Clinical trial NCT04187599: Post-market Follow Up Study on Paragon CRT® 100 (Paflufocon D)
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Myopia
Lead sponsor: CooperVision International Limited (CVIL)
Sponsor class: INDUSTRY
Collaborators: name: TigerMed
First posted: 2019-12-05
Enrollment: 250
Sex: ALL
Minimum age (years): 8
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective, open label, 12 month follow up study
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: product effectiveness
timeFrame: 1 month
measure: uncorrected visual acuity
timeFrame: At baseline
measure: uncorrected visual acuity
timeFrame: 1 day
measure: uncorrected visual acuity
timeFrame: At 1 week
measure: uncorrected visual acuity
timeFrame: At 2 weeks
measure: uncorrected visual acuity
timeFrame: At 1 month
measure: uncorrected visual acuity
timeFrame: At 3 months
measure: uncorrected visual acuity
timeFrame: At 6 months
measure: uncorrected visual acuity
timeFrame: At 9 months
measure: uncorrected visual acuity
timeFrame: At 12 months/final visit
measure: The dioptric power of subject
timeFrame: At Baseline
measure: The dioptric power of subject
timeFrame: At 1 day
measure: The dioptric power of subject
timeFrame: At 1 week
measure: The dioptric power of subject
timeFrame: At 2 weeks
measure: The dioptric power of subject
timeFrame: At 1 month
measure: The dioptric power of subject
timeFrame: At 3 months
measure: The dioptric power of subject
timeFrame: At 6 months
measure: The dioptric power of subject
timeFrame: At 9 months
measure: The dioptric power of subject
timeFrame: At 12 months/final visit
measure: The relevant important parameters of corneal topography of subject
timeFrame: At Baseline
measure: The relevant important parameters of corneal topography of subject
timeFrame: At 1 day
measure: The relevant important parameters of corneal topography of subject
timeFrame: At 1 week
measure: The relevant important parameters of corneal topography of subject
timeFrame: At 2 weeks
measure: The relevant important parameters of corneal topography of subject
timeFrame: At 1 month
measure: The relevant important parameters of corneal topography of subject
timeFrame: At 3 months
measure: The relevant important parameters of corneal topography of subject
timeFrame: At 6 months
measure: The relevant important parameters of corneal topography of subject
timeFrame: At 9 months
measure: The relevant important parameters of corneal topography of subject
timeFrame: At 12 months/final visit
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Changsha Aier Eye Hospital
city: Shanghai
country: China
facility: Eye & ENT Hospital of Fudan University
city: Tianjin
country: China
facility: Tianjin Eye Hospital
city: Wenzhou
country: China
facility: The Affiliated Eye Hospital of Wenzhou Medical University
Study officials:
affiliation: The Affiliated Eye Hospital of Wenzhou Medical University
name: Jiang Jun, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Eye & ENT Hospital of Fudan University
name: Qu Xiao Mei, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Changsha Aier Eye Hospital
name: Yang Zhi Kuan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tianjin Eye Hospital
name: Li Li Hua, MD
role: PRINCIPAL_INVESTIGATOR
References: