Visual Acuity
Conditions
Brief summary
This will be a 4-visit, randomized, controlled, single-masked, bilateral wear, dispensing, 2-treatment, 2-sequence, 2-period crossover study.
Interventions
DEVICEAcuvue Oasys 1 Day for Astigmatism
CONTROL
DEVICETRA100/TRA200 series toric contact lens with HEVL-blocking chromophore
TEST
Sponsors
Johnson & Johnson Vision Care, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 39 Years
Healthy volunteers
Yes
Inclusion criteria
* Potential subjects must satisfy all of the following criteria to be enrolled in the study: The subject must: 1. Read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form. 2. Appear able and willing to adhere to the instructions set forth in this clinical protocol. 3. Be between 18 and 39 years of age (inclusive) at the time of screening. 4. Habitually wear soft contact lenses in both eyes in a daily or daily disposable wear modality (i.e., not extended wear modality). Habitual wearer is defined as a minimum of 6 hours per day, for a minimum of 2 days per week during the past four weeks. 5. Possess a wearable pair of spectacles that provide correction for distance vision. 6. In both eyes, have refractive error suitable for correction with the toric contact lens powers available in this study: 1. Sphere powers (DS) -1.50 through -4.00 in 0.25 steps 2. Cylinder powers (DC) -0.75 and -1.25 3. Axes (°) 170, 180, 10, 80, 90, 100 7. Have best corrected monocular distance visual acuity of 20/30 or better in each eye.
Exclusion criteria
* Potential subjects who meet any of the following criteria will be excluded from participating in the study: The subject must not: 1. Be currently pregnant or lactating. 2. Be diabetic. 3. Be currently using any ocular medications or have an ocular infection of any type. 4. By self-report, have any ocular or systemic disease, allergies, infection, or use of medication that might contraindicate or interfere with contact lens wear, or otherwise compromise study endpoints, including infectious disease (e.g., hepatitis, tuberculosis), contagious immunosuppressive disease (e.g., Human Immunodeficiency Virus \[HIV\]), autoimmune disease (e.g. rheumatoid arthritis, Sjögren's syndrome), or history of serious mental illness or seizures. See section 9.1 for additional details regarding excluded systemic medications. 5. Have habitually worn rigid gas permeable (RGP) lenses, orthokeratology lenses, or hybrid lenses (e.g. SynergEyes, SoftPerm) within the past 6 months. 6. Be currently wearing monovision or multifocal contact lenses. 7. Be currently wearing lenses in an extended wear modality. 8. Have a history of strabismus or amblyopia. 9. Be an employee (e.g., Investigator, Coordinator, Technician) or immediate family member of an employee (including partner, child, parent, grandparent, grandchild or sibling of the employee or their spouse) of the clinical site. 10. Have participated in a contact lens or lens care product clinical trial within 7 days prior to study enrollment. 11. Have clinically significant (grade 3 or higher on the FDA grading scale) slit lamp findings (e.g., corneal edema, neovascularization or staining, tarsal abnormalities or bulbar injection) or other corneal or ocular disease or abnormalities that contraindicate contact lens wear or may otherwise compromise study endpoints (including entropion, ectropion, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, moderate or above corneal distortion, herpetic keratitis). 12. Have fluctuations in vision due to clinically significant dry eye or other ocular conditions. 13. Have had or have planned (within the study period) any ocular or intraocular surgery (e.g., radial keratotomy, PRK, LASIK, iridotomy, retinal laser photocoagulation, etc.).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Eyes With Grade 3 or Higher Slit Lamp Findings | Up to 1-Week Follow-up | Slit Lamp Findings (SLF) were assessed using a biomicroscope and was graded using the FDA grading scale (Grade: 0, 1,2, 3 and 4) with grade 0 represents the absence of findings and 1 to 4 representing successively worse findings (i.e. Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). This was performed on each subject eye at every study visit (baseline, unscheduled visits and 1-week follow-up). The data was then dichotomized into two groups. Those with grade 3 or higher and those with grade 2 or lower. The proportion of eyes with SLF with grade 3 or higher was reported for each lens. |
