Myopia
Conditions
Brief summary
The purpose of this study is to compare ACUVUE® ADVANCE® Plus contact lenses made prior to process qualification (prePQ) against the ACUVUE® ADVANCE® Plus lenses made after the process qualification (postPQ).
Interventions
DEVICEAcuvue Advance Plus prePQ
silicone hydrogel contact lens manufactured prior to equipment process qualification activities.
DEVICEAcuvue Advance Plus postPQ
silicone hydrogel contact lens manufactured after equipment process qualification activities.
Sponsors
Johnson & Johnson Vision Care, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 39 Years
Healthy volunteers
No
Inclusion criteria
* The subject must be at least 18 years of age and no more than 39 years of age. * 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 (minimum of 6 hours per day). * 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 |
|---|---|---|
| Visual Acuity (VA) | 6-8 days after lens wear | Snellen VA was measured to the nearest letter then converted to the logMAR scale for the analysis. Values \< 0 imply a clinically positive result; while values \> 0 infer a clinically negative result. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Corneal Staining | 6-8 days after lens wear | Corneal staining type was assessed by Investigator using a slit lamp and graded on a 5-point scale; 0=none, 1=trace, 2=mild, 3=moderate, 4=severe. |
| Limbal Redness | 6-8 days after lens wear | Limbal redness was assessed by using a 5-point scale: 0=none, 1=trace, 2=mild, 3=moderate, 4=severe. |
| Bulbar Redness | 6-8 days after lens wear | Scale of 0 increasing to 4. 0=None, 4=Severe Redness |
Countries
United States
Participant flow
Recruitment details
4 investigation sites were used within the U.S. for this study, with a study duration of Oct 23, 2010 to Nov 7, 2010.
Pre-assignment details
44 subjects enrolled; 42 completed as cohort, two subjects were discontinued.
Participants by arm
| Arm | Count |
|---|---|
| All Subjects Acuvue Advance Plus silicone hydrogel contact lens manufactured prior to qualification were worn first and Acuvue AdvancePlus silicone hydrogel contact lens manufactured after qualification were worn second. | 44 |
| Total | 44 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| 1-Week Follow Up | Lost to Follow-up | 1 | 0 |
| Baseline | Protocol Violation | 0 | 1 |
Baseline characteristics
| Characteristic | All Subjects |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 44 Participants |
| Age, Continuous | 28.3 years STANDARD_DEVIATION 5.66 |
| Region of Enrollment United States | 44 participants |
| Sex: Female, Male Female | 26 Participants |
| Sex: Female, Male Male | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 44 | 0 / 44 |
| serious Total, serious adverse events | 0 / 44 | 0 / 44 |
Outcome results
Primary
Visual Acuity (VA)
Snellen VA was measured to the nearest letter then converted to the logMAR scale for the analysis. Values \< 0 imply a clinically positive result; while values \> 0 infer a clinically negative result.
Time frame: 6-8 days after lens wear
Population: Population analyzed are those who were enrolled, randomized, and completed the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Acuvue Advance Plus preQ | Visual Acuity (VA) | -0.088 logMAR scale | Standard Deviation 0.0328 |
| Acuvue Advance Plus postQ | Visual Acuity (VA) | -0.083 logMAR scale | Standard Deviation 0.0377 |
Comparison: Ho: after time period (6-8 days of lens wear), the test lens - control lens will be greater than or equal to the non-inferiority margin specified .~Ha: after time period, test-control will be less than the margin specified concluding that the test lens will be inferior to control lens in terms of LogMAR scale95% CI: [-0.00092, 0.01045]Mixed Models Analysis
Secondary
Bulbar Redness
Scale of 0 increasing to 4. 0=None, 4=Severe Redness
Time frame: 6-8 days after lens wear
Population: Population analyzed consisted of those who were enrolled, randomized, and completed the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Acuvue Advance Plus preQ | Bulbar Redness | 0.71 units on a scale | Standard Deviation 0.673 |
| Acuvue Advance Plus postQ | Bulbar Redness | 0.71 units on a scale | Standard Deviation 0.596 |
Secondary
Corneal Staining
Corneal staining type was assessed by Investigator using a slit lamp and graded on a 5-point scale; 0=none, 1=trace, 2=mild, 3=moderate, 4=severe.
Time frame: 6-8 days after lens wear
Population: Population analyzed are those who were enrolled, randomized, and completed the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Acuvue Advance Plus preQ | Corneal Staining | 0.23 units on a scale | Standard Deviation 0.424 |
| Acuvue Advance Plus postQ | Corneal Staining | 0.17 units on a scale | Standard Deviation 0.375 |
Secondary
Limbal Redness
Limbal redness was assessed by using a 5-point scale: 0=none, 1=trace, 2=mild, 3=moderate, 4=severe.
Time frame: 6-8 days after lens wear
Population: Population analyzed are those who were enrolled, randomized, and completed the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Acuvue Advance Plus preQ | Limbal Redness | 0.71 units on a scale | Standard Deviation 0.457 |
| Acuvue Advance Plus postQ | Limbal Redness | 0.79 units on a scale | Standard Deviation 0.682 |