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

Study to Evaluate Safety and Effectiveness of the Boston Orthokeratology (Oprifocon A) Shaping Lens in the Arise Orthokeratology Lens Design With Non-spherical Posterior Peripheral Curves

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

Study Overview

• Status: Recruiting
• Conditions: Astigmatism
• Intervention / Treatment: Device: orthokeratology lens

Detailed Description

The Bausch + Lomb Vision Shaping Treatment VST is based on a reverse geometry orthokeratology design that includes a base curve/treatment curve, a reverse curve, alignment curves and peripheral curves. The base curve is used to only flatten the cornea and is not considered a fitting curve. The parameters of the Arise Orthokeratology Lens are controlled to be within the bounds determined by the spherical posterior curves of other lens designs prescribed for the Bausch + Lomb Vision Shaping Treatment. The term peripheral curves excludes the base curve and includes the zones defined as the reverse curve, alignment curves and peripheral curves. Peripheral curves are designed to help control centration of the lens. When there are elevation differences between the flat and steep meridians on the cornea (e.g., corneal toricity), spherical peripheral curves, including the reverse curve, alignment curves and peripheral curves, may not align completely to the cornea and can result in a lens with sub-optimal centration. Aspheric curves and toric (e.g., dual axis) peripheral curves on reverse geometry lenses for overnight orthokeratology have been available in the US market for more than 10 years for fitting lenses. The intent of the Arise Orthokeratology Lens is to provide a stable and centered lens that helps ensure the treatment zone of the lens is well positioned in relation to the pupil and is shaping the central portion of the cornea for optimal results.

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Meg Swartzenberg; Phone Number: (585) 623-9588; Email: Margaret.Swartzenberg@bausch.com

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32204
      • Recruiting
      • Levenson Eye Associates
      • Contact: Frank Mcdoland; Phone Number: 904-366-3781; Email: fwmcdonald@hotmail.com
  • Michigan
    • Bloomfield, Michigan, United States, 48301
      • Recruiting
      • Birmingham Vision Care P.C.
      • Contact: Patricia Poma-Nowinski; Phone Number: 248-539-4800; Email: drpoma@birminghamvision.com
  • Minnesota
    • Edina, Minnesota, United States, 55436
      • Recruiting
      • Cornea and Contact Lens Institute of Minnesota
      • Contact: Zachary Holland; Phone Number: 952-300-2151; Email: zachary.holland10@gmail.com
  • Missouri
    • Saint Louis, Missouri, United States, 63144
      • Recruiting
      • The Koetting Associates
      • Contact: Nick Castellano; Phone Number: 314-863-0000; Email: ncastellano@koettingassociates.com
  • Tennessee
    • Nashville, Tennessee, United States, 37205
      • Recruiting
      • Optometric Physicians of Middle Tennessee
      • Contact: Richard Durocher; Phone Number: 615-519-6242; Email: RD@OPMT.COM
  • Washington
    • Kirkland, Washington, United States, 98034
      • Recruiting
      • Speciality Eyecare Group
      • Contact: David Kading; Phone Number: 425-821-8900; Email: drdave@specialtyeye.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Participants should be12 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.

2. orthokeratology lens naïve.
3. Spherical refractive error no greater than -5.00D.
4. Astigmatism no greater than 1.50D.
5. Corneal topography sagittal height differential of ≥ 30 microns between the two main meridians (flat and steep) at an 8mm chord.
6. Participants should have keratometric readings from 39.00 to 48.00D.
7. Participants should have a clear and undistorted Mire Reflex.
8. Participants should be willing and able to comply with all treatment and follow-up study visits and procedures.
9. Participants must be willing to refrain from wearing habitual soft contact lenses during the study period.

Exclusion Criteria:

1. 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.
2. 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.
3. Prior eyelid, strabismus, intraocular, or refractive surgery.
4. Keratoconus or an irregular cornea.
5. 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.
6. Subjects using any systemic or topical medications that will, in the Investigator's opinion, affect ocular physiology or lens performance.
7. A known allergy to fluorescein, benoxinate, or proparacaine.
8. A history of corneal hypoesthesia (reduced corneal sensitivity), corneal ulcer, corneal infiltrates, ocular viral or fungal infections or recurrent ocular infections.
9. Subjects with an active ocular disease or who are using any ocular medication.
10. 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.
11. 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.
12. 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.
13. 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.
14. Subjects who are amblyopic.
15. Immediate family or close relative is a member of the office staff, including the Investigator(s).

16. Females of childbearing potential (those who are not surgically sterilized or postmenopausal) if they meet any one of the following:

    • currently pregnant
    • plan to become pregnant during the study
    • breastfeeding

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Safety and effectiveness of the Arise Orthokeratology Lens; Treatment effect of overnight orthokeratology over a 3-month period	Device: orthokeratology lens; Each subject will wear the study lenses in both eyes overnight for approximately 3 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The rate of serious adverse events at the subject and eye levels	overnight over 3 months

Collaborators and Investigators

• Sponsor: Bausch & Lomb Incorporated

Study record dates

Study Major Dates

• Study Start (Actual): July 11, 2023
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: August 2, 2023
• First Submitted That Met QC Criteria: August 2, 2023
• First Posted (Actual): August 9, 2023

Study Record Updates

• Last Update Posted (Actual): April 2, 2024
• Last Update Submitted That Met QC Criteria: April 1, 2024
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Astigmatism
• Other Study ID Numbers: 918

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes