recorded in the scale of 0 to 2 (0=centered - optimal, 1 = decentered slightly, 2 = substantially decentered (>0.5mm)). | Posted | Number | percentage of eyes | Four weeks | eyes | eyes |
|
|
|
| Secondary | Corneal Coverage | Corneal coverage (yes=full corneal coverage all times / no=incomplete corneal coverage) | Posted | Number | percentage of eyes | Baseline (after 15 minutes of lens dispense) | eyes | eyes |
|
|
|
| Secondary | Corneal Coverage | Corneal coverage (yes=full corneal coverage all times / no=incomplete corneal coverage) | Posted | Number | percentage of eyes | Two weeks | eyes | eyes |
|
|
|
| Secondary | Corneal Coverage | Corneal coverage (yes=full corneal coverage all times / no=incomplete corneal coverage) | Posted | Number | percentage of eyes | Four weeks | eyes | eyes |
|
|
|
| Secondary | Post-Blink Movement | Post-blink movement measured by scale 0-4 (0=insufficient, 1=minimal, unacceptable movement, 2=optimal movement, 3=moderate, but acceptable movement, 4=excessive, unacceptable movement) | Posted | Number | percentage of eyes | Baseline (after 15 minutes of lens dispense) | eyes | eyes |
|
|
|
| Secondary | Post-Blink Movement | Post-blink movement measured by scale 0-4 (0=insufficient, 1=minimal, unacceptable movement, 2=optimal movement, 3=moderate, but acceptable movement, 4=excessive, unacceptable movement) | Posted | Number | percentage of eyes | Two weeks | eyes | eyes |
|
|
|
| Secondary | Post-Blink Movement | Post-blink movement measured by scale 0-4 (0=insufficient, 1=minimal, unacceptable movement, 2=optimal movement, 3=moderate, but acceptable movement, 4=excessive, unacceptable movement) | Posted | Number | percentage of eyes | Four weeks | eyes | eyes |
|
|
|
| Secondary | Lens Tightness - Push-up Test | Lens tightness - push-up test 0-100% continuous scale (100%=movement, 50%=optimum, 0%=Falls from cornea without lid support) | Posted | Mean | Standard Deviation | percentage of eyes | Baseline (after 15 minutes of lens dispense) | eyes | eyes |
|
|
|
| Secondary | Lens Tightness - Push-up Test | Lens tightness - push-up test 0-100% continuous scale (100%=movement, 50%=optimum, 0%=Falls from cornea without lid support) | Posted | Mean | Standard Deviation | percentage of eyes | Two weeks | eyes | eyes |
|
|
|
| Secondary | Lens Tightness - Push-up Test | Lens tightness - push-up test 0-100% continuous scale (100%=movement, 50%=optimum, 0%=Falls from cornea without lid support) | Posted | Mean | Standard Deviation | percentage of eyes | Four weeks | eyes | eyes |
|
|
|
| Secondary | Overall Lens Fit Acceptance | Overall lens fit acceptance - Graded on a scale of 0-4 (0=should not be worn, 1=borderline but not acceptable, 2=minimal acceptable, 3=not perfect but OK to dispense, 4=perfect) | Posted | Number | percentage of eyes | Baseline (after 15 minutes of lens dispense) | eyes | eyes |
|
|
|
| Secondary | Overall Lens Fit Acceptance | Overall lens fit acceptance - Graded on a scale of 0-4 (0=should not be worn, 1=borderline but not acceptable, 2=minimal acceptable, 3=not perfect but OK to dispense, 4=perfect) | Posted | Number | percentage of eyes | Two weeks | eyes | eyes |
|
|
|
| Secondary | Overall Lens Fit Acceptance | Overall lens fit acceptance - Graded on a scale of 0-4 (0=should not be worn, 1=borderline but not acceptable, 2=minimal acceptable, 3=not perfect but OK to dispense, 4=perfect) | Posted | Number | percentage of eyes | Four weeks | eyes | eyes |
|
|
|
| Secondary | Rating of Lens Surface Wettability | Lens surface wettability rated on the appearance on the lens surface (0-4 scale, 0=Very poor: immediately displaying non-wetting areas on lens surface, 4=Excellent: appearance of a healthy cornea with very long drying time). | Posted | Mean | Standard Deviation | units on a scale | Baseline (after 15 minutes of lens dispense) | eyes | eyes |
|
|
|
| Secondary | Rating of Lens Surface Wettability | Lens surface wettability rated on the appearance on the lens surface (0-4 scale, 0=Very poor: immediately displaying non-wetting areas on lens surface, 4=Excellent: appearance of a healthy cornea with very long drying time). | Posted | Mean | Standard Deviation | units on a scale | Two weeks | eyes | eyes |
