Euclid Phoenix Lens Design Trial 2 for Myopia and Cornea Conditions

This study is testing two types of Euclid orthokeratology lenses (special contact lenses worn overnight to reshape the cornea and improve vision) in 50 participants aged 6 to 35. One lens has a standard coating, and the other has an enhanced coating. Researchers want to see if the enhanced coating improves how well the lens stays wet (lens wettability) and how comfortable it is for patients. For children in the study, they will also monitor how their eyes grow (axial elongation). The study will be considered successful if the enhanced lens shows better wettability compared to the standard lens after 12 months.

Study design: This is a prospective, randomized, double-masked study with two groups, involving 50 participants. This means participants will be randomly assigned to receive one of the two lens types, and neither they nor the researchers will know which lens they are using.
What's involved: Not specified in the trial record.
Compensation: Not stated in the trial record.
Follow-up: Lens wettability will be measured at 12 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

Euclid Phoenix Lens Design Trial 2

UNKNOWN

NAAges 6–35InterventionalTreatment

Euclid Systems Corporation

~50 participants

Updated 2024-04-30 on ClinicalTrials.gov

What's tested:Euclid orthokeratology (standard coating)Euclid orthokeratology (enhanced coating)

At a glance

Recruiting sites

0 of 5 listed sites are recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Lens wettability

Measured over 12 months

Conditions

Myopia

Cornea

Where it's being run

5 sites across 4 states

Minnesota2

New Jersey1

Tennessee1

Washington1

Who to contact

Sally Dillehay, OD, EdD

[email protected]

7705214358‬

Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.

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

What this trial measures

Lens wettability12 months
Lens wettability as measured on eye using a 1 to 5 scale

Trialytics