Myopia
Conditions
Brief summary
This study is intended to show that the investigational contact lens is clinically equivalent to a currently approved contact lens, when worn as single-use on a daily basis.
Interventions
DEVICEnarafilcon B
contact lens
DEVICEetafilcon A
contact lens
Sponsors
Johnson & Johnson Vision Care, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* eyes must be best-corrected to a visual acuity of 20/30 or better in each eye * must be able and willing to wear soft contact lenses on a single use, daily wear basis for the duration of the study * distance spherical contact lens prescription must be within the range available for the study
Exclusion criteria
* systemic diseases which may interfere with contact lens wear * ocular infection or clinically significant ocular disease * any previous intraocular surgery * grade 2 or greater slit lamp findings * currently pregnant or lactating * more than 1.00D of refractive astigmatism in either eye
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Slit Lamp Findings - Corneal Edema | after 1 week of lens wear | Investigators examined subjects using a slit lamp and the following scale: 0=none, 1=trace, 2=mild, 3=moderate, 4=severe. This outcome measures the number of eyes that had corneal edema graded 2 or higher at the 1-week visit. |
| Corneal Edema at Month 1 | after 1 month of lens wear | Number of eyes with corneal edema graded 2 or higher at the 1 month visit. Investigators examined subjects using a slit lamp and the following scale: 0=none, 1=trace, 2=mild, 3=moderate, 4=severe. |
| Slit Lamp Findings - Corneal Neovascularization | after 1 week of lens wear | Investigators examined subjects using a slit lamp and the following scale:0=none, 1=trace, 2=mild, 3=moderate, 4= severe. This outcome measures the number of eyes that had corneal neovascularization graded 2 or higher at the 1-week visit. |
| Average Wear Time | after 1 week of lens wear | — |
| Slit Lamp Findings - Corneal Staining | after 1 week of lens wear | Investigators examined subjects using a slit lamp and the following scale:0=none, 1=trace, 2=mild, 3=moderate, 4= severe. This outcome measures the number of eyes that had corneal staining graded 2 or higher at the 1-week visit. |
| Slit Lamp Findings - Injection | after 1 week of lens wear | Investigators examined subjects using a slit lamp and the following scale:0=none, 1=trace, 2=mild, 3=moderate, 4= severe. This outcome measures the number of eyes that had injection graded 2 or higher at the 1-week visit. |
| Slit Lamp Findings - Tarsal Abnormalities | after 1 week of lens wear | Investigators examined subjects using a slit lamp and the following scale:0=none, 1=trace, 2=mild, 3=moderate, 4= severe. This outcome measures the number of eyes that had tarsal abnormalities graded 2 or higher at the 1-week visit. |
| Slit Lamp Findings - Infiltrates | after 1 week of lens wear | Investigators examined subjects using a slit lamp and recorded the presence or absence of infiltrates. This outcome measures the number of eyes that had infiltrates present at the 1-week visit. |
| Subject Reported Symptoms | after 1 week of lens wear | Number of eyes in which subjects reported lens-related symptoms after 1 week of lens wear. |
| Visual Acuity (VA) | after 1 week | Investigators assessed visual acuity per eye using a Snellen visual acuity chart. This outcome measures the number of eyes, wearing vision correction, that measured visual acuity worse than 20/30 at the 1-week visit. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Narafilcon B single use, daily wear contact lens | 25 |
| Etafilcon A contact lens worn as single use, daily wear | 25 |
| Total | 50 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Protocol Violation | 0 | 1 |
Baseline characteristics
| Characteristic | Narafilcon B | Etafilcon A | Total |
|---|---|---|---|
| Age, Continuous | 29.2 years STANDARD_DEVIATION 8.19 | 29.2 years STANDARD_DEVIATION 8.08 | 29.2 years STANDARD_DEVIATION 8.13 |
| Region of Enrollment United States | 25 participants | 25 participants | 50 participants |
| Sex: Female, Male Female | 17 Participants | 18 Participants | 35 Participants |
| Sex: Female, Male Male | 8 Participants | 7 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 25 | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 | 0 / 25 |
Outcome results
Primary
Average Wear Time
Time frame: after 1 week of lens wear
Population: This analysis includes all participants that completed the study per protocol.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Narafilcon B | Average Wear Time | 13.9 hours per day | Standard Deviation 1.91 |
| Etafilcon A | Average Wear Time | 13.7 hours per day | Standard Deviation 2.41 |
Comparison: The hypothesis is that narafilcon B will not be statistically different from etafilcon A.p-value: 0.6403t-test, 2 sided
Primary
Average Wear Time
Time frame: after 1 month of lens wear
Population: This analysis includes all participants that completed the study per protocol.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Narafilcon B | Average Wear Time | 13.6 hours per day | Standard Deviation 2.33 |
| Etafilcon A | Average Wear Time | 13.8 hours per day | Standard Deviation 2.24 |
Comparison: The hypothesis is that narafilcon B is not statistically different from etafilcon A.p-value: 0.7217t-test, 2 sided
Primary
Corneal Edema at Month 1
Number of eyes with corneal edema graded 2 or higher at the 1 month visit. Investigators examined subjects using a slit lamp and the following scale: 0=none, 1=trace, 2=mild, 3=moderate, 4=severe.
