Myopia
Conditions
Brief summary
The purpose of this study is to evaluate the performance of the investigational CooperVision silicone hydrogel lens compared to a currently-marketed silicone hydrogel contact lens up to 30 days of daily lens wear.
Interventions
DEVICEsenfilcon A contact lens
senofilcon A spherical contact lens worn in a daily wear modality
DEVICEinvestigational enfilcon A
investigational enfilcon A, worn daily wear modality
Sponsors
CooperVision, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Be at least 18 years of age as of the date of evaluation for the study. 2. Not using any ocular medications 3. Have a self-reported full eye examination within 2 years. 4. Have: * read the Informed Consent * be given an explanation of the Informed Consent * indicate understanding of the Informed Consent * signed the Informed Consent document. 5. Be willing and able to adhere to the instructions set forth in this protocol and able to keep all specified appointments. 6. Be an adapted, current full-time silicone hydrogel or soft contact lens wearer. An adapted full-time wearer is defined as wearing contact lenses on a daily basis for at least 8 hours per day for at least one month prior to participation in the study. 7. Possess wearable and visually functional eyeglasses. 8. Be in good general health, based on his/her knowledge. 9. Require spectacle lens powers between -1.00 and -6.00 diopters sphere with no more than 0.75 diopter of refractive astigmatism in order to have the best spherical equivalent power of -6.50 or less. 10. Be willing to wear contact lenses in both eyes. 11. Have manifest refraction Snellen visual acuities (VA) equal to or better than 20/25 (less than or equal to LogMAR 0.10) in each eye. 12. Upon completing the fitting process with the lenses to be worn in the study, have contact lens Snellen VA equal to or better than 20/30 in each eye.
Exclusion criteria
1. Wearing lenses in a monovision modality and is unwilling to be fit with distance lenses in both eyes. NOTE: Subjects may not wear lenses in a monovision modality at any time during the study as it will interfere with the visual acuity analysis. 2. Any active participation in another one-day clinical trial within 7 days prior to this study or another dispensing trial within 30 days prior to this study. 3. Currently pregnant (to the best of the subject's knowledge), is lactating or is planning a pregnancy within the next month. 4. Has a known sensitivity to ingredients used in the over the counter contact lens care approved for use in the study. 5. Previous refractive surgery/anterior segment surgery; or current or previous orthokeratology treatment or irregular cornea. 6. Is aphakic or pseudophakic. 7. Unable to achieve a satisfactory fit with the lens designs used in the study 8. Ocular or systemic disease such as, but not limited to: anterior uveitis or iritis (past or present), glaucoma, Sjögren's syndrome, lupus erythematosus, sclerodermia, keratoconus or type II diabetes. 9. The need for topical ocular medications or any medication which might contradict contact lens wear or which would require the lenses to be removed during the day. 10. The presence of clinically anterior segment infection, inflammations or abnormalities; such as iritis; or any infection of the eye, lids, or associated structures. 11. A history of herpetic keratitis. 12. A known history of corneal hypoesthesia (reduced corneal sensitivity) or active corneal ulcer, corneal infiltrates or fungal infection. 13. A history of papillary conjunctivitis that has interfered with contact lens wear. 14. Slit lamp findings that would contraindicate contact lens wear, including but not limited to: * Pathological dry eye or associated dry eye symptoms with decreased tear levels and punctuate staining \> grade 2 * Pterygium * Corneal scars within the visual axis * Corneal edema or corneal staining ≥ grade 2 * Neovascularization or ghost vessels \> 1.0 mm in from the limbus * Giant papillary conjunctivitis (GPC) of \> grade 2. * Seborrheic eczema, seborrheic conjunctivitis or blepharitis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subjective Comfort Preference - Participants Preference Response | V1 (Initial), V2 (Day-7), V3 (Day-14), V4 (Day-30) | Subjective responses of participants administered by questionnaire and measured on a linear scale (0-100) measured at each visit. |
| Ocular Health | Change from baseline over 30 days measured at V1 (Initial), V2 (Day-7), V3 (Day-14), V4 (Day-30) | Ocular health determined by biomicroscopy recorded on a severity scale (0-4) for change from baseline over 30 days. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Investigator Surface Preference | V1 (Initial), V2 (Day-7), V3 (Day-14), V4 (Day-30) | Investigator Surface Preference rated on a linear scale (Lens assessment biomicroscopy: 1=strong R, 2=slight R, 3=No Pref, 4=slight L, 5=strong L) |
| Investigator Fit Preference | V1 (Initial), V2 (Day-7), V3 (Day-14), V4 (Day-30) | Investigator Fit Preference rated on a linear scale (Lens assessment biomicroscopy: 1=strong R, 2=slight R, 3=No Pref, 4=slight L, 5=strong L) |
Countries
United Kingdom, United States
Participant flow
Recruitment details
28 recruited, 4 disqualified due to significant anterior ocular health findings, 4 passed screening and scheduled for lense fit/dispense when study discontinued.
