Euclid Phoenix Lens Design Trial 2

NCT06392607 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: EU-PHX-RCT-002
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Myopia; Cornea

Outcome Measures

Primary Outcomes (1)

• Lens wettability

  Lens wettability as measured on eye using a 1 to 5 scale

  12 months

Secondary Outcomes (1)

• Patient comfort ratings

  12 months

Study Arms (2)

Euclid orthokeartology (standard coating)

EXPERIMENTAL

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)

Euclid orthokeartology (enhanced coating)

EXPERIMENTAL

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)

Interventions

Euclid orthokeratology (standard coating) DEVICE

Lens with the current coating

Euclid orthokeartology (standard coating)

Euclid orthokeratology (enhanced coating) DEVICE

Lens with the enhanced coating

Euclid orthokeartology (enhanced coating)

Eligibility Criteria

• Age: 6 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Euclid Systems Corporation: lead

Study Sites (5)

Cornea and Contact Lens Institute of Minnesota

Edina, Minnesota, 55436, United States

Location

Pinecone Vision Center

Sartell, Minnesota, 56377, United States

Location

Somerset Eye Care

North Brunswick, New Jersey, 08902, United States

Location

Southern College of Optometry

Memphis, Tennessee, 38104, United States

Location

Specialty Eyecare Group

Kirkland, Washington, 98034, United States

Location

MeSH Terms

Conditions

Myopia; Corneal Diseases

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Central Study Contacts

Sally Dillehay, OD, EdD

CONTACT

7705214358‬; sally.dillehay@clintrialsolutions.org

Brett O'Connor, OD

CONTACT

9048947427; boconnor@clintrialsolutions.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2024
• First Posted: April 30, 2024
• Study Start: May 1, 2024
• Primary Completion: August 1, 2025
• Study Completion: September 1, 2025
• Last Updated: April 30, 2024

Record last verified: 2024-04

Locations

US (5)