MyopiaNCT06389916
Euclid Phoenix Lens Design Trial
A study testing Euclid orthokeratology MAX (current design) and Euclid orthokeratology MAX Phoenix (new design) in people with Myopia and Cornea, run by Euclid Systems Corporation at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 18 yearsHealthy volunteers can take part
- What is being tested?
- Euclid orthokeratology MAX (current design) and Euclid orthokeratology MAX Phoenix (new design)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 5 sitesUnited States
- Study dates
- 1 Nov 2023to Apr 2024
- 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 18 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 6-18 (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.
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- 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.
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
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Insight Vision Center Optometry
Costa Mesa, California, 92626
Cornea and Contact Lens Institute of Minnesota
Edina, Minnesota, 55436
Somerset Eye Care
North Brunswick, New Jersey, 08902
Dau Family Eye Care
Saint Johns, Florida, 32259
Treehouse Eyes
Tysons Corner, Virginia, 22182
About this study
Official title: Euclid Phoenix Lens Design Trial Phase 1
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.
Read the 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.
- Being tested
- Euclid orthokeratology MAX (current design), Euclid orthokeratology MAX Phoenix (new design)
- 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 MAX (current design)Device
The current lens design
Euclid orthokeratology MAX Phoenix (new design)Device
The new lens design
| Study group | Role | What they receive |
|---|---|---|
| Euclid orthokeratology MAX (current design) | Experimental | Euclid Orthokeratology (oprifocon A) 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 MAX (current design) |
| Euclid orthokeratology MAX Phoenix (new design) | Experimental | Euclid Orthokeratology (oprifocon A) 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 MAX Phoenix (new design) |
What is being measured
The primary outcome is the main question the study is designed to answer.
First fit success rate
Percentage of children successfully fit in the first lens pair ordered (as determined by the PI)
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2024
- Study start1 Nov 2023
- Primary completionApr 2024 (estimated)
- Study completionApr 2024 (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
- 30 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
- NCT06389916
- Sponsor's protocol ID
- EU-PHX-RCT-001
- Status last verified
- Apr 2024
- First submitted
- 31 Oct 2023
- Last updated
- 29 Apr 2024
- Results posted
- No
- 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 29 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Euclid Phoenix Lens Design Trial Phase 1
- ClinicalTrials.gov ID
- NCT06389916
- Acronym / sponsor ID
- EU-PHX-RCT-001
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Euclid Systems CorporationIndustry (pharma, biotech, devices)
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- Apr 2024 (estimated)
- Study completion
- Apr 2024 (estimated)
- First posted
- 29 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.
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.
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 orthokeratology MAX (current design) | Experimental | Device: Euclid orthokeratology MAX (current design)Euclid Orthokeratology (oprifocon A) 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 orthokeratology MAX Phoenix (new design) | Experimental | Device: Euclid orthokeratology MAX Phoenix (new design)Euclid Orthokeratology (oprifocon A) 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 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (14 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 6-18 (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.
Key exclusion criteria (16 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 MAX (current design)The current lens design | Device | Euclid orthokeratology MAX (current design) |
| Euclid orthokeratology MAX Phoenix (new design)The new lens design | Device | Euclid orthokeratology MAX Phoenix (new design) |
Primary outcome
First fit success rate
Time frame: 1 month
Percentage of children successfully fit in the first lens pair ordered (as determined by the PI)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 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.
The record lists no contact. Use the official record to reach the sponsor.
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 MAX (current design) and Euclid orthokeratology MAX Phoenix (new design) 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 14 inclusion and 16 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 29 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
First fit success rate (time frame: 1 month). 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 29 Apr 2024.