Euclid Phoenix Lens Design Trial 2

Euclid Phoenix Lens Design Trial Part 2

Lens wettability and subjective comfort of Euclid orthokeratology lenses with and without an enhanced coating will be compared in 50 children. Axial elongation will be monitored in pediatric patients who qualify and consent.

Study Overview

• Status: Not yet recruiting
• Conditions: Myopia; Cornea
• Intervention / Treatment: Device: Euclid orthokeratology (standard coating); Device: Euclid orthokeratology (enhanced coating)

Detailed Description

The primary objective of this trial is to provide an assessment of the lens wettability and patient comfort with an enhanced surface treatment for the Emerald Lens design when used by practitioners with moderate experience with fitting Euclid orthokeratology lenses.

The hypothesis to be tested is that the proportion of participants with a lens wettability score of > 3 (on a 5 point scale) with the enhanced surface treatment will be greater than that of the current lens surface, using a 1 to 5 scale

The primary outcome variable is lens wettability as measured on eye using a 1 to 5 scale

This clinical investigation will be a prospective, randomized, double-masked two-arm non-crossover trial.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sally Dillehay, OD, EdD; Phone Number: 7705214358‬; Email: sally.dillehay@clintrialsolutions.org
• Study Contact Backup: Name: Brett O'Connor, OD; Phone Number: 9048947427; Email: boconnor@clintrialsolutions.org

Study Locations

• United States
  • Minnesota
    • Edina, Minnesota, United States, 55436
      • Cornea and Contact Lens Institute of Minnesota
      • Contact: Zachary Holland
    • Sartell, Minnesota, United States, 56377
      • PineCone Vision Center
      • Contact: Trevor Fosso, OD
  • New Jersey
    • North Brunswick, New Jersey, United States, 08902
      • Somerset Eye Care
      • Contact: Tobin Ansel
  • Tennessee
    • Memphis, Tennessee, United States, 38104
      • Southern College of Optometry
      • Contact: Chris Lievens
  • Washington
    • Kirkland, Washington, United States, 98034
      • Specialty Eyecare Group
      • Contact: David Kading

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Be of legal age or, if under legal age have written consent of their parent or guardian to participate.
• Sign written Informed Consent (and the California Bill of Rights, if applicable).
• Ages 6-35 (inclusive) and able to understand and assent to participation

• Current wearers of Euclid Emerald (Oprifocon A) Orthokeratology lenses, which at initiation of fitting, had

  • Need of optical correction for myopia, from -1.00 to -5.00 Diopters (D).
  • Refractive astigmatism of less than -1.50 D.
• Have a minimum Best Spectacle Corrected Visual Acuity (BSCVA) of 20/40 or better in each eye.
• Have acceptable or optimal fit with study lenses (once fitting has been completed) and be willing to wear these lenses as directed for the duration of the study.

• On examination, have ocular findings considered to be within normal limits, including:

  • No evidence of active infection involving the conjunctiva, lids or adnexa.
  • No evidence of structural abnormalities of the lid, conjunctiva or adnexal tissue considered significant by the investigator to include minimum levels (Grade 2 or less) of tarsal-conjunctival abnormalities
  • Clear corneas with no evidence of edema, staining, opacities, corneal neovascularization greater than a trace amount (i.e. All vessels extending less than 1.5 mm from the limbus); all as observed on slit lamp examination.
  • No iritis.
  • No herpes keratitis (recurrent or otherwise) or other active ocular disease that would contraindicate lens wear or lessen attainability of VA sought in this study (20/40 or better).
  • No evidence of dry eye or meibomian gland dysfunction
• Normal binocularity (no amblyopia or strabismus, and no anisometropia of greater than 2.00D)
• Be willing and able to follow instructions and attend the schedule of follow-up visits.

Exclusion Criteria:

• Does not meet the any of the above inclusion criteria
• Not able or willing to provide informed consent and assent
• Requires concurrent ocular medication
• Eye injury or surgery within twelve weeks immediately prior to enrollment
• Pre-existing ocular condition that would preclude contact lens fitting
• Currently enrolled in an ophthalmic clinical trial
• Pregnant or lactating or expect to become pregnant during the trial
• Evidence of systemic or ocular abnormality, infection or disease likely to affect successful wear of contact lenses or use of their accessory solutions.
• Allergy or sensitivity to any product used in this trial
• Any systemic disease including autoimmune disease, immunocompromising diseases, connective tissue disease, clinically significant atopic diseases, insulin dependent diabetes, use of medications including corticosteroids and antimetabolites that may affect the eye or be exaggerated by contact lenses.
• Strabismus/amblyopia
• Habitual uncorrected anisometropia ≥ 2.00D
• Subjects who have undergone corneal refractive surgery
• Subjects with severe corneal irregularity contraindicating lens wear
• Inability to wear contact lenses, or an unacceptable contact lens fit
• Poor or unacceptable fit with any study lens
• Employees, staff or family members of personnel at the site

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Euclid orthokeartology (standard coating); Euclid Orthokeratology Contact Lenses are lathe cut contact lenses with spherical posterior surfaces. The posterior curve is selected to properly fit an individual eye for orthokeratology and the anterior curve is selected to provide the necessary optical power for a temporary reduction of myopia. A peripheral curve system on the posterior surface allows tear exchange between the lens and the cornea.	Device: Euclid orthokeratology (standard coating); Lens with the current coating
Experimental: Euclid orthokeartology (enhanced coating); Euclid Orthokeratology Contact Lenses are lathe cut contact lenses with spherical posterior surfaces. The posterior curve is selected to properly fit an individual eye for orthokeratology and the anterior curve is selected to provide the necessary optical power for a temporary reduction of myopia. A peripheral curve system on the posterior surface allows tear exchange between the lens and the cornea.	Device: Euclid orthokeratology (enhanced coating); Lens with the enhanced coating

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lens wettability	Lens wettability as measured on eye using a 1 to 5 scale	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient comfort ratings	Patient comfort as measured by patient reported outcome using a 1 to 5 scale	12 months

Collaborators and Investigators

• Sponsor: Euclid Systems Corporation

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): August 1, 2025
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: April 26, 2024
• First Submitted That Met QC Criteria: April 26, 2024
• First Posted (Actual): April 30, 2024

Study Record Updates

• Last Update Posted (Actual): April 30, 2024
• Last Update Submitted That Met QC Criteria: April 26, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: EU-PHX-RCT-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

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.: No