Myopia
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEfanfilcon A test lens
Silicone hydrogel contact lens
DEVICEocufilcon D control lens
hydrogel contact lens
DEVICEetafilcon A control lens
hydrogel contact lens
Sponsors
CooperVision, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Subjects will be masked to lens type. Investigators will be unmasked.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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: 1. No amblyopia 2. No strabismus 3. No evidence of lid abnormality or infection 4. No conjunctival abnormality or infection that would contraindicate contact lens wear 5. No clinically significant slit lamp findings (i.e. corneal staining, stromal edema, staining, scarring, vascularization, infiltrates or abnormal opacities) 6. No other active ocular disease. * 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
* Using CooperVision Avaira Vitality, J&J Acuvue 2 or CooperVision Biomedics 55. * Require toric or multifocal contact lenses. * Previously shown a sensitivity to any of the study solution components. * Any systemic or ocular disease or allergies affecting ocular health. * Using systemic or topical medications that will in the investigator's opinion affect ocular physiology or lens performance. * Clinically significant (\>Grade 3) corneal staining, corneal stromal edema, corneal vascularization, tarsal abnormalities, bulbar hyperemia, limbal hyperemia, or any other abnormality of the cornea that would contraindicate contact lens wear. * Any corneal infiltrates or any corneal scarring or neovascularization within the central 5mm of the cornea. * Keratoconus or other corneal irregularity. * Aphakia or amblyopia. * Have undergone corneal refractive surgery or any anterior segment surgery. * Abnormal lacrimal secretions. * Has diabetes. * Known/reported infectious disease (e.g., hepatitis, tuberculosis) or an immunosuppressive disease (e.g., HIV). * History of chronic eye disease (e.g. glaucoma). * Pregnant or lactating or planning a pregnancy at the time of enrolment. * Participation in any concurrent clinical trial or in last 30 days.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subjective Overall Comfort Rating | Two weeks | Subjective overall comfort rating was assessed on a 0-10 subjective scale, 0=extremely uncomfortable, 10=can't feel lenses |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Average Comfortable Wearing Time | Two weeks | Average comfortable wearing time was assessed by time of day when first aware of lenses using 24-hour clock, to the nearest 10 minutes. |
| Lens Centration | Baseline (after 15 minutes) | Lens centration will be recorded in the scale of 0 to 2 (0=centered - optimal, 1 = decentered slightly, 2 = substantially decentered (\>0.5mm)). |
| Corneal Coverage | Baseline (after 15 minutes of lens dispense) | Corneal coverage (yes=full corneal coverage all times / no=incomplete corneal coverage) |
| Post-Blink Movement | Baseline (after 15 minutes of lens dispense) | 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) |
| Lens Tightness - Push-up Test | Baseline (after 15 minutes of lens dispense) | Lens tightness - push-up test 0-100% continuous scale (100%=movement, 50%=optimum, 0%=Falls from cornea without lid support) |
| Average Wearing Time | Two weeks | Average wearing time - measured by time of day using 24-hour clock, to the nearest 10 minutes |
| Rating of Lens Surface Wettability | Baseline (after 15 minutes of lens dispense) | 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). |
| Presence of Film Deposits | Two weeks | 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). |
| Number of White Spot Deposits | Two weeks | Number of white spot deposits assessed using slit lamp with white light, low medium magnification |
| Primary Gaze Lag | Baseline (after 15 minutes of lens dispense) | 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) |
| Comfort Throughout the Day | Day 3 - 8:00am | 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 Lens Fit Acceptance | Baseline (after 15 minutes of lens dispense) | 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) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 58 |
| 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 | 56 |
| Total | 114 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| First Intervention | Withdrawal by Subject | 2 | 0 |
| Second Intervention | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Ocufilcon D Control Lens, Then Fanfilcon A Test Lens | Etafilcon A Controls, Then Fanfilcon A Test Lens | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 58 Participants | 56 Participants | 114 Participants |
| Age, Continuous | 33.4 years STANDARD_DEVIATION 9.42 | 32.7 years STANDARD_DEVIATION 9 | 33.1 years STANDARD_DEVIATION 9.18 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 12 Participants | 11 Participants | 23 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 46 Participants | 45 Participants | 91 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 56 Participants | 52 Participants | 108 Participants |
| Region of Enrollment United States | 58 participants | 56 participants | 114 participants |
| Sex: Female, Male Female | 38 Participants | 41 Participants | 79 Participants |
| Sex: Female, Male Male | 20 Participants | 15 Participants | 35 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 58 | 0 / 57 | 0 / 56 | 0 / 56 |
| other Total, other adverse events | 2 / 58 | 0 / 57 | 0 / 56 | 0 / 56 |
| serious Total, serious adverse events | 0 / 58 | 0 / 57 | 0 / 56 | 0 / 56 |
Outcome results
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
Time frame: Two weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ocufilcon D - Group A | Subjective Overall Comfort Rating | 8.2 units on a scale | Standard Deviation 2.04 |
| Fanfilcon A - Group A | Subjective Overall Comfort Rating | 8.6 units on a scale | Standard Deviation 1.19 |
| Etafilcon A - Group B | Subjective Overall Comfort Rating | 8.3 units on a scale | Standard Deviation 1.72 |
| Fanfilcon A - Group B | Subjective Overall Comfort Rating | 8.3 units on a scale | Standard Deviation 1.64 |
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
Time frame: Four weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ocufilcon D - Group A | Subjective Overall Comfort Rating | 7.9 units on a scale | Standard Deviation 2.1 |
| Fanfilcon A - Group A | Subjective Overall Comfort Rating | 8.6 units on a scale | Standard Deviation 1.26 |
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.
Time frame: Two weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ocufilcon D - Group A | Average Comfortable Wearing Time | 11.60 hours/day | Standard Deviation 3.743 |
| Fanfilcon A - Group A | Average Comfortable Wearing Time | 12.45 hours/day | Standard Deviation 3.669 |
| Etafilcon A - Group B | Average Comfortable Wearing Time | 12.18 hours/day | Standard Deviation 3.21 |
| Fanfilcon A - Group B | Average Comfortable Wearing Time | 11.67 hours/day | Standard Deviation 3.33 |
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.
Time frame: Four weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ocufilcon D - Group A | Average Comfortable Wearing Time | 11.37 hours/day | Standard Deviation 3.869 |
| Fanfilcon A - Group A | Average Comfortable Wearing Time | 12.40 hours/day | Standard Deviation 3.379 |
Secondary
Average Wearing Time
Average wearing time - measured by time of day using 24-hour clock, to the nearest 10 minutes
Time frame: Four weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ocufilcon D - Group A | Average Wearing Time | 14.21 hours/day | Standard Deviation 1.501 |
| Fanfilcon A - Group A | Average Wearing Time | 14.42 hours/day | Standard Deviation 1.504 |
Secondary
Average Wearing Time
Average wearing time - measured by time of day using 24-hour clock, to the nearest 10 minutes
Time frame: Two weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ocufilcon D - Group A | Average Wearing Time | 14.01 hours/day | Standard Deviation 1.689 |
| Fanfilcon A - Group A | Average Wearing Time | 14.7 hours/day | Standard Deviation 1.674 |
| Etafilcon A - Group B | Average Wearing Time | 13.84 hours/day | Standard Deviation 1.756 |
| Fanfilcon A - Group B | Average Wearing Time | 13.80 hours/day | Standard Deviation 1.757 |
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
Time frame: Day 3 - 8:00pm
Population: Overall number of participants analyzed differ based on the number of text responses received.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ocufilcon D - Group A | Comfort Throughout the Day | 8.11 units on a scale | Standard Deviation 1.912 |
| Fanfilcon A - Group A | Comfort Throughout the Day | 8.57 units on a scale | Standard Deviation 1.377 |
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
Time frame: Day 3 - 4:00pm
Population: Overall number of participants analyzed differ based on the number of text responses received.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ocufilcon D - Group A | Comfort Throughout the Day | 8.85 units on a scale | Standard Deviation 1.384 |
| Fanfilcon A - Group A | Comfort Throughout the Day | 8.71 units on a scale | Standard Deviation 1.458 |
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
Time frame: Day 3 - 12:00pm
Population: Overall number of participants analyzed differ based on the number of text responses received.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ocufilcon D - Group A | Comfort Throughout the Day | 8.58 units on a scale | Standard Deviation 1.601 |
| Fanfilcon A - Group A | Comfort Throughout the Day | 9.27 units on a scale | Standard Deviation 1.18 |
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
Time frame: Day 26 - 8:00pm
Population: Overall number of participants analyzed differ based on the number of text responses received.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ocufilcon D - Group A | Comfort Throughout the Day | 7.79 units on a scale | Standard Deviation 2.127 |
| Fanfilcon A - Group A | Comfort Throughout the Day | 8.29 units on a scale | Standard Deviation 1.774 |
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
Time frame: Day 26 - 4:00pm
Population: Overall number of participants analyzed differ based on the number of text responses received.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ocufilcon D - Group A | Comfort Throughout the Day | 8.04 units on a scale | Standard Deviation 1.876 |
| Fanfilcon A - Group A | Comfort Throughout the Day | 8.62 units on a scale | Standard Deviation 1.609 |
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
Time frame: Day 3 - 8:00am
Population: Overall number of participants analyzed differ based on the number of text responses received.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ocufilcon D - Group A | Comfort Throughout the Day | 8.55 units on a scale | Standard Deviation 1.607 |
| Fanfilcon A - Group A | Comfort Throughout the Day | 9.22 units on a scale | Standard Deviation 1.146 |
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
Time frame: Day 7 - 4:00pm
Population: Overall number of participants analyzed differ based on the number of text responses received.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ocufilcon D - Group A | Comfort Throughout the Day | 8.39 units on a scale | Standard Deviation 1.869 |
| Fanfilcon A - Group A | Comfort Throughout the Day | 8.84 units on a scale | Standard Deviation 1.261 |
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
Time frame: Day 7 - 12:00pm
Population: Overall number of participants analyzed differ based on the number of text responses received.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ocufilcon D - Group A | Comfort Throughout the Day | 8.48 units on a scale | Standard Deviation 1.75 |
| Fanfilcon A - Group A | Comfort Throughout the Day | 8.98 units on a scale | Standard Deviation 1.336 |
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
Time frame: Day 7 - 8:00am
