Ametropia
Conditions
Brief summary
The primary objective of thes study is to confirm that the ocular response to the Test lenses are similar to those of the Control lenses when used in a 1 week planned replacement, daily wear modality over a 1-month period.
Detailed description
The test lens and control lens were randomized in a 2:1 ratio to evaluate the test lens and control contact lens.
Interventions
DEVICEenfilcon A
DEVICEgalyfilcon A
Sponsors
CooperVision, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Prior to being considered eligible to participate in this study, each subject MUST: * Be at least 18 years of age as of the date of evaluation for the study. * Have read the Informed Consent, been given an explanation of the Informed Consent, indicated understanding of the Informed Consent, signed the Informed Consent document. * Be willing and able to adhere to the instructions set forth in this protocol and able to keep all specified appointments. * Be an adapted, current full-time silicone hydrogel or soft contact lens wearer. An adapted full-time wearer is defined as wearing contact lenses in both eyes on a daily basis for at least 8 hours per day for at least one month prior to participation in the study. * Possess wearable and visually functional eyeglasses. * Be in good general health, based on his/her knowledge. * Require spectacle lens powers between -1.00 and -6.00 diopters sphere with no more than 2.00 diopters of refractive astigmatism and be willing to wear contact lenses in both eyes. * Have: manifest refraction Snellen visual acuities (VA) equal to or better than 20/25 in each eye. * 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
Subjects may not be enrolled in this study if any of the following apply: The subject is/has: * 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. * Poor personal hygiene. * Any active participation in another clinical trial within 30 days prior to this study. * Currently pregnant (to the best of the subject's knowledge), is lactating or is planning a pregnancy within the study period. * A member, relative or household member of the investigator or of the investigational office staff. * Has a known sensitivity to ingredients used in the care products approved for use in the study. * Previous refractive surgery; or current or previous orthokeratology treatment. * Is aphakic or psuedophakic. * 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. * The need for topical ocular medications or any medication which might interfere with contact lens wear or which would require the lenses to be removed during the day. * The presence of clinically significant (grade 3 or 4) anterior segment abnormalities. * Any; inflammations such as iritis; or any infection or allergic reaction of the eye, lids, or associated structures. * A known history of corneal hypoesthesia (reduced corneal sensitivity), corneal ulcer, corneal infiltrates or fungal infections. * A history of papillary conjunctivitis that has interfered with contact lens wear. * 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, Neovascularization or ghost vessels \> 1.0 mm in from the limbus, Giant papillary conjunctivitis (GPC) of \> Grade 1, Anterior uveitis or iritis, Seborrheic eczema, seborrheic conjunctivitis or blepharitis To be eligible to be randomized for study product a subject must have ALL of the Inclusion Criteria and have NONE of the
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective Assessment: Ocular Response - Biomicroscopy | Change from baseline/dispensing visits, post-dispensing visit and all follow-ups visits | The primary safety endpoint are the objective slit lamp findings associated with the enfilcon A contact lenses compared with those same findings reported as associated with the galyfilcon A contact lenses. The incidence of biomicroscopy findings (0=not present, 4=severe) over the duration of the study with the highest reported grade was chosen for each unique eye. Biomicroscopy measurements were obtained at Baseline/Dispensing (baseline and dispensing visit combined), Post-Dispensing (after lenses were dispensed and allowed to settle) and All Follow-Ups (week 1 visit, week 2 visit, month 1 visit combined). The average grade for unique eyes with findings greater than 0 (none) is compared. |
| Comparison of Objective Findings - Number of Adverse Events in Unique Eyes | Any occurrence from baseline to 1 month visit | The primary safety endpoint are the objective findings of the number of adverse events in unique eyes associated with the enfilcon A contact lenses compared with those same findings as associated with the galyfilcon A contact lenses. The number of adverse events over the duration of the study was reported for each unique eye (bilateral or unilateral). Observations for adverse events were reported for any occurrence from Baseline through end of month 1 visit. |
Countries
United States
Participant flow
Recruitment details
52 subjects evaluated. Of these 52 subjects, 2 found ineligible and not randomized resulting in 50 subjects randomized, 33 test, 17 control. Of 50 subjects randomized, 2 discontinued and not included in results data, 31 test, 17 control, 1 lost to follow-up, 1 Sponsor/IRB decision due to pregnancy at one month visit.
