Myopia
Conditions
Brief summary
This is a study to evaluate the performance of fanfilcon A lens when worn on a daily wear modality over approximately 1 month in comparison to the lotrafilcon B lens.
Detailed description
This is a 45 subject, 1-month dispensing, crossover, double-masked, randomized, bilateral study comparing the test lens against the control lens. Both test and control lenses will be used in a daily wear modality for 1 month each.
Interventions
DEVICEfanfilcon A
contact lens
DEVICElotrafilcon B
contact lens
Sponsors
CooperVision, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
17 Years to No maximum
Healthy volunteers
No
Inclusion criteria
A person is eligible for inclusion in the study if he/she: * Is at least 17 years of age and has full legal capacity to volunteer; * Has read and signed an information consent letter; * Is willing and able to follow instructions and maintain the appointment schedule; * Is correctable to a visual acuity of 20/30 or better (in each eye) with their habitual correction and the assigned study lenses; * Is an adapted soft contact lens wearer (For the purpose of this study: Current lens wear at least 3 days per week, 8 hours each day); * Demonstrates an acceptable fit with the study lenses.
Exclusion criteria
A person will be excluded from the study if he/she: * Is participating in any concurrent clinical or research study; * Is a habitual wearer of lotrafilcon B or enfilcon A lenses. * Has any known active\* ocular disease and/or infection; * Has a systemic condition that in the opinion of the investigator may affect a study outcome variable; * Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable; * Has known sensitivity to the diagnostic pharmaceuticals to be used in the study; * Is pregnant, lactating or planning a pregnancy at the time of enrollment; (by verbal confirmation at the Screening Visit) * Is aphakic; * Has undergone refractive error surgery; * For the purposes of this study, active ocular disease is defined as infection or inflammation which requires therapeutic treatment. Mild (i.e. not considered clinically relevant) lid abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and conjunctival staining and dry eye are not considered active ocular disease. Neovascularization and corneal scars are the result of previous hypoxia, infection or inflammation and are therefore not active.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subjective Comfort | Baseline, 1 month | Subjective ratings on comfort at insertion (at baseline), comfort when lenses are first put in, comfort during the day's wear, and comfort prior to lens removal (1 month) for fanfilcon A and lotrafilcon B lens. (Scale 0-10, 10=Can't feel the lenses, 0=Painful). |
| Subjective Preference | 1 month | Subjective ratings on preference for fanfilcon A and lotrafilcon B lens. (Strongly prefer fanfilcon A, slightly prefer fanfilcon A, no preference, slightly prefer lotrafilcon B, strongly prefer lotrafilcon B). Subject preference in terms of comfort, dryness, clear vision, Lens Handling, digital devices, all day natural comfort, All day comfort, same comfort at the end of the day (EOD), comfortable after the end of 4 weeks, Same comfort at 4 weeks as initial, comfortable in dry environments, help focus effortlessly while using digital devices, help with end of day (EOD) dryness, help eyes feel less tired at EOD (including computer or digital device use), offering clear vision during driving. |
| Lens Wettability | Baseline, 1 month | Lens wettability for fanfilcon A and lotrafilcon B lens. (Scale 0-4, 0.25 steps, 0=excellent, 4=severely reduced) |
| Surface Deposits | Baseline, 1 month | Surface deposits for fanfilcon A and lotrafilcon B lens. (Scale 0-4, 0.25 steps, 0=excellent, 4=severely reduced) |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Overall Participants Study participants are randomized to wear fanfilcon A lens or lotrafilcon B lens for 1 month during the crossover study
fanfilcon A: contact lens lotrafilcon B: contact lens | 49 |
| Total | 49 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| First Intervention (1 Month) | Lens discomfort | 1 | 1 |
Baseline characteristics
| Characteristic | Overall Participants |
|---|---|
| Age, Continuous | 27.1 years |
| Sex: Female, Male Female | 38 Participants |
| Sex: Female, Male Male | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 49 | 0 / 49 |
| serious Total, serious adverse events | 0 / 49 | 0 / 49 |
Outcome results
Primary
Lens Wettability
Lens wettability for fanfilcon A and lotrafilcon B lens. (Scale 0-4, 0.25 steps, 0=excellent, 4=severely reduced)
Time frame: Baseline, 1 month
Population: One participant excluded from analysis at 1 month.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fanfilcon A | Lens Wettability | Baseline | 0.76 units on a scale | Standard Deviation 0.61 |
| Fanfilcon A | Lens Wettability | 1 month | 0.85 units on a scale | Standard Deviation 0.71 |
| Lotrafilcon B | Lens Wettability | Baseline | 0.56 units on a scale | Standard Deviation 0.46 |
| Lotrafilcon B | Lens Wettability | 1 month | 1.08 units on a scale | Standard Deviation 0.71 |
Primary
Subjective Comfort
Subjective ratings on comfort at insertion (at baseline), comfort when lenses are first put in, comfort during the day's wear, and comfort prior to lens removal (1 month) for fanfilcon A and lotrafilcon B lens. (Scale 0-10, 10=Can't feel the lenses, 0=Painful).