Population: Overall number of participants analyzed differ based on the number of text responses received.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ocufilcon D - Group A | Comfort Throughout the Day | 8.13 units on a scale | Standard Deviation 1.727 |
| Fanfilcon A - Group A | Comfort Throughout the Day | 8.84 units on a scale | Standard Deviation 1.328 |
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
Time frame: Day 26 - 12:00pm
Population: Overall number of participants analyzed differ based on the number of text responses received.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ocufilcon D - Group A | Comfort Throughout the Day | 8.22 units on a scale | Standard Deviation 1.741 |
| Fanfilcon A - Group A | Comfort Throughout the Day | 8.80 units on a scale | Standard Deviation 1.392 |
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
Time frame: Day 26 - 8:00am
Population: Overall number of participants analyzed differ based on the number of text responses received.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ocufilcon D - Group A | Comfort Throughout the Day | 8.35 units on a scale | Standard Deviation 1.861 |
| Fanfilcon A - Group A | Comfort Throughout the Day | 8.58 units on a scale | Standard Deviation 1.277 |
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
Time frame: Day 12 - 8:00pm
Population: Overall number of participants analyzed differ based on the number of text responses received.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ocufilcon D - Group A | Comfort Throughout the Day | 8.22 units on a scale | Standard Deviation 2.023 |
| Fanfilcon A - Group A | Comfort Throughout the Day | 8.39 units on a scale | Standard Deviation 1.382 |
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
Time frame: Day 12 - 4:00pm
Population: Overall number of participants analyzed differ based on the number of text responses received.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ocufilcon D - Group A | Comfort Throughout the Day | 8.34 units on a scale | Standard Deviation 1.71 |
| Fanfilcon A - Group A | Comfort Throughout the Day | 8.56 units on a scale | Standard Deviation 1.459 |
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
Time frame: Day 12 - 12:00pm
Population: Overall number of participants analyzed differ based on the number of text responses received.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ocufilcon D - Group A | Comfort Throughout the Day | 8.68 units on a scale | Standard Deviation 1.721 |
| Fanfilcon A - Group A | Comfort Throughout the Day | 8.73 units on a scale | Standard Deviation 1.387 |
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
Time frame: Day 12 - 8:00am
Population: Overall number of participants analyzed differ based on the number of text responses received.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ocufilcon D - Group A | Comfort Throughout the Day | 8.28 units on a scale | Standard Deviation 1.896 |
| Fanfilcon A - Group A | Comfort Throughout the Day | 8.85 units on a scale | Standard Deviation 1.348 |
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
Time frame: Day 7 - 8:00pm
Population: Overall number of participants analyzed differ based on the number of text responses received.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ocufilcon D - Group A | Comfort Throughout the Day | 8.22 units on a scale | Standard Deviation 1.92 |
| Fanfilcon A - Group A | Comfort Throughout the Day | 8.48 units on a scale | Standard Deviation 1.722 |
Secondary
Corneal Coverage
Corneal coverage (yes=full corneal coverage all times / no=incomplete corneal coverage)
Time frame: Baseline (after 15 minutes of lens dispense)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ocufilcon D - Group A | Corneal Coverage | yes | 100 percentage of eyes |
| Ocufilcon D - Group A | Corneal Coverage | no | 0 percentage of eyes |
| Fanfilcon A - Group A | Corneal Coverage | no | 0 percentage of eyes |
| Fanfilcon A - Group A | Corneal Coverage | yes | 100 percentage of eyes |
| Etafilcon A - Group B | Corneal Coverage | yes | 100 percentage of eyes |
| Etafilcon A - Group B | Corneal Coverage | no | 0 percentage of eyes |
| Fanfilcon A - Group B | Corneal Coverage | yes | 100 percentage of eyes |
| Fanfilcon A - Group B | Corneal Coverage | no | 0 percentage of eyes |
Secondary
Corneal Coverage
Corneal coverage (yes=full corneal coverage all times / no=incomplete corneal coverage)
Time frame: Two weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ocufilcon D - Group A | Corneal Coverage | yes | 98 percentage of eyes |
| Ocufilcon D - Group A | Corneal Coverage | no | 2 percentage of eyes |
| Fanfilcon A - Group A | Corneal Coverage | no | 2 percentage of eyes |
| Fanfilcon A - Group A | Corneal Coverage | yes | 98 percentage of eyes |
| Etafilcon A - Group B | Corneal Coverage | yes | 100 percentage of eyes |
| Etafilcon A - Group B | Corneal Coverage | no | 0 percentage of eyes |
| Fanfilcon A - Group B | Corneal Coverage | yes | 100 percentage of eyes |
| Fanfilcon A - Group B | Corneal Coverage | no | 0 percentage of eyes |
Secondary
Corneal Coverage
Corneal coverage (yes=full corneal coverage all times / no=incomplete corneal coverage)
Time frame: Four weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ocufilcon D - Group A | Corneal Coverage | yes | 100 percentage of eyes |
| Ocufilcon D - Group A | Corneal Coverage | no | 0 percentage of eyes |
| Fanfilcon A - Group A | Corneal Coverage | yes | 98 percentage of eyes |
| Fanfilcon A - Group A | Corneal Coverage | no | 2 percentage of 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)).