|
|
|
| Secondary | Rating of Lens Surface Wettability | Lens surface wettability rated on the appearance on the lens surface (0-4 scale, 0=Very poor: immediately displaying non-wetting areas on lens surface, 4=Excellent: appearance of a healthy cornea with very long drying time). | Posted | Mean | Standard Deviation | units on a scale | Four weeks | eyes | eyes |
|
|
|
| Secondary | Presence of Film Deposits | Presence of film deposits on front surface of the lens graded 0-4 (0=No film, 1=Slight film visible only under magnification, 2=Moderate film only under magnification, 3=Moderate film visible to the naked eye, 4=heavy film visible to the naked eye). | Posted | Number | percentage of eyes | Two weeks | eyes | eyes |
|
|
|
| Secondary | Presence of Film Deposits | Presence of film deposits on front surface of the lens graded 0-4 (0=No film, 1=Slight film visible only under magnification, 2=Moderate film only under magnification, 3=Moderate film visible to the naked eye, 4=heavy film visible to the naked eye). | Posted | Number | percentage of eyes | Four weeks | eyes | eyes |
|
|
|
| Secondary | Number of White Spot Deposits | Number of white spot deposits assessed using slit lamp with white light, low medium magnification | Posted | Mean | Standard Deviation | number of white spots | Two weeks | eyes | eyes |
|
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| Secondary | Number of White Spot Deposits | Number of white spot deposits assessed using slit lamp with white light, low medium magnification | Posted | Mean | Standard Deviation | number of white spots | Four weeks | eyes | eyes |
|
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|
| Secondary | Primary Gaze Lag | Primary gaze lag measured by scale 0-4 (0=insufficient, 1=minimal, unacceptable movement, 2=optimal movement, 3=moderate, but acceptable movement, 4=excessive, unacceptable movement) | Posted | Number | eyes | Baseline (after 15 minutes of lens dispense) | eyes | eyes |
|
|
|
| Secondary | Primary Gaze Lag | Primary gaze lag measured by scale 0-4 (0=insufficient, 1=minimal, unacceptable movement, 2=optimal movement, 3=moderate, but acceptable movement, 4=excessive, unacceptable movement) | Posted | Number | eyes | Two weeks | eyes | eyes |
|
|
|
| Secondary | Primary Gaze Lag | Primary gaze lag measured by scale 0-4 (0=insufficient, 1=minimal, unacceptable movement, 2=optimal movement, 3=moderate, but acceptable movement, 4=excessive, unacceptable movement) | Posted | Number | eyes | Four weeks | eyes | eyes |
|
|
|
| Secondary | Comfort Throughout the Day | Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses | Overall number of participants analyzed differ based on the number of text responses received. | Posted | Mean | Standard Deviation | units on a scale | Day 3 - 8:00am |
|
|
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| Secondary | Comfort Throughout the Day | Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses | Overall number of participants analyzed differ based on the number of text responses received. | Posted | Mean | Standard Deviation | units on a scale | Day 3 - 12:00pm |
|
|
|
| Secondary | Comfort Throughout the Day | Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses | Overall number of participants analyzed differ based on the number of text responses received. | Posted | Mean | Standard Deviation | units on a scale | Day 3 - 4:00pm |
|
|
|
| Secondary | Comfort Throughout the Day | Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses | Overall number of participants analyzed differ based on the number of text responses received. | Posted | Mean | Standard Deviation | units on a scale | Day 3 - 8:00pm |
|
|
|
| Secondary | Comfort Throughout the Day | Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses | Overall number of participants analyzed differ based on the number of text responses received. | Posted | Mean | Standard Deviation | units on a scale | Day 7 - 8:00am |
|
|
|
| Secondary | Comfort Throughout the Day | Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses | Overall number of participants analyzed differ based on the number of text responses received. | Posted | Mean | Standard Deviation | units on a scale | Day 7 - 12:00pm |
