Hyperopia
Conditions
Brief summary
The purpose of this study is to compare the performance of the ACUVUE® ADVANCE® Plus lenses against ACUVUE® ADVANCE® lenses in the plus power parameters.
Interventions
DEVICEAcuvue Advance Plus
Silicone hydrogel contact lens.
DEVICEAcuvue Advance
Silicone hydrogel contact lens
Sponsors
Johnson & Johnson Vision Care, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* The subject must be at least 18 years of age and no more than 45 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 (defined as a minimum of 6 hours with a minimum of at least 1 month's wear prior to the study). * The subject's optimal verified spherical equivalent distance correction must be between +1.00 and + 6.00D. * 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 the 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, bifocal, in monovision contact lens wear, or is worn as extended wear. * Need any near correction.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Acuity One Week After Lens Wear | 1 week | Visual acuity was measured using ETDRS visual acuity test. ETDRS stands for Early Treatment Diabetic Retinopathy Study. Binocular and monocular measurements were collected. |
| Visual Acuity at Time of Initial Fit | After 10-15 minutes of lens wear | Visual acuity will be measured using ETDRS visual acuity test. ETDRS stands for Early Treatment Diabetic Retinopathy Study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Contact Lens Comfort Using Contact Lens User Experience (CLUE) | 1 week | The subjective comfort questionnaire CLUE, assesses the overall lens comfort. The CLUE Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0 to 120. |
| Subject Reported Vision Using Contact Lens User Experience (CLUE). | 1 week | Overall vision was assessed by a subjective vision questionnaire. The CLUE Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0 to 120. |
| Contact Lens Comfort at Initial Fit Using Contact Lens User Experience (CLUE) | Baseline | Comfort was assessed using a subjective comfort questionnaire. The CLUE Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. CLUE scores have a range of 0-120. |
| Subject Reported Vision at Initial Fit Using Contact Lens User Experience (CLUE) | Baseline | Vision at initial fit was assessed using a subjective vision questionnaire. The CLUE Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0 to 120. |
Countries
United States
Participant flow
Recruitment details
This is a 3 site, 3 visit, randomized, double-masked, bilateral crossover trial comparing Acuvue Advance to Acuvue Advance Plus lenses.
Pre-assignment details
Of the 38 subjects enrolled, 2 were ineligible and not-randomized, 3 discontinued, and 33 completed as cohort.
Participants by arm
| Arm | Count |
|---|---|
| All Subjects Subjects who were randomized and successfully completed the study. | 33 |
| Total | 33 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Baseline | Lack of Efficacy | 1 | 2 |
Baseline characteristics
| Characteristic | All Subjects |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 33 Participants |
| Age, Continuous | 29.8 years STANDARD_DEVIATION 5.66 |
| Region of Enrollment United States | 33 participants |
| Sex: Female, Male Female | 21 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 33 | 0 / 33 |
| serious Total, serious adverse events | 0 / 33 | 0 / 33 |
Outcome results
Primary
Visual Acuity at Time of Initial Fit
Visual acuity will be measured using ETDRS visual acuity test. ETDRS stands for Early Treatment Diabetic Retinopathy Study.
Time frame: After 10-15 minutes of lens wear
Population: Analysis is conducted on those were enrolled and completed the trial.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Acuvue Advance Plus | Visual Acuity at Time of Initial Fit | Low Luminance/High Contrast (Binocular) | 0.13 LogMAR | Standard Deviation 0.087 |
| Acuvue Advance Plus | Visual Acuity at Time of Initial Fit | Low Luminance/High Contrast (Monocular) | 0.16 LogMAR | Standard Deviation 0.106 |
| Acuvue Advance Plus | Visual Acuity at Time of Initial Fit | High Luminance/Low Contrast (Binocular) | 0.14 LogMAR | Standard Deviation 0.076 |
| Acuvue Advance Plus | Visual Acuity at Time of Initial Fit | High Luminance/Low Contrast (Monocular) | 0.24 LogMAR | Standard Deviation 0.123 |
| Acuvue Advance | Visual Acuity at Time of Initial Fit | High Luminance/Low Contrast (Monocular) | 0.21 LogMAR | Standard Deviation 0.111 |
| Acuvue Advance | Visual Acuity at Time of Initial Fit | Low Luminance/High Contrast (Binocular) | 0.11 LogMAR | Standard Deviation 0.073 |
| Acuvue Advance | Visual Acuity at Time of Initial Fit | High Luminance/Low Contrast (Binocular) | 0.13 LogMAR | Standard Deviation 0.094 |
| Acuvue Advance | Visual Acuity at Time of Initial Fit | Low Luminance/High Contrast (Monocular) | 0.15 LogMAR | Standard Deviation 0.101 |
Comparison: For Low Luminance/ High Contrast Grouping (Monocular):~Ho: The test lens (Advance Plus) will be non-inferior to the control lens (Advance).~Ha: The test lens (Advance Plus) will be \<= to the control lens (Advance).95% CI: [0.0041, 0.0282]Mixed Models Analysis
Comparison: For High Luminance/ Low Contrast Grouping (Binocular):~Ho: The test lens (Advance Plus) will be non-inferior from the control lens (Advance).~Ha: The test lens (Advance Plus) will be \<= to the control lens (Advance).95% CI: [0.009, 0.3305]Mixed Models Analysis
Primary
Visual Acuity One Week After Lens Wear
Visual acuity was measured using ETDRS visual acuity test. ETDRS stands for Early Treatment Diabetic Retinopathy Study. Binocular and monocular measurements were collected.