Time frame: Two weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ocufilcon D - Group A | Lens Centration | Optimal | 88 percentage of eyes |
| Ocufilcon D - Group A | Lens Centration | Slight | 12 percentage of eyes |
| Ocufilcon D - Group A | Lens Centration | Substantial | 0 percentage of eyes |
| Fanfilcon A - Group A | Lens Centration | Substantial | 0 percentage of eyes |
| Fanfilcon A - Group A | Lens Centration | Slight | 7 percentage of eyes |
| Fanfilcon A - Group A | Lens Centration | Optimal | 93 percentage of eyes |
| Etafilcon A - Group B | Lens Centration | Optimal | 83 percentage of eyes |
| Etafilcon A - Group B | Lens Centration | Slight | 17 percentage of eyes |
| Etafilcon A - Group B | Lens Centration | Substantial | 0 percentage of eyes |
| Fanfilcon A - Group B | Lens Centration | Substantial | 0 percentage of eyes |
| Fanfilcon A - Group B | Lens Centration | Slight | 5 percentage of eyes |
| Fanfilcon A - Group B | Lens Centration | Optimal | 95 percentage of 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)).
Time frame: Baseline (after 15 minutes)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ocufilcon D - Group A | Lens Centration | Optimal | 85 percentage of eyes |
| Ocufilcon D - Group A | Lens Centration | Substantial | 0 percentage of eyes |
| Ocufilcon D - Group A | Lens Centration | Slight | 15 percentage of eyes |
| Fanfilcon A - Group A | Lens Centration | Optimal | 93 percentage of eyes |
| Fanfilcon A - Group A | Lens Centration | Substantial | 0 percentage of eyes |
| Fanfilcon A - Group A | Lens Centration | Slight | 7 percentage of eyes |
| Etafilcon A - Group B | Lens Centration | Slight | 9 percentage of eyes |
| Etafilcon A - Group B | Lens Centration | Optimal | 91 percentage of eyes |
| Etafilcon A - Group B | Lens Centration | Substantial | 0 percentage of eyes |
| Fanfilcon A - Group B | Lens Centration | Optimal | 94 percentage of eyes |
| Fanfilcon A - Group B | Lens Centration | Substantial | 0 percentage of eyes |
| Fanfilcon A - Group B | Lens Centration | Slight | 6 percentage of 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)).
Time frame: Four weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ocufilcon D - Group A | Lens Centration | Optimal | 86 percentage of eyes |
| Ocufilcon D - Group A | Lens Centration | Slight | 14 percentage of eyes |
| Ocufilcon D - Group A | Lens Centration | Substantial | 0 percentage of eyes |
| Fanfilcon A - Group A | Lens Centration | Optimal | 89 percentage of eyes |
| Fanfilcon A - Group A | Lens Centration | Slight | 11 percentage of eyes |
| Fanfilcon A - Group A | Lens Centration | Substantial | 0 percentage of 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)
Time frame: Baseline (after 15 minutes of lens dispense)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ocufilcon D - Group A | Lens Tightness - Push-up Test | 49.6 percentage of eyes | Standard Deviation 5.36 |
| Fanfilcon A - Group A | Lens Tightness - Push-up Test | 49.0 percentage of eyes | Standard Deviation 3.8 |
| Etafilcon A - Group B | Lens Tightness - Push-up Test | 52.1 percentage of eyes | Standard Deviation 8.26 |
| Fanfilcon A - Group B | Lens Tightness - Push-up Test | 50.2 percentage of eyes | Standard Deviation 5.69 |
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)
Time frame: Two weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ocufilcon D - Group A | Lens Tightness - Push-up Test | 49.7 percentage of eyes | Standard Deviation 4.12 |
| Fanfilcon A - Group A | Lens Tightness - Push-up Test | 48.4 percentage of eyes | Standard Deviation 4.55 |
| Etafilcon A - Group B | Lens Tightness - Push-up Test | 50.6 percentage of eyes | Standard Deviation 5.88 |
| Fanfilcon A - Group B | Lens Tightness - Push-up Test | 48.0 percentage of eyes | Standard Deviation 7.95 |
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)
Time frame: Four weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ocufilcon D - Group A | Lens Tightness - Push-up Test | 48.4 percentage of eyes | Standard Deviation 5.62 |
| Fanfilcon A - Group A | Lens Tightness - Push-up Test | 49.8 percentage of eyes | Standard Deviation 3.67 |
Secondary
Number of White Spot Deposits
Number of white spot deposits assessed using slit lamp with white light, low medium magnification
Time frame: Four weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ocufilcon D - Group A | Number of White Spot Deposits | 0.15 number of white spots | Standard Deviation 0.988 |
| Fanfilcon A - Group A | Number of White Spot Deposits | 0.18 number of white spots | Standard Deviation 0.94 |
Secondary
Number of White Spot Deposits
Number of white spot deposits assessed using slit lamp with white light, low medium magnification
Time frame: Two weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ocufilcon D - Group A | Number of White Spot Deposits | 0.01 number of white spots | Standard Deviation 0.094 |
