Myopia
Conditions
Brief summary
The objective of the study is to evaluate and compare the performance of verofilcon A to somofilcon A when worn on a daily disposable modality over a period of approximately one week each.
Detailed description
The study is a prospective, double masked (investigator and participant), bilateral, randomized,one week cross-over dispensing study, which evaluates somofilcon A (test lens) and verofilcon A (control lens).
Interventions
DEVICEsomofilcon A
Subjects will be randomized to wear somofilcon A daily disposable lenses.
DEVICEverofilcon A
Subjects will be randomized to wear verofilcon A daily disposable lenses.
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
Yes
Inclusion criteria
\- A person is eligible for inclusion in the study if he/she: 1. Is at least 17 years of age and has full legal capacity to volunteer; 2. Has read and signed an information consent letter; 3. Is willing and able to follow instructions and maintain the appointment schedule; 4. Habitually wears soft contact lenses in daily wear, for minimum of 6-months; 5. Is correctable to a visual acuity of 20/40 or better (in each eye) with the study lenses; 6. Has an astigmatism of ≤ 1.00 D in subjective refraction; 7. Can be fit with study contact lenses with a power between -2.00 and -5.00 DS; 8. Demonstrates an acceptable fit with the study lenses; 9. Habitually wears single vision soft contact lenses for at least 8 hours per day, 5 days a week, and is willing to wear contact lenses for at least 12 hours a day in the study.
Exclusion criteria
\- A person may be excluded from the study if he/she: 1. Is participating in any concurrent clinical or research study; 2. Has any known active\* ocular disease and/or infection; 3. Has a systemic condition that in the opinion of the investigator may affect a study outcome variable; 4. Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable; 5. Has known sensitivity to the diagnostic pharmaceuticals to be used in the study; 6. Is pregnant, lactating or planning a pregnancy at the time of enrolment because the associated hormonal changes cause changes in the tear layer which impact contact lens comfort. Verbal confirmation at the screening visit is sufficient; 7. Is aphakic; 8. Has undergone refractive error surgery; 9. Is an employee of the Centre for Ocular Research & Education; 10. Has participated in the BOXER (i.e. EX-MKTG-107, phases 1 or 2) or MIKI (EX-MKTG-114) Study; 11. Has participated in any clinical trials within a week prior to the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subjective Ratings for Lens Handling for Lens Insertion | 1 week | Subjective ratings for Lens handling for lens insertion (0 - 10 integer scale), (0- very difficult, 10- very easy). |
| Subjective Ratings for Lens Handling for Lens Removal | 1 week | Subjective ratings for Lens handling for lens removal (0 - 10 integer scale), (0-very difficult, 10- very easy). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lens Fit - Centration | Baseline | Lens Fit Centration was measured on a scale of 0-3 (0-optimal, 1-slight decentration, 2-moderate decentration but not encroaching limbus, 3- excessive & occasionally encroaching limbus) |
| Lens Fit - Post-blink Movement | Baseline | Post-blink lens movement was measured using an eyepiece reticule while viewing the contact lens in vivo at 8x magnification in primary gaze, in 0.1mm steps |
| Lens Fit - Lens Push-up Tightness | Baseline | The lens push-up tightness was graded using a 0 - 100 scale (5% steps) where 0% = falls from cornea without lid support, 50% = optimum and 100% = no movement |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Overall Study Subjects will be randomized to wear somofilcon A daily disposable lenses and verofilcon A daily disposable lenses for one week. | 51 |
| Total | 51 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| First Intervention | COVID-19 Suspension | 2 | 0 |
| First Intervention | Withdrawal by Subject | 0 | 1 |
| Second Intervention | Adverse Event | 0 | 1 |
Baseline characteristics
| Characteristic | Overall Study | — |
|---|---|---|
| Age, Categorical <=18 years | 1 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 50 Participants | — |
| Age, Continuous | 29.8 years STANDARD_DEVIATION 12.3 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Canada | 51 participants | — |
| Sex: Female, Male Female | 40 Participants | — |
| Sex: Female, Male Male | 11 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 51 | 0 / 51 |
| other Total, other adverse events | 2 / 51 | 1 / 51 |
| serious Total, serious adverse events | 0 / 51 | 0 / 51 |
Outcome results
Primary
Subjective Ratings for Lens Handling for Lens Insertion
Subjective ratings for Lens handling for lens insertion (0 - 10 integer scale), (0- very difficult, 10- very easy).