Participants by arm
| Arm | Count |
|---|---|
| Enfilcon A The test (experimental) lens is a silicone hydrogel contact lens following a daily wear 1 week planned replacement modality. | 33 |
| Galyfilcon A The control (active comparator) lens is a silicone hydrogel contact lens following a daily wear 1 week planned replacement modality. | 17 |
| Total | 50 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Physician Decision | 1 | 0 |
Baseline characteristics
| Characteristic | Galyfilcon A | Enfilcon A | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 17 Participants | 33 Participants | 50 Participants |
| Age, Continuous | 33.8 years STANDARD_DEVIATION 11.5 | 34.8 years STANDARD_DEVIATION 11.11 | 34.4 years STANDARD_DEVIATION 11.13 |
| Region of Enrollment United States | 17 participants | 33 participants | 50 participants |
| Sex: Female, Male Female | 12 Participants | 23 Participants | 35 Participants |
| Sex: Female, Male Male | 5 Participants | 10 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 33 | 0 / 17 |
| other Total, other adverse events | 0 / 33 | 1 / 17 |
| serious Total, serious adverse events | 0 / 33 | 0 / 17 |
Outcome results
Primary
Comparison of Objective Findings - Number of Adverse Events in Unique Eyes
The primary safety endpoint are the objective findings of the number of adverse events in unique eyes associated with the enfilcon A contact lenses compared with those same findings as associated with the galyfilcon A contact lenses. The number of adverse events over the duration of the study was reported for each unique eye (bilateral or unilateral). Observations for adverse events were reported for any occurrence from Baseline through end of month 1 visit.
Time frame: Any occurrence from baseline to 1 month visit
Population: Unique eyes are defined as each individual eye in the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Enfilcon A | Comparison of Objective Findings - Number of Adverse Events in Unique Eyes | 0 number of adverse events |
| Galyfilcon A | Comparison of Objective Findings - Number of Adverse Events in Unique Eyes | 2 number of adverse events |
Primary
Objective Assessment: Ocular Response - Biomicroscopy
The primary safety endpoint are the objective slit lamp findings associated with the enfilcon A contact lenses compared with those same findings reported as associated with the galyfilcon A contact lenses. The incidence of biomicroscopy findings (0=not present, 4=severe) over the duration of the study with the highest reported grade was chosen for each unique eye. Biomicroscopy measurements were obtained at Baseline/Dispensing (baseline and dispensing visit combined), Post-Dispensing (after lenses were dispensed and allowed to settle) and All Follow-Ups (week 1 visit, week 2 visit, month 1 visit combined). The average grade for unique eyes with findings greater than 0 (none) is compared.
Time frame: Change from baseline/dispensing visits, post-dispensing visit and all follow-ups visits
Population: Unique eyes are defined as each individual eye in the study and are only counted once for each of the visit groupings.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Enfilcon A | Objective Assessment: Ocular Response - Biomicroscopy | Stromal Edema, Post-Dispensing | NA units on a scale |
| Enfilcon A | Objective Assessment: Ocular Response - Biomicroscopy | Neovascularization, Post-Dispensing | NA units on a scale |
| Enfilcon A | Objective Assessment: Ocular Response - Biomicroscopy | Limbal Hyperemia, Baseline/Dispensing | 1.07 units on a scale |
| Enfilcon A | Objective Assessment: Ocular Response - Biomicroscopy | Bulbar Hyperemia, All Follow-up | 1.00 units on a scale |
| Enfilcon A | Objective Assessment: Ocular Response - Biomicroscopy | Epithelial Edema, Baseline/Dispensing | 1.00 units on a scale |
| Enfilcon A | Objective Assessment: Ocular Response - Biomicroscopy | Epithelial Edema, Post-Dispensing | NA units on a scale |
| Enfilcon A | Objective Assessment: Ocular Response - Biomicroscopy | Epithelial Edema, All Follow-up | NA units on a scale |
| Enfilcon A | Objective Assessment: Ocular Response - Biomicroscopy | Stromal Edema, Basline/Dispensing | NA units on a scale |
| Enfilcon A | Objective Assessment: Ocular Response - Biomicroscopy | Stromal Edema, All Follow-up | NA units on a scale |