| Fanfilcon A - Group A | Number of White Spot Deposits | 0.05 number of white spots | Standard Deviation 0.567 |
| Etafilcon A - Group B | Number of White Spot Deposits | 0.03 number of white spots | Standard Deviation 0.211 |
| Fanfilcon A - Group B | Number of White Spot Deposits | 0.22 number of white spots | Standard Deviation 1.145 |
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)
Time frame: Baseline (after 15 minutes of lens dispense)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ocufilcon D - Group A | Overall Lens Fit Acceptance | OK | 22 percentage of eyes |
| Ocufilcon D - Group A | Overall Lens Fit Acceptance | Borderline | 0 percentage of eyes |
| Ocufilcon D - Group A | Overall Lens Fit Acceptance | Perfect | 78 percentage of eyes |
| Ocufilcon D - Group A | Overall Lens Fit Acceptance | Minimal | 0 percentage of eyes |
| Ocufilcon D - Group A | Overall Lens Fit Acceptance | Should not be worn | 0 percentage of eyes |
| Fanfilcon A - Group A | Overall Lens Fit Acceptance | Minimal | 0 percentage of eyes |
| Fanfilcon A - Group A | Overall Lens Fit Acceptance | OK | 9 percentage of eyes |
| Fanfilcon A - Group A | Overall Lens Fit Acceptance | Perfect | 91 percentage of eyes |
| Fanfilcon A - Group A | Overall Lens Fit Acceptance | Borderline | 0 percentage of eyes |
| Fanfilcon A - Group A | Overall Lens Fit Acceptance | Should not be worn | 0 percentage of eyes |
| Etafilcon A - Group B | Overall Lens Fit Acceptance | Minimal | 0 percentage of eyes |
| Etafilcon A - Group B | Overall Lens Fit Acceptance | Should not be worn | 0 percentage of eyes |
| Etafilcon A - Group B | Overall Lens Fit Acceptance | Borderline | 0 percentage of eyes |
| Etafilcon A - Group B | Overall Lens Fit Acceptance | OK | 18 percentage of eyes |
| Etafilcon A - Group B | Overall Lens Fit Acceptance | Perfect | 82 percentage of eyes |
| Fanfilcon A - Group B | Overall Lens Fit Acceptance | OK | 21 percentage of eyes |
| Fanfilcon A - Group B | Overall Lens Fit Acceptance | Borderline | 0 percentage of eyes |
| Fanfilcon A - Group B | Overall Lens Fit Acceptance | Should not be worn | 0 percentage of eyes |
| Fanfilcon A - Group B | Overall Lens Fit Acceptance | Minimal | 0 percentage of eyes |
| Fanfilcon A - Group B | Overall Lens Fit Acceptance | Perfect | 79 percentage of 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)
Time frame: Four weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ocufilcon D - Group A | Overall Lens Fit Acceptance | Should not be worn | 0 percentage of eyes |
| Ocufilcon D - Group A | Overall Lens Fit Acceptance | OK | 23 percentage of eyes |
| Ocufilcon D - Group A | Overall Lens Fit Acceptance | Minimal | 0 percentage of eyes |
| Ocufilcon D - Group A | Overall Lens Fit Acceptance | Perfect | 77 percentage of eyes |
| Ocufilcon D - Group A | Overall Lens Fit Acceptance | Borderline | 0 percentage of eyes |
| Fanfilcon A - Group A | Overall Lens Fit Acceptance | Perfect | 85 percentage of eyes |
| Fanfilcon A - Group A | Overall Lens Fit Acceptance | Borderline | 0 percentage of eyes |
| Fanfilcon A - Group A | Overall Lens Fit Acceptance | Should not be worn | 0 percentage of eyes |
| Fanfilcon A - Group A | Overall Lens Fit Acceptance | Minimal | 0 percentage of eyes |
| Fanfilcon A - Group A | Overall Lens Fit Acceptance | OK | 15 percentage of 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)
Time frame: Two weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ocufilcon D - Group A | Overall Lens Fit Acceptance | OK | 16 percentage of eyes |
| Ocufilcon D - Group A | Overall Lens Fit Acceptance | Borderline | 0 percentage of eyes |
| Ocufilcon D - Group A | Overall Lens Fit Acceptance | Perfect | 84 percentage of eyes |
| Ocufilcon D - Group A | Overall Lens Fit Acceptance | Minimal | 0 percentage of eyes |
| Ocufilcon D - Group A | Overall Lens Fit Acceptance | Should not be worn | 0 percentage of eyes |
| Fanfilcon A - Group A | Overall Lens Fit Acceptance | Minimal | 0 percentage of eyes |
| Fanfilcon A - Group A | Overall Lens Fit Acceptance | OK | 12 percentage of eyes |
| Fanfilcon A - Group A | Overall Lens Fit Acceptance | Perfect | 88 percentage of eyes |
| Fanfilcon A - Group A | Overall Lens Fit Acceptance | Borderline | 0 percentage of eyes |
| Fanfilcon A - Group A | Overall Lens Fit Acceptance | Should not be worn | 0 percentage of eyes |
| Etafilcon A - Group B | Overall Lens Fit Acceptance | Minimal | 0 percentage of eyes |
| Etafilcon A - Group B | Overall Lens Fit Acceptance | Should not be worn | 0 percentage of eyes |
| Etafilcon A - Group B | Overall Lens Fit Acceptance | Borderline | 0 percentage of eyes |
| Etafilcon A - Group B | Overall Lens Fit Acceptance | OK | 26 percentage of eyes |
| Etafilcon A - Group B | Overall Lens Fit Acceptance | Perfect | 74 percentage of eyes |
| Fanfilcon A - Group B | Overall Lens Fit Acceptance | OK | 13 percentage of eyes |