Time frame: 1 week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Somofilcon A | Subjective Ratings for Lens Handling for Lens Insertion | 9.3 units on a scale | Standard Deviation 0.9 |
| Verofilcon A | Subjective Ratings for Lens Handling for Lens Insertion | 9.2 units on a scale | Standard Deviation 1.2 |
Primary
Subjective Ratings for Lens Handling for Lens Removal
Subjective ratings for Lens handling for lens removal (0 - 10 integer scale), (0-very difficult, 10- very easy).
Time frame: 1 week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Somofilcon A | Subjective Ratings for Lens Handling for Lens Removal | 9.1 units on a scale | Standard Deviation 1.3 |
| Verofilcon A | Subjective Ratings for Lens Handling for Lens Removal | 8.8 units on a scale | Standard Deviation 1.9 |
Secondary
Lens Fit - Centration
Lens Fit Centration was measured on a scale of 0-3 (0-optimal, 1-slight decentration, 2-moderate decentration but not encroaching limbus, 3- excessive & occasionally encroaching limbus)
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Somofilcon A | Lens Fit - Centration | 0.7 units on a scale | Standard Deviation 0.7 |
| Verofilcon A | Lens Fit - Centration | 0.4 units on a scale | Standard Deviation 0.5 |
Secondary
Lens Fit - Centration
Lens Fit Centration was measured on a scale of 0-3 (0-optimal, 1-slight decentration, 2-moderate decentration but not encroaching limbus, 3- excessive & occasionally encroaching limbus)
Time frame: 1-week
Population: One subject missed follow-up assessment for lens-fit centration.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Somofilcon A | Lens Fit - Centration | 0.5 units on a scale | Standard Deviation 0.6 |
| Verofilcon A | Lens Fit - Centration | 0.3 units on a scale | Standard Deviation 0.5 |
Secondary
Lens Fit - Lens Push-up Tightness
The lens push-up tightness was graded using a 0 - 100 scale (5% steps) where 0% = falls from cornea without lid support, 50% = optimum and 100% = no movement
Time frame: 1-week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Somofilcon A | Lens Fit - Lens Push-up Tightness | 51 units on a scale | Standard Deviation 5 |
| Verofilcon A | Lens Fit - Lens Push-up Tightness | 51 units on a scale | Standard Deviation 5 |
Secondary
Lens Fit - Lens Push-up Tightness
The lens push-up tightness was graded using a 0 - 100 scale (5% steps) where 0% = falls from cornea without lid support, 50% = optimum and 100% = no movement
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Somofilcon A | Lens Fit - Lens Push-up Tightness | 50 units on a scale | Standard Deviation 4 |
| Verofilcon A | Lens Fit - Lens Push-up Tightness | 49 units on a scale | Standard Deviation 5 |
Secondary
Lens Fit - Post-blink Movement
Post-blink lens movement was measured using an eyepiece reticule while viewing the contact lens in vivo at 8x magnification in primary gaze, in 0.1mm steps
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Somofilcon A | Lens Fit - Post-blink Movement | 0.2 mm | Standard Deviation 0.1 |
| Verofilcon A | Lens Fit - Post-blink Movement | 0.2 mm | Standard Deviation 0.1 |
Secondary
Lens Fit - Post-blink Movement
Post-blink lens movement was measured using an eyepiece reticule while viewing the contact lens in vivo at 8x magnification in primary gaze, in 0.1mm steps
Time frame: 1-week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Somofilcon A | Lens Fit - Post-blink Movement | 0.2 mm | Standard Deviation 0.1 |
| Verofilcon A | Lens Fit - Post-blink Movement | 0.2 mm | Standard Deviation 0.1 |