Time frame: after 1 month of lens wear
Population: This analysis includes all participants that completed the study per protocol.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Narafilcon B | Corneal Edema at Month 1 | 0 eyes |
| Etafilcon A | Corneal Edema at Month 1 | 0 eyes |
Primary
Slit Lamp Findings - Corneal Edema
Investigators examined subjects using a slit lamp and the following scale: 0=none, 1=trace, 2=mild, 3=moderate, 4=severe. This outcome measures the number of eyes that had corneal edema graded 2 or higher at the 1-week visit.
Time frame: after 1 week of lens wear
Population: This analysis includes all participants that completed the study per protocol.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Narafilcon B | Slit Lamp Findings - Corneal Edema | 0 eyes |
| Etafilcon A | Slit Lamp Findings - Corneal Edema | 0 eyes |
Primary
Slit Lamp Findings - Corneal Neovascularization
Investigators examined subjects using a slit lamp and the following scale:0=none, 1=trace, 2=mild, 3=moderate, 4= severe. This outcome measures the number of eyes that had corneal neovascularization graded 2 or higher at the 1-week visit.
Time frame: after 1 week of lens wear
Population: This analysis includes all participants that completed the study per protocol.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Narafilcon B | Slit Lamp Findings - Corneal Neovascularization | 0 eyes |
| Etafilcon A | Slit Lamp Findings - Corneal Neovascularization | 0 eyes |
Primary
Slit Lamp Findings - Corneal Neovascularization
Investigators examined subjects using a slit lamp and the following scale:0=none, 1=trace, 2=mild, 3=moderate, 4= severe. This outcome measures the number of eyes that had corneal neovascularization graded 2 or higher at the 1-week visit.
Time frame: after 1 month of lens wear
Population: This analysis includes all participants that completed the study per protocol.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Narafilcon B | Slit Lamp Findings - Corneal Neovascularization | 0 eyes |
| Etafilcon A | Slit Lamp Findings - Corneal Neovascularization | 0 eyes |
Primary
Slit Lamp Findings - Corneal Staining
Investigators examined subjects using a slit lamp and the following scale:0=none, 1=trace, 2=mild, 3=moderate, 4= severe. This outcome measures the number of eyes that had corneal staining graded 2 or higher at the 1-week visit.
Time frame: after 1 week of lens wear
Population: This analysis includes all participants that completed the study per protocol.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Narafilcon B | Slit Lamp Findings - Corneal Staining | 0 eyes |
| Etafilcon A | Slit Lamp Findings - Corneal Staining | 0 eyes |
Primary
Slit Lamp Findings - Corneal Staining
Investigators examined subjects using a slit lamp and the following scale:0=none, 1=trace, 2=mild, 3=moderate, 4= severe. This outcome measures the number of eyes that had corneal staining graded 2 or higher at the 1-week visit.
Time frame: after 1 month of lens wear
Population: This analysis includes all participants that completed the study per protocol.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Narafilcon B | Slit Lamp Findings - Corneal Staining | 1 eyes |
| Etafilcon A | Slit Lamp Findings - Corneal Staining | 0 eyes |
Primary
Slit Lamp Findings - Infiltrates
Investigators examined subjects using a slit lamp and recorded the presence or absence of infiltrates. This outcome measures the number of eyes that had infiltrates present at the 1-week visit.
Time frame: after 1 week of lens wear
Population: This analysis includes all participants that completed the study per protocol.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Narafilcon B | Slit Lamp Findings - Infiltrates | 0 eyes |
| Etafilcon A | Slit Lamp Findings - Infiltrates | 0 eyes |
Primary
Slit Lamp Findings - Infiltrates
Investigators examined subjects using a slit lamp and recorded the presence or absence of infiltrates. This outcome measures the number of eyes that had infiltrates present at the 1-week visit.
