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

NCT04954833 | Completed Results

• 1 other identifier: CR-6441
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Visual Acuity

Outcome Measures

Primary Outcomes (1)

• Monocular Distance Visual Acuity (logMAR)

  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.

  10 minutes post lens insertion

Secondary Outcomes (1)

• Percentage of Subjects' Eyes With Acceptable Lens Fit

  10 minutes post lens insertion

Study Arms (2)

TEST/CONTROL

EXPERIMENTAL

Eligible subjects will randomly be assigned to one of two unique sequences of the two lens types, Test/Control.

Device: EMO-200; Device: EMO-118

CONTROL/TEST

EXPERIMENTAL

Eligible subjects will randomly be assigned to one of two unique sequences of the two lens types, Control/Test.

Device: EMO-200; Device: EMO-118

Interventions

EMO-200 DEVICE

TEST Lens

CONTROL/TEST; TEST/CONTROL

EMO-118 DEVICE

CONTROL Lens

CONTROL/TEST; TEST/CONTROL

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Potential subjects must satisfy all of the following criteria to be enrolled in the study:
• 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.
• Appear able and willing to adhere to the instructions set forth in this clinical protocol.
• Between 7 and 12 (inclusive) years of age at the time of screening.
• Have normal eyes (i.e., no ocular medications or infections of any type).
• Have non-vertex corrected subjective spherical distance refraction in the range of -0.75 D to -4.50 D (inclusive) in each eye.
• 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.
• 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).
• Have \< 1.50 D difference in subjective best-sphere refraction between the two eyes.

You may not qualify if:

• Potential subjects who meet any of the following criteria will be excluded from participating in the study:
• Currently pregnant or lactating.
• 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.
• Use of systemic medications (e.g., chronic steroid use) that are known to interfere with contact lens wear and/or participation in the study.
• Any current use of ocular medication (occasional use of re-wetting drops is allowed).
• Any previous or planned (during the course of the study) ocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.).
• Participation in any contact lens or lens care product clinical trial within 30 days prior to study enrollment.
• Current or recent (within 60 days from enrollment) wear of orthokeratology lenses.
• Current or recent (within 30 days from enrollment) rigid lens wearers.
• Immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician).
• Children who are wards of the State or any other agency, institution, or entity.
• 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.
• 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.
• 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.
• Any central corneal scar.

Sponsors & Collaborators

• Johnson & Johnson Vision Care, Inc.: lead

Study Sites (1)

William J. Bogus, OD

Salt Lake City, Utah, 84106, United States

Location

Results Point of Contact

• Title: Xu Cheng
• Organization: Johnson & Johnson Vision Care, Inc. (JJVC)

xcheng6@its.jnj.com

1-800-843-2020

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2021
• First Posted: July 8, 2021
• Study Start: June 14, 2021
• Primary Completion: August 16, 2021
• Study Completion: August 16, 2021
• Last Updated: April 27, 2025
• Results First Posted: August 22, 2024

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share

Locations

US (1)