Visual Acuity
Conditions
Brief summary
This study is a randomized, 5-visit, partial subject masked, 2x3 bilateral crossover, dispensing clinical trial. During the study, each test article will be worn in a daily wear modality for at least 6 hours per day and 5 days per week for approximately 2 weeks each. The subject will wear either the Test or Control article twice and the other study article once. The primary objective of this study is to demonstrate that the Test lens works as well, if not better compared to the Control lens with respect to CLUE (Contact Lens User Experience) comfort, Slit Lamp findings, and Distance Monocular logMAR Visual Acuity. This study will also aim to show acceptable lens fit for subjects wearing the Test lens.
Interventions
DEVICECONTROL
ACUVUE OASYS
DEVICETEST
senofilcon A with new UV blocker
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 49 Years
Healthy volunteers
Yes
Inclusion criteria
* Potential subjects must satisfy all of the following inclusion criteria to be enrolled in the study: 1. The subject must read and sign the Informed Consent form. 2. The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol. 3. Healthy adult males or females age ≥18 and ≤49 years of age with signed informed consent. Eligible presbyopes will be those that wear full distance contact lenses in both eyes, then wear reading glasses over them. 4. The subject's optimal vertexed spherical equivalent distance correction must be between -1.00 and - 6.00 Diopter (D). 5. The subject's refractive cylinder must be ≤ 1.00D in each eye. 6. The subject must have visual acuity best correctable to 20/25+3 or better for each eye. 7. Subjects must own a wearable pair of spectacles. 8. The subject is a current spherical soft contact lens wearer (defined as a minimum of 6 hours of Daily Wear per day, at least 5 days per week, for a minimum of 1 month prior to the study) and willing to wear the study lenses on a similar basis. 9. Subjects must be able and willing to wear the study lenses at least 6 hours a day, a minimum of 5 days per week 10. The subject must have normal eyes (i.e., no ocular medications or infections of any type).
Exclusion criteria
* Potential subjects who meet any of the following criteria will be excluded from participating in the study: 1. Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued). 2. Any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear. This may include, but not be limited to, diabetes, hyperthyroidism, recurrent herpes simplex/zoster, Sjögren's syndrome, xerophthalmia, acne rosacea, Stevens-Johnson syndrome, and immunosuppressive diseases or any infectious diseases (e.g. hepatitis, tuberculosis). 3. Use of any of the following medications within 1 week prior to enrollment: oral retinoid isotretinoin (e.g. Accutane), oral tetracyclines, topical scopolamine, oral (e.g., Chlor-Trimeton, and Benadryl) and ophthalmic antihistamines, oral phenothiazines (e.g., Haldol, Mellaril, Thorazine, Elavil, Pamelor, Compazine), oral and ophthalmic Beta-adrenergic blockers (e.g., Propranolol, Timolol, and Practolol), systemic steroids, and any prescribed or over the counter (OTC) ocular medication. 4. Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or moderate or above corneal distortion. 5. Any previous, or planned, ocular or intraocular surgery (e.g., radial keratotomy, photorefractive keratectomy (PRK), LASIK, etc.). 6. Any Grade 3 or greater slit lamp findings (e.g.., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the FDA classification scale, any previous history or signs of a contact lens-related corneal inflammatory event (e.g., past peripheral ulcer or round peripheral scar), or any other ocular abnormality that may contraindicate contact lens wear. 7. Any known hypersensitivity or allergic reaction to Optifree®PureMoist® multi-purpose care solution or Eye-Cept® rewetting drop solution 8. Any ocular infection, allergy or clinically significant ocular disease (e.g. corneal edema, uveitis, severe keratoconjunctivitis sicca, ocular hypertension), or ocular conditions (e.g. strabismus), which might interfere with the study. 9. Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear. 10. Toric, extended wear, monovision or multi-focal contact lens correction. 11. Participation in any contact lens or lens care product clinical trial within 30 days prior to study enrollment. 12. Participation in clinical trials involving the Test lens within 3 months prior to study enrollment. 13. History of binocular vision abnormality or strabismus. 14. Employee, relative or friends of employees of any ophthalmic company, or investigational clinic (e.g., Investigator, Coordinator, Technician).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Comfort | 2-Week Follow-up | Overall 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 comfort score from the 3 study periods was reported. |
| Distance Monocular LogMAR Visual Acuity | 2-Week Follow-up | Distance Monocular LogMAR visual acuity was assessed at 4 meters using an ETDRS chart at the 2-week follow-up for each subject eye during each of the three study periods. The average visual acuity for each lens type from the 3 study periods was reported. |
| Contact Lens Fitting Acceptance Rate | Up to 2-Week Follow-up | Contact lens fitting acceptance was assessed for each subject eye using a biomicroscope at post lens insertion and the 2-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. The lens fit acceptance rate for both post lens fitting at the 2-week follow-up was reported for each lens type. |
| Number of Grade 3 or Higher Slit Lamp Findings | Up to 2-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 2-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 number of SLF with grade 3 or higher by lens was reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Quality of Vision | 2-Week Follow-up | Overall quality of 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 vision score from the 3 study periods was reported. |
| Overall Handling | 2-Week Follow-up | Overall 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 handling score from the 3 study periods was reported. |
Countries
United States
Participant flow
Recruitment details
A total of 133 subjects were enrolled into this study. Of the enrolled subjects, 130 were dispensed at least one study lens and 3 subjects failed to meet all eligibility criteria. Of the dispensed subjects 127 completed the study while 3 subjects were discontinued.
Participants by arm
| Arm | Count |
|---|---|
| Dispensed Subjects All subjects that were dispensed at least one study lens. | 130 |
| Total | 130 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Period 1 | Adverse Event | 1 | 0 |
| Period 1 | no longer meets eligibility criteria | 0 | 1 |
| Period 2 | Lost to Follow-up | 1 | 0 |
Baseline characteristics
| Characteristic | Dispensed Subjects |
|---|---|
| Age, Continuous | 31.6 Years STANDARD_DEVIATION 7.69 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 2 Participants |
| Race/Ethnicity, Customized Asian | 4 Participants |
| Race/Ethnicity, Customized Black or African American | 12 Participants |
| Race/Ethnicity, Customized Other | 1 Participants |
| Race/Ethnicity, Customized White | 111 Participants |
| Sex: Female, Male Female | 88 Participants |
| Sex: Female, Male Male | 42 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 130 | 0 / 130 |
| other Total, other adverse events | 0 / 130 | 0 / 130 |
| serious Total, serious adverse events | 0 / 130 | 0 / 130 |
Outcome results
Primary
Contact Lens Fitting Acceptance Rate
Contact lens fitting acceptance was assessed for each subject eye using a biomicroscope at post lens insertion and the 2-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. The lens fit acceptance rate for both post lens fitting at the 2-week follow-up was reported for each lens type.
Time frame: Up to 2-Week Follow-up
Population: Subjects that completed all study visits.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Test | Contact Lens Fitting Acceptance Rate | 1 proportion of eyes |
| Control | Contact Lens Fitting Acceptance Rate | 1 proportion of eyes |
Comparison: It was calculated that 70 participants randomized in a 1:1 fashion between the two sequences would have at least 80% power to detect a the 2-week follow-up. Sample size was determined using simulations methods for repeated measures. Analysis was only performed on eyes wearing the Tesl lens.95% CI: [0.96, 1]Bayesian Methods
Primary
Distance Monocular LogMAR Visual Acuity
Distance Monocular LogMAR visual acuity was assessed at 4 meters using an ETDRS chart at the 2-week follow-up for each subject eye during each of the three study periods. The average visual acuity for each lens type from the 3 study periods was reported.
Time frame: 2-Week Follow-up
Population: All subjects that completed all study visits without a major protocol deviation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test | Distance Monocular LogMAR Visual Acuity | -0.095 logMAR | Standard Deviation 0.0831 |
| Control | Distance Monocular LogMAR Visual Acuity | -0.075 logMAR | Standard Deviation 0.0806 |
Comparison: It was calculated that 40 participants randomized in a 1:1 fashion between the two sequences would have at least 80% power to detect a 0.05 difference in LogMAR visual acuity at the 2-week follow-up. Sample size was determined using simulations methods for repeated measures.95% CI: [0.01, 0.03]Bayesian multivariate normal random-effe
Primary
Number of 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 2-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 number of SLF with grade 3 or higher by lens was reported.
Time frame: Up to 2-Week Follow-up
Population: Subjects that were dispensed at least one study lens.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Test | Number of Grade 3 or Higher Slit Lamp Findings | 0 Slit Lamp Finding |
| Control | Number of Grade 3 or Higher Slit Lamp Findings | 1 Slit Lamp Finding |
Comparison: It was calculated that 120 participants randomized in a 1:1 fashion between the two sequences would have at least 80% power to detect 5% difference between the Test and Control lens with respect to the proportion of eyes with Grade 3 or higher slit lamp findings across all study visits. Sample size was determined using simulations methods. Sample size for this study was primarily driven by the slit lamp findings.95% CI: [-0.0237, 0.0129]Bayesian beta-binomial model
Primary
Overall Comfort
Overall 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 comfort score from the 3 study periods was reported.
Time frame: 2-Week Follow-up
Population: All subjects that completed all study visits without a major protocol deviation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test | Overall Comfort | 67.509 Units on a Scale | Standard Deviation 23.8724 |
| Control | Overall Comfort | 61.185 Units on a Scale | Standard Deviation 24.2024 |
Comparison: It was calculated that 60 participants randomized in a 1:1 fashion between the two sequences would have at least 80% power to detect a 5 points difference in mean overall comfort at the 2-week follow-up. Sample size was determined using Stroup's Method (alpha=0.05).95% CI: [1.16, 9.09]Bayesian multivariate normal random-effe
Secondary
Overall Handling
Overall 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 handling score from the 3 study periods was reported.
Time frame: 2-Week Follow-up
Population: All subjects that completed all study visits without a major protocol deviation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test | Overall Handling | 72.11 Units on a Scale | Standard Deviation 20.046 |
| Control | Overall Handling | 66.79 Units on a Scale | Standard Deviation 20.007 |
Comparison: Sample size calculations were based on the primary endpoints.95% CI: [0.36, 6.29]Bayesian multivariate normal random-effe
Secondary
Overall Quality of Vision
Overall quality of 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 vision score from the 3 study periods was reported.
Time frame: 2-Week Follow-up
Population: All subjects that completed all study visits without a major protocol deviation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test | Overall Quality of Vision | 69.16 Units on a Scale | Standard Deviation 20.362 |
| Control | Overall Quality of Vision | 60.329 Units on a Scale | Standard Deviation 22.289 |
Comparison: Sample size calculations were based on the primary endpoints.95% CI: [3.69, 10.74]Bayesian multivariate normal random-effe