Back to resultsPost-market Follow Up Study on Paragon CRT® 100 (Paflufocon D)
Primary Purpose
Myopia
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Paragon CRT®100 Contact Lens
Sponsored by
About this trial
This is an interventional treatment trial for Myopia
Eligibility Criteria
Inclusion Criteria:
- 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).
- Is willing to comply with the wear and visit schedule.
- Is willing to participate and signed the informed consent form.
Exclusion Criteria:
- Age under 8 years old
- 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
- Best corrected visual acuity less than 1.0D
- Pregnant, lactating or near-pregnancy
The eye has the following conditions:
- Acute and subacute inflammations or infection of the anterior segment of the eye
- Any eye disease, injury, or abnormality that affects the cornea, conjunctiva or eyelids, e.g. dacryocystitis, conjunctivitis, blepharitis and other inflammation, glaucoma, etc.
- Severe insufficiency of tears (TBUT≤5s).
- Allergy to any ingredient, such as mercury or thimerosal, in a solution which is to be used to care
- Any active corneal infection (bacterial, fungal or viral).
- Manifested strabismus
- Abnormal intra-ocular pressure
- 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.)
- Under medications or long-term medications that lead to dry eye with clinical signs or affects vision and corneal curvature.
- Examination result indicate any contraindication or not suitable for OrthoK lens wear
- 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
- Only eye fulfills inclusion criteria
- History of any ocular operations
- Unable to follow investigator's instruction
- Any other condition not suitable for the study per investigator's judgement
Sites / Locations
- Changsha Aier Eye HospitalRecruiting
- Eye & ENT Hospital of Fudan UniversityRecruiting
- Tianjin Eye HospitalRecruiting
- The Affiliated Eye Hospital of Wenzhou Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Paragon CRT®100 Contact Lens
Arm Description
participants will wear the Paragon CRT®100 lens with a follow up for no less than 12 months.
Outcomes
Primary Outcome Measures
product effectiveness
Effectiveness=number of eyes with both uncorrected visual acuity and dioptric power meet the "effective" standards/total number of eyes evaluated*100%
uncorrected visual acuity
Use standard LogMAR chart to measure the distant uncorrected visual acuity. Use 5.0 system to record LogMAR visual acuity
uncorrected visual acuity
Use standard LogMAR chart to measure the distant uncorrected visual acuity. Use 5.0 system to record LogMAR visual acuity
uncorrected visual acuity
Use standard LogMAR chart to measure the distant uncorrected visual acuity. Use 5.0 system to record LogMAR visual acuity
uncorrected visual acuity
Use standard LogMAR chart to measure the distant uncorrected visual acuity. Use 5.0 system to record LogMAR visual acuity
uncorrected visual acuity
Use standard LogMAR chart to measure the distant uncorrected visual acuity. Use 5.0 system to record LogMAR visual acuity
uncorrected visual acuity
Use standard LogMAR chart to measure the distant uncorrected visual acuity. Use 5.0 system to record LogMAR visual acuity
uncorrected visual acuity
Use standard LogMAR chart to measure the distant uncorrected visual acuity. Use 5.0 system to record LogMAR visual acuity
uncorrected visual acuity
Use standard LogMAR chart to measure the distant uncorrected visual acuity. Use 5.0 system to record LogMAR visual acuity
uncorrected visual acuity
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
Measure dioptric power (subjective dioptric power): include spherical power, cylindrical power, and cylindrical axis
The dioptric power of subject
Measure dioptric power (subjective dioptric power): include spherical power, cylindrical power, and cylindrical axis
The dioptric power of subject
Measure dioptric power (subjective dioptric power): include spherical power, cylindrical power, and cylindrical axis
The dioptric power of subject
Measure dioptric power (subjective dioptric power): include spherical power, cylindrical power, and cylindrical axis
The dioptric power of subject
Measure dioptric power (subjective dioptric power): include spherical power, cylindrical power, and cylindrical axis
The dioptric power of subject
Measure dioptric power (subjective dioptric power): include spherical power, cylindrical power, and cylindrical axis
The dioptric power of subject
Measure dioptric power (subjective dioptric power): include spherical power, cylindrical power, and cylindrical axis
The dioptric power of subject
Measure dioptric power (subjective dioptric power): include spherical power, cylindrical power, and cylindrical axis
The dioptric power of subject
Measure dioptric power (subjective dioptric power): include spherical power, cylindrical power, and cylindrical axis
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.
