Evaluating the effectiveness and safety of Paragon CRT® 100 Contact Lenses for myopia

Post-market Follow Up Study on Paragon CRT® 100 (Paflufocon D) Rigid Gas Permeable Contact Lenses for Corneal Refractive Therapy for Temporary Myopic Refractive Power Reduction

This study is testing if Paragon CRT® 100 Contact Lenses can safely help people with myopia see better over the long term.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 250 (estimated)
• Ages: 8 Years and up
• Sex: All
• Sponsor: CooperVision International Limited (CVIL) (Industry-sponsored)
• Locations: 4 sites (Shanghai and 3 other locations)
• Trial ID: NCT04187599 on ClinicalTrials.gov

What this trial studies

This clinical study aims to assess the long-term effectiveness and safety of the Paragon CRT® 100 Contact Lenses in reducing myopic refractive power. It consists of two phases: a prospective phase that follows participants for a minimum of 12 months to evaluate effectiveness and safety, and a retrospective phase that reviews long-term safety data. Participants will be required to comply with a specific wear and visit schedule throughout the study.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 8 years and older with specific refractive parameters suitable for the contact lenses.

Not a fit: Patients with ocular abnormalities, a history of corneal surgery, or certain eye conditions will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a safe and effective option for managing myopia in patients.

How similar studies have performed: Other studies have shown promise in using contact lenses for myopia management, indicating potential success for this approach.

Eligibility criteria

Inclusion Criteria:

1. Patient contact lens refraction should fit within the available parameters of the study lenses (spherical power within -4.00D and the cylinder power within 1.50D).
2. Is willing to comply with the wear and visit schedule.
3. Is willing to participate and signed the informed consent form.

Exclusion Criteria:

1. Age under 8 years old
2. Any ocular abnormalities, undergone corneal surgery, or history of ocular trauma, active corneal infections (corneal inflammation), corneal curvature less than 40.00D or more than 46.00D
3. Best corrected visual acuity less than 1.0D
4. Pregnant, lactating or near-pregnancy
5. The eye has the following conditions:

   1. Acute and subacute inflammations or infection of the anterior segment of the eye
   2. Any eye disease, injury, or abnormality that affects the cornea, conjunctiva or eyelids, e.g. dacryocystitis, conjunctivitis, blepharitis and other inflammation, glaucoma, etc.
   3. Severe insufficiency of tears (TBUT≤5s).
   4. Allergy to any ingredient, such as mercury or thimerosal, in a solution which is to be used to care
   5. Any active corneal infection (bacterial, fungal or viral).
6. Manifested strabismus
7. Abnormal intra-ocular pressure
8. Suffering from systemic diseases, resulting in low immunity, or affecting corneal re-shaping (such as acute and chronic sinusitis, diabetes, Down syndrome, rheumatoid arthritis, mental patients, etc.)
9. Under medications or long-term medications that lead to dry eye with clinical signs or affects vision and corneal curvature.
10. Examination result indicate any contraindication or not suitable for OrthoK lens wear
11. Participated in pharmaceutical clinical study 3 months before the date of the screening or participated any other medical devices research study within 30 days of the screening
12. Only eye fulfills inclusion criteria
13. History of any ocular operations
14. Unable to follow investigator's instruction
15. Any other condition not suitable for the study per investigator's judgement

Where this trial is running

Shanghai and 3 other locations

• Changsha Aier Eye Hospital — Shanghai, China (Recruiting)
• Eye & ENT Hospital of Fudan University — Shanghai, China (Recruiting)
• Tianjin Eye Hospital — Tianjin, China (Recruiting)
• The Affiliated Eye Hospital of Wenzhou Medical University — Wenzhou, China (Recruiting)

Study contacts

• Principal investigator: Jiang Jun, MD — The Affiliated Eye Hospital of Wenzhou Medical University
• Study coordinator: Jose Vega, OD, MSc

Conditions Myopia