MyopiaNCT07751172
Evaluation of Orthokeratology Lenses With a 5MM Optic Zone Diameter
A study testing Lens A (paflufocon D) in people with Myopia and Astigmatism, run by CooperVision International Limited (CVIL) at 3 sites in 2 countries.
Trial summary
To evaluate the clinical performance and user-reported experience of Paragon CRT contact lenses with a 5mm Optic Zone Diameter (OZD) Read more about this study
- Who is it for?
- Ages 7 to 35 years
- Conditions the study is for
- Myopia, Astigmatism
- What is being tested?
- Lens A (paflufocon D)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 14 Aug 2026to Dec 2026
- Phase
- Interventional
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 7 to 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- A person is eligible for inclusion in the study if they:
- Are 6- 35 years of age
- If under 18 years old they are accompanied by a parent or legal guardian who is able to read, understand and sign the parental information and permission document
- Have had a self-reported visual exam in the last two years
- 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
- Are willing to comply with the wear schedule (approximately 8 hours 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 lens 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 report 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; ISO scale) anterior segment abnormalities.
- Present at screening visit with slit lamp findings that would contraindicate orthokeratology contact lens wear such as:
- 1. Pathological dry eye or associated findings 2. Pterygium, pinguecula, or corneal scars within the visual axis 3. Neovascularization > 0.75 mm from of the limbus 4. Giant papillary conjunctivitis (GPC) worse than grade 1 5. Anterior uveitis or iritis (past or present) 6. Seborrheic eczema, Seborrheic conjunctivitis 7. History of corneal ulcers or fungal infections 8. Poor personal hygiene 9. Aphakia
Trial locations and contacts
3 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
3 sites in 2 countries
United States2 sites, 2 recruiting
- Recruiting
Bellaire Family Eye Care
Bellaire, Texas, 77401
Sarah Maldonado, 7136648087, Sarah@BFEYE.COM
Ashley Tucker, OD
- Recruiting
Treehouse Eyes Pleasanton Center
Pleasanton, California, 94588
Fiona Hu, 925-209-2129, fiona.hu@treehouseeyes.com
Yue (Maria) Liu, OD
Spain1 site, 1 recruiting
- Not yet recruiting
Complutense University of Madrid Av.
Madrid, Moncloa - Aravaca,, 28040
Juan Gonzalo Carracedo Rodriguez, PhD, +34616513539, jgcarrac@ucm.es
About this study
To evaluate the clinical performance and user-reported experience of Paragon CRT contact lenses with a 5mm Optic Zone Diameter (OZD)
Read the detailed description
Prospective, multi-site, clinical study evaluating the first-fit success, visual performance, and ocular health outcomes of 5mm OZD orthokeratology lenses fit empirically.
- Conditions
- Myopia, Astigmatism
- Being tested
- Lens A (paflufocon D)
- Medical subject headings
- Myopia, Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lens A (paflufocon D)Device
5 minutes of daily wear
| Study group | Role | What they receive |
|---|---|---|
| Paragon CRT Orthokeratology contact lens | Other | Not described Receives: Device: Lens A (paflufocon D) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comfort at 5 Minutes and 1 Month After Final Lens Dispense
To assess participant-reported comfort of empirically fitted orthokeratology contact lenses by comparing comfort scores measured 5 minutes after lens insertion at the final dispense visit with comfort scores reported after 1 month of lens wear. Comfort will be assessed using a 0 to 10 scale, where 0 indicates "painful" and 10 indicates "cannot feel the lenses
Measured: 5 minutes after insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2026
- Study start14 Aug 2026
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (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
- 70 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
- NCT07751172
- Sponsor's protocol ID
- SEC-26-27
- Status last verified
- Jul 2026
- First submitted
- 31 Jul 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No