Time frame: 1 week
Population: Subjects analyzed were those who were enrolled, randomized, and completed the study. Both monocular and binocular measurements were taken and included in analysis.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Acuvue Advance Plus | Visual Acuity One Week After Lens Wear | Low Luminance/ High Contrast (Binocular) | 0.11 LogMAR | Standard Error 0.082 |
| Acuvue Advance Plus | Visual Acuity One Week After Lens Wear | Low Luminance/ High Contrast (Monocular) | 0.14 LogMAR | Standard Error 0.1 |
| Acuvue Advance Plus | Visual Acuity One Week After Lens Wear | High Luminance/ Low Contrast (Binocular) | 0.12 LogMAR | Standard Error 0.075 |
| Acuvue Advance Plus | Visual Acuity One Week After Lens Wear | High Luminance/ Low Contrast (Monocular) | 0.22 LogMAR | Standard Error 0.108 |
| Acuvue Advance | Visual Acuity One Week After Lens Wear | High Luminance/ Low Contrast (Monocular) | 0.21 LogMAR | Standard Error 0.097 |
| Acuvue Advance | Visual Acuity One Week After Lens Wear | Low Luminance/ High Contrast (Binocular) | 0.10 LogMAR | Standard Error 0.063 |
| Acuvue Advance | Visual Acuity One Week After Lens Wear | High Luminance/ Low Contrast (Binocular) | 0.13 LogMAR | Standard Error 0.067 |
| Acuvue Advance | Visual Acuity One Week After Lens Wear | Low Luminance/ High Contrast (Monocular) | 0.14 LogMAR | Standard Error 0.088 |
Comparison: For Low Luminance/ High Contrast grouping (Monocular):~Ho: The test lens (Acuvue Advance Plus) will be non-inferior to the control lens (Acuvue Advance).~Ha: The test lens (Acuvue Advance Plus) will be \<= to the control lens (Acuvue Advance).95% CI: [-0.0044, 0.0187]Mixed Models Analysis
Comparison: High Luminance/ Low Contrast grouping (Binocular):~Ho: The test lens (Acuvue Advance Plus) will be non-inferior to the control lens (Acuvue Advance).~Ha: The test lens (Acuvue Advance Plus) will be \<= to the control lens (Acuvue Advance).95% CI: [-0.0086, 0.0146]Mixed Models Analysis
Secondary
Contact Lens Comfort at Initial Fit Using Contact Lens User Experience (CLUE)
Comfort was assessed using a subjective comfort questionnaire. The CLUE Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. CLUE scores have a range of 0-120.
Time frame: Baseline
Population: Analysis was on those who were enrolled and completed the study.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Acuvue Advance Plus | Contact Lens Comfort at Initial Fit Using Contact Lens User Experience (CLUE) | 65.3 CLUE points | Standard Error 3.14 |
| Acuvue Advance | Contact Lens Comfort at Initial Fit Using Contact Lens User Experience (CLUE) | 59.0 CLUE points | Standard Error 3.19 |
Secondary
Contact Lens Comfort Using Contact Lens User Experience (CLUE)
The subjective comfort questionnaire CLUE, assesses the overall lens comfort. The CLUE Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0 to 120.
Time frame: 1 week
Population: Analysis was on those who were enrolled and completed the study.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Acuvue Advance Plus | Contact Lens Comfort Using Contact Lens User Experience (CLUE) | 49.2 CLUE points | Standard Error 3.28 |
| Acuvue Advance | Contact Lens Comfort Using Contact Lens User Experience (CLUE) | 50.7 CLUE points | Standard Error 3.26 |
Secondary
Subject Reported Vision at Initial Fit Using Contact Lens User Experience (CLUE)
Vision at initial fit was assessed using a subjective vision questionnaire. The CLUE Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0 to 120.
Time frame: Baseline
Population: Subjects analyzed included only those who were enrolled and completed the study.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Acuvue Advance Plus | Subject Reported Vision at Initial Fit Using Contact Lens User Experience (CLUE) | 46.7 CLUE points | Standard Error 3.9 |
| Acuvue Advance | Subject Reported Vision at Initial Fit Using Contact Lens User Experience (CLUE) | 49.6 CLUE points | Standard Error 3.98 |
Secondary
Subject Reported Vision Using Contact Lens User Experience (CLUE).
Overall vision was assessed by a subjective vision questionnaire. The CLUE Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0 to 120.
Time frame: 1 week
Population: Analysis was on those who were enrolled and completed the study.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Acuvue Advance Plus | Subject Reported Vision Using Contact Lens User Experience (CLUE). | 42.5 CLUE points | Standard Error 2.87 |
| Acuvue Advance | Subject Reported Vision Using Contact Lens User Experience (CLUE). | 39.9 CLUE points | Standard Error 2.86 |