Evaluating Visual Acuity and Initial Fit Performance of Two Soft Contact Lenses

Completed

Conditions: Visual Acuity

Interventions: Device: EMO-200
Device: EMO-118

Registration Number: NCT04954833

Lead Sponsor: Johnson & Johnson Vision Care, Inc.

Brief Summary: This is a multi-center, randomized, controlled, double-masked, 2x2 cross-over, non-dispensing study to compare visual acuity and lens fit performance.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 60

Inclusion Criteria

Potential subjects must satisfy all of the following criteria to be enrolled in the study:
1. The subject's parents or legal guardians must read, understand, and sign the STATEMENT OF INFORMED CONSENT (Parental Permission Form and Authorization to Use and Disclose Medical Information). The subject must 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. Appear able and willing to adhere to the instructions set forth in this clinical protocol.
3. Between 7 and 12 (inclusive) years of age at the time of screening.
4. Have normal eyes (i.e., no ocular medications or infections of any type).
5. Have non-vertex corrected subjective spherical distance refraction in the range of -0.75 D to -4.50 D (inclusive) in each eye.
6. Have refractive cylinder in the range of 0.00 D to -1.00 D (inclusive) in each eye with any degree of axis, by subjective sphero-cylindrical refraction.
7. Have sphero-cylindrical best-corrected visual acuity of 0.04 logMAR (20/20-2) or better in each eye, and the difference of sphero-cylindrical best-corrected visual acuity between the two eyes is less than 0.20 logMAR (2 lines).
8. Have < 1.50 D difference in subjective best-sphere refraction between the two eyes.

Exclusion Criteria

Potential subjects who meet any of the following criteria will be excluded from participating in the study:
1. Currently pregnant or lactating.
2. Have any systemic disease (e.g., Sjögren'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, or other diseases, by parent of legal guardian's self-report, which are known to interfere with contact lens wear and/or participation in the study.
3. Use of systemic medications (e.g., chronic steroid use) that are known to interfere with contact lens wear and/or participation in the study.
4. Any current use of ocular medication (occasional use of re-wetting drops is allowed).
5. Any previous or planned (during the course of the study) ocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.).
6. Participation in any contact lens or lens care product clinical trial within 30 days prior to study enrollment.
7. Current or recent (within 60 days from enrollment) wear of orthokeratology lenses.
8. Current or recent (within 30 days from enrollment) rigid lens wearers.
9. Immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician).
10. Children who are wards of the State or any other agency, institution, or entity.
11. 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 not be limited to entropion, ectropion, extrusions, chalazia, recurrent styes, ocular hypertension, glaucoma, history of recurrent corneal erosions, aphakia, uveitis, severe keratoconjunctivitis sicca, keratoconus, keratoconus suspect, and pellucid marginal degeneration.
12. Grade 3 or greater palpebral conjunctival observations or any other Grade 2 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, conjunctival injection) on the ISO 11980 classification scale.
13. 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 or subjects' participation in the study.
14. Any central corneal scar.
15. Any corneal distortion resulting from ocular diseases or previous hard or rigid gas permeable contact lens wear.
16. Binocular vision abnormality, intermittent strabismus or strabismus.
17. Pupil diameter under bright illumination is less than 2 mm in either eye.

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
TEST/CONTROL	EMO-200	Eligible subjects will randomly be assigned to one of two unique sequences of the two lens types, Test/Control.
TEST/CONTROL	EMO-118	Eligible subjects will randomly be assigned to one of two unique sequences of the two lens types, Test/Control.
CONTROL/TEST	EMO-118	Eligible subjects will randomly be assigned to one of two unique sequences of the two lens types, Control/Test.
CONTROL/TEST	EMO-200	Eligible subjects will randomly be assigned to one of two unique sequences of the two lens types, Control/Test.

Primary Outcome Measures

Name	Time	Method
Monocular Distance Visual Acuity (logMAR)	10 minutes post lens insertion	Visual acuity on logMAR (Logarithm of Minimal Angle of Resolution) scale was evaluated at distance (4 meters) under high luminance high contrast lighting condition 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 0.00 is equivalent to Snellen visual acuity of 20/20.

Secondary Outcome Measures

Name	Time	Method
Percentage of Subjects' Eyes With Acceptable Lens Fit	10 minutes post lens insertion	Lens fit acceptance was assessed post lens fitting for each subject eye using a biomicroscope. Acceptable fit was a binary response where Y=1 if lens fit was deemed acceptable by the investigator and Y=0 otherwise. An unacceptable fit was observed if any of the following criteria were met: 1.) limbal exposure at primary gaze or with extreme eye movement, 2.) edge lift, 3.) excessive movement in primary and up gaze or 4.) insufficient movement in the three conditions- primary gaze, up gaze and Josephson push up. Time Frame 10 minutes post lens insertion