Time frame: Baseline, 1 month
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| Fanfilcon A | Subjective Comfort | Baseline - Comfort at Insertion | 10 units on a scale | Standard Deviation 0.93 |
| Fanfilcon A | Subjective Comfort | 1 Month - Comfort during the day's wear | 9 units on a scale | Standard Deviation 1.32 |
| Fanfilcon A | Subjective Comfort | 1 Month - Comfort just prior to lens removal | 8 units on a scale | Standard Deviation 1.78 |
| Fanfilcon A | Subjective Comfort | 1 Month - Comfort when lenses are first put in | 10 units on a scale | Standard Deviation 1.26 |
| Lotrafilcon B | Subjective Comfort | 1 Month - Comfort just prior to lens removal | 7 units on a scale | Standard Deviation 2.14 |
| Lotrafilcon B | Subjective Comfort | Baseline - Comfort at Insertion | 9 units on a scale | Standard Deviation 1.83 |
| Lotrafilcon B | Subjective Comfort | 1 Month - Comfort when lenses are first put in | 9 units on a scale | Standard Deviation 1.44 |
| Lotrafilcon B | Subjective Comfort | 1 Month - Comfort during the day's wear | 8 units on a scale | Standard Deviation 1.53 |
Primary
Subjective Preference
Subjective ratings on preference for fanfilcon A and lotrafilcon B lens. (Strongly prefer fanfilcon A, slightly prefer fanfilcon A, no preference, slightly prefer lotrafilcon B, strongly prefer lotrafilcon B). Subject preference in terms of comfort, dryness, clear vision, Lens Handling, digital devices, all day natural comfort, All day comfort, same comfort at the end of the day (EOD), comfortable after the end of 4 weeks, Same comfort at 4 weeks as initial, comfortable in dry environments, help focus effortlessly while using digital devices, help with end of day (EOD) dryness, help eyes feel less tired at EOD (including computer or digital device use), offering clear vision during driving.