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.
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.
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.
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.
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.
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.
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04187599
First Posted
November 26, 2019
Last Updated
December 4, 2019
Sponsor
Coopervision, Inc.
Collaborators
TigerMed
1. Study Identification
Unique Protocol Identification Number
NCT04187599
Brief Title
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
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Recruiting
Study Start Date
August 29, 2019 (Actual)
Primary Completion Date
November 30, 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Coopervision, Inc.
Collaborators
TigerMed
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Prospective, open label, 12 month follow up study
Masking
None (Open Label)
Allocation
N/A
Enrollment
250 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Paragon CRT®100 Contact Lens
Arm Type
Experimental
Arm Description
participants will wear the Paragon CRT®100 lens with a follow up for no less than 12 months.
Intervention Type
Device
Intervention Name(s)
Paragon CRT®100 Contact Lens
Intervention Description
Paragon CRT® 100 Contact Lenses for Corneal Refractive Therapy are indicated for use in the reduction of myopic refractive error in nondiseased eyes.
Primary Outcome Measure Information:
Title
product effectiveness
Description
Effectiveness=number of eyes with both uncorrected visual acuity and dioptric power meet the "effective" standards/total number of eyes evaluated*100%
Time Frame
1 month
Title
uncorrected visual acuity
Description
Use standard LogMAR chart to measure the distant uncorrected visual acuity. Use 5.0 system to record LogMAR visual acuity
Time Frame
At baseline
Title
uncorrected visual acuity
Description
Use standard LogMAR chart to measure the distant uncorrected visual acuity. Use 5.0 system to record LogMAR visual acuity
Time Frame
1 day
Title
uncorrected visual acuity
Description
Use standard LogMAR chart to measure the distant uncorrected visual acuity. Use 5.0 system to record LogMAR visual acuity
Time Frame
At 1 week
Title
uncorrected visual acuity
Description
Use standard LogMAR chart to measure the distant uncorrected visual acuity. Use 5.0 system to record LogMAR visual acuity
Time Frame
At 2 weeks
Title
uncorrected visual acuity
Description
Use standard LogMAR chart to measure the distant uncorrected visual acuity. Use 5.0 system to record LogMAR visual acuity
Time Frame
At 1 month
Title
uncorrected visual acuity
Description
Use standard LogMAR chart to measure the distant uncorrected visual acuity. Use 5.0 system to record LogMAR visual acuity
Time Frame
At 3 months
Title
uncorrected visual acuity
Description
Use standard LogMAR chart to measure the distant uncorrected visual acuity. Use 5.0 system to record LogMAR visual acuity
Time Frame
At 6 months
Title
uncorrected visual acuity
Description
Use standard LogMAR chart to measure the distant uncorrected visual acuity. Use 5.0 system to record LogMAR visual acuity
Time Frame
At 9 months
Title
uncorrected visual acuity
Description
Use standard LogMAR chart to measure the distant uncorrected visual acuity. Use 5.0 system to record LogMAR visual acuity
Time Frame
At 12 months/final visit
Title
The dioptric power of subject
Description
Measure dioptric power (subjective dioptric power): include spherical power, cylindrical power, and cylindrical axis
Time Frame
At Baseline
Title
The dioptric power of subject
Description
Measure dioptric power (subjective dioptric power): include spherical power, cylindrical power, and cylindrical axis
Time Frame
At 1 day
Title
The dioptric power of subject
Description
Measure dioptric power (subjective dioptric power): include spherical power, cylindrical power, and cylindrical axis
Time Frame
At 1 week
Title
The dioptric power of subject
Description
Measure dioptric power (subjective dioptric power): include spherical power, cylindrical power, and cylindrical axis
Time Frame
At 2 weeks
Title
The dioptric power of subject
Description
Measure dioptric power (subjective dioptric power): include spherical power, cylindrical power, and cylindrical axis
Time Frame
At 1 month
Title
The dioptric power of subject
Description
Measure dioptric power (subjective dioptric power): include spherical power, cylindrical power, and cylindrical axis
Time Frame
At 3 months
Title
The dioptric power of subject
Description
Measure dioptric power (subjective dioptric power): include spherical power, cylindrical power, and cylindrical axis
Time Frame
At 6 months
Title
The dioptric power of subject
Description
Measure dioptric power (subjective dioptric power): include spherical power, cylindrical power, and cylindrical axis
Time Frame
At 9 months
Title
The dioptric power of subject
Description
Measure dioptric power (subjective dioptric power): include spherical power, cylindrical power, and cylindrical axis
Time Frame
At 12 months/final visit
Title
The relevant important parameters of corneal topography of subject
Description
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.
