MyopiaNCT05389072
Evaluation of The Comfort of Orthokeratology Lenses Fit Using A New Software
A study of Myopia, run by CooperVision International Limited (CVIL) at 4 sites in 2 countries.
Trial summary
As new orthokeratology fitting software emerges onto the market, it is of interest to assess their usefulness in guiding eye practitioners with lens fit. The goal of this study is to evaluate the comfort of Paragon orthokeratology lenses when they are fit using the new Procornea software. Read more about this study
- Who is it for?
- Ages 6 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 1 Jun 2022to May 2023
- 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
- Are 6- 35 years of age
- Have had a self-reported visual exam in the last two years
- Have a contact lens refraction that fits within the available parameters of the study lenses
- Are able to read (or be read to), understand and sign the assent document if under 18 years old or are able to read, understand and sign the consent document if aged 18 or older (Children 6-years of age will not be asked to sign the assent form as per STERLING IRB.);
- Are under 18 years old and are accompanied by a parent or legal guardian who is able to read, understand and sign the parental information and permission document;
- Are willing to comply with the wear schedule (8 hour per night for every night, while sleeping)
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- Are willing to comply with the visit schedule
- Have a refractive spherical component of their prescription between -0.50 and up to -6.00 diopters (inclusive) AND a refractive cylinder of no more than -1.75 diopters
- Have a refractive spherical component ≥ cylinder component
- Have a minimum visual acuity of +0.20 logMAR with each eye, when refracted at the Screening visit
- Have clear corneas and no active ocular disease
- Have no medication, medical condition, or ocular conditions that contraindicate contact wear OR are expected to affect lens comfort or vision across the 1-month study duration, in the opinion of the investigator
- Can be shown to have stable keratometry for at least the previous 1 month, if they have previously worn orthokeratology lenses.
Who cannot join
- Present at screening visit with the presence of ocular or systemic disease or reports the use medications which might interfere with orthokeratology contact lens wear, such as keratoconus, diabetes mellitus, steroid eye drops
- Have a post-treatment predicted flat K value ≤38.00D (e.g. Patient baseline flat keratometry value = 40.00, patient has 2.00D of myopic refractive error. 40.00-2.00= 38.00D)
- Have a known sensitivity to the diagnostic sodium fluorescein to be used in the study
- Are pregnant, planning a pregnancy or lactating
- Have amblyopia
- Have presbyopia or has dependence on spectacles for near work over the contact lenses
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- Present at screening visit with the presence of clinically significant (grade >3; Efron scale) anterior segment abnormalities.
- Present at screening visit with slit lamp findings that would contraindicate orthokeratology contact lens wear such as:
- Pathological dry eye or associated findings
- Pterygium, pinguecula, or corneal scars within the visual axis
- Neovascularization > 0.75 mm from of the limbus
- Giant papillary conjunctivitis (GPC) worse than grade 1
- Anterior uveitis or iritis (past or present)
- Seborrheic eczema, Seborrheic conjunctivitis
- History of corneal ulcers or fungal infections
- Poor personal hygiene
- Aphakia
Trial locations and contacts
4 sites in 2 countries.
Kelly Voltz, OD contact
4 sites in 2 countries
United States3 sites, 3 recruiting
- Recruiting
Bellaire Family EyeCare
Bellaire, Texas, 77401
Ashley Tucker, MD
713-664-8087
- Recruiting
Carillon Vision Care
Glenview, Illinois, 60025
Andrew Neukirch, 847-657-8787, eyedocdrummer@gmail.com
- Recruiting
4S Eyecare and Optometry
San Diego, California, 92127
Keith Wan, 858-675-2020, keithmwan@gmail.com
Spain1 site, 1 recruiting
- Not yet recruiting
University Complutense of Madrid
Madrid
Gonzalo Carracedo, jgcarrac@ucm.es
About this study
As new orthokeratology fitting software emerges onto the market, it is of interest to assess their usefulness in guiding eye practitioners with lens fit. The goal of this study is to evaluate the comfort of Paragon orthokeratology lenses when they are fit using the new Procornea software.