|
|
|
| Secondary | Comfort Throughout the Day | Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses | Overall number of participants analyzed differ based on the number of text responses received. | Posted | Mean | Standard Deviation | units on a scale | Day 7 - 4:00pm |
|
|
|
| Secondary | Comfort Throughout the Day | Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses | Overall number of participants analyzed differ based on the number of text responses received. | Posted | Mean | Standard Deviation | units on a scale | Day 7 - 8:00pm |
|
|
|
| Secondary | Comfort Throughout the Day | Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses | Overall number of participants analyzed differ based on the number of text responses received. | Posted | Mean | Standard Deviation | units on a scale | Day 12 - 8:00am |
|
|
|
| Secondary | Comfort Throughout the Day | Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses | Overall number of participants analyzed differ based on the number of text responses received. | Posted | Mean | Standard Deviation | units on a scale | Day 12 - 12:00pm |
|
|
|
| Secondary | Comfort Throughout the Day | Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses | Overall number of participants analyzed differ based on the number of text responses received. | Posted | Mean | Standard Deviation | units on a scale | Day 12 - 4:00pm |
|
|
|
| Secondary | Comfort Throughout the Day | Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses | Overall number of participants analyzed differ based on the number of text responses received. | Posted | Mean | Standard Deviation | units on a scale | Day 12 - 8:00pm |
|
|
|
| Secondary | Comfort Throughout the Day | Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses | Overall number of participants analyzed differ based on the number of text responses received. | Posted | Mean | Standard Deviation | units on a scale | Day 26 - 8:00am |
|
|
|
| Secondary | Comfort Throughout the Day | Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses | Overall number of participants analyzed differ based on the number of text responses received. | Posted | Mean | Standard Deviation | units on a scale | Day 26 - 12:00pm |
|
|
|
| Secondary | Comfort Throughout the Day | Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses | Overall number of participants analyzed differ based on the number of text responses received. | Posted | Mean | Standard Deviation | units on a scale | Day 26 - 4:00pm |
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|
|
| Secondary | Comfort Throughout the Day | Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses | Overall number of participants analyzed differ based on the number of text responses received. | Posted | Mean | Standard Deviation | units on a scale | Day 26 - 8:00pm |
|
|
|
| 0 |
| 58 |
| 0 |
| 58 |
| 2 |
| 58 |
| EG001 | Fanfilcon A - Group A | Subjects were randomized to wear fanfilcon A test lens for four weeks. Fanfilcon A - SiHy contact lens | 0 | 57 | 0 | 57 | 0 | 57 |
| EG002 | Etafilcon A - Group B | Subjects were randomized to wear etafilcon A control lens for two weeks. Etafilcon A - hydrogel contact lens | 0 | 56 | 0 | 56 | 0 | 56 |
| EG003 | Fanfilcon A - Group B | Subjects were randomized to wear fanfilcon A test lens for two weeks. Fanfilcon A - SiHy contact lens | 0 | 56 | 0 | 56 | 0 | 56 |
Not provided
Not provided
| Slight |
|
| Substantial |
|
| Slight |
|
| Substantial |
|
| Substantial |
|
| no |
|
| no |
|
|
| Minimal |
|
| Optimal |
|
| Moderate |
|
| Excessive |
|
|
| Minimal |
|
| Optimal |
|
| Moderate |
|
| Excessive |
|
| Optimal |
|
| Moderate |
|
| Excessive |
|
|
|
| Borderline |
|
| Minimal |
|
| OK |
|
| Perfect |
|
|
| Borderline |
|
| Minimal |
|
| OK |
|
| Perfect |
|
| Minimal |
|
| OK |
|
| Perfect |
|
| eyes |
|
| eyes |
|
| eyes |
|
| Grade 1 |
|
| Grade 2 |
|
| Grade 3 |
|
| Grade 4 |
|
| Grade 2 |
|
| Grade 3 |
|
| Grade 4 |
|
|
| Minimal |
|
| Optimal |
|
| Moderate |
|
| Excessive |
|
| Minimal |
|
| Optimal |
|
| Moderate |
|
| Excessive |
|
| Optimal |
|
| Moderate |
|
| Excessive |
|