| Proportion of Eyes With Rotational Stability Less Than or Equal to 5 Degrees | 15-minutes after lens insertion | Rotational Stability was assessed for each subject eye using a slit lamp 15-minutes after lens insertion. Rotational Stability was dichotomized into a binary response where Y=1 if Rotational Stability was less than or equal to 5 degrees and Y=0 otherwise (Rotational Stability greater than 5 degrees). The proportion of eyes with Rotational Stability less than or equal to 5 degrees was report for each lens. |
| Proportion of Eyes With Acceptable Lens Fitting | Up to 1-Week Follow-up | Contact lens fitting acceptance was assessed for each subject eye using a biomicroscope post lens insertion at the 1-week follow-up. Lens fit was a binary variable where acceptable lens fit=1 and unacceptable lens fit=0. The proportion of eyes with acceptable lens fit was reported for each lens. |
| Distance Monocular logMAR Visual Acuity | 1-Week Follow-up | Distance Monocular visual acuity was measured on a logMAR (Logarithm of Minimal Angle of Resolution) scale under high luminance high contrast condition. Visual acuity is assessed using ETDRS (Early Treatment Diabetic Retinopathy Study) charts. Letter-by-letter results calculated the visual performance score for each chart read. LogMAR scores closer to zero, or below zero, indicate a better visual acuity. A logMAR visual performance score of 0.0 is equivalent to Snellen visual acuity of 20/20. |
| CLUE Vision Score | 1-Week Follow-up | Subjective vision was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) 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 0-120. |
| Proportion of Eyes With Absolute Rotation Less Than or Equal to 10 Degrees | 15-minutes after lens insertion | Absolute rotation was assessed for each subject eye using a slit lamp 15-minutes after lens insertion. Acceptable absolute rotation was dichotomized into a binary response where Y=1 if absolute rotation was less than or equal to 10 degrees and Y=0 otherwise (absolute rotation greater than 10 degrees). The proportion of eyes with absolute rotation less than or equal to 10 degrees was report for each lens. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CLUE Handling Score | 1-Week Follow-up | Subjective handling was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) 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 0-120. The average CLUE handling score was reported. |
| CLUE Comfort Score | 1-Week Follow-up | Subjective comfort was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) 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 0-120. The average CLUE comfort score was reported. |
Countries
United States
Participant flow
Recruitment details
A total of 188 subjects were enrolled in this study. All 188 enrolled subjects were dispensed at least one study lens. Of those dispensed, 179 subjects completed the study while 9 subjects were discontinued.
Participants by arm
| Arm | Count |
|---|---|
| Dispensed Subjects All subjects dispensed at least one study lens. | 188 |
| Total | 188 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Period 1 | COVID-19 Related | 3 | 3 |
| Period 1 | Withdrew Consent during Study | 1 | 0 |
| Period 2 | Other: Incorrect Study Lens Dispensed | 0 | 1 |
| Period 2 | Unsatisfactory Lens Fitting due to Study Lens | 0 | 1 |
Baseline characteristics
| Characteristic | Dispensed Subjects |
|---|---|
| Age, Continuous | 29.3 Years STANDARD_DEVIATION 5.66 |
| Race/Ethnicity, Customized Asian | 3 Participants |
| Race/Ethnicity, Customized Black or African American | 8 Participants |
| Race/Ethnicity, Customized Multiple | 1 Participants |
| Race/Ethnicity, Customized White | 176 Participants |
| Region of Enrollment United States | 188 Participants |
| Sex: Female, Male Female | 127 Participants |
| Sex: Female, Male Male | 61 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 185 | 0 / 184 |
| other Total, other adverse events | 0 / 185 | 0 / 184 |
| serious Total, serious adverse events | 0 / 185 | 0 / 184 |
Outcome results
Primary
CLUE Vision Score
Subjective vision was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) 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 0-120.
