Post-market Follow Up Study on Paragon CRT® 100 (Paflufocon D)

Not Applicable

Recruiting

• Conditions: Myopia
• Interventions: Device: Paragon CRT®100 Contact Lens

• Registration Number: NCT04187599
• Lead Sponsor: Coopervision, Inc.

Brief Summary

The main objective of this post market clinical study is to evaluate the effectiveness and safety of the Paragon CRT®100 Contact Lens.

Detailed Description

This clinical study has two phases: prospective and retrospective.

Prospective Phase - evaluates the post-market long-term effectiveness and safety of the Paragon CRT® 100 Contact Lenses, for temporary myopic refractive power reduction with minimum 12-month period follow-up.

Retrospective phase - evaluates the post-market long-term safety of the Paragon CRT® 100 Contact Lenses, for temporary myopic refractive power reduction.

Study Timeline

• Study Start: 2019-08-29
• Study First Submitted: 2019-11-26
• Status Verified: 2019-12
• Study First Submitted QC: 2019-12-04
• Last Update Submitted: 2019-12-04
• Study First Posted: 2019-12-05
• Last Update Posted: 2019-12-05
• Primary Completion: 2020-11-30
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 250

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Paragon CRT®100 Contact Lens	Paragon CRT®100 Contact Lens	participants will wear the Paragon CRT®100 lens with a follow up for no less than 12 months.

Primary Outcome Measures

Name	Time	Method
uncorrected visual acuity	At 12 months/final visit	Use standard LogMAR chart to measure the distant uncorrected visual acuity. Use 5.0 system to record LogMAR visual acuity
The dioptric power of subject	At 12 months/final visit	Measure dioptric power (subjective dioptric power): include spherical power, cylindrical power, and cylindrical axis
product effectiveness	1 month	Effectiveness=number of eyes with both uncorrected visual acuity and dioptric power meet the "effective" standards/total number of eyes evaluated\*100%
The relevant important parameters of corneal topography of subject	At 12 months/final visit	The corneal topographer is used for measurement, and the relevant parameters include: corneal curvature on the steep meridian Ks, corneal curvature on the flat meridian Kf, and corneal astigmatism.

Trial Locations

Locations (4)

Eye & ENT Hospital of Fudan University; 🇨🇳 Shanghai, China

Changsha Aier Eye Hospital; 🇨🇳 Shanghai, China

Tianjin Eye Hospital; 🇨🇳 Tianjin, China

The Affiliated Eye Hospital of Wenzhou Medical University; 🇨🇳 Wenzhou, China