Time frame: 1 month
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fanfilcon A | Subjective Preference | Same comfort at 4 weeks as initial | 43 percentage of participants |
| Fanfilcon A | Subjective Preference | All day comfort | 27 percentage of participants |
| Fanfilcon A | Subjective Preference | Comfortable after the end of 4 weeks | 50 percentage of participants |
| Fanfilcon A | Subjective Preference | Same comfort at EOD | 41 percentage of participants |
| Fanfilcon A | Subjective Preference | Help eyes feel less tired at EOD | 36.36 percentage of participants |
| Fanfilcon A | Subjective Preference | Clear vision | 38.64 percentage of participants |
| Fanfilcon A | Subjective Preference | Comfort | 52 percentage of participants |
| Fanfilcon A | Subjective Preference | Help with EOD dryness | 34 percentage of participants |
| Fanfilcon A | Subjective Preference | Lens Handling | 9 percentage of participants |
| Fanfilcon A | Subjective Preference | Help focus effortlessly while using digital device | 29.55 percentage of participants |
| Fanfilcon A | Subjective Preference | Digital devices | 27.27 percentage of participants |
| Fanfilcon A | Subjective Preference | Offering clear vision during driving. | 34 percentage of participants |
| Fanfilcon A | Subjective Preference | Comfortable in dry environments | 38.64 percentage of participants |
| Fanfilcon A | Subjective Preference | All day natural comfort | 45 percentage of participants |
| Fanfilcon A | Subjective Preference | Dryness | 43 percentage of participants |
| Lotrafilcon B | Subjective Preference | Digital devices | 27.27 percentage of participants |
| Lotrafilcon B | Subjective Preference | Same comfort at 4 weeks as initial | 25 percentage of participants |
| Lotrafilcon B | Subjective Preference | All day comfort | 39 percentage of participants |
| Lotrafilcon B | Subjective Preference | Dryness | 23 percentage of participants |
| Lotrafilcon B | Subjective Preference | Comfortable after the end of 4 weeks | 18 percentage of participants |
| Lotrafilcon B | Subjective Preference | Lens Handling | 16 percentage of participants |
| Lotrafilcon B | Subjective Preference | Same comfort at EOD | 25 percentage of participants |
| Lotrafilcon B | Subjective Preference | Offering clear vision during driving. | 29 percentage of participants |
| Lotrafilcon B | Subjective Preference | Comfort | 16 percentage of participants |
| Lotrafilcon B | Subjective Preference | Help eyes feel less tired at EOD | 18.18 percentage of participants |
| Lotrafilcon B | Subjective Preference | Help focus effortlessly while using digital device | 27.27 percentage of participants |
| Lotrafilcon B | Subjective Preference | Comfortable in dry environments | 15.91 percentage of participants |
| Lotrafilcon B | Subjective Preference | Clear vision | 25.0 percentage of participants |
| Lotrafilcon B | Subjective Preference | All day natural comfort | 20 percentage of participants |
| Lotrafilcon B | Subjective Preference | Help with EOD dryness | 25 percentage of participants |
| No Preference | Subjective Preference | Same comfort at EOD | 11 percentage of participants |
| No Preference | Subjective Preference | Comfort | 9 percentage of participants |
| No Preference | Subjective Preference | Dryness | 11 percentage of participants |
| No Preference | Subjective Preference | Clear vision | 29.55 percentage of participants |
| No Preference | Subjective Preference | Lens Handling | 52 percentage of participants |
| No Preference | Subjective Preference | Digital devices | 40.91 percentage of participants |
| No Preference | Subjective Preference | All day natural comfort | 14 percentage of participants |
| No Preference | Subjective Preference | All day comfort | 11 percentage of participants |
| No Preference | Subjective Preference | Comfortable after the end of 4 weeks | 7 percentage of participants |
| No Preference | Subjective Preference | Same comfort at 4 weeks as initial | 11 percentage of participants |
| No Preference | Subjective Preference | Comfortable in dry environments | 29.55 percentage of participants |
| No Preference | Subjective Preference | Help focus effortlessly while using digital device | 34.09 percentage of participants |
| No Preference | Subjective Preference | Help with EOD dryness | 23 percentage of participants |
