Myopia
Conditions
Brief summary
This is a one week 2x2 crossover study comparing delefilcon A with etafilcon A, with a primary hypothesis of comparing the handling of each lens. Additional secondary markers are measured looking at subjective comfort and vision of the lenses.
Interventions
DEVICEdelefilcon A
Daily wear soft contact lens for bilateral distance vision correction use.
DEVICEetafilcon A
Daily wear soft contact lens for bilateral distance vision correction use.
Sponsors
Johnson & Johnson Vision Care, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* The subject must be between 18 and 45 years of age (inclusive) with no presbyopic add. * The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form. This should be recorded on the Case Report Form (CRF). * The subject must be willing to wear the study lenses for at least 8 hours per day, 7 days per week. * The subject must be a current successful soft contact lens wearer in both eyes * The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol. * The subject's subjective refraction must result in a vertex corrected spherical contact lens prescription in the range of -1.00D to -6.00D in each eye. * The subject's refractive astigmatism must be less than or equal to 0.75D in both eyes. * The subject must have best corrected visual acuity of 20/30 (6/9) or better in each eye. * The subject must require a visual correction in both eyes (no monofit or monovision allowed). * The subject must have normal eyes with no evidence of abnormality or disease. For the purposes of this study a normal eye is defined as one having: 1. No amblyopia. 2. No evidence of lid abnormality or infection (including blepharitis/meibomitis). 3. No conjunctival abnormality or infection. 4. No clinically significant slit lamp findings (i.e. stromal edema, vascularization, infiltrates or abnormal opacities). 5. No other active ocular disease.
Exclusion criteria
* Any ocular or systemic allergies or diseases that may interfere with contact lens wear. * Any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear. * Clinically significant (Grade 3 or 4) corneal edema, corneal vascularization, corneal staining, or any other abnormalities of the cornea which would contraindicate contact lens wear. * Clinically significant (Grade 3 or 4) tarsal abnormalities or bulbar injection which might interfere with contact lens wear. * Any ocular infection. * Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear. * Pregnancy or lactation. * No extended wear in the last 3 months. * Diabetes. * Infectious diseases (e.g. hepatitis, tuberculosis) or an immunosuppressive disease (e.g. HIV). * Employee or family member of the staff of the investigational site.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subject Reported Ease of Removal | 6-10 Days | Measured on a 5 point-scale of excellence (excellent, very good, good, fair and poor) per a participant. Outcome is reported as aggregate number of subjects who reported Excellent/Very Good at their 1-week visit. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subject Reported Overall Comfort | 6-10 Days | Measured on a 5 point-scale of excellence (excellent, very good, good, fair and poor) per a participant. Summary is reported as an aggregate of Excellent/Very Good at their 1-week visit. |
| Subject Reported Overall Vision | 6-10 Days | Measured on a 5 point-scale of excellence (excellent, very good, good, fair and poor) per a participant using an aggregate summary of excellent/very good at their 1-week visit. |
| Binocular Snellen Visual Acuity | 6-10 Days | Snellen visual acuity percentage of eyes with a visual acuity of eyesight testing at a 20/20 level or better by eye. |
| Overall Corneal Staining | 6-10 Days | Proportion of subjects that have corneal staining on the 0-4 the NEI/Industry Workshop guidelines scale, measured by eye. Grade 1 or higher is reported as a percentage of total eyes. |
Countries
United States
Participant flow
Pre-assignment details
There were 183 subjects enrolled with 183 subjects randomized.
Participants by arm
| Arm | Count |
|---|---|
| All Subjects All subjects who were enrolled in the study. | 183 |
| Total | 183 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Period 1 | protocol deviation | 1 | 2 |
Baseline characteristics
| Characteristic | All Subjects |
|---|---|
| Age, Continuous | 31.61 years STANDARD_DEVIATION 7.061 |
| Region of Enrollment United States | 183 participants |
| Sex: Female, Male Female | 125 Participants |
| Sex: Female, Male Male | 58 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 90 | 0 / 90 |
| serious Total, serious adverse events | 0 / 90 | 0 / 90 |
Outcome results
Primary
Subject Reported Ease of Removal
Measured on a 5 point-scale of excellence (excellent, very good, good, fair and poor) per a participant. Outcome is reported as aggregate number of subjects who reported Excellent/Very Good at their 1-week visit.
Time frame: 6-10 Days
Population: Subjects analyzed were those who enrolled, randomized, and completed the study per protocol.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Delefilcon A | Subject Reported Ease of Removal | 47.2 percentage of participants |
| Etafilcon A | Subject Reported Ease of Removal | 75.6 percentage of participants |
Secondary
Binocular Snellen Visual Acuity
Snellen visual acuity percentage of eyes with a visual acuity of eyesight testing at a 20/20 level or better by eye.
Time frame: 6-10 Days
Population: Subjects are those who were enrolled, randomized, and completed the study per protocol. Number of subjects is total in sample due to stratification by device and binocular measurement setting only.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Delefilcon A | Binocular Snellen Visual Acuity | 95.0 percentage of eyes |
| Etafilcon A | Binocular Snellen Visual Acuity | 94.7 percentage of eyes |
Secondary
Overall Corneal Staining
Proportion of subjects that have corneal staining on the 0-4 the NEI/Industry Workshop guidelines scale, measured by eye. Grade 1 or higher is reported as a percentage of total eyes.
Time frame: 6-10 Days
Population: Subjects are those who were enrolled, randomized, and completed the study per protocol. Percentage of eyes.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Delefilcon A | Overall Corneal Staining | 19.4 percentage of eyes |
| Etafilcon A | Overall Corneal Staining | 11.9 percentage of eyes |
Secondary
Subject Reported Overall Comfort
Measured on a 5 point-scale of excellence (excellent, very good, good, fair and poor) per a participant. Summary is reported as an aggregate of Excellent/Very Good at their 1-week visit.
Time frame: 6-10 Days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Delefilcon A | Subject Reported Overall Comfort | 71.1 percentage of participants |
| Etafilcon A | Subject Reported Overall Comfort | 61.1 percentage of participants |
Secondary
Subject Reported Overall Vision
Measured on a 5 point-scale of excellence (excellent, very good, good, fair and poor) per a participant using an aggregate summary of excellent/very good at their 1-week visit.
Time frame: 6-10 Days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Delefilcon A | Subject Reported Overall Vision | 76.1 percentage of participants |
| Etafilcon A | Subject Reported Overall Vision | 72.2 percentage of participants |