Myopia
Conditions
Brief summary
This is a prospective, multi-center, subject-masked, bilateral wear, one month dispensing study comparing the clinical performance of the subjects' habitual comfilcon A sphere lens (control) following a refit with comfilcon A asphere lens (test). After the dispensing visit, subjects will return for follow-up evaluations after 2 weeks, and 1 month.
Detailed description
This is a prospective, multi-center, subject-masked, bilateral wear, one month dispensing study comparing the clinical performance of the subjects' habitual comfilcon A sphere lens (control) following a refit with comfilcon A asphere lens (test). After the dispensing visit, subjects will return for follow-up evaluations after 2 weeks, and 1 month. Both comfilcon A sphere lens (control) and comfilcon A asphere lens (test) are Coopervison lenses.
Interventions
DEVICEcomfilcon A sphere lens (control)
contact lens
DEVICEcomfilcon A asphere lens (test)
contact lens
Sponsors
CooperVision, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 34 Years
Healthy volunteers
Yes
Inclusion criteria
A person is eligible for inclusion in the study if he/she: * Is between 18 and 34 years of age (inclusive) * Has had a self-reported eye exam in the last two years * Is an adapted comfilcon A sphere contact lens wearer * Uses digital devices, (e.g. computer, tablet, smart phone, iPad), for more than 4 hours a day, 5 days a week. * Has a contact lens spherical prescription between -1.00 to -6.00 (inclusive) * Has a spectacle cylinder no greater than 0.75D (Diopters) in each eye. * Can achieve best corrected spectacle distance visual acuity of 20/25 (0.10 logMAR) or better in each eye. * Can achieve a distance visual acuity of 20/30 (0.18 logMAR) or better in each eye with the study contact lenses. * Has clear corneas and no active ocular disease * Has read, understood and signed the information consent letter. * Has a contact lens refraction that fits within the available parameters of the study lenses. * Is willing to comply with the wear schedule (at least 5 days per week, \> 8 hours/day assuming there are no contraindications for doing so). * Is willing to comply with the visit schedule
Exclusion criteria
A person will be excluded from the study if he/she: * Has a history of not achieving comfortable CL (Contact Lens) wear (5 days per week; \> 8 hours/day) * Presents with clinically significant anterior segment abnormalities * Presents with ocular or systemic disease or need of medications which might interfere with contact lens wear. * Presents with slit lamp findings that would contraindicate contact lens wear such as: * Pathological dry eye or associated findings * Significant pterygium, pinguecula, or corneal scars within the visual axis * Neovascularization \> 0.75 mm in from of the limbus * Giant papillary conjunctivitis (GCP) worse than grade 1 * Anterior uveitis or iritis (or history in past year) * Seborrheic eczema of eyelid region, Seborrheic conjunctivitis * History of corneal ulcers or fungal infections * Poor personal hygiene * Has a known history of corneal hypoesthesia (reduced corneal sensitivity) * Has aphakia, keratoconus or a highly irregular cornea. * Has presbyopia or has dependence on spectacles for near work over the contact lenses. * Has undergone corneal refractive surgery. * Is participating in any other type of eye related clinical or research study. * Is habitually using rewetting/ lubricating eye drops (more than once per day)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lens Fit - Centration | baseline, 2 weeks, 1 month | Lens fit evaluation of centration for comfilcon A sphere and comfilcon A asphere lens. (Scale: optimum, decentration acceptable and decentration unacceptable). |
| Lens Fit - Corneal Coverage | baseline, 2 weeks, 1 month | Lens fit evaluation of corneal coverage for comfilcon A sphere and comfilcon A asphere lens. ('yes' - full coverage, or 'no' - incomplete corneal coverage). |
| Lens Fit - Post-blink Movement | baseline, 2 weeks, 1 month | Lens fit evaluation of post-blink movement for comfilcon A sphere and comfilcon A asphere lens. (Scale 0-4, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement). |
| Lens Preference/Acceptability | baseline, 2 weeks, 1 month | Investigators preference/acceptability for comfilcon A sphere and comfilcon A asphere lenses. (Choices: strongly prefer study lenses, slightly prefer study lenses, slightly prefer habitual lenses, strongly prefer habitual lenses). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Comfilcon A Sphere (Control) and Comfilcon A Asphere (Test) Habitual wearers of comfilcon A sphere lens (control) are refitted with comfilcon A asphere lens (test).
comfilcon A sphere lens (control): contact lens
comfilcon A asphere lens (test): contact lens | 54 |
| Total | 54 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | discomfort | 2 |
Baseline characteristics
| Characteristic | Comfilcon A Sphere (Control) and Comfilcon A Asphere (Test) |
|---|---|
| Age, Continuous | 26 years |
| Sex: Female, Male Female | 35 Participants |
| Sex: Female, Male Male | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 52 |
| serious Total, serious adverse events | 0 / 52 |
Outcome results
Primary
Lens Fit - Centration
Lens fit evaluation of centration for comfilcon A sphere and comfilcon A asphere lens. (Scale: optimum, decentration acceptable and decentration unacceptable).
