MyopiaNCT05984290
Study of Safety and Effectiveness of the Boston Orthokeratology Shaping Lens in the Arise Orthokeratology Lens
A study testing orthokeratology lens in people with Myopia, run by Bausch & Lomb Incorporated at 6 sites in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Myopia
- What is being tested?
- orthokeratology lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 6 sitesUnited States
- Study dates
- 11 Jul 2023to 27 Jun 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Show all 10Show fewer
- 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.
Who cannot join
- 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.
Show all 19Show fewer
- 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:
- They are currently pregnant
- They plan to become pregnant during the study
- They are breastfeeding
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Birmingham Vision Care P.C.
Bloomfield, Michigan, 48301
Cornea and Contact Lens Institute of Minnesota
Edina, Minnesota, 55436
Levenson Eye Associates
Jacksonville, Florida, 32204
Speciality Eyecare Group
Kirkland, Washington, 98034
Optometric Physicians of Middle Tennessee
Nashville, Tennessee, 37205
The Koetting Associates
St Louis, Missouri, 63144
About this study
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
The objective of this orthokeratology study is to evaluate the safety and effectiveness of the Arise Orthokeratology Lens with non-spherical posterior peripheral curves
Read the 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.
- Conditions
- Myopia
- Being tested
- orthokeratology lens
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
orthokeratology lensDevice
Each subject will wear the study lenses in both eyes overnight for approximately 3 months.
| Study group | Role | What they receive |
|---|---|---|
| Safety and effectiveness of the Arise Orthokeratology Lens | Experimental | Treatment effect of overnight orthokeratology over a 3-month period Receives: Device: orthokeratology lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Rate of Serious Adverse Events at the Subject Level
Measured: 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
Measured: Assessed at 3 month follow up visit
The Rate of Serious Adverse Events at the Eye Level
Measured: Assessed from dispensing through 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2023
- Study start11 Jul 2023
- Primary completion27 Jun 2024
- Study completion27 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for MyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bausch & Lomb Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05984290
- Sponsor's protocol ID
- 918
- Status last verified
- Aug 2025
- First submitted
- 2 Aug 2023
- Last updated
- 24 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05984290
- Acronym / sponsor ID
- 918
- Conditions
- Myopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Bausch & Lomb IncorporatedIndustry (pharma, biotech, devices)
- Study start
- 11 Jul 2023 (actual)
- Primary completion
- 27 Jun 2024 (actual)
- Study completion
- 27 Jun 2024 (actual)
- First posted
- 9 Aug 2023 (actual)
- Results
- Posted 24 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Safety and effectiveness of the Arise Orthokeratology Lens | Experimental | Device: orthokeratology lensTreatment effect of overnight orthokeratology over a 3-month period |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| orthokeratology lensEach subject will wear the study lenses in both eyes overnight for approximately 3 months. | Device | Safety and effectiveness of the Arise Orthokeratology Lens |
Primary outcome
The Rate of Serious Adverse Events at the Subject Level
Time frame: 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
Time frame: Assessed at 3 month follow up visit
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
The Rate of Serious Adverse Events at the Eye Level
Time frame: Assessed from dispensing through 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing orthokeratology lens in people with Myopia, run by Bausch & Lomb Incorporated at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Rate of Serious Adverse Events at the Subject Level (time frame: Assessed from dispensing through 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2025.