Time Frame
At Baseline
Title
The relevant important parameters of corneal topography of subject
Description
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.
Time Frame
At 1 day
Title
The relevant important parameters of corneal topography of subject
Description
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.
Time Frame
At 1 week
Title
The relevant important parameters of corneal topography of subject
Description
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.
Time Frame
At 2 weeks
Title
The relevant important parameters of corneal topography of subject
Description
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.
Time Frame
At 1 month
Title
The relevant important parameters of corneal topography of subject
Description
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.
Time Frame
At 3 months
Title
The relevant important parameters of corneal topography of subject
Description
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.
Time Frame
At 6 months
Title
The relevant important parameters of corneal topography of subject
Description
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.
Time Frame
At 9 months
Title
The relevant important parameters of corneal topography of subject
Description
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.
Time Frame
At 12 months/final visit
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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).
Is willing to comply with the wear and visit schedule.
Is willing to participate and signed the informed consent form.
Exclusion Criteria:
Age under 8 years old
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
Best corrected visual acuity less than 1.0D
Pregnant, lactating or near-pregnancy
The eye has the following conditions:
Acute and subacute inflammations or infection of the anterior segment of the eye
Any eye disease, injury, or abnormality that affects the cornea, conjunctiva or eyelids, e.g. dacryocystitis, conjunctivitis, blepharitis and other inflammation, glaucoma, etc.
Severe insufficiency of tears (TBUT≤5s).
Allergy to any ingredient, such as mercury or thimerosal, in a solution which is to be used to care
Any active corneal infection (bacterial, fungal or viral).
Manifested strabismus
Abnormal intra-ocular pressure
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.)
Under medications or long-term medications that lead to dry eye with clinical signs or affects vision and corneal curvature.
Examination result indicate any contraindication or not suitable for OrthoK lens wear
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
Only eye fulfills inclusion criteria
History of any ocular operations
Unable to follow investigator's instruction
Any other condition not suitable for the study per investigator's judgement
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jose Vega, OD, MSc
Phone
9256402964
Email
jvega2@coopervision.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jiang Jun, MD
Organizational Affiliation
The Affiliated Eye Hospital of Wenzhou Medical University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Qu Xiao Mei, MD
Organizational Affiliation
Eye & ENT Hospital of Fudan University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yang Zhi Kuan, MD
Organizational Affiliation
Changsha Aier Eye Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Li Li Hua, MD
Organizational Affiliation
Tianjin Eye Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Changsha Aier Eye Hospital
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yang Zhikuan, MD
Phone
133 8007 1988
Facility Name
Eye & ENT Hospital of Fudan University
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qu Xiaomei, MD
Phone
137 6066 4837
Facility Name
Tianjin Eye Hospital
City
Tianjin
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Li Li Hua
Phone
136 5180 3988
Facility Name
The Affiliated Eye Hospital of Wenzhou Medical University
City
Wenzhou
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiang Jun
Phone
135 0651 1080
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Post-market Follow Up Study on Paragon CRT® 100 (Paflufocon D)
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