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

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

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

Study Overview

• Status: Recruiting
• Conditions: Myopia
• Intervention / Treatment: Device: 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 Type: Interventional
• Enrollment (Anticipated): 250
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jose Vega, OD, MSc; Phone Number: 9256402964; Email: jvega2@coopervision.com

Study Locations

• China
  • Shanghai, China
    • Recruiting
    • Changsha Aier Eye Hospital
    • Contact: Yang Zhikuan, MD; Phone Number: 133 8007 1988
  • Shanghai, China
    • Recruiting
    • Eye & ENT Hospital of Fudan University
    • Contact: Qu Xiaomei, MD; Phone Number: 137 6066 4837
  • Tianjin, China
    • Recruiting
    • Tianjin Eye Hospital
    • Contact: Li Li Hua; Phone Number: 136 5180 3988
  • Wenzhou, China
    • Recruiting
    • The Affiliated Eye Hospital of Wenzhou Medical University
    • Contact: Jiang Jun; Phone Number: 135 0651 1080

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Paragon CRT®100 Contact Lens; participants will wear the Paragon CRT®100 lens with a follow up for no less than 12 months.	Device: Paragon CRT®100 Contact Lens; Paragon CRT® 100 Contact Lenses for Corneal Refractive Therapy are indicated for use in the reduction of myopic refractive error in nondiseased eyes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
product effectiveness	Effectiveness=number of eyes with both uncorrected visual acuity and dioptric power meet the "effective" standards/total number of eyes evaluated*100%	1 month
uncorrected visual acuity	Use standard LogMAR chart to measure the distant uncorrected visual acuity. Use 5.0 system to record LogMAR visual acuity	At baseline
uncorrected visual acuity	Use standard LogMAR chart to measure the distant uncorrected visual acuity. Use 5.0 system to record LogMAR visual acuity	1 day
uncorrected visual acuity	Use standard LogMAR chart to measure the distant uncorrected visual acuity. Use 5.0 system to record LogMAR visual acuity	At 1 week
uncorrected visual acuity	Use standard LogMAR chart to measure the distant uncorrected visual acuity. Use 5.0 system to record LogMAR visual acuity	At 2 weeks
uncorrected visual acuity	Use standard LogMAR chart to measure the distant uncorrected visual acuity. Use 5.0 system to record LogMAR visual acuity	At 1 month
uncorrected visual acuity	Use standard LogMAR chart to measure the distant uncorrected visual acuity. Use 5.0 system to record LogMAR visual acuity	At 3 months
uncorrected visual acuity	Use standard LogMAR chart to measure the distant uncorrected visual acuity. Use 5.0 system to record LogMAR visual acuity	At 6 months
uncorrected visual acuity	Use standard LogMAR chart to measure the distant uncorrected visual acuity. Use 5.0 system to record LogMAR visual acuity	At 9 months
uncorrected visual acuity	Use standard LogMAR chart to measure the distant uncorrected visual acuity. Use 5.0 system to record LogMAR visual acuity	At 12 months/final visit
The dioptric power of subject	Measure dioptric power (subjective dioptric power): include spherical power, cylindrical power, and cylindrical axis	At Baseline
The dioptric power of subject	Measure dioptric power (subjective dioptric power): include spherical power, cylindrical power, and cylindrical axis	At 1 day
The dioptric power of subject	Measure dioptric power (subjective dioptric power): include spherical power, cylindrical power, and cylindrical axis	At 1 week
The dioptric power of subject	Measure dioptric power (subjective dioptric power): include spherical power, cylindrical power, and cylindrical axis	At 2 weeks
The dioptric power of subject	Measure dioptric power (subjective dioptric power): include spherical power, cylindrical power, and cylindrical axis	At 1 month
The dioptric power of subject	Measure dioptric power (subjective dioptric power): include spherical power, cylindrical power, and cylindrical axis	At 3 months
The dioptric power of subject	Measure dioptric power (subjective dioptric power): include spherical power, cylindrical power, and cylindrical axis	At 6 months
The dioptric power of subject	Measure dioptric power (subjective dioptric power): include spherical power, cylindrical power, and cylindrical axis	At 9 months
The dioptric power of subject	Measure dioptric power (subjective dioptric power): include spherical power, cylindrical power, and cylindrical axis	At 12 months/final visit
The relevant important parameters of corneal topography of subject	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.	At Baseline
The relevant important parameters of corneal topography of subject	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.	At 1 day
The relevant important parameters of corneal topography of subject	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.	At 1 week
The relevant important parameters of corneal topography of subject	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.	At 2 weeks
The relevant important parameters of corneal topography of subject	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.	At 1 month
The relevant important parameters of corneal topography of subject	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.	At 3 months
The relevant important parameters of corneal topography of subject	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.	At 6 months
The relevant important parameters of corneal topography of subject	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.	At 9 months
The relevant important parameters of corneal topography of subject	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.	At 12 months/final visit

Collaborators and Investigators

• Sponsor: Paragon Vision Sciences
• Collaborators: TigerMed
• Investigators: Principal Investigator: Jiang Jun, MD, The Affiliated Eye Hospital of Wenzhou Medical University; Principal Investigator: Qu Xiao Mei, MD, Eye & ENT Hospital of Fudan University; Principal Investigator: Yang Zhi Kuan, MD, Changsha Aier Eye Hospital; Principal Investigator: Li Li Hua, MD, Tianjin Eye Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 29, 2019
• Primary Completion (Anticipated): November 30, 2020
• Study Completion (Anticipated): December 31, 2020

Study Registration Dates

• First Submitted: November 26, 2019
• First Submitted That Met QC Criteria: December 4, 2019
• First Posted (Actual): December 5, 2019

Study Record Updates

• Last Update Posted (Actual): December 5, 2019
• Last Update Submitted That Met QC Criteria: December 4, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: SEC-P012019-CRT100

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes