Myopia
Conditions
Brief summary
The purpose of this study is to compare the visual acuity, limbal and bulbar redness of the new galyfilcon A prototype lenses against Avaira® lenses when worn as daily wear for seven (7) days.
Interventions
Prototype silicone hydrogel contact lens
DEVICEenfilcon A lens
Marketed silicone hydrogel contact lens
Sponsors
Johnson & Johnson Vision Care, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 39 Years
Healthy volunteers
No
Inclusion criteria
* The subject is a current spherical soft contact lens wearer and willing to wear the study lenses on a daily wear basis for the duration of the study. * The subject's optimal vertexed spherical equivalent distance correction must be between -1.00 and - 5.00D. * Any cylinder power must be ≤ -0.75D. * The subject must have visual acuity best correctable to 20/25+3 or better for each eye. * The subject must read and sign the Statement of Informed Consent. * The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
Exclusion criteria
* Ocular or systemic allergies or disease which might interfere with contact lens wear. * Systemic disease or use of medication which might 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. * Diabetes. * Infectious diseases (e.g. hepatitis, tuberculosis) or an immuno-suppressive disease (e.g. HIV). * Habitual contact lens type is toric, multifocal, or is worn as extended wear.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Monocular Visual Acuity Assessment | Post lens insertion (baseline) | Snellen monocular visual acutity (VA) assessed by the Investigator and was converted to the LogMAR scale. |
| Binocular Visual Acuity | Post lens insertion (baseline) | Snellen binocular visual acuity assessed by the Investigator and was converted to the LogMAR scale. A value \<0 implies clinically positive results, a value \>0 implies clinically negative results |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Limbal Redness of Grade 3 or Above | After 6-8 days of lens wear | Limbal redness was assessed using a 5-point slit lamp classification scale (5-Worst, 0-None). Only those eyes with limbal redness grade \>= 3 were reported for purposes of this analysis. Grades 3 -5 are considered to be part of the adverse events reporting. |
| Bulbar Redness of Grade 3 or Above | After 6-8 days of lens wear | Bulbar redness was assessed using a 5-point slit lamp classification scale (5-Worst, 0-None). Only those eyes with bulbar redness grade \>= 3 were reported for purposes of this analysis. Grades 3 -5 are considered to be part of the adverse events reporting. |
Countries
United States
Participant flow
Pre-assignment details
There were 39 enrolled, with one screen failure prior to randomization, leaving 38 starting and completing the study.
Participants by arm
| Arm | Count |
|---|---|
| All Subjects All subjects who enrolled in the study. | 39 |
| Total | 39 |
Baseline characteristics
| Characteristic | All Subjects |
|---|---|
| Age, Continuous | 28.2 years STANDARD_DEVIATION 6.58 |
| Region of Enrollment United States | 39 participants |
| Sex: Female, Male Female | 26 Participants |
| Sex: Female, Male Male | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 38 |
| serious Total, serious adverse events | 0 / 38 |
Outcome results
Primary
Binocular Visual Acuity
Snellen binocular visual acuity assessed by the Investigator and was converted to the LogMAR scale. A value \<0 implies clinically positive results, a value \>0 implies clinically negative results
Time frame: Post lens insertion (baseline)
Population: Analysis was conducted on subjects who enrolled, were randomized, and successfully complete the study per protocol.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Galyfilcon A Prototype Lens | Binocular Visual Acuity | -0.08 LogMAR | Standard Error 0.032 |
| Enfilcon A Lens | Binocular Visual Acuity | -0.08 LogMAR | Standard Error 0.032 |
Comparison: The alternative hypothesis is the binocular visual acuity of the galyfilcon A prototype lens is non-inferior to that of the enfilcon A lens.95% CI: [-0.018, 0.018]Mixed Models Analysis
Primary
Monocular Visual Acuity Assessment
Snellen monocular visual acutity (VA) assessed by the Investigator and was converted to the LogMAR scale.
Time frame: Post lens insertion (baseline)
Population: Analysis was conducted on subjects who were enrolled, randomized, and successfully completed the study.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Galyfilcon A Prototype Lens | Monocular Visual Acuity Assessment | -0.05 logMAR | Standard Error 0.0317 |
| Enfilcon A Lens | Monocular Visual Acuity Assessment | -0.04 logMAR | Standard Error 0.0317 |
Comparison: The alternative hypothesis is the monocular visual acuity of the galyfilcon A prototype lens is non-inferior to that of the enfilcon A lens.95% CI: [-0.022, 0.003]Mixed Models Analysis
Secondary
Bulbar Redness of Grade 3 or Above
Bulbar redness was assessed using a 5-point slit lamp classification scale (5-Worst, 0-None). Only those eyes with bulbar redness grade \>= 3 were reported for purposes of this analysis. Grades 3 -5 are considered to be part of the adverse events reporting.
Time frame: After 6-8 days of lens wear
Population: Analysis was conducted on subjects who successfully completed the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Galyfilcon A Prototype Lens | Bulbar Redness of Grade 3 or Above | 0 Subject Eyes |
| Enfilcon A Lens | Bulbar Redness of Grade 3 or Above | 0 Subject Eyes |
Secondary
Limbal Redness of Grade 3 or Above
Limbal redness was assessed using a 5-point slit lamp classification scale (5-Worst, 0-None). Only those eyes with limbal redness grade \>= 3 were reported for purposes of this analysis. Grades 3 -5 are considered to be part of the adverse events reporting.
Time frame: After 6-8 days of lens wear
Population: Analysis was conducted on subjects who successfully completed the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Galyfilcon A Prototype Lens | Limbal Redness of Grade 3 or Above | 0 Subject Eyes |
| Enfilcon A Lens | Limbal Redness of Grade 3 or Above | 0 Subject Eyes |