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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: jvega2@coopervision.com
• Phone: 9256402964

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.