Evaluation of On-eye Optical Performances of the RMY-100 Lens

NCT03670277 | Completed Results FDA Device

• 1 other identifier: CR-6000
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

This is a two-arm parallel, non-masked, bilateral, non-dispensing study with one Test arm and one concurrent, non-randomized Control arm to evaluate the one-eye optical performances of the test soft contact lens and compare with eyes treated with orthokeratology.

Conditions

Visual Acuity

Outcome Measures

Primary Outcomes (2)

• Distance Spherical Aberration (Z4, 0)

  Spherical aberration (Z4, 0) for a 5-mm pupil was measured by an aberrometer (COAS by AMO) with a distant viewing target at 4 m at the Baseline and post lens fitting. The Control Group only had 1 study Visit that record Baseline measurements, no intervention from the sponsor was implemented for this group, therefore data was collected on a bare eye. The Test group was fitted with the study lens at Visit 2 and data was collected with the Test lens on eye.

  Up to Post Lens Fitting Evaluation

• Near Spherical Aberration (Z4, 0)

  Spherical aberration (Z4, 0) for a 5 mm pupil was measured by an aberrometer (COAS by AMO) with a near view target at 25 cm. at the Baseline and post lens fitting. The Control Group only had 1 study Visit that record Baseline measurements, no intervention from the sponsor was implemented for this group, therefore data was collected on a bare eye. The Test group was fitted with the study lens at Visit 2 and data was collected with the Test lens on eye.

  Up to Post Lens Fitting Evaluation

Secondary Outcomes (2)

• Distance Off-axis Refraction at ±10°, ±20°, and ±30° Retinal Eccentricities.

  Up to Post Lens Fitting Evaluation

• Near Off-axis Refraction at ±30° Retinal Eccentricities.

  Up to Post Lens Fitting Evaluation

Study Arms (2)

TEST arm

EXPERIMENTAL

For subjects enrolled in the Test arm, the Test Soft Contact Lens will be bilaterally fitted to the subject's eyes. Endpoint measures will be collected over one eye only - Test Arm: OD only.

Device: etafilcon A

CONTROL arm

EXPERIMENTAL

Subjects enrolled in the Control Arm will be established orthokeratology lens wearers. Endpoint measures will be collected over one eye only - Control Arm: Better OK fitted eyes based on investigator's judgement.

Device: Habitual Orthokeratology Lenses

Interventions

etafilcon A DEVICE

Test Soft Contact Lens

TEST arm

Habitual Orthokeratology Lenses DEVICE

CONTROL

CONTROL arm

Eligibility Criteria

• Age: 7 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Potential subjects must satisfy all of the following criteria to be enrolled in the study:
• Pediatric subjects (\<18 years old) must read (or be read to), understand, and sign the Statement of Information and Assent and receive a fully executed copy of the form.
• Adult subjects (≥18 years old) and parent(s) or legal guardian(s) of pediatric subjects must read, understand and sign the Statement of Informed Consent 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 25 years of age (inclusive).
• Have normal eyes (i.e., no ocular medications or infections of any type).
• Vertex-corrected distance subjective best-sphere refraction must be between -1.00D and -5.00D (inclusive) in each eye.
• Cylindrical refraction must be 1.00D or less in each eye, by subjective sphero-cylindrical refraction.
• Have sphero-cylindrical best-corrected visual acuity of 20/25 or better in each eye.
• Are existing orthokeratology patients whose current treatment has been stabilized for at least 1 months and with complete pre-treatment record, e.g., spherocylindrical refraction and corneal topography. Pre-treatment wavefront aberration measures are preferred by not required.

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.
• Any systemic allergies, infectious disease (e.g., hepatitis, tuberculosis), autoimmune disease (e.g., rheumatoid arthritis), or other diseases, by 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 topical medication (occasional use of re-wetting drops is allowed).
• Any previous or planned ocular or intraocular surgery, including refractive surgery.
• Participation in any contact lens or lens care product clinical trial within 7 days prior to study enrollment.
• Employee or their children/relatives of investigational clinic (e.g., Investigator, Coordinator, Technician). 8 . 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, aphakia, uveitis, ocular hypertension, glaucoma, severe keratoconjunctivitis sicca, history of recurrent corneal erosions, keratoconus, keratoconus suspect, pellucid marginal degeneration, entropion, ectropion, extrusions, chalazia, and recurrent styes.
• Any Grade 3 or greater slit lamp findings (eg, edema, corneal neovascularization, corneal staining, tarsal abnormalities, and conjunctival injection) on the FDA scale.

Sponsors & Collaborators

• Johnson & Johnson Vision Care, Inc.: lead

Study Sites (1)

Centre for Ocular Research & Education

Waterloo, Ontario, Canada

Location

Results Point of Contact

• Title: Xu Cheng, MD, PhD, FAAO - Sr. Principal Clinical Scientist
• Organization: Johnson & Johnson Vision Care

xcheng6@its.jnj.com

1-800-843-2020

Study Officials

• Xu Cheng

  Johnson & Johnson Vision Care, Inc.

  STUDY CHAIR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2018
• First Posted: September 13, 2018
• Study Start: August 22, 2018
• Primary Completion: February 19, 2019
• Study Completion: February 19, 2019
• Last Updated: April 25, 2025
• Results First Posted: January 14, 2022

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)