Time frame: 1-Week Follow-up
Population: All dispensed subjects regardless of deviation from protocol with data collected at the 1-week follow-up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test-senofilcon A (C3) | CLUE Vision Score | 68.75 Units on a scale | Standard Deviation 21.547 |
| Control-senofilcon A (C3) | CLUE Vision Score | 70.18 Units on a scale | Standard Deviation 19.912 |
Comparison: It was calculated using a 1-sided one sample mean t-test with a type I error rate of 0.025 that 165 subjects provide at least 99% statistical power to test for superiority.Linear Mixed Model
Primary
Distance Monocular logMAR Visual Acuity
Distance Monocular visual acuity was measured on a logMAR (Logarithm of Minimal Angle of Resolution) scale under high luminance high contrast condition. Visual acuity is assessed using ETDRS (Early Treatment Diabetic Retinopathy Study) charts. Letter-by-letter results calculated the visual performance score for each chart read. LogMAR scores closer to zero, or below zero, indicate a better visual acuity. A logMAR visual performance score of 0.0 is equivalent to Snellen visual acuity of 20/20.
Time frame: 1-Week Follow-up
Population: All dispensed subjects regardless of deviation from protocol with data collected at the 1-week follow-up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test-senofilcon A (C3) | Distance Monocular logMAR Visual Acuity | -0.107 logMAR | Standard Deviation 0.074 |
| Control-senofilcon A (C3) | Distance Monocular logMAR Visual Acuity | -0.104 logMAR | Standard Deviation 0.0705 |
Comparison: It was calculated using a 1-sided one sample mean t-test with a type I error rate of 0.025 that 9 subjects provide at least 99% statistical power to test for superiority.Linear Mixed Model
Primary
Proportion of Eyes With Absolute Rotation Less Than or Equal to 10 Degrees
Absolute rotation was assessed for each subject eye using a slit lamp 15-minutes after lens insertion. Acceptable absolute rotation was dichotomized into a binary response where Y=1 if absolute rotation was less than or equal to 10 degrees and Y=0 otherwise (absolute rotation greater than 10 degrees). The proportion of eyes with absolute rotation less than or equal to 10 degrees was report for each lens.
Time frame: 15-minutes after lens insertion
Population: All dispensed subjects regardless of subsequent withdrawal from study or deviation from protocol.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Test-senofilcon A (C3) | Proportion of Eyes With Absolute Rotation Less Than or Equal to 10 Degrees | 0.9784 Proportion of eyes |
| Control-senofilcon A (C3) | Proportion of Eyes With Absolute Rotation Less Than or Equal to 10 Degrees | 0.9918 Proportion of eyes |
Comparison: It was calculated using a Bayesian beta-binomial model for correlated data with a reference rate of 0.99 and an intraclass correlation of 0.70, that 100 subjects were required to test for superiority to achieve a minimum statistical power of 99% with 95% central posterior credible interval.95% CI: [0.95, 0.989]Bayesian beta- binomial model
Primary
Proportion of Eyes With Acceptable Lens Fitting
Contact lens fitting acceptance was assessed for each subject eye using a biomicroscope post lens insertion at the 1-week follow-up. Lens fit was a binary variable where acceptable lens fit=1 and unacceptable lens fit=0. The proportion of eyes with acceptable lens fit was reported for each lens.
Time frame: Up to 1-Week Follow-up
Population: All dispensed subjects regardless of subsequent withdrawal from study or deviation from protocol.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Test-senofilcon A (C3) | Proportion of Eyes With Acceptable Lens Fitting | 1 Proportion of eyes |
| Control-senofilcon A (C3) | Proportion of Eyes With Acceptable Lens Fitting | 1 Proportion of eyes |
Comparison: It was calculated using a Bayesian beta-binomial model for correlated data with a reference rate of 0.99 and an intraclass correlation of 0.70, that 100 subjects were required to test for superiority to achieve a minimum statistical power of 99% with 95% central posterior credible interval.95% CI: [0.977, 0.997]Bayesian beta- binomial model
Primary
Proportion of Eyes With Grade 3 or Higher Slit Lamp Findings
Slit Lamp Findings (SLF) were assessed using a biomicroscope and was graded using the FDA grading scale (Grade: 0, 1,2, 3 and 4) with grade 0 represents the absence of findings and 1 to 4 representing successively worse findings (i.e. Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). This was performed on each subject eye at every study visit (baseline, unscheduled visits and 1-week follow-up). The data was then dichotomized into two groups. Those with grade 3 or higher and those with grade 2 or lower. The proportion of eyes with SLF with grade 3 or higher was reported for each lens.