| Enfilcon A | Objective Assessment: Ocular Response - Biomicroscopy | Neovascularization, Baseline/Dispensing | 1.00 units on a scale |
| Enfilcon A | Objective Assessment: Ocular Response - Biomicroscopy | Neovascularization, All Follow-up | 1.00 units on a scale |
| Enfilcon A | Objective Assessment: Ocular Response - Biomicroscopy | Corneal Staining, Baseline/Dispensing | 1.06 units on a scale |
| Enfilcon A | Objective Assessment: Ocular Response - Biomicroscopy | Corneal Staining, Post-Dispensing | 1.00 units on a scale |
| Enfilcon A | Objective Assessment: Ocular Response - Biomicroscopy | Corneal Staining, All Follow-up | 1.02 units on a scale |
| Enfilcon A | Objective Assessment: Ocular Response - Biomicroscopy | Limbal Hyperemia, Post-Dispensing | 1.00 units on a scale |
| Enfilcon A | Objective Assessment: Ocular Response - Biomicroscopy | Limbal Hyperemia, All Follow-up | 1.00 units on a scale |
| Enfilcon A | Objective Assessment: Ocular Response - Biomicroscopy | Bulbar Hyperemia, Baseline/Dispensing | 1.00 units on a scale |
| Enfilcon A | Objective Assessment: Ocular Response - Biomicroscopy | Bulbar Hyperemia, Post-Dispensing | 1.00 units on a scale |
| Enfilcon A | Objective Assessment: Ocular Response - Biomicroscopy | Palpebral Conjunctiva, Baseline/Dispensing | 1.11 units on a scale |
| Enfilcon A | Objective Assessment: Ocular Response - Biomicroscopy | Palpebral Conjunctiva, Post-Dispensing | 1.00 units on a scale |
| Enfilcon A | Objective Assessment: Ocular Response - Biomicroscopy | Palpebral Conjunctiva, All Follow-up | 1.05 units on a scale |
| Galyfilcon A | Objective Assessment: Ocular Response - Biomicroscopy | Corneal Staining, Baseline/Dispensing | 1.08 units on a scale |
| Galyfilcon A | Objective Assessment: Ocular Response - Biomicroscopy | Palpebral Conjunctiva, All Follow-up | 1.16 units on a scale |
| Galyfilcon A | Objective Assessment: Ocular Response - Biomicroscopy | Corneal Staining, Post-Dispensing | 1.00 units on a scale |
| Galyfilcon A | Objective Assessment: Ocular Response - Biomicroscopy | Bulbar Hyperemia, Post-Dispensing | 1.00 units on a scale |
| Galyfilcon A | Objective Assessment: Ocular Response - Biomicroscopy | Corneal Staining, All Follow-up | 1.04 units on a scale |
| Galyfilcon A | Objective Assessment: Ocular Response - Biomicroscopy | Epithelial Edema, Baseline/Dispensing | NA units on a scale |
| Galyfilcon A | Objective Assessment: Ocular Response - Biomicroscopy | Limbal Hyperemia, Baseline/Dispensing | 1.00 units on a scale |
| Galyfilcon A | Objective Assessment: Ocular Response - Biomicroscopy | Epithelial Edema, Post-Dispensing | NA units on a scale |
| Galyfilcon A | Objective Assessment: Ocular Response - Biomicroscopy | Bulbar Hyperemia, All Follow-up | 1.00 units on a scale |
| Galyfilcon A | Objective Assessment: Ocular Response - Biomicroscopy | Epithelial Edema, All Follow-up | NA units on a scale |
| Galyfilcon A | Objective Assessment: Ocular Response - Biomicroscopy | Limbal Hyperemia, Post-Dispensing | 1.00 units on a scale |
| Galyfilcon A | Objective Assessment: Ocular Response - Biomicroscopy | Stromal Edema, Basline/Dispensing | NA units on a scale |
| Galyfilcon A | Objective Assessment: Ocular Response - Biomicroscopy | Stromal Edema, Post-Dispensing | NA units on a scale |
| Galyfilcon A | Objective Assessment: Ocular Response - Biomicroscopy | Palpebral Conjunctiva, Post-Dispensing | 1.14 units on a scale |
| Galyfilcon A | Objective Assessment: Ocular Response - Biomicroscopy | Stromal Edema, All Follow-up | NA units on a scale |
| Galyfilcon A | Objective Assessment: Ocular Response - Biomicroscopy | Limbal Hyperemia, All Follow-up | 1.00 units on a scale |
| Galyfilcon A | Objective Assessment: Ocular Response - Biomicroscopy | Neovascularization, Baseline/Dispensing | 1.00 units on a scale |
| Galyfilcon A | Objective Assessment: Ocular Response - Biomicroscopy | Neovascularization, Post-Dispensing | 1.00 units on a scale |
| Galyfilcon A | Objective Assessment: Ocular Response - Biomicroscopy | Palpebral Conjunctiva, Baseline/Dispensing | 1.12 units on a scale |
| Galyfilcon A | Objective Assessment: Ocular Response - Biomicroscopy | Neovascularization, All Follow-up | 1.00 units on a scale |
| Galyfilcon A | Objective Assessment: Ocular Response - Biomicroscopy | Bulbar Hyperemia, Baseline/Dispensing | 1.00 units on a scale |