Visual Acuity
Conditions
Brief summary
This study is a feasibility, multi-site, randomized, double-masked, 2-arm parallel group design, 2-week dispensing study with weekly visits to evaluate visual acuity.
Interventions
DEVICEsenofilcon A contact lenses made with a novel manufacturing technology
TEST Lens
DEVICEsenofilcon A contact lenses made with the current manufacturing technology
CONTROL Lens
Sponsors
Johnson & Johnson Vision Care, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
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: 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 (inclusive) years of age at the time of screening. 4. By self-report, habitually wear spherical soft silicone hydrogel contact lenses in both eyes in a daily reusable or daily disposable wear modality (i.e. not extended wear modality). Habitual wear is defined as a minimum of 6 hours of wear per day, for a minimum of 5 days per week during the past 30 days. 5. Possess a wearable pair of spectacles that provide correction for distance vision. 6. The spherical equivalent of the subject's vertex-corrected distance refraction must be between -1.00 and -6.00 DS (inclusive) in each eye. 7. The magnitude of the cylindrical component of the subject's vertex-corrected distance refraction must be between 0.00 and 1.00 DC (inclusive) in each eye. 8. The best corrected, monocular, distance visual acuity must be 20/25 or better in each eye.
Exclusion criteria
Potential subjects who meet any of the following criteria will be excluded from participating in the study: 1. Be currently pregnant or lactating. 2. Be currently using any ocular medications or have any ocular infection of any type. 3. By self-report, have any ocular or systemic disease, allergies, infection, or use of medication that the investigator believes 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. 4. Be currently wearing monovision or multifocal contact lenses. 5. Be currently wearing lenses in an extended wear modality. 6. Have participated in a contact lens or lens care product clinical trial within 7 days prior to study enrollment. 7. 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. 8. 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 the investigator believes will 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). (Specify method of determination if needed). 9. Have fluctuations in vision due to clinically significant dry eye or other ocular conditions. 10. 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 |
|---|---|---|
| Monocular logMAR Visual Acuity | 2-Week Follow-up | Monocular visual acuity was measured on a logMAR (Logarithm of Minimal Angle of Resolution) scale under high luminance low contrast (HLLC), and low luminance high contrast (LLHC) at distance (4 meters) using an 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. |
| Average Daily Wearing Time | 2-Week Follow-up | Average daily wear time was assessed by calculating the number of hours between subjects reported time of insertion and time of removal of the study lenses, on an average day. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CLUE Comfort Score | 2-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. The average CLUE comfort score for each lens type was reported. |
| CLUE Vision Score | 2-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. The average CLUE vision score for each lens type was reported. |
Countries
United States
Participant flow
Recruitment details
A total of 123 subjects were enrolled in this study. Of those enrolled, all 123 subjects were dispensed at least one study lens. Of those dispensed, 118 subjects completed the study while 5 subjects were discontinued.
Participants by arm
| Arm | Count |
|---|---|
| Senofilcon A Contact Lenses Made With the Current Manufacturing Technology Subjects that wore the Senofilcon A contact lenses made with the current manufacturing technology lens during the study. | 62 |
| Senofilcon A Contact Lenses Made With a Novel Manufacturing Technology Subjects that wore the Senofilcon A contact lenses made with a novel manufacturing technology lens during the study. | 61 |
| Total | 123 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | COVID-19 Related | 1 | 2 |
| Overall Study | Senofilcon A contact lenses made with a novel manufacturing technology Article Not Available. | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Senofilcon A Contact Lenses Made With a Novel Manufacturing Technology | Total | Senofilcon A Contact Lenses Made With the Current Manufacturing Technology |
|---|---|---|---|
| Age, Continuous | 30.7 Years STANDARD_DEVIATION 5.85 | 30.4 Years STANDARD_DEVIATION 5.42 | 30.1 Years STANDARD_DEVIATION 5 |
| Race/Ethnicity, Customized Asian | 2 Participants | 4 Participants | 2 Participants |
| Race/Ethnicity, Customized Black or African American | 6 Participants | 14 Participants | 8 Participants |
| Race/Ethnicity, Customized Multiple | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized White | 52 Participants | 104 Participants | 52 Participants |
| Region of Enrollment United States participants | 61 Participants | 123 Participants | 62 Participants |
| Sex: Female, Male Female | 42 Participants | 90 Participants | 48 Participants |
| Sex: Female, Male Male | 19 Participants | 33 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 62 | 0 / 61 |
| other Total, other adverse events | 0 / 62 | 0 / 61 |
| serious Total, serious adverse events | 0 / 62 | 0 / 61 |
Outcome results
Primary
Average Daily Wearing Time
Average daily wear time was assessed by calculating the number of hours between subjects reported time of insertion and time of removal of the study lenses, on an average day.
