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

Primary Purpose

Astigmatism

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
orthokeratology lens
Sponsored by
Bausch & Lomb Incorporated
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Astigmatism

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. orthokeratology lens naïve. Spherical refractive error no greater than -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. Participants should have keratometric readings from 39.00 to 48.00D. Participants should have a clear and undistorted Mire Reflex. Participants should be willing and able to comply with all treatment and follow-up study visits and procedures. Participants must be willing to refrain from wearing habitual soft contact lenses during the study period. Exclusion Criteria: 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). 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

Sites / Locations

  • Levenson Eye AssociatesRecruiting
  • Birmingham Vision Care P.C.Recruiting
  • Cornea and Contact Lens Institute of MinnesotaRecruiting
  • The Koetting AssociatesRecruiting
  • Optometric Physicians of Middle TennesseeRecruiting
  • Speciality Eyecare GroupRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Safety and effectiveness of the Arise Orthokeratology Lens

Arm Description

Treatment effect of overnight orthokeratology over a 3-month period

Outcomes

Primary Outcome Measures

The rate of serious adverse events at the subject and eye levels

Secondary Outcome Measures

Full Information

First Posted
August 2, 2023
Last Updated
August 30, 2023
Sponsor
Bausch & Lomb Incorporated
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1. Study Identification

Unique Protocol Identification Number
NCT05984290
Brief Title
Study of Safety and Effectiveness of the Boston Orthokeratology Shaping Lens in the Arise Orthokeratology Lens
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 11, 2023 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bausch & Lomb Incorporated

4. Oversight

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

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Astigmatism

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Safety and effectiveness of the Arise Orthokeratology Lens
Arm Type
Experimental
Arm Description
Treatment effect of overnight orthokeratology over a 3-month period
Intervention Type
Device
Intervention Name(s)
orthokeratology lens
Intervention Description
Each subject will wear the study lenses in both eyes overnight for approximately 3 months.
Primary Outcome Measure Information:
Title
The rate of serious adverse events at the subject and eye levels
Time Frame
overnight over 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. orthokeratology lens naïve. Spherical refractive error no greater than -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. Participants should have keratometric readings from 39.00 to 48.00D. Participants should have a clear and undistorted Mire Reflex. Participants should be willing and able to comply with all treatment and follow-up study visits and procedures. Participants must be willing to refrain from wearing habitual soft contact lenses during the study period. Exclusion Criteria: 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). 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Meg Swartzenberg
Phone
(585) 623-9588
Email
Margaret.Swartzenberg@bausch.com
Facility Information:
Facility Name
Levenson Eye Associates
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32204
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Frank Mcdoland
Phone
904-366-3781
Email
fwmcdonald@hotmail.com
Facility Name
Birmingham Vision Care P.C.
City
Bloomfield
State/Province
Michigan
ZIP/Postal Code
48301
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patricia Poma-Nowinski
Phone
248-539-4800
Email
drpoma@birminghamvision.com
Facility Name
Cornea and Contact Lens Institute of Minnesota
City
Edina
State/Province
Minnesota
ZIP/Postal Code
55436
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zachary Holland
Phone
952-300-2151
Email
zachary.holland10@gmail.com
Facility Name
The Koetting Associates
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63144
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nick Castellano
Phone
314-863-0000
Email
ncastellano@koettingassociates.com
Facility Name
Optometric Physicians of Middle Tennessee
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37205
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Richard Durocher
Phone
615-519-6242
Email
RD@OPMT.COM
Facility Name
Speciality Eyecare Group
City
Kirkland
State/Province
Washington
ZIP/Postal Code
98034
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Kading
Phone
425-821-8900
Email
drdave@specialtyeye.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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