Myopia
Conditions
Brief summary
The purpose of this study is to investigate the overall clinical performance of the somofilcon A daily disposable test soft contact lens compared to the somofilcon A daily disposable control soft contact lens.
Detailed description
The purpose of this study is to evaluate the clinical performance of an investigational silicone-hydrogel contact lens (test) against a marketed silicone-hydrogel contact lens (control) when worn on a daily disposable wear modality over 1 week (for each lens) in a randomized, bilateral, cross-over, dispensing study.
Interventions
DEVICEsomofilcon A 1 day test lens
Contact lens
DEVICEsomofilcon A 1 day control lens
Contact lens
Sponsors
CooperVision, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Both the participants and study investigators will be masked to the randomization schedule of the contact lenses used.
Intervention model description
This will be a, prospective, double-masked, randomized, bilateral, 1 week cross-over, dispensing study
Eligibility
Sex/Gender
ALL
Age
17 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Is at least 17 years of age and has full legal capacity to volunteer; * Has had a self-reported oculo-visual examination in the last two years; * Has read, understood, and signed the information consent letter; * Is willing and able to follow instructions and maintain the appointment schedule; * Has a visual acuity of 20/30 or better (in each eye) with their habitual vision correction, or 20/20 best-corrected vision (for binocular distance acuity); * Must be able to achieve 20/30 or better (in each eye) with the study lenses; * Currently wears soft contact lenses for at least 3 days per week, 8 hours each day; * Requires spectacle lens powers between -0.75 and -06.50 diopters sphere (0.25D steps); * Has no more than 0.75 diopters of refractive astigmatism; * Has clear corneas and no active\* ocular disease; * Has not worn lenses for at least 12 hours before the examination.
Exclusion criteria
* Is presently participating in any other clinical or research study including eye related clinical or research study; * Has never worn contact lenses before. * Has any systemic disease affecting ocular health. * Has any active\* ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of contact lenses. * Is using any systemic or topical medications that will affect a study outcome variable, and/or ocular health. * Has any known sensitivity to fluorescein dye or products to be used in the study. * Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye. * Has any clinically significant lid or conjunctival abnormalities, active neovascularization or any central corneal scars. * Is aphakic. * Has undergone corneal refractive surgery. * Is pregnant, lactating, or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comfort | up to 1 week | Subjective comfort scored 0-100 (0=Cannot be worn, 100=Cannot be felt ever) |
| Preference | up to 1 week | Overall lens that subject prefers or no preference |
| Vision | Up to 1 week | Visual acuity measured in logMAR |
| Subjective Vision | up to 1 week | Subjective vision scored 0-100 (0=Extremely poor, 100=Excellent vision all the time) |
| Corneal Staining | up to 1 week | Amount of staining observed on the cornea scored 0-4 (0=none, 4=severe) in 0.25 steps |
| Conjunctival Staining | up to 1 week | Amount of staining observed on the conjunctiva scored 0-4 (0=none, 4=severe) in 0.25 steps |
Countries
Canada
Participant flow
Pre-assignment details
Three (3) subjects did not meet inclusion criteria and were excluded from the analysis. One subject was enrolled and later discontinued.
Participants by arm
| Arm | Count |
|---|---|
| Somofilcon A 1 Day Test vs Control Contact Lens Each subjects randomized to wear either the test or control as a matched pair and cross over to second matched pair.
