MyopiaNCT06392607
Euclid Phoenix Lens Design Trial 2
A study testing Euclid orthokeratology (standard coating) and Euclid orthokeratology (enhanced coating) in people with Myopia and Cornea, run by Euclid Systems Corporation at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 35 yearsHealthy volunteers can take part
- What is being tested?
- Euclid orthokeratology (standard coating) and Euclid orthokeratology (enhanced coating)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 5 sitesUnited States
- Study dates
- May 2024to Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 6 to 35 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Cornea and Contact Lens Institute of Minnesota
Edina, Minnesota, 55436
Zachary Holland
Specialty Eyecare Group
Kirkland, Washington, 98034
David Kading
Southern College of Optometry
Memphis, Tennessee, 38104
Chris Lievens
Somerset Eye Care
North Brunswick, New Jersey, 08902
Tobin Ansel
Pinecone Vision Center
Sartell, Minnesota, 56377
Trevor Fosso, OD
About this study
Official title: 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.
Read the 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.
- Being tested
- Euclid orthokeratology (standard coating), Euclid orthokeratology (enhanced coating)
- Medical subject headings
- Myopia, Corneal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Euclid orthokeratology (standard coating)Device
Lens with the current coating
Euclid orthokeratology (enhanced coating)Device
Lens with the enhanced coating
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Euclid orthokeratology (enhanced coating) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lens wettability
Lens wettability as measured on eye using a 1 to 5 scale
Measured: 12 months
Secondary outcomes (1)
Patient comfort ratings
Patient comfort as measured by patient reported outcome using a 1 to 5 scale
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2024
- Study startMay 2024 (estimated)
- Primary completionAug 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Euclid Systems Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06392607
- Sponsor's protocol ID
- EU-PHX-RCT-002
- Status last verified
- Apr 2024
- First submitted
- 26 Apr 2024
- Last updated
- 30 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Euclid Phoenix Lens Design Trial Part 2
- ClinicalTrials.gov ID
- NCT06392607
- Acronym / sponsor ID
- EU-PHX-RCT-002
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Euclid Systems CorporationIndustry (pharma, biotech, devices)
- Study start
- May 2024 (estimated)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 30 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Euclid orthokeartology (standard coating) | Experimental | Device: Euclid orthokeratology (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. |
| Euclid orthokeartology (enhanced coating) | Experimental | Device: Euclid orthokeratology (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. |
Who may qualify
- Ages
- 6 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (17 listed)
- 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
- Have a minimum Best Spectacle Corrected Visual Acuity (BSCVA) of 20/40 or better in each eye.
Key exclusion criteria (17 listed)
- 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
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 |
|---|---|---|
| Euclid orthokeratology (standard coating)Lens with the current coating | Device | Euclid orthokeartology (standard coating) |
| Euclid orthokeratology (enhanced coating)Lens with the enhanced coating | Device | Euclid orthokeartology (enhanced coating) |
Primary outcome
Lens wettability
Time frame: 12 months
Lens wettability as measured on eye using a 1 to 5 scale
1 secondary outcome
Patient comfort ratings
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2024.
- Individual participant dataSharing planned: Undecided
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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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Euclid orthokeratology (standard coating) and Euclid orthokeratology (enhanced coating) in people with Myopia and Cornea, run by Euclid Systems Corporation at 5 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 17 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 30 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sally Dillehay, OD, EdD (7705214358, sally.dillehay@clintrialsolutions.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lens wettability (time frame: 12 months). 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 30 Apr 2024.