Myopia
Conditions
Brief summary
The purpose of the study is to evaluate the possible benefits of second generation silicone hydrogel contact lenses.
Interventions
DEVICEsenofilcon A
contact lens
DEVICElotrafilcon B
contact lens
DEVICEbalafilcon A
contact lens
DEVICEmethafilcon A
contact lens
DEVICEvifilcon A
contact lens
Sponsors
Johnson & Johnson Vision Care, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 39 Years
Healthy volunteers
No
Inclusion criteria
Subjects must: * be existing soft contact lens wearers of the study control lenses * require a distance visual correction in both eyes * have a contact lens spherical distance requirement between -1.00 diopters (D) and -8.00D in both eyes * have astigmatism less than or equal to 1.00D in both eyes * be able to wear lenses available for this study * be corrected to a visual acuity of 6/9 (20/30) or better in each eye * have normal eyes with no evidence of abnormality or disease
Exclusion criteria
Subject are excluded for the following reasons: * monovision corrected * worn lenses extended wear in the last 3 months. * require concurrent ocular medication * grade 3 or 4 abnormalities * grade 3 corneal staining in more than two regions * anterior ocular surgery * any other ocular surgery or injury within 8 weeks prior to study enrollment * abnormal lachrymal secretions * pre-existing ocular irritation that would preclude contact lens fitting * corneal irregularities * Polymethyl methacrylate (PMMA) or Rigid Gas Permeable (RGP) lens wear in past 12 weeks * any systemic illness which would preclude contact lens wear * diabetes * infectious or immunosuppressive disease * pregnancy or lactating, or planning pregnancy at time or enrollment * participating in a concurrent clinical study or within last 60 days * allergy to the standardized study care solution
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Limbal Hyperemia (Redness) | 2 weeks | Subject distribution according to limbal hyperemia scale in each eye during the 2-week Follow-up Visit. For this scale, 0 is lowest and 4 is greatest. If present in at least one eye, then it is counted. |
| Bulbar Hyperemia (Redness) | 2 weeks | Subject distribution according to bulbar hyperemia scale in each eye during the 2-week Follow-up Visit. For this scale, 0 is lowest and 4 is greatest. If present in at least one eye, then it is counted. |
| Corneal Staining | 2 weeks | Subject distribution according to corneal staining with fluorescein scale in each eye during the 2-week Follow-up Visit. For this scale, 0 is lowest and 4 is greatest. If present in at least one eye, then it is counted. |
Countries
Brazil
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Senofilcon A contact lens
senofilcon A: contact lens | 30 |
| Balafilcon A contact lens
balafilcon A: contact lens | 13 |
| Methafilcon A contact lens
methafilcon A: contact lens | 16 |
| Total | 59 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 3 | 0 | 1 | 3 |
| Overall Study | Withdrawal by Subject | 3 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Senofilcon A | Balafilcon A | Methafilcon A | Total |
|---|---|---|---|---|
| Age, Continuous | 23.9 years STANDARD_DEVIATION 3.9 | 22.7 years STANDARD_DEVIATION 3.5 | 27.0 years STANDARD_DEVIATION 4.2 | 24.5 years STANDARD_DEVIATION 4.2 |
| Region of Enrollment Brazil | 30 participants | 13 participants | 16 participants | 59 participants |
| Sex: Female, Male Female | 26 Participants | 7 Participants | 13 Participants | 46 Participants |
| Sex: Female, Male Male | 4 Participants | 6 Participants | 3 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 1 / 35 | 2 / 3 | 0 / 13 | 0 / 17 | 1 / 3 |
| serious Total, serious adverse events | 0 / 35 | 0 / 3 | 0 / 13 | 0 / 17 | 0 / 3 |
Outcome results
Primary
Bulbar Hyperemia (Redness)
Subject distribution according to bulbar hyperemia scale in each eye during the 2-week Follow-up Visit. For this scale, 0 is lowest and 4 is greatest. If present in at least one eye, then it is counted.
Time frame: 2 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Senofilcon A | Bulbar Hyperemia (Redness) | Grade 3 | 0 eyes |
| Senofilcon A | Bulbar Hyperemia (Redness) | Grade 2 | 5 eyes |
| Senofilcon A | Bulbar Hyperemia (Redness) | Grade 0 | 43 eyes |
| Senofilcon A | Bulbar Hyperemia (Redness) | Grade 1 | 12 eyes |
| Senofilcon A | Bulbar Hyperemia (Redness) | Grade 4 | 0 eyes |
| Balafilcon A | Bulbar Hyperemia (Redness) | Grade 2 | 2 eyes |
| Balafilcon A | Bulbar Hyperemia (Redness) | Grade 0 | 12 eyes |
| Balafilcon A | Bulbar Hyperemia (Redness) | Grade 1 | 12 eyes |
| Balafilcon A | Bulbar Hyperemia (Redness) | Grade 3 | 0 eyes |
| Balafilcon A | Bulbar Hyperemia (Redness) | Grade 4 | 0 eyes |
| Methafilcon A | Bulbar Hyperemia (Redness) | Grade 4 | 0 eyes |
| Methafilcon A | Bulbar Hyperemia (Redness) | Grade 3 | 0 eyes |
| Methafilcon A | Bulbar Hyperemia (Redness) | Grade 0 | 20 eyes |
| Methafilcon A | Bulbar Hyperemia (Redness) | Grade 2 | 4 eyes |
| Methafilcon A | Bulbar Hyperemia (Redness) | Grade 1 | 8 eyes |
Primary
Bulbar Hyperemia (Redness)
Subject distribution according to bulbar hyperemia scale in each eye during the 4-week Follow-up Visit. For this scale, 0 is lowest and 4 is greatest. If present in at least one eye, then it is counted.
Time frame: 4 weeks
Population: Analysis is on those who are enrolled, randomized to a study arm, and completed the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Senofilcon A | Bulbar Hyperemia (Redness) | Grade 3 | 0 eyes |
| Senofilcon A | Bulbar Hyperemia (Redness) | Grade 2 | 3 eyes |
| Senofilcon A | Bulbar Hyperemia (Redness) | Grade 0 | 45 eyes |
| Senofilcon A | Bulbar Hyperemia (Redness) | Grade 1 | 12 eyes |
| Senofilcon A | Bulbar Hyperemia (Redness) | Grade 4 | 0 eyes |
| Balafilcon A | Bulbar Hyperemia (Redness) | Grade 2 | 0 eyes |
| Balafilcon A | Bulbar Hyperemia (Redness) | Grade 0 | 11 eyes |
| Balafilcon A | Bulbar Hyperemia (Redness) | Grade 1 | 13 eyes |
| Balafilcon A | Bulbar Hyperemia (Redness) | Grade 3 | 0 eyes |
| Balafilcon A | Bulbar Hyperemia (Redness) | Grade 4 | 0 eyes |
| Methafilcon A | Bulbar Hyperemia (Redness) | Grade 4 | 0 eyes |
| Methafilcon A | Bulbar Hyperemia (Redness) | Grade 3 | 0 eyes |
| Methafilcon A | Bulbar Hyperemia (Redness) | Grade 0 | 23 eyes |
| Methafilcon A | Bulbar Hyperemia (Redness) | Grade 2 | 0 eyes |
| Methafilcon A | Bulbar Hyperemia (Redness) | Grade 1 | 9 eyes |
Primary
Corneal Staining
Subject distribution according to corneal staining with fluorescein scale in each eye during the 2-week Follow-up Visit. For this scale, 0 is lowest and 4 is greatest. If present in at least one eye, then it is counted.
Time frame: 2 weeks
Population: Analysis was on those subjects who were enrolled, randomized to a study arm, and completed the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Senofilcon A | Corneal Staining | Grade 0 | 27 eyes |
| Senofilcon A | Corneal Staining | Grade 1 | 27 eyes |
| Senofilcon A | Corneal Staining | Grade 2 | 6 eyes |
| Senofilcon A | Corneal Staining | Grade 4 | 0 eyes |
| Senofilcon A | Corneal Staining | Grade 3 | 0 eyes |
| Balafilcon A | Corneal Staining | Grade 2 | 2 eyes |
| Balafilcon A | Corneal Staining | Grade 0 | 8 eyes |
| Balafilcon A | Corneal Staining | Grade 4 | 0 eyes |
| Balafilcon A | Corneal Staining | Grade 3 | 0 eyes |
| Balafilcon A | Corneal Staining | Grade 1 | 16 eyes |
| Methafilcon A | Corneal Staining | Grade 3 | 0 eyes |
| Methafilcon A | Corneal Staining | Grade 2 | 3 eyes |
| Methafilcon A | Corneal Staining | Grade 1 | 19 eyes |
| Methafilcon A | Corneal Staining | Grade 0 | 10 eyes |
| Methafilcon A | Corneal Staining | Grade 4 | 0 eyes |
Primary
Corneal Staining
Subject distribution according to corneal staining with fluorescein scale in each eye during the 4-week Follow-up Visit. For this scale, 0 is lowest and 4 is greatest. If present in at least one eye, then it is counted.