| Fanfilcon A - Group B | Overall Lens Fit Acceptance | Borderline | 0 percentage of eyes |
| Fanfilcon A - Group B | Overall Lens Fit Acceptance | Should not be worn | 0 percentage of eyes |
| Fanfilcon A - Group B | Overall Lens Fit Acceptance | Minimal | 0 percentage of eyes |
| Fanfilcon A - Group B | Overall Lens Fit Acceptance | Perfect | 88 percentage of 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)
Time frame: Baseline (after 15 minutes of lens dispense)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ocufilcon D - Group A | Post-Blink Movement | Moderate | 5 percentage of eyes |
| Ocufilcon D - Group A | Post-Blink Movement | Minimal | 4 percentage of eyes |
| Ocufilcon D - Group A | Post-Blink Movement | Excessive | 0 percentage of eyes |
| Ocufilcon D - Group A | Post-Blink Movement | Optimal | 91 percentage of eyes |
| Ocufilcon D - Group A | Post-Blink Movement | Insufficient | 0 percentage of eyes |
| Fanfilcon A - Group A | Post-Blink Movement | Optimal | 94 percentage of eyes |
| Fanfilcon A - Group A | Post-Blink Movement | Moderate | 6 percentage of eyes |
| Fanfilcon A - Group A | Post-Blink Movement | Excessive | 0 percentage of eyes |
| Fanfilcon A - Group A | Post-Blink Movement | Minimal | 0 percentage of eyes |
| Fanfilcon A - Group A | Post-Blink Movement | Insufficient | 0 percentage of eyes |
| Etafilcon A - Group B | Post-Blink Movement | Optimal | 84 percentage of eyes |
| Etafilcon A - Group B | Post-Blink Movement | Insufficient | 2 percentage of eyes |
| Etafilcon A - Group B | Post-Blink Movement | Minimal | 9 percentage of eyes |
| Etafilcon A - Group B | Post-Blink Movement | Moderate | 5 percentage of eyes |
| Etafilcon A - Group B | Post-Blink Movement | Excessive | 0 percentage of eyes |
| Fanfilcon A - Group B | Post-Blink Movement | Moderate | 13 percentage of eyes |
| Fanfilcon A - Group B | Post-Blink Movement | Minimal | 5 percentage of eyes |
| Fanfilcon A - Group B | Post-Blink Movement | Insufficient | 0 percentage of eyes |
| Fanfilcon A - Group B | Post-Blink Movement | Optimal | 82 percentage of eyes |
| Fanfilcon A - Group B | Post-Blink Movement | Excessive | 0 percentage of 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)
Time frame: Four weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ocufilcon D - Group A | Post-Blink Movement | Minimal | 4 percentage of eyes |
| Ocufilcon D - Group A | Post-Blink Movement | Moderate | 16 percentage of eyes |
| Ocufilcon D - Group A | Post-Blink Movement | Optimal | 80 percentage of eyes |
| Ocufilcon D - Group A | Post-Blink Movement | Excessive | 0 percentage of eyes |
| Ocufilcon D - Group A | Post-Blink Movement | Insufficient | 0 percentage of eyes |
| Fanfilcon A - Group A | Post-Blink Movement | Excessive | 0 percentage of eyes |
| Fanfilcon A - Group A | Post-Blink Movement | Insufficient | 0 percentage of eyes |
| Fanfilcon A - Group A | Post-Blink Movement | Minimal | 2 percentage of eyes |
| Fanfilcon A - Group A | Post-Blink Movement | Optimal | 96 percentage of eyes |
| Fanfilcon A - Group A | Post-Blink Movement | Moderate | 2 percentage of 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)
Time frame: Two weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ocufilcon D - Group A | Post-Blink Movement | Optimal | 91 percentage of eyes |
| Ocufilcon D - Group A | Post-Blink Movement | Insufficient | 0 percentage of eyes |
| Ocufilcon D - Group A | Post-Blink Movement | Moderate | 5 percentage of eyes |
| Ocufilcon D - Group A | Post-Blink Movement | Minimal | 4 percentage of eyes |
| Ocufilcon D - Group A | Post-Blink Movement | Excessive | 0 percentage of eyes |
| Fanfilcon A - Group A | Post-Blink Movement | Optimal | 98 percentage of eyes |
| Fanfilcon A - Group A | Post-Blink Movement | Minimal | 0 percentage of eyes |
| Fanfilcon A - Group A | Post-Blink Movement | Moderate | 2 percentage of eyes |
| Fanfilcon A - Group A | Post-Blink Movement | Insufficient | 0 percentage of eyes |
| Fanfilcon A - Group A | Post-Blink Movement | Excessive | 0 percentage of eyes |
| Etafilcon A - Group B | Post-Blink Movement | Excessive | 0 percentage of eyes |
| Etafilcon A - Group B | Post-Blink Movement | Insufficient | 0 percentage of eyes |
| Etafilcon A - Group B | Post-Blink Movement | Minimal | 11 percentage of eyes |
| Etafilcon A - Group B | Post-Blink Movement | Optimal | 83 percentage of eyes |
| Etafilcon A - Group B | Post-Blink Movement | Moderate | 6 percentage of eyes |
| Fanfilcon A - Group B | Post-Blink Movement | Excessive | 0 percentage of eyes |
| Fanfilcon A - Group B | Post-Blink Movement | Moderate | 4 percentage of eyes |
| Fanfilcon A - Group B | Post-Blink Movement | Minimal | 5 percentage of eyes |
| Fanfilcon A - Group B | Post-Blink Movement | Insufficient | 0 percentage of eyes |
| Fanfilcon A - Group B | Post-Blink Movement | Optimal | 91 percentage of 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).
