Paragon CRT Lenses for Near-sightedness

Not yet recruiting at 2 trial locations
KV
Overseen ByKelly Voltz
Age: < 65
Sex: Any
Trial Phase: Academic
Sponsor: CooperVision International Limited (CVIL)
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests special contact lenses designed to assist with near-sightedness (difficulty seeing things at a distance). The goal is to evaluate the effectiveness of these lenses and gather user feedback on wearing them overnight. Individuals diagnosed with near-sightedness, who have had an eye exam in the last two years, and who do not have any eye diseases might be suitable candidates. Participants must be comfortable wearing these lenses every night for about 8 hours while sleeping. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance vision correction options.

What prior data suggests that Paragon CRT contact lenses with a 5mm Optic Zone Diameter are safe for near-sightedness?

Research has shown that Paragon CRT contact lenses are generally safe and effective for most users. Studies have found that over 90% of users achieve 20/40 vision or better, and more than 93% achieve 20/32 vision or better with these lenses.

The FDA has approved Paragon CRT lenses for overnight wear to temporarily reduce nearsightedness, indicating thorough testing for safety. While some risk exists, it is comparable to other hard contact lenses.

In summary, these lenses have a strong safety record and effectively improve vision for many individuals.12345

Why are researchers excited about this trial?

Unlike traditional glasses or standard contact lenses that merely correct vision for a period of time, Paragon CRT lenses offer a unique approach by temporarily reshaping the cornea overnight, providing clear vision during the day without the need for glasses or contacts. This non-surgical method, known as orthokeratology, is particularly exciting because it offers a reversible, non-invasive alternative to procedures like LASIK. Additionally, these lenses have a 5mm Optic Zone Diameter, which is specifically designed to optimize vision correction for near-sighted individuals. Researchers are enthusiastic about this treatment because it provides freedom from daytime corrective lenses and a new level of convenience for patients.

What evidence suggests that Paragon CRT lenses are effective for near-sightedness?

Research has shown that Paragon CRT contact lenses, studied in this trial, effectively improve vision in people who are nearsighted (myopic). Studies indicate that over 90% of users achieve 20/40 vision or better, sufficient for driving without glasses. Additionally, 65% of users reach 20/20 vision, considered perfect. These lenses also slow the progression of nearsightedness by gently reshaping the cornea, the eye's front part. Thus, they not only enhance current vision but also help prevent further deterioration over time.13567

Are You a Good Fit for This Trial?

This trial is for people with nearsightedness (myopia) and/or astigmatism who are interested in using special contact lenses to correct their vision. Participants should be healthy enough for contact lens wear and not have any eye conditions that would prevent safe use.

Inclusion Criteria

I am between 6 and 35 years old.
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)
See 9 more

Exclusion Criteria

Have presbyopia or have dependence on spectacles for near work over the contact lenses
Are pregnant, planning a pregnancy or lactating
Have a post-treatment predicted flat K value less than or equal to 38.00D
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are fitted with Paragon CRT orthokeratology contact lenses and assessed for comfort and visual performance

1 month
Initial fitting and follow-up visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Paragon CRT contact lenses with 5mm Optic Zone Diameter

Trial Overview

The study is testing Paragon CRT orthokeratology contact lenses made from paflufocon D, featuring a 5mm optic zone diameter, to see how well they work and how comfortable they are for users.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Paragon CRT Orthokeratology contact lensExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

CooperVision International Limited (CVIL)

Lead Sponsor

Trials
171
Recruited
14,600+
Dr. Patrizia Cavazzoni profile image

Dr. Patrizia Cavazzoni

CooperVision International Limited (CVIL)

Chief Medical Officer

MD from Harvard Medical School

Steven Robins profile image

Steven Robins

CooperVision International Limited (CVIL)

President, Americas

Bachelor of Arts from Bates College, participated in Pfizer Global Leadership Program with Harvard University

CooperVision, Inc.

Industry Sponsor

Citations

CRT Lenses

In the FDA trials for Paragon CRT® contact lenses, more than 90% were able to see 20/40 or better (the legal vision requirement for driving without glasses in ...

Comparison of two main orthokeratology lens designs in ...

Results. CRT lenses markedly limited AL elongation and reduced corneal curvature flattening in participants younger than 13 years (p < 0.0001), ...

Clinical Studies

In studies, 65 percent of the patients using the Paragon CRT® Contact Lenses achieved 20/20 vision. More than 93 percent achieved 20/32 vision or better

CRT & Ortho-K: The Ultimate Solution to Myopia Progression

Discover how CRT and Ortho-K lenses effectively manage myopia by reshaping the cornea to slow myopia progression and provide clear, ...

Orthokeratology (CRT & VST) - Contact Lenses - The Eye Center

According to FDA trials conducted on both CRT and VST lenses, more than 65% of ortho-k patients achieved 20/20 visual acuity. A whopping number of more than 90% ...

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paragonvision.com

paragonvision.com/faq/

FAQ

Yes! Paragon CRT® Contact Lenses are the first therapeutic lens design approved by the FDA for overnight orthokeratology for the temporary reduction of myopia.

Considering Contact Lens Corneal Refractive Therapy?

Paragon CRTTM of Paragon CRTTM 100 contact lenses for orthokeratology will provide a risk that is greater than other rigid gas permeable contact lenses.