somofilcon A 1 day test lens: Test / Contact lens
somofilcon A 1 day control lens: Test / Contact lens | 32 |
| Total | 32 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| First Intervention (1 Week) | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Somofilcon A 1 Day Test vs Control Contact Lens |
|---|---|
| Age, Categorical <=18 years | 1 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 31 Participants |
| Age, Continuous | 26 years STANDARD_DEVIATION 9 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 32 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment Canada | 32 participants |
| Sex: Female, Male Female | 29 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 32 | 0 / 32 |
| other Total, other adverse events | 0 / 32 | 0 / 32 |
| serious Total, serious adverse events | 0 / 32 | 0 / 32 |
Outcome results
Primary
Comfort
Subjective comfort scored 0-100 (0=Cannot be worn, 100=Cannot be felt ever)
Time frame: up to 1 week
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Somofilcon A 1 Day Test Lens | Comfort | Comfort at Insertion after 1 week | 86 score on a scale | Standard Deviation 11 |
| Somofilcon A 1 Day Test Lens | Comfort | Comfort end day after 1 week | 75 score on a scale | Standard Deviation 15 |
| Somofilcon A 1 Day Test Lens | Comfort | Comfort during day after 1 week | 84 score on a scale | Standard Deviation 11 |
| Somofilcon A 1 Day Test Lens | Comfort | Overall comfort after 1 week of lens wear | 82 score on a scale | Standard Deviation 11 |
| Somofilcon A 1 Day Test Lens | Comfort | Comfort at Dispense | 90 score on a scale | Standard Deviation 8 |
| Somofilcon A 1 Day Control Lens | Comfort | Overall comfort after 1 week of lens wear | 85 score on a scale | Standard Deviation 12 |
| Somofilcon A 1 Day Control Lens | Comfort | Comfort at Dispense | 89 score on a scale | Standard Deviation 11 |
| Somofilcon A 1 Day Control Lens | Comfort | Comfort at Insertion after 1 week | 87 score on a scale | Standard Deviation 16 |
| Somofilcon A 1 Day Control Lens | Comfort | Comfort during day after 1 week | 86 score on a scale | Standard Deviation 11 |
| Somofilcon A 1 Day Control Lens | Comfort | Comfort end day after 1 week | 78 score on a scale | Standard Deviation 16 |
Primary
Conjunctival Staining
Amount of staining observed on the conjunctiva scored 0-4 (0=none, 4=severe) in 0.25 steps
Time frame: up to 1 week
Population: Baseline n=32 participants / 64 eyes, 1 week n= 31 participants / 62 eyes due to non-serious adverse event participant's measurements weren't completed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Somofilcon A 1 Day Test Lens | Conjunctival Staining | 1 week | 0.72 score on a scale | Standard Deviation 0.57 |
| Somofilcon A 1 Day Test Lens | Conjunctival Staining | Baseline | 0.20 score on a scale | Standard Deviation 0.25 |
| Somofilcon A 1 Day Control Lens | Conjunctival Staining | 1 week | 0.91 score on a scale | Standard Deviation 0.71 |
| Somofilcon A 1 Day Control Lens | Conjunctival Staining | Baseline | 0.20 score on a scale | Standard Deviation 0.25 |
Primary
Corneal Staining
Amount of staining observed on the cornea scored 0-4 (0=none, 4=severe) in 0.25 steps
Time frame: up to 1 week
Population: Baseline n=32 participants / 64 eyes, 1 week n = 31 participants / 62 eyes due to non-serious adverse event participant's measurements weren't completed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Somofilcon A 1 Day Test Lens | Corneal Staining | Baseline | 0.16 score on a scale | Standard Deviation 0.25 |
| Somofilcon A 1 Day Test Lens | Corneal Staining | 1 week | 0.20 score on a scale | Standard Deviation 0.26 |
| Somofilcon A 1 Day Control Lens | Corneal Staining | Baseline | 0.16 score on a scale | Standard Deviation 0.25 |