Time frame: Four weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ocufilcon D - Group A | Presence of Film Deposits | Grade 1 | 22 percentage of eyes |
| Ocufilcon D - Group A | Presence of Film Deposits | Grade 3 | 0 percentage of eyes |
| Ocufilcon D - Group A | Presence of Film Deposits | Grade 2 | 2 percentage of eyes |
| Ocufilcon D - Group A | Presence of Film Deposits | Grade 4 | 2 percentage of eyes |
| Ocufilcon D - Group A | Presence of Film Deposits | Grade 0 | 74 percentage of eyes |
| Fanfilcon A - Group A | Presence of Film Deposits | Grade 4 | 2 percentage of eyes |
| Fanfilcon A - Group A | Presence of Film Deposits | Grade 0 | 79 percentage of eyes |
| Fanfilcon A - Group A | Presence of Film Deposits | Grade 1 | 17 percentage of eyes |
| Fanfilcon A - Group A | Presence of Film Deposits | Grade 2 | 2 percentage of eyes |
| Fanfilcon A - Group A | Presence of Film Deposits | Grade 3 | 0 percentage of 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).
Time frame: Two weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ocufilcon D - Group A | Presence of Film Deposits | Grade 3 | 0 percentage of eyes |
| Ocufilcon D - Group A | Presence of Film Deposits | Grade 1 | 12 percentage of eyes |
| Ocufilcon D - Group A | Presence of Film Deposits | Grade 4 | 0 percentage of eyes |
| Ocufilcon D - Group A | Presence of Film Deposits | Grade 2 | 3 percentage of eyes |
| Ocufilcon D - Group A | Presence of Film Deposits | Grade 0 | 85 percentage of eyes |
| Fanfilcon A - Group A | Presence of Film Deposits | Grade 2 | 2 percentage of eyes |
| Fanfilcon A - Group A | Presence of Film Deposits | Grade 3 | 0 percentage of eyes |
| Fanfilcon A - Group A | Presence of Film Deposits | Grade 4 | 0 percentage of eyes |
| Fanfilcon A - Group A | Presence of Film Deposits | Grade 1 | 13 percentage of eyes |
| Fanfilcon A - Group A | Presence of Film Deposits | Grade 0 | 86 percentage of eyes |
| Etafilcon A - Group B | Presence of Film Deposits | Grade 2 | 2 percentage of eyes |
| Etafilcon A - Group B | Presence of Film Deposits | Grade 0 | 85 percentage of eyes |
| Etafilcon A - Group B | Presence of Film Deposits | Grade 1 | 13 percentage of eyes |
| Etafilcon A - Group B | Presence of Film Deposits | Grade 3 | 0 percentage of eyes |
| Etafilcon A - Group B | Presence of Film Deposits | Grade 4 | 1 percentage of eyes |
| Fanfilcon A - Group B | Presence of Film Deposits | Grade 3 | 0 percentage of eyes |
| Fanfilcon A - Group B | Presence of Film Deposits | Grade 1 | 13 percentage of eyes |
| Fanfilcon A - Group B | Presence of Film Deposits | Grade 0 | 86 percentage of eyes |
| Fanfilcon A - Group B | Presence of Film Deposits | Grade 2 | 2 percentage of eyes |
| Fanfilcon A - Group B | Presence of Film Deposits | Grade 4 | 0 percentage of 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)
Time frame: Baseline (after 15 minutes of lens dispense)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ocufilcon D - Group A | Primary Gaze Lag | Insufficient | 0 eyes |
| Ocufilcon D - Group A | Primary Gaze Lag | Moderate | 4 eyes |
| Ocufilcon D - Group A | Primary Gaze Lag | Excessive | 0 eyes |
| Ocufilcon D - Group A | Primary Gaze Lag | Optimal | 107 eyes |
| Ocufilcon D - Group A | Primary Gaze Lag | Minimal | 5 eyes |
| Fanfilcon A - Group A | Primary Gaze Lag | Optimal | 106 eyes |
| Fanfilcon A - Group A | Primary Gaze Lag | Moderate | 6 eyes |
| Fanfilcon A - Group A | Primary Gaze Lag | Insufficient | 0 eyes |
| Fanfilcon A - Group A | Primary Gaze Lag | Minimal | 0 eyes |
| Fanfilcon A - Group A | Primary Gaze Lag | Excessive | 0 eyes |
| Etafilcon A - Group B | Primary Gaze Lag | Insufficient | 2 eyes |
| Etafilcon A - Group B | Primary Gaze Lag | Minimal | 8 eyes |
| Etafilcon A - Group B | Primary Gaze Lag | Optimal | 100 eyes |
| Etafilcon A - Group B | Primary Gaze Lag | Moderate | 2 eyes |
| Etafilcon A - Group B | Primary Gaze Lag | Excessive | 0 eyes |
| Fanfilcon A - Group B | Primary Gaze Lag | Moderate | 13 eyes |
