Clinical trial NCT06389916: Euclid Phoenix Lens Design Trial
Official title: Euclid Phoenix Lens Design Trial Phase 1
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Myopia
Cornea
Lead sponsor: Euclid Systems Corporation
Sponsor class: INDUSTRY
First posted: 2024-04-29
Enrollment: 30
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The "first fit" success rate of the current Euclid orthokeratology "MAX" lens design will be compared to that of the new Euclid orthokeratology MAX "Phoenix" lens design in 30 children.

Detailed description: The primary objective of this trial is to provide an assessment of the "first fit" success of the Euclid orthokeratology "Phoenix" lens design versus its current "MAX" lens design when used by practitioners with moderate experience with fitting Euclid MAX orthokeratology lenses.

The hypothesis to be tested is that the "first fit" success of the redesign Euclid MAX "Phoenix" lens design is greater than that of the current MAX lens design.

The primary outcome variable is the percentage of participants successfully fit with the first lenses empirically ordered for the existing MAX lens design versus a modified MAX lens ("Phoenix") design.

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

Eligibility criteria: 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 6-18 (inclusive) and able to understand and assent to participation
* Have need of optical correction for myopia, from -1.00 to -5.00 dioptcrs (D).
* Have a refractive astigmatism of less than -1.50 D.
* Have a minimum Best Spectacle Corrected Visual Acuity (BSCVA) of 20/40 or better.
* Have reasonable expectations of improvement in visual acuity with the Euclid Orthokeratology Lens of 20/40 or better after overnight wear without corrective aids.
* Be at least 18 years old to give informed consent.
* Not a current or former wearer of orthokeratology lenses
* Not a current wearer of soft contact lenses
* Have acceptable or optimal fit with study lenses 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
* 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
* Habitually uncorrected anisometropia ≥2.00
* 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

Primary outcomes:
measure: First fit success rate
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Costa Mesa
country: United States
facility: Insight Vision Center Optometry
state: California
city: Saint Johns
country: United States
facility: Dau Family Eye Care
state: Florida
city: Edina
country: United States
facility: Cornea and Contact Lens Institute of Minnesota
state: Minnesota
city: North Brunswick
country: United States
facility: Somerset Eye Care
state: New Jersey
city: Tysons Corner
country: United States
facility: Treehouse Eyes
state: Virginia
Study officials:
References: