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

NCT ID: NCT03670277

Last Updated: 2025-04-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-22
• Study Completion Date: 2019-02-19

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TEST arm

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.

Group Type: EXPERIMENTAL

etafilcon A

Intervention Type: DEVICE

Test Soft Contact Lens

CONTROL arm

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.

Group Type: EXPERIMENTAL

Habitual Orthokeratology Lenses

Intervention Type: DEVICE

CONTROL

Interventions

etafilcon A

Test Soft Contact Lens

Intervention Type: DEVICE

Habitual Orthokeratology Lenses

CONTROL

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Potential subjects must satisfy all of the following criteria to be enrolled in the study:

1. 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.

2. 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.

3. Appear able and willing to adhere to the instructions set forth in this clinical protocol.

4. Between 7 and 25 years of age (inclusive).

5. Have normal eyes (i.e., no ocular medications or infections of any type).

6. Vertex-corrected distance subjective best-sphere refraction must be between -1.00D and -5.00D (inclusive) in each eye.

7. Cylindrical refraction must be 1.00D or less in each eye, by subjective sphero-cylindrical refraction.

8. Have sphero-cylindrical best-corrected visual acuity of 20/25 or better in each eye.

Below inclusion criterion is for subjects to be enrolled to the Control group only:

9. 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.

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. 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.

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 topical medication (occasional use of re-wetting drops is allowed).

5. Any previous or planned ocular or intraocular surgery, including refractive surgery.

6. Participation in any contact lens or lens care product clinical trial within 7 days prior to study enrollment.

7. 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.

9 . Any Grade 3 or greater slit lamp findings (eg, edema, corneal neovascularization, corneal staining, tarsal abnormalities, and conjunctival injection) on the FDA scale.

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Johnson & Johnson Vision Care, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xu Cheng

Role: STUDY_CHAIR

Johnson & Johnson Vision Care, Inc.

Locations

Centre for Ocular Research & Education

Waterloo, Ontario, Canada

Countries

Canada

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CR-6000

Identifier Type: -

Identifier Source: org_study_id