| Fanfilcon A - Group B | Primary Gaze Lag | Minimal | 6 eyes |
| Fanfilcon A - Group B | Primary Gaze Lag | Insufficient | 0 eyes |
| Fanfilcon A - Group B | Primary Gaze Lag | Optimal | 93 eyes |
| Fanfilcon A - Group B | Primary Gaze Lag | Excessive | 0 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)
Time frame: Two weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ocufilcon D - Group A | Primary Gaze Lag | Moderate | 4 eyes |
| Ocufilcon D - Group A | Primary Gaze Lag | Minimal | 2 eyes |
| Ocufilcon D - Group A | Primary Gaze Lag | Excessive | 0 eyes |
| Ocufilcon D - Group A | Primary Gaze Lag | Optimal | 108 eyes |
| Ocufilcon D - Group A | Primary Gaze Lag | Insufficient | 0 eyes |
| Fanfilcon A - Group A | Primary Gaze Lag | Optimal | 109 eyes |
| Fanfilcon A - Group A | Primary Gaze Lag | Moderate | 3 eyes |
| Fanfilcon A - Group A | Primary Gaze Lag | Excessive | 0 eyes |
| Fanfilcon A - Group A | Primary Gaze Lag | Minimal | 0 eyes |
| Fanfilcon A - Group A | Primary Gaze Lag | Insufficient | 0 eyes |
| Etafilcon A - Group B | Primary Gaze Lag | Optimal | 97 eyes |
| Etafilcon A - Group B | Primary Gaze Lag | Insufficient | 0 eyes |
| Etafilcon A - Group B | Primary Gaze Lag | Minimal | 8 eyes |
| Etafilcon A - Group B | Primary Gaze Lag | Moderate | 7 eyes |
| Etafilcon A - Group B | Primary Gaze Lag | Excessive | 0 eyes |
| Fanfilcon A - Group B | Primary Gaze Lag | Moderate | 2 eyes |
| Fanfilcon A - Group B | Primary Gaze Lag | Minimal | 2 eyes |
| Fanfilcon A - Group B | Primary Gaze Lag | Insufficient | 0 eyes |
| Fanfilcon A - Group B | Primary Gaze Lag | Optimal | 108 eyes |
| Fanfilcon A - Group B | Primary Gaze Lag | Excessive | 0 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)
Time frame: Four weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ocufilcon D - Group A | Primary Gaze Lag | Minimal | 2 eyes |
| Ocufilcon D - Group A | Primary Gaze Lag | Moderate | 14 eyes |
| Ocufilcon D - Group A | Primary Gaze Lag | Optimal | 96 eyes |
| Ocufilcon D - Group A | Primary Gaze Lag | Excessive | 0 eyes |
| Ocufilcon D - Group A | Primary Gaze Lag | Insufficient | 0 eyes |
| Fanfilcon A - Group A | Primary Gaze Lag | Excessive | 0 eyes |
| Fanfilcon A - Group A | Primary Gaze Lag | Insufficient | 0 eyes |
| Fanfilcon A - Group A | Primary Gaze Lag | Minimal | 2 eyes |
| Fanfilcon A - Group A | Primary Gaze Lag | Optimal | 106 eyes |
| Fanfilcon A - Group A | Primary Gaze Lag | Moderate | 2 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).
Time frame: Baseline (after 15 minutes of lens dispense)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ocufilcon D - Group A | Rating of Lens Surface Wettability | 3.93 units on a scale | Standard Deviation 0.266 |
| Fanfilcon A - Group A | Rating of Lens Surface Wettability | 3.96 units on a scale | Standard Deviation 0.172 |
| Etafilcon A - Group B | Rating of Lens Surface Wettability | 3.94 units on a scale | Standard Deviation 0.286 |
| Fanfilcon A - Group B | Rating of Lens Surface Wettability | 3.92 units on a scale | Standard Deviation 0.265 |
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).
Time frame: Two weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ocufilcon D - Group A | Rating of Lens Surface Wettability | 3.74 units on a scale | Standard Deviation 0.49 |
| Fanfilcon A - Group A | Rating of Lens Surface Wettability | 3.69 units on a scale | Standard Deviation 0.512 |
| Etafilcon A - Group B | Rating of Lens Surface Wettability | 3.73 units on a scale | Standard Deviation 0.611 |
| Fanfilcon A - Group B | Rating of Lens Surface Wettability | 3.80 units on a scale | Standard Deviation 0.437 |
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).
Time frame: Four weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ocufilcon D - Group A | Rating of Lens Surface Wettability | 3.55 units on a scale | Standard Deviation 0.736 |
| Fanfilcon A - Group A | Rating of Lens Surface Wettability | 3.81 units on a scale | Standard Deviation 0.365 |