| Somofilcon A 1 Day Control Lens | Corneal Staining | 1 week | 0.18 score on a scale | Standard Deviation 0.42 |
Primary
Preference
Overall lens that subject prefers or no preference
Time frame: up to 1 week
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Somofilcon A 1 Day Test Lens | Preference | Strongly preferred somofilcon A 1 Day Test lens | 5 Participants |
| Somofilcon A 1 Day Test Lens | Preference | Slightly preferred somofilcon A 1 Day Test lens | 9 Participants |
| Somofilcon A 1 Day Test Lens | Preference | Strongly preferred somofilcon A 1 Day control lens | 12 Participants |
| Somofilcon A 1 Day Test Lens | Preference | No preference | 1 Participants |
| Somofilcon A 1 Day Test Lens | Preference | Slightly preferred somofilcon A 1 Day Control lens | 5 Participants |
Primary
Subjective Vision
Subjective vision scored 0-100 (0=Extremely poor, 100=Excellent vision all the time)
Time frame: up to 1 week
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Somofilcon A 1 Day Test Lens | Subjective Vision | 1 week | 88 score on a scale | Standard Deviation 12 |
| Somofilcon A 1 Day Test Lens | Subjective Vision | Dispense | 92 score on a scale | Standard Deviation 9 |
| Somofilcon A 1 Day Control Lens | Subjective Vision | Dispense | 92 score on a scale | Standard Deviation 6 |
| Somofilcon A 1 Day Control Lens | Subjective Vision | 1 week | 91 score on a scale | Standard Deviation 11 |
Primary
Vision
Visual acuity measured in logMAR
Time frame: Up to 1 week
Population: Dispensing - n=32 participants total, 1 week = 31 participants total due to a nonserious adverse events for somofilcon A 1 day test lens.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Somofilcon A 1 Day Test Lens | Vision | High Illumination high contrast monocular | -0.10 Log(MAR) | Standard Deviation 0.07 |
| Somofilcon A 1 Day Test Lens | Vision | High Illumination high contrast binocular | -0.15 Log(MAR) | Standard Deviation 0.06 |
| Somofilcon A 1 Day Test Lens | Vision | Low Illumination high contrast monocular | -0.08 Log(MAR) | Standard Deviation 0.05 |
| Somofilcon A 1 Day Test Lens | Vision | Low Illumination high contrast binocular | -0.13 Log(MAR) | Standard Deviation 0.06 |
| Somofilcon A 1 Day Control Lens | Vision | High Illumination high contrast binocular | -0.15 Log(MAR) | Standard Deviation 0.07 |
| Somofilcon A 1 Day Control Lens | Vision | Low Illumination high contrast monocular | -0.07 Log(MAR) | Standard Deviation 0.07 |
| Somofilcon A 1 Day Control Lens | Vision | Low Illumination high contrast binocular | -0.13 Log(MAR) | Standard Deviation 0.07 |
| Somofilcon A 1 Day Control Lens | Vision | High Illumination high contrast monocular | -0.10 Log(MAR) | Standard Deviation 0.07 |
| Somofilcon A 1 Day Control Lens Dispense | Vision | Low Illumination high contrast monocular | -0.09 Log(MAR) | Standard Deviation 0.07 |
| Somofilcon A 1 Day Control Lens Dispense | Vision | High Illumination high contrast binocular | -0.15 Log(MAR) | Standard Deviation 0.06 |
| Somofilcon A 1 Day Control Lens Dispense | Vision | Low Illumination high contrast binocular | -0.13 Log(MAR) | Standard Deviation 0.06 |
| Somofilcon A 1 Day Control Lens Dispense | Vision | High Illumination high contrast monocular | -0.11 Log(MAR) | Standard Deviation 0.07 |
| Somofilcon A 1 Day Control Lens 1 Week | Vision | Low Illumination high contrast binocular | -0.14 Log(MAR) | Standard Deviation 0.05 |
| Somofilcon A 1 Day Control Lens 1 Week | Vision | High Illumination high contrast binocular | -0.16 Log(MAR) | Standard Deviation 0.06 |
| Somofilcon A 1 Day Control Lens 1 Week | Vision | High Illumination high contrast monocular | -0.11 Log(MAR) | Standard Deviation 0.06 |
| Somofilcon A 1 Day Control Lens 1 Week | Vision | Low Illumination high contrast monocular | -0.10 Log(MAR) | Standard Deviation 0.06 |