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

Myopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04187599
• Other study ID #: SEC-P012019-CRT100
• Status: Recruiting
• Phase: N/A
• Start date: August 29, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: December 2019
• Source: Paragon Vision Sciences
• Contact: Jose Vega, OD, MSc
• Phone: 9256402964
• Email: jvega2[@]coopervision.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: December 31, 2020
• Est. primary completion date: November 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Myopia

Intervention

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.

Locations

Country	Name	City	State
China	Changsha Aier Eye Hospital	Shanghai
China	Eye & ENT Hospital of Fudan University	Shanghai
China	Tianjin Eye Hospital	Tianjin
China	The Affiliated Eye Hospital of Wenzhou Medical University	Wenzhou

Sponsors (2)

Lead Sponsor	Collaborator
Paragon Vision Sciences	TigerMed

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	The dioptric power of subject	Measure dioptric power (subjective dioptric power): include spherical power, cylindrical power, and cylindrical axis	At Baseline
Primary	The dioptric power of subject	Measure dioptric power (subjective dioptric power): include spherical power, cylindrical power, and cylindrical axis	At 1 day
Primary	The dioptric power of subject	Measure dioptric power (subjective dioptric power): include spherical power, cylindrical power, and cylindrical axis	At 1 week
Primary	The dioptric power of subject	Measure dioptric power (subjective dioptric power): include spherical power, cylindrical power, and cylindrical axis	At 2 weeks
Primary	The dioptric power of subject	Measure dioptric power (subjective dioptric power): include spherical power, cylindrical power, and cylindrical axis	At 1 month
Primary	The dioptric power of subject	Measure dioptric power (subjective dioptric power): include spherical power, cylindrical power, and cylindrical axis	At 3 months
Primary	The dioptric power of subject	Measure dioptric power (subjective dioptric power): include spherical power, cylindrical power, and cylindrical axis	At 6 months
Primary	The dioptric power of subject	Measure dioptric power (subjective dioptric power): include spherical power, cylindrical power, and cylindrical axis	At 9 months
Primary	The dioptric power of subject	Measure dioptric power (subjective dioptric power): include spherical power, cylindrical power, and cylindrical axis	At 12 months/final visit
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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