Time frame: 2-Week Follow-up
Population: All subjects who successfully completed all study visits without a major protocol deviation at 2-Week Follow-up evaluation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Senofilcon A Contact Lenses Made With the Current Manufacturing Technology | Average Daily Wearing Time | 14.2 hours | Standard Deviation 2.12 |
| Senofilcon A Contact Lenses Made With a Novel Manufacturing Technology | Average Daily Wearing Time | 14.5 hours | Standard Deviation 1.97 |
Comparison: It was calculated using a 2 independent sample means t-test with a 2-sided type I error rate of 5% with at least 80% statistical power, that 100 subjects were required to test for non-inferiority of the Senofilcon A contact lenses made with a novel manufacturing technology compared to the Senofilcon A contact lenses made with the current manufacturing technology.95% CI: [-0.46, 1.01]Linear Mixed Model
Primary
Monocular logMAR Visual Acuity
Monocular visual acuity was measured on a logMAR (Logarithm of Minimal Angle of Resolution) scale under high luminance low contrast (HLLC), and low luminance high contrast (LLHC) at distance (4 meters) using an 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: 2-Week Follow-up
Population: All subjects who successfully completed all study visits without a major protocol deviation at 2-Week Follow-up evaluation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Senofilcon A Contact Lenses Made With the Current Manufacturing Technology | Monocular logMAR Visual Acuity | High Luminance Low Contrast | 0.051 logMAR | Standard Deviation 0.1082 |
| Senofilcon A Contact Lenses Made With the Current Manufacturing Technology | Monocular logMAR Visual Acuity | Low Luminance High Contrast | 0.044 logMAR | Standard Deviation 0.1042 |
| Senofilcon A Contact Lenses Made With a Novel Manufacturing Technology | Monocular logMAR Visual Acuity | High Luminance Low Contrast | 0.032 logMAR | Standard Deviation 0.0947 |
| Senofilcon A Contact Lenses Made With a Novel Manufacturing Technology | Monocular logMAR Visual Acuity | Low Luminance High Contrast | 0.036 logMAR | Standard Deviation 0.083 |
Comparison: It was calculated using a 2 independent sample means t-test with a 2-sided type I error rate of 5% with at least 80% statistical power, that 100 subjects were required to test for non-inferiority of the Senofilcon A contact lenses made with a novel manufacturing technology compared to the Senofilcon A contact lenses made with the current manufacturing technology for distance (4m) under HLLC.95% CI: [-0.04, 0]Linear Mixed Model
Comparison: It was calculated using a 2 independent sample means t-test with a 2-sided type I error rate of 5% with at least 80% statistical power, that 100 subjects were required to test for non-inferiority of the Senofilcon A contact lenses made with a novel manufacturing technology compared to the Senofilcon A contact lenses made with the current manufacturing technology for distance (4m) under LLHC.95% CI: [-0.03, 0.02]Linear Mixed Model
Secondary
CLUE Comfort 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. The average CLUE comfort score for each lens type was reported.
Time frame: 2-Week Follow-up
Population: All subjects who successfully completed all study visits without a major protocol deviation at 2-Week Follow-up evaluation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Senofilcon A Contact Lenses Made With the Current Manufacturing Technology | CLUE Comfort Score | 71.53 Units on a scale | Standard Deviation 28.439 |
| Senofilcon A Contact Lenses Made With a Novel Manufacturing Technology | CLUE Comfort Score | 76.06 Units on a scale | Standard Deviation 21.838 |
95% CI: [-4.1, 12]Linear Mixed Model
Secondary
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. The average CLUE vision score for each lens type was reported.
Time frame: 2-Week Follow-up
Population: All subjects who successfully completed all study visits without a major protocol deviation at 2-Week Follow-up evaluation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Senofilcon A Contact Lenses Made With the Current Manufacturing Technology | CLUE Vision Score | 73.28 Units on a scale | Standard Deviation 24.077 |
| Senofilcon A Contact Lenses Made With a Novel Manufacturing Technology | CLUE Vision Score | 74.26 Units on a scale | Standard Deviation 20.615 |
95% CI: [-7.1, 6.5]Linear Mixed Model