Participants by arm
| Arm | Count |
|---|---|
| Overall Study Group Participants wear one enfilcon A (test) contact lens in one eye and one senofilcon A (comparator) contact lens in the other. Both lenses are worn daily wear. | 20 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 3 |
| Overall Study | exited w/o incident /study discontinued | 17 |
Baseline characteristics
| Characteristic | Overall Study Group |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants |
| Age, Continuous | 23 Years STANDARD_DEVIATION 3 |
| Sex: Female, Male Female | 16 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 3 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
Ocular Health
Ocular health determined by biomicroscopy recorded on a severity scale (0-4) for change from baseline over 30 days.
Time frame: Change from baseline over 30 days measured at V1 (Initial), V2 (Day-7), V3 (Day-14), V4 (Day-30)
Population: Not all subjects completed the study measures at each outcome measurement time frame before the study was terminated. 20 participants completed V1 and only 1 participant completed the V2 follow-up. Change from baseline V1 over 30 days V4 cannot be analyzed.
Primary
Subjective Comfort Preference - Participants Preference Response
Subjective responses of participants administered by questionnaire and measured on a linear scale (0-100) measured at each visit.
Time frame: V1 (Initial), V2 (Day-7), V3 (Day-14), V4 (Day-30)
Population: Not all subjects completed the study measures at each outcome measurement time frame before the study was terminated. 20 participants completed V1 and only 1 participant completed the V2 follow-up. V3 and V4 cannot be analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Enfilcon A + Senofilcon A | Subjective Comfort Preference - Participants Preference Response | Preferred Test lens Visit 1 | 7 participants |
| Enfilcon A + Senofilcon A | Subjective Comfort Preference - Participants Preference Response | No Preference Visit 1 | 8 participants |
| Enfilcon A + Senofilcon A | Subjective Comfort Preference - Participants Preference Response | Preferred Control Lens Visit 1 | 5 participants |
| Enfilcon A + Senofilcon A | Subjective Comfort Preference - Participants Preference Response | Preferred Test lens Visit 2 | 0 participants |
| Enfilcon A + Senofilcon A | Subjective Comfort Preference - Participants Preference Response | No Preference Visit 2 | 1 participants |
| Enfilcon A + Senofilcon A | Subjective Comfort Preference - Participants Preference Response | Preferred Control lens Visit 2 | 0 participants |
Secondary
Investigator Fit Preference
Investigator Fit Preference rated on a linear scale (Lens assessment biomicroscopy: 1=strong R, 2=slight R, 3=No Pref, 4=slight L, 5=strong L)
Time frame: V1 (Initial), V2 (Day-7), V3 (Day-14), V4 (Day-30)
Population: Not all subjects completed the study measures at each outcome measurement time frame before the study was terminated. 20 participants completed V1 and only 1 participant completed the V2 follow-up. V3 and V4 cannot be analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Enfilcon A + Senofilcon A | Investigator Fit Preference | Preferred Control Lens V2 | 0 participants |
| Enfilcon A + Senofilcon A | Investigator Fit Preference | Preferred Test Lens V1 | 7 participants |
| Enfilcon A + Senofilcon A | Investigator Fit Preference | No Preference V1 | 10 participants |
| Enfilcon A + Senofilcon A | Investigator Fit Preference | Preferred Control Lens V1 | 3 participants |
| Enfilcon A + Senofilcon A | Investigator Fit Preference | Preferred Test Lens V2 | 1 participants |
| Enfilcon A + Senofilcon A | Investigator Fit Preference | No Preference V2 | 0 participants |
Secondary
Investigator Surface Preference
Investigator Surface Preference rated on a linear scale (Lens assessment biomicroscopy: 1=strong R, 2=slight R, 3=No Pref, 4=slight L, 5=strong L)
Time frame: V1 (Initial), V2 (Day-7), V3 (Day-14), V4 (Day-30)
Population: Not all subjects completed the study measures at each outcome measurement time frame before the study was terminated. 20 participants completed V1 and only 1 participant completed the V2 follow-up. V3 and V4 cannot be analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Enfilcon A + Senofilcon A | Investigator Surface Preference | Preferred Test Lens V1 | 6 participants |
| Enfilcon A + Senofilcon A | Investigator Surface Preference | No Preference V1 | 5 participants |
| Enfilcon A + Senofilcon A | Investigator Surface Preference | Preferred Control Lens V1 | 9 participants |
| Enfilcon A + Senofilcon A | Investigator Surface Preference | Preferred Test Lens V2 | 0 participants |
| Enfilcon A + Senofilcon A | Investigator Surface Preference | No Preference V2 | 1 participants |
| Enfilcon A + Senofilcon A | Investigator Surface Preference | Preferred Control Lens V2 | 0 participants |