Time frame: Up to 1-Week Follow-up
Population: All dispensed subjects regardless of subsequent withdrawal from study or deviation from protocol.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Test-senofilcon A (C3) | Proportion of Eyes With Grade 3 or Higher Slit Lamp Findings | 0 Proportion of eyes |
| Control-senofilcon A (C3) | Proportion of Eyes With Grade 3 or Higher Slit Lamp Findings | 0 Proportion of eyes |
Comparison: It was calculated using a Bayesian beta-binomial model for correlated data with a reference rate of 0.01 and an intraclass correlation of 0.70, that 100 subjects were required to test for superiority to achieve a minimum statistical power of 99% with 95% central posterior credible Interval.95% CI: [0, 0.01]Bayesian beta-binomial model
Primary
Proportion of Eyes With Rotational Stability Less Than or Equal to 5 Degrees
Rotational Stability was assessed for each subject eye using a slit lamp 15-minutes after lens insertion. Rotational Stability was dichotomized into a binary response where Y=1 if Rotational Stability was less than or equal to 5 degrees and Y=0 otherwise (Rotational Stability greater than 5 degrees). The proportion of eyes with Rotational Stability less than or equal to 5 degrees was report for each lens.
Time frame: 15-minutes after lens insertion
Population: All dispensed subjects regardless of subsequent withdrawal from study or deviation from protocol.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Test-senofilcon A (C3) | Proportion of Eyes With Rotational Stability Less Than or Equal to 5 Degrees | 1 Proportion of eyes |
| Control-senofilcon A (C3) | Proportion of Eyes With Rotational Stability Less Than or Equal to 5 Degrees | 1 Proportion of eyes |
Comparison: It was calculated using a Bayesian beta-binomial model for correlated data with a reference rate of 0.99 and an intraclass correlation of 0.70, that 100 subjects were required to test for superiority to achieve a minimum statistical power of 99% with 95% central posterior credible interval.95% CI: [0.976, 0.997]Bayesian beta-binomial model
Secondary
CLUE Comfort Score
Subjective comfort was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) 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 0-120. The average CLUE comfort score was reported.
Time frame: 1-Week Follow-up
Population: All dispensed subjects regardless of deviation from protocol with data collected at the 1-week follow-up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test-senofilcon A (C3) | CLUE Comfort Score | 66.20 Units on a scale | Standard Deviation 24.134 |
| Control-senofilcon A (C3) | CLUE Comfort Score | 67.04 Units on a scale | Standard Deviation 22.269 |
Comparison: It was calculated using a 1-sided one sample mean t-test with a type I error rate of 0.025 that 135 subjects provide at least 97% statistical power to test for superiority.Linear Mixed Model
Secondary
CLUE Handling Score
Subjective handling was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) 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 0-120. The average CLUE handling score was reported.
Time frame: 1-Week Follow-up
Population: All dispensed subjects regardless of deviation from protocol with data collected at the 1-week follow-up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test-senofilcon A (C3) | CLUE Handling Score | 70.30 Units on a scale | Standard Deviation 20.999 |
| Control-senofilcon A (C3) | CLUE Handling Score | 70.87 Units on a scale | Standard Deviation 22.752 |
Comparison: It was calculated using a 1-sided one sample mean t-test with a type I error rate of 0.025 that 135 subjects provide at least 97% statistical power to test for superiority.Linear Mixed Model