Can a new lens design improve overnight vision correction?
NCT ID NCT07751172
First seen Aug 07, 2026 · Last updated Aug 12, 2026 · Updated 2 times
Summary
This trial evaluates Paragon CRT contact lenses with a 5mm optic zone diameter, worn overnight to temporarily reshape the cornea and correct myopia and astigmatism. Participants aged 6 to 35 will wear the lenses daily for a short period, and their comfort and visual performance will be assessed. The study aims to see if this lens design provides a comfortable and effective alternative to traditional glasses or daytime contacts.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Paragon CRT orthokeratology contact lenses with a 5mm optic zone diameter
- What this could lead to
- If successful, this could lead to more comfortable and effective overnight contact lenses for correcting nearsightedness and astigmatism.
- What could go wrong
- The trial is relatively small and early, and results may not apply to all lens wearers. There is also a risk of discomfort or other lens-related issues.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
-
About 70 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
-
Aug 2026
An estimate. Start dates often move.
- Expected to finish
-
Dec 2026
An estimate. End dates often move.
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
7 to 35 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: A person is eligible for inclusion in the study if they: 1. Are 6- 35 years of age 2. 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 3. Have had a self-reported visual exam in the last two years 4. 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 5. Are willing to comply with the wear schedule (approximately 8 hours per night for every night, while sleeping) 6. Are willing to comply with the visit schedule 7. 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 8. Have a refractive spherical component ≥ cylinder component 9. Have a minimum visual acuity of +0.20 logMAR with each eye, when refracted at the Screening visit 10. Have clear corneas and no active ocular disease. 11. 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 12. Can be shown to have stable keratometry for at least the previous 1 month, if they have previously worn orthokeratology lenses. Exclusion Criteria: 1. 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 2. 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) 3. Have a known sensitivity to the diagnostic sodium fluorescein to be used in the study 4. Are pregnant, planning a pregnancy or lactating 5. Have amblyopia 6. Have presbyopia or has dependence on spectacles for near work over the contact lenses 7. Present at screening visit with the presence of clinically significant (grade ≥3; ISO scale) anterior segment abnormalities. 8. 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
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Astigmatism are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
3 sites in 2 countries. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Bellaire Family Eye Care
Bellaire, Texas, 77401, United States
-
Complutense University of Madrid Av.
Madrid, Moncloa - Aravaca,, 28040, Spain
-
Treehouse Eyes Pleasanton Center
Pleasanton, California, 94588, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Two lens designs go Head-to-Head for aging eyes
- Can AI protect Kids' eyesight where eye doctors are scarce?
- Two toric lenses go head to head in vision test
- Eye scans as a window to the body: study probes retinal imaging across diseases
- Lens showdown: which contact lens wins in dim light?
- Myopia glasses may keep working even after kids take them off