Time frame: 4 weeks
Population: Analysis is on those subjects who were enrolled, randomized to a study arm, and completed the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Senofilcon A | Corneal Staining | Grade 3 | 0 eyes |
| Senofilcon A | Corneal Staining | Grade 2 | 8 eyes |
| Senofilcon A | Corneal Staining | Grade 0 | 33 eyes |
| Senofilcon A | Corneal Staining | Grade 1 | 19 eyes |
| Senofilcon A | Corneal Staining | Grade 4 | 0 eyes |
| Balafilcon A | Corneal Staining | Grade 2 | 0 eyes |
| Balafilcon A | Corneal Staining | Grade 0 | 8 eyes |
| Balafilcon A | Corneal Staining | Grade 1 | 16 eyes |
| Balafilcon A | Corneal Staining | Grade 3 | 0 eyes |
| Balafilcon A | Corneal Staining | Grade 4 | 0 eyes |
| Methafilcon A | Corneal Staining | Grade 4 | 0 eyes |
| Methafilcon A | Corneal Staining | Grade 3 | 0 eyes |
| Methafilcon A | Corneal Staining | Grade 0 | 10 eyes |
| Methafilcon A | Corneal Staining | Grade 2 | 4 eyes |
| Methafilcon A | Corneal Staining | Grade 1 | 18 eyes |
Primary
Limbal Hyperemia (Redness)
Subject distribution according to limbal hyperemia scale in each eye during the 2-week Follow-up Visit. For this scale, 0 is lowest and 4 is greatest. If present in at least one eye, then it is counted.
Time frame: 2 weeks
Population: Analysis is on those subjects who were enrolled, randomized, and completed the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Senofilcon A | Limbal Hyperemia (Redness) | Grade 3 | 0 eyes |
| Senofilcon A | Limbal Hyperemia (Redness) | Grade 2 | 8 eyes |
| Senofilcon A | Limbal Hyperemia (Redness) | Grade 0 | 40 eyes |
| Senofilcon A | Limbal Hyperemia (Redness) | Grade 1 | 12 eyes |
| Senofilcon A | Limbal Hyperemia (Redness) | Grade 4 | 0 eyes |
| Balafilcon A | Limbal Hyperemia (Redness) | Grade 2 | 8 eyes |
| Balafilcon A | Limbal Hyperemia (Redness) | Grade 0 | 14 eyes |
| Balafilcon A | Limbal Hyperemia (Redness) | Grade 1 | 4 eyes |
| Balafilcon A | Limbal Hyperemia (Redness) | Grade 3 | 0 eyes |
| Balafilcon A | Limbal Hyperemia (Redness) | Grade 4 | 0 eyes |
| Methafilcon A | Limbal Hyperemia (Redness) | Grade 4 | 0 eyes |
| Methafilcon A | Limbal Hyperemia (Redness) | Grade 3 | 0 eyes |
| Methafilcon A | Limbal Hyperemia (Redness) | Grade 0 | 24 eyes |
| Methafilcon A | Limbal Hyperemia (Redness) | Grade 2 | 4 eyes |
| Methafilcon A | Limbal Hyperemia (Redness) | Grade 1 | 4 eyes |
Primary
Limbal Hyperemia (Redness)
Subject distribution according to limbal hyperemia scale in each eye during the 4-week Follow-up Visit. For this scale, 0 is lowest and 4 is greatest. If present in at least one eye, then it is counted.
Time frame: 4 weeks
Population: Analysis is on those subjects who are enrolled, randomized to a study arm, and who completed the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Senofilcon A | Limbal Hyperemia (Redness) | Grade 4 | 0 eyes |
| Senofilcon A | Limbal Hyperemia (Redness) | Grade 1 | 10 eyes |
| Senofilcon A | Limbal Hyperemia (Redness) | Grade 2 | 6 eyes |
| Senofilcon A | Limbal Hyperemia (Redness) | Grade 3 | 0 eyes |
| Senofilcon A | Limbal Hyperemia (Redness) | Grade 0 | 46 eyes |
| Balafilcon A | Limbal Hyperemia (Redness) | Grade 3 | 0 eyes |
| Balafilcon A | Limbal Hyperemia (Redness) | Grade 0 | 16 eyes |
| Balafilcon A | Limbal Hyperemia (Redness) | Grade 1 | 4 eyes |
| Balafilcon A | Limbal Hyperemia (Redness) | Grade 2 | 4 eyes |
| Balafilcon A | Limbal Hyperemia (Redness) | Grade 4 | 0 eyes |
| Methafilcon A | Limbal Hyperemia (Redness) | Grade 2 | 2 eyes |
| Methafilcon A | Limbal Hyperemia (Redness) | Grade 4 | 0 eyes |
| Methafilcon A | Limbal Hyperemia (Redness) | Grade 0 | 18 eyes |
| Methafilcon A | Limbal Hyperemia (Redness) | Grade 3 | 0 eyes |
| Methafilcon A | Limbal Hyperemia (Redness) | Grade 1 | 12 eyes |