- Conditions
- Myopia
- Being tested
- control contact lens
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
control contact lensDevice
control CRT lens
| Study group | Role | What they receive |
|---|---|---|
| Control Lens | Experimental | Not described Receives: Device: control contact lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comfort
Comfort of lenses (VAS 0-10, 0,5 steps) after insertion, subjects will be graded on a scale from 0 to 10 with 0=painful, 10= can't feel the lenses
Measured: 1 week
Comfort
Comfort of lenses (VAS 0-10, 0,5 steps) after insertion, subjects will be graded on a scale from 0 to 10 with 0=painful, 10= can't feel the lenses
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 posted24 May 2022
- Study start1 Jun 2022
- Primary completionMay 2023 (estimated)
- Study completionMay 2023 (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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 57 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CooperVision International Limited (CVIL)
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CooperVision, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05389072
- Sponsor's protocol ID
- SEC-P042021
- Status last verified
- Sep 2022
- First submitted
- 19 May 2022
- Last updated
- 26 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of The Comfort of Orthokeratology Lenses Fit Using A New Software
- ClinicalTrials.gov ID
- NCT05389072
- Acronym / sponsor ID
- SEC-P042021
- Conditions
- Myopia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 57 participants (estimated)
- Lead sponsor
- CooperVision International Limited (CVIL)Industry (pharma, biotech, devices)
- Collaborators
- CooperVision, Inc.
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- May 2023 (estimated)
- Study completion
- May 2023 (estimated)
- First posted
- 24 May 2022 (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.
As new orthokeratology fitting software emerges onto the market, it is of interest to assess their usefulness in guiding eye practitioners with lens fit. The goal of this study is to evaluate the comfort of Paragon orthokeratology lenses when they are fit using the new Procornea software.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Control Lens | Experimental | Device: control contact lens |
Who may qualify
- Ages
- 6 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (13 listed)
- Are 6- 35 years of age
- Have had a self-reported visual exam in the last two years
- Have a contact lens refraction that fits within the available parameters of the study lenses
- Are able to read (or be read to), understand and sign the assent document if under 18 years old or are able to read, understand and sign the consent document if aged 18 or older (Children 6-years of age will not be asked to sign the assent form as per STERLING IRB.);
- Are under 18 years old and are accompanied by a parent or legal guardian who is able to read, understand and sign the parental information and permission document;
Key exclusion criteria (17 listed)
- Present at screening visit with the presence of ocular or systemic disease or reports the use medications which might interfere with orthokeratology contact lens wear, such as keratoconus, diabetes mellitus, steroid eye drops
- Have a post-treatment predicted flat K value ≤38.00D (e.g. Patient baseline flat keratometry value = 40.00, patient has 2.00D of myopic refractive error. 40.00-2.00= 38.00D)
- Have a known sensitivity to the diagnostic sodium fluorescein to be used in the study
- Are pregnant, planning a pregnancy or lactating
- Have amblyopia
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 |
|---|---|---|
| control contact lenscontrol CRT lens | Device | Control Lens |
Primary outcome
Comfort
Time frame: 1 week
Comfort of lenses (VAS 0-10, 0,5 steps) after insertion, subjects will be graded on a scale from 0 to 10 with 0=painful, 10= can't feel the lenses
Comfort
Time frame: 1 month
Comfort of lenses (VAS 0-10, 0,5 steps) after insertion, subjects will be graded on a scale from 0 to 10 with 0=painful, 10= can't feel the lenses
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2022.
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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.
Kelly Voltz, OD contact
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Myopia, run by CooperVision International Limited (CVIL) at 4 sites in 2 countries.
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 13 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 26 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Spain. 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 Jose Vega, OD (925-621-3761, jvega2@coopervision.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comfort (time frame: 1 week). The study lists 2 primary outcomes in all. 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 26 Sep 2022.