| No Preference | Subjective Preference | Help eyes feel less tired at EOD | 31.82 percentage of participants |
| No Preference | Subjective Preference | Offering clear vision during driving. | 26 percentage of participants |
| Slightly Prefer Lotrafilcon B | Subjective Preference | Comfortable in dry environments | 4.55 percentage of participants |
| Slightly Prefer Lotrafilcon B | Subjective Preference | Clear vision | 4.55 percentage of participants |
| Slightly Prefer Lotrafilcon B | Subjective Preference | Same comfort at 4 weeks as initial | 14 percentage of participants |
| Slightly Prefer Lotrafilcon B | Subjective Preference | Help with EOD dryness | 11 percentage of participants |
| Slightly Prefer Lotrafilcon B | Subjective Preference | Digital devices | 2.27 percentage of participants |
| Slightly Prefer Lotrafilcon B | Subjective Preference | Lens Handling | 23 percentage of participants |
| Slightly Prefer Lotrafilcon B | Subjective Preference | Dryness | 14 percentage of participants |
| Slightly Prefer Lotrafilcon B | Subjective Preference | Offering clear vision during driving. | 11 percentage of participants |
| Slightly Prefer Lotrafilcon B | Subjective Preference | Same comfort at EOD | 14 percentage of participants |
| Slightly Prefer Lotrafilcon B | Subjective Preference | Comfort | 16 percentage of participants |
| Slightly Prefer Lotrafilcon B | Subjective Preference | Help focus effortlessly while using digital device | 4.55 percentage of participants |
| Slightly Prefer Lotrafilcon B | Subjective Preference | All day comfort | 18 percentage of participants |
| Slightly Prefer Lotrafilcon B | Subjective Preference | Help eyes feel less tired at EOD | 11.36 percentage of participants |
| Slightly Prefer Lotrafilcon B | Subjective Preference | Comfortable after the end of 4 weeks | 20 percentage of participants |
| Slightly Prefer Lotrafilcon B | Subjective Preference | All day natural comfort | 14 percentage of participants |
| Strongly Prefer Lotrafilcon B | Subjective Preference | Comfortable after the end of 4 weeks | 5 percentage of participants |
| Strongly Prefer Lotrafilcon B | Subjective Preference | Help eyes feel less tired at EOD | 2.27 percentage of participants |
| Strongly Prefer Lotrafilcon B | Subjective Preference | Same comfort at 4 weeks as initial | 7 percentage of participants |
| Strongly Prefer Lotrafilcon B | Subjective Preference | Digital devices | 2.27 percentage of participants |
| Strongly Prefer Lotrafilcon B | Subjective Preference | Comfort | 7 percentage of participants |
| Strongly Prefer Lotrafilcon B | Subjective Preference | Comfortable in dry environments | 11.36 percentage of participants |
| Strongly Prefer Lotrafilcon B | Subjective Preference | Lens Handling | 0 percentage of participants |
| Strongly Prefer Lotrafilcon B | Subjective Preference | Help focus effortlessly while using digital device | 4.55 percentage of participants |
| Strongly Prefer Lotrafilcon B | Subjective Preference | Clear vision | 2.27 percentage of participants |
| Strongly Prefer Lotrafilcon B | Subjective Preference | Offering clear vision during driving. | 0 percentage of participants |
| Strongly Prefer Lotrafilcon B | Subjective Preference | Help with EOD dryness | 7 percentage of participants |
| Strongly Prefer Lotrafilcon B | Subjective Preference | Dryness | 9 percentage of participants |
| Strongly Prefer Lotrafilcon B | Subjective Preference | Same comfort at EOD | 9 percentage of participants |
| Strongly Prefer Lotrafilcon B | Subjective Preference | All day comfort | 5 percentage of participants |
| Strongly Prefer Lotrafilcon B | Subjective Preference | All day natural comfort | 7 percentage of participants |
Primary
Surface Deposits
Surface deposits for fanfilcon A and lotrafilcon B lens. (Scale 0-4, 0.25 steps, 0=excellent, 4=severely reduced)
Time frame: Baseline, 1 month
Population: One participant excluded from analysis at 1 month.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fanfilcon A | Surface Deposits | Baseline | 0.14 units on a scale | Standard Deviation 0.22 |
| Fanfilcon A | Surface Deposits | 1 Month | 0.34 units on a scale | Standard Deviation 0.45 |
| Lotrafilcon B | Surface Deposits | Baseline | 0.26 units on a scale | Standard Deviation 0.26 |
| Lotrafilcon B | Surface Deposits | 1 Month | 0.41 units on a scale | Standard Deviation 0.56 |