Visual Acuity
Conditions
Brief summary
This is a multi-site, bilateral, dispensing, randomized, controlled, single-masked, 3x3 crossover study with a run-in period.
Interventions
DEVICE1-Day Acuvue Moist
Run-in Contact Lens
DEVICEEMO-118
Test Lens1
DEVICEEMO-114
Test Lens2
DEVICEMiSight® 1 day
Control Lens
Sponsors
Johnson & Johnson Vision Care, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
7 Years to 17 Years
Healthy volunteers
Yes
Inclusion criteria
* Potential subjects must satisfy all of the following criteria to be enrolled in the study: 1. Read (or be read to) and sign the CHILDREN'S ASSENT (Information and Assent Form) and receive a fully executed copy of the form. 2. Have parents or legal guardians who must read, understand, and sign the STATEMENT OF INFORMED CONSENT (Parental Permission Form and Authorization to Use and Disclose Medical Information). 3. Appear able and willing to adhere to the instructions set forth in this clinical protocol. 4. Be between 7 and 17 (inclusive) years of age at the time of screening. 5. By self-report, habitually wear soft contact lenses or be a current non-contact lens wearer interested in soft lens wear. 6. The non-vertex corrected best sphere distance refraction must be between -1.00 D and -4.50 D (inclusive) in each eye. 7. The magnitude of the cylindrical component of the subject's vertex-corrected distance refraction must be less than or equal to 0.75 D (inclusive) in each eye with any degree of axis. 8. The distance visual acuity with best sphere distance correction must be 20/25 or better in each eye. 9. Have ≤ 1.50 D difference in subjective best-sphere refraction between the two eyes. 10. Have 20/40 or better vision in each eye with wearable spectacles or uncorrected.
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 diabetic. 3. Be currently using any ocular medications. Lubricants (artificial tears) eyedrops are allowed. 4. Have any current ocular infection of any type. 5. Have any systemic disease (e.g., Sjogren's Syndrome), allergies, infectious disease (e.g., hepatitis, tuberculosis), contagious immunosuppressive diseases (e.g., HIV), autoimmune disease (e.g., rheumatoid arthritis), any underlying medical condition that makes subjects at risk of severe COVID complications, a history of serious mental illness or seizures, or other diseases, by parent or legal guardian's self-report, which are known to interfere with contact lens wear and/or participation in the study. 6. Use of systemic medication (e.g., chronic steroid use) that are known to interfere with contact lens wear and/or participation in the study. See section 9.1 for additional details regarding excluded systemic medications. 7. Have habitually worn rigid gas permeable (RGP) lenses, orthokeratology lenses, or hybrid lenses (e.g. SynergEyes, SoftPerm) within the past 30 days. 8. Be currently wearing lenses in an extended wear modality. 9. Be currently wearing soft contact lenses for astigmatism in either eye. 10. Have participated in a contact lens or lens care product clinical trial within 7 days prior to study enrollment. 11. 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. 12. Children who are wards of the State or any other agency, institution, or entity. 13. Have any ocular allergies, infections, or other ocular abnormalities that are known to interfere with contact lens wear and/or participation in the study. This may include, but is not limited to, entropion, ectropion, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, moderate or above corneal distortion, herpetic keratitis. 14. Have grade 3 or greater palpebral conjunctival observations or any other grade 2 slit lamp findings on the ISO 11980 classification scale. 15. Have strabismus (intermittent or constant) or amblyopia. 16. Have a history or signs of a contact lens-related corneal inflammatory event (e.g., past peripheral ulcer or round peripheral scar). 17. Have any central corneal scar. 18. Have a pupil diameter under bright illumination of less than 2 mm in either eye.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Binocular Visual Performance (LogMAR) | Up to 2-Week Follow-up | Visual performance was calculated as binocular contact lens-corrected distance visual acuity using a Logarithm of Minimal Angle of Resolution (logMAR) visual acuity scale. This was evaluated under high luminance and high contrast conditions (HLHC) at 4 meters from Early Treatment Diabetic Retinopathy Study (ETDRS) charts at the 2-week follow-up visit. Lower visual performance values indicate better vision. A value of 0.0 logMAR is equivalent to 20/20 Snellen Visual Acuity. The average visual performance was reported for each lens type. Binocular visual performance for Run-in lens was measured at 1-week follow-up visit. |
Countries
United States
Participant flow
Recruitment details
A total of 79 subjects were enrolled in this study. Of those enrolled, 75 subjects were randomized and dispensed at least one study lens, while 4 subjects failed to meet all eligibility criteria. Of those dispensed, 65 subjects completed the study while, 10 subjects were discontinued from the study.
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| 3 | Covid-19 related | 2 | 0 | 0 | 0 | 0 | 1 |
| 4 | Unsatisfactory Visual Response due to Test Article | 1 | 0 | 0 | 0 | 0 | 0 |
| Period 1 | Subject No Longer Meets Eligibility Criteria | 0 | 0 | 0 | 0 | 1 | 0 |
| Period 1 | Unsatisfactory Visual Response due to Test Article | 0 | 1 | 0 | 0 | 0 | 0 |
| Period 2 | COVID-19 Related | 0 | 0 | 0 | 1 | 0 | 1 |
| Period 2 | Subject Withdrawn by PI due to Non Compliance to Protocol | 0 | 0 | 0 | 0 | 0 | 1 |
| Period 2 | Unsatisfactory Visual Response due to Test Article | 0 | 1 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Total |
|---|---|
| Age, Continuous | 12.6 Years STANDARD_DEVIATION 2.36 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 6 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 5 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 60 Participants |
| Region of Enrollment United States | 75 Participants |
| Sex: Female, Male Female | 50 Participants |
| Sex: Female, Male Male | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 75 | 0 / 69 | 0 / 70 | 0 / 69 |
| other Total, other adverse events | 0 / 75 | 0 / 69 | 0 / 70 | 0 / 69 |
| serious Total, serious adverse events | 0 / 75 | 0 / 69 | 0 / 70 | 0 / 69 |
Outcome results
Primary
Binocular Visual Performance (LogMAR)
Visual performance was calculated as binocular contact lens-corrected distance visual acuity using a Logarithm of Minimal Angle of Resolution (logMAR) visual acuity scale. This was evaluated under high luminance and high contrast conditions (HLHC) at 4 meters from Early Treatment Diabetic Retinopathy Study (ETDRS) charts at the 2-week follow-up visit. Lower visual performance values indicate better vision. A value of 0.0 logMAR is equivalent to 20/20 Snellen Visual Acuity. The average visual performance was reported for each lens type. Binocular visual performance for Run-in lens was measured at 1-week follow-up visit.
Time frame: Up to 2-Week Follow-up
Population: All subjects who successfully completed all study visits without a major protocol deviation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Run-in: Etafilcon A | Binocular Visual Performance (LogMAR) | -0.10 logMAR | Standard Deviation 0.057 |
| Senofilcon A C3 (EMO-114) [Test 2] | Binocular Visual Performance (LogMAR) | -0.10 logMAR | Standard Deviation 0.063 |
| Senofilcon A C3 (EMO-118) [Test 1] | Binocular Visual Performance (LogMAR) | -0.07 logMAR | Standard Deviation 0.064 |
| Omafilcon A (MS1D) [Control] | Binocular Visual Performance (LogMAR) | -0.11 logMAR | Standard Deviation 0.059 |
95% CI: [0.02, 0.06]Linear Mixed Model