Study of Safety and Effectiveness of the Boston Orthokeratology Shaping Lens in the Arise Orthokeratology Lens

NCT05984290 | Completed Results FDA Device

• 1 other identifier: 918
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 6

Brief Summary

The objective of this orthokeratology study is to evaluate the safety and effectiveness of the Arise Orthokeratology Lens with non-spherical posterior peripheral curves

Conditions

Myopia

Outcome Measures

Primary Outcomes (3)

• The Rate of Serious Adverse Events at the Subject Level

  Assessed from dispensing through 3 months

• Percentage of Subjects Who Achieve Monocular Uncorrected Distance Visual Acuity (UDVA) of 20/40 or Better in Both Eyes

  Using the high contrast distance UDVA collected at the 3-Month Follow-up Visit, subjects with non-missing Snellen VA of 20/40 or less in both eyes will be classified as "20/40 or Better". Subjects with at least one missing value at the 3-Month Follow-up Visit will not be classified and their classification value will be assigned as a missing value. The denominator for percentages will be the number of non-missing values

  Assessed at 3 month follow up visit

• The Rate of Serious Adverse Events at the Eye Level

  Assessed from dispensing through 3 months

Study Arms (1)

Safety and effectiveness of the Arise Orthokeratology Lens

EXPERIMENTAL

Treatment effect of overnight orthokeratology over a 3-month period

Device: orthokeratology lens

Interventions

orthokeratology lens DEVICE

Each subject will wear the study lenses in both eyes overnight for approximately 3 months.

Safety and effectiveness of the Arise Orthokeratology Lens

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Be 12 years or older on the date the Informed Consent Form (ICF) is signed and, as subject or parent or legal guardian of a minor subject, have capacity to read, understand and provide written voluntary informed consent on the IRB-approved ICF and provide authorization as appropriate for local privacy regulations.
• Be orthokeratology lens naïve.
• Spherical refractive error between plano and -5.00D.
• Astigmatism no greater than 1.50D.
• Corneal topography sagittal height differential of ≥ 30 microns between the two main meridians (flat and steep) at an 8mm chord.
• Has keratometric readings from 39.00 to 48.00D.
• Has a clear and undistorted Mire Reflex.
• Be willing and able to comply with all treatment and follow-up study visits and procedures.
• Must be willing to refrain from wearing habitual soft contact lenses during the study period.
• Subjects must be correctable through spherocylindrical refraction to 42 letters (0.1 logMAR) or better (distance, high contrast) in each eye.

You may not qualify if:

• Subject is considered by the Investigator, to not be a suitable candidate for participation or it is not in the best interest of the subject to participate in the study.
• Subjects who have worn rigid gas permeable (RGP) contact lenses within the last 30 days or who have worn polymethylmethacrylate (PMMA) lenses within the last three months.
• Prior eyelid, strabismus, intraocular, or refractive surgery.
• Keratoconus or an irregular cornea.
• Subjects with any systemic disease currently affecting ocular health or in the Investigator's opinion may have an effect on ocular health during the course of the study.
• Subjects using any systemic or topical medications that will, in the Investigator's opinion, affect ocular physiology or lens performance.
• A known allergy to fluorescein, benoxinate, or proparacaine.
• A history of corneal hypoesthesia (reduced corneal sensitivity), corneal ulcer, corneal infiltrates, ocular viral or fungal infections or recurrent ocular infections.
• Subjects with an active ocular disease or who are using any ocular medication.
• Subjects with any Grade 2 or greater finding during the slit lamp examination. Subjects with corneal infiltrates, of ANY GRADE, are NOT eligible. Refer to Appendix B: Methods of Clinical Evaluation.
• Subjects with any "Present" finding during the slit lamp examination that, in the Investigator's judgement, interferes with contact lens wear. Refer to Appendix B: Methods of Clinical evaluation.
• Subjects with any scar or neovascularization within the central 6mm of the cornea. Subjects with minor peripheral corneal scarring (that does not extend into the central area), that in the Investigator's judgement, does not interfere with contact lens wear, are eligible for this study.
• Subjects participating in any drug or device clinical investigation within 2 weeks prior to entry into this study (Screening Visit) and/or planning to do so during the period of study participation.
• Subjects who are amblyopic.
• Immediate family or close relative is a member of the office staff, including the Investigator(s).

Sponsors & Collaborators

• Bausch & Lomb Incorporated: lead

Study Sites (6)

Levenson Eye Associates

Jacksonville, Florida, 32204, United States

Location

Birmingham Vision Care P.C.

Bloomfield, Michigan, 48301, United States

Location

Cornea and Contact Lens Institute of Minnesota

Edina, Minnesota, 55436, United States

Location

The Koetting Associates

St Louis, Missouri, 63144, United States

Location

Optometric Physicians of Middle Tennessee

Nashville, Tennessee, 37205, United States

Location

Speciality Eyecare Group

Kirkland, Washington, 98034, United States

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Director, Medical Affairs, Vision Care R&D
• Organization: Bausch & Lomb Incorporated

marjorie.rah@bausch.com

585-413-6397

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2023
• First Posted: August 9, 2023
• Study Start: July 11, 2023
• Primary Completion: June 27, 2024
• Study Completion: June 27, 2024
• Last Updated: August 24, 2025
• Results First Posted: August 24, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)