Time frame: after 1 month of lens wear
Population: This analysis includes all participants that completed the study per protocol.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Narafilcon B | Slit Lamp Findings - Infiltrates | 0 eyes |
| Etafilcon A | Slit Lamp Findings - Infiltrates | 0 eyes |
Primary
Slit Lamp Findings - Injection
Investigators examined subjects using a slit lamp and the following scale:0=none, 1=trace, 2=mild, 3=moderate, 4= severe. This outcome measures the number of eyes that had injection graded 2 or higher at the 1-week visit.
Time frame: after 1 week of lens wear
Population: This analysis includes all participants that completed the study per protocol.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Narafilcon B | Slit Lamp Findings - Injection | 0 eyes |
| Etafilcon A | Slit Lamp Findings - Injection | 0 eyes |
Primary
Slit Lamp Findings - Injection
Investigators examined subjects using a slit lamp and the following scale:0=none, 1=trace, 2=mild, 3=moderate, 4= severe. This outcome measures the number of eyes that had injection graded 2 or higher at the 1-week visit.
Time frame: after 1 month of lens wear
Population: This analysis includes all participants that completed the study per protocol.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Narafilcon B | Slit Lamp Findings - Injection | 0 eyes |
| Etafilcon A | Slit Lamp Findings - Injection | 0 eyes |
Primary
Slit Lamp Findings - Tarsal Abnormalities
Investigators examined subjects using a slit lamp and the following scale:0=none, 1=trace, 2=mild, 3=moderate, 4= severe. This outcome measures the number of eyes that had tarsal abnormalities graded 2 or higher at the 1-week visit.
Time frame: after 1 week of lens wear
Population: This analysis includes all participants that completed the study per protocol.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Narafilcon B | Slit Lamp Findings - Tarsal Abnormalities | 0 eyes |
| Etafilcon A | Slit Lamp Findings - Tarsal Abnormalities | 0 eyes |
Primary
Slit Lamp Findings - Tarsal Abnormalities
Investigators examined subjects using a slit lamp and the following scale:0=none, 1=trace, 2=mild, 3=moderate, 4= severe. This outcome measures the number of eyes that had tarsal abnormalities graded 2 or higher at the 1-week visit.
Time frame: after 1 month of lens wear
Population: This analysis includes all participants that completed the study per protocol.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Narafilcon B | Slit Lamp Findings - Tarsal Abnormalities | 0 eyes |
| Etafilcon A | Slit Lamp Findings - Tarsal Abnormalities | 0 eyes |
Primary
Subject Reported Symptoms
Number of eyes in which subjects reported lens-related symptoms after 1 month of lens wear.
Time frame: after 1 month of lens wear
Population: This analysis includes all participants that completed the study per protocol.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Narafilcon B | Subject Reported Symptoms | 14 eyes |
| Etafilcon A | Subject Reported Symptoms | 5 eyes |
Comparison: The hypothesis is that narafilcon B is not statistically different from etafilcon A.p-value: 0.1069Fisher Exact
Primary
Subject Reported Symptoms
Number of eyes in which subjects reported lens-related symptoms after 1 week of lens wear.
Time frame: after 1 week of lens wear
Population: This analysis includes all participants that completed the study per protocol.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Narafilcon B | Subject Reported Symptoms | 15 eyes |
| Etafilcon A | Subject Reported Symptoms | 8 eyes |
Comparison: The hypothesis is that narafilcon B is not statistically different from etafilcon A.p-value: 0.0466Fisher Exact
Primary
Visual Acuity (VA)
Investigators assessed visual acuity per eye using a Snellen visual acuity chart. This outcome measures the number of eyes, wearing vision correction, that measured visual acuity worse than 20/30 at the 1-week visit.
Time frame: after 1 week
Population: This analysis includes all participants that completed the study per protocol.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Narafilcon B | Visual Acuity (VA) | 0 eyes |
| Etafilcon A | Visual Acuity (VA) | 0 eyes |
Comparison: The hypothesis is that narafilcon B is not statistically different from etafilcon A.p-value: 0.4605Chi-squared
Primary
Visual Acuity (VA)
Investigators assessed visual acuity per eye using a Snellen visual acuity chart. This outcome measures the number of eyes, wearing vision correction, that measured visual acuity worse than 20/30 at the 1-month visit.
Time frame: after 1 month
Population: This analysis includes all participants that completed the study per protocol.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Narafilcon B | Visual Acuity (VA) | 0 eyes |
| Etafilcon A | Visual Acuity (VA) | 0 eyes |
Comparison: The hypothesis is that narafilcon B is not statistically different from etafilcon A.p-value: 0.5774Chi-squared