Time frame: baseline, 2 weeks, 1 month
Population: One participants data for both the 2 week and 1 month visit was not included due to participant protocol deviation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Comfilcon A Sphere (Control) | Lens Fit - Centration | Baseline, Acceptable | 4 participants |
| Comfilcon A Sphere (Control) | Lens Fit - Centration | At 2 weeks, unacceptable | NA participants |
| Comfilcon A Sphere (Control) | Lens Fit - Centration | At 2 weeks, optimum | NA participants |
| Comfilcon A Sphere (Control) | Lens Fit - Centration | At 1 month, optimum | NA participants |
| Comfilcon A Sphere (Control) | Lens Fit - Centration | Baseline, Unacceptable | 0 participants |
| Comfilcon A Sphere (Control) | Lens Fit - Centration | At 1 month, acceptable | NA participants |
| Comfilcon A Sphere (Control) | Lens Fit - Centration | At 2 weeks, acceptable | NA participants |
| Comfilcon A Sphere (Control) | Lens Fit - Centration | At 1 month, unacceptable | NA participants |
| Comfilcon A Sphere (Control) | Lens Fit - Centration | Baseline, Optimum | 48 participants |
| Comfilcon A Asphere (Test) | Lens Fit - Centration | At 1 month, unacceptable | 0 participants |
| Comfilcon A Asphere (Test) | Lens Fit - Centration | Baseline, Optimum | 46 participants |
| Comfilcon A Asphere (Test) | Lens Fit - Centration | Baseline, Acceptable | 6 participants |
| Comfilcon A Asphere (Test) | Lens Fit - Centration | Baseline, Unacceptable | 0 participants |
| Comfilcon A Asphere (Test) | Lens Fit - Centration | At 2 weeks, optimum | 45 participants |
| Comfilcon A Asphere (Test) | Lens Fit - Centration | At 2 weeks, acceptable | 6 participants |
| Comfilcon A Asphere (Test) | Lens Fit - Centration | At 2 weeks, unacceptable | 0 participants |
| Comfilcon A Asphere (Test) | Lens Fit - Centration | At 1 month, optimum | 46 participants |
| Comfilcon A Asphere (Test) | Lens Fit - Centration | At 1 month, acceptable | 5 participants |
Primary
Lens Fit - Corneal Coverage
Lens fit evaluation of corneal coverage for comfilcon A sphere and comfilcon A asphere lens. ('yes' - full coverage, or 'no' - incomplete corneal coverage).
Time frame: baseline, 2 weeks, 1 month
Population: One participants data for both the 2 week and 1 month visit was not included due to participant protocol deviation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Comfilcon A Sphere (Control) | Lens Fit - Corneal Coverage | Baseline, yes | 52 participants |
| Comfilcon A Sphere (Control) | Lens Fit - Corneal Coverage | 2 weeks, yes | 51 participants |
| Comfilcon A Sphere (Control) | Lens Fit - Corneal Coverage | 1 month, yes | 51 participants |
| Comfilcon A Asphere (Test) | Lens Fit - Corneal Coverage | Baseline, yes | 52 participants |
| Comfilcon A Asphere (Test) | Lens Fit - Corneal Coverage | 2 weeks, yes | 51 participants |
| Comfilcon A Asphere (Test) | Lens Fit - Corneal Coverage | 1 month, yes | 51 participants |
Primary
Lens Fit - Post-blink Movement
Lens fit evaluation of post-blink movement for comfilcon A sphere and comfilcon A asphere lens. (Scale 0-4, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement).
Time frame: baseline, 2 weeks, 1 month
Population: One participants data for both the 2 week and 1 month visit was not included due to participant protocol deviation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Comfilcon A Sphere (Control) | Lens Fit - Post-blink Movement | After 1 month | NA units on a scale | — |
| Comfilcon A Sphere (Control) | Lens Fit - Post-blink Movement | Baseline | 1.9 units on a scale | Standard Deviation 0.6 |
| Comfilcon A Sphere (Control) | Lens Fit - Post-blink Movement | After 2 weeks | NA units on a scale | — |
| Comfilcon A Asphere (Test) | Lens Fit - Post-blink Movement | After 1 month | 1.9 units on a scale | Standard Deviation 0.5 |
| Comfilcon A Asphere (Test) | Lens Fit - Post-blink Movement | Baseline | 1.9 units on a scale | Standard Deviation 0.3 |
| Comfilcon A Asphere (Test) | Lens Fit - Post-blink Movement | After 2 weeks | 1.9 units on a scale | Standard Deviation 0.4 |
Primary
Lens Preference/Acceptability
Investigators preference/acceptability for comfilcon A sphere and comfilcon A asphere lenses. (Choices: strongly prefer study lenses, slightly prefer study lenses, slightly prefer habitual lenses, strongly prefer habitual lenses).
Time frame: baseline, 2 weeks, 1 month
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Comfilcon A Sphere (Control) | Lens Preference/Acceptability | Strongly prefer comfilcon A asphere | 5 participants |
| Comfilcon A Sphere (Control) | Lens Preference/Acceptability | Slightly prefer comfilcon A asphere | 39 participants |
| Comfilcon A Sphere (Control) | Lens Preference/Acceptability | Strongly prefer comfilcon A sphere | 8 participants |
| Comfilcon A Sphere (Control) | Lens Preference/Acceptability | Slightly prefer comfilcon A sphere | 0 participants |