MyopiaNCT04187599
Post-market Follow Up Study on Paragon CRT® 100 (Paflufocon D)
A study testing Paragon CRT®100 Contact Lens in people with Myopia, run by CooperVision International Limited (CVIL) at 4 sites in China.
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. Read more about this study
- Who is it for?
- Ages 8 years and olderHealthy volunteers can take part
- Conditions the study is for
- Myopia
- What is being tested?
- Paragon CRT®100 Contact Lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 4 sitesChina
- Study dates
- 29 Aug 2019to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 20Show fewer
- 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
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China4 sites, 4 recruiting
- Recruiting
Changsha Aier Eye Hospital
Shanghai
Yang Zhikuan, MD, 133 8007 1988
- Recruiting
Eye & ENT Hospital of Fudan University
Shanghai
Qu Xiaomei, MD, 137 6066 4837
- Recruiting
Tianjin Eye Hospital
Tianjin
Li Li Hua, 136 5180 3988
- Recruiting
The Affiliated Eye Hospital of Wenzhou Medical University
Wenzhou
Jiang Jun, 135 0651 1080
About this study
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
The main objective of this post market clinical study is to evaluate the effectiveness and safety of the Paragon CRT®100 Contact Lens.
Read the 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.
- Conditions
- Myopia
- Being tested
- Paragon CRT®100 Contact Lens
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paragon CRT®100 Contact LensDevice
Paragon CRT® 100 Contact Lenses for Corneal Refractive Therapy are indicated for use in the reduction of myopic refractive error in nondiseased eyes.
| Study group | Role | What they receive |
|---|---|---|
| Paragon CRT®100 Contact Lens | Experimental | participants will wear the Paragon CRT®100 lens with a follow up for no less than 12 months. Receives: Device: Paragon CRT®100 Contact Lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
product effectiveness
Effectiveness=number of eyes with both uncorrected visual acuity and dioptric power meet the "effective" standards/total number of eyes evaluated*100%
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: At 12 months/final visit
The dioptric power of subject
Measure dioptric power (subjective dioptric power): include spherical power, cylindrical power, and cylindrical axis
Measured: At Baseline
The dioptric power of subject
Measure dioptric power (subjective dioptric power): include spherical power, cylindrical power, and cylindrical axis
Measured: At 1 day
The dioptric power of subject
Measure dioptric power (subjective dioptric power): include spherical power, cylindrical power, and cylindrical axis
Measured: At 1 week
The dioptric power of subject
Measure dioptric power (subjective dioptric power): include spherical power, cylindrical power, and cylindrical axis
Measured: At 2 weeks
The dioptric power of subject
Measure dioptric power (subjective dioptric power): include spherical power, cylindrical power, and cylindrical axis
Measured: At 1 month
The dioptric power of subject
Measure dioptric power (subjective dioptric power): include spherical power, cylindrical power, and cylindrical axis
Measured: At 3 months
The dioptric power of subject
Measure dioptric power (subjective dioptric power): include spherical power, cylindrical power, and cylindrical axis
Measured: At 6 months
The dioptric power of subject
Measure dioptric power (subjective dioptric power): include spherical power, cylindrical power, and cylindrical axis
Measured: At 9 months
The dioptric power of subject
Measure dioptric power (subjective dioptric power): include spherical power, cylindrical power, and cylindrical axis
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At 12 months/final visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2019
- Study start29 Aug 2019
- Primary completion30 Nov 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, open label, 12 month follow up study
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CooperVision International Limited (CVIL)
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- TigerMed
- Responsible party
- Sponsor
- Investigators
- Jiang Jun, MD, Principal investigator, The Affiliated Eye Hospital of Wenzhou Medical UniversityQu Xiao Mei, MD, Principal investigator, Eye & ENT Hospital of Fudan UniversityYang Zhi Kuan, MD, Principal investigator, Changsha Aier Eye HospitalLi Li Hua, MD, Principal investigator, Tianjin Eye Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04187599
- Sponsor's protocol ID
- SEC-P012019-CRT100
- Status last verified
- Dec 2019
- First submitted
- 26 Nov 2019
- Last updated
- 5 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04187599
- Acronym / sponsor ID
- SEC-P012019-CRT100
- Conditions
- Myopia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- CooperVision International Limited (CVIL)Industry (pharma, biotech, devices)
- Collaborators
- TigerMed
- Study start
- 29 Aug 2019 (actual)
- Primary completion
- 30 Nov 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 5 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, open label, 12 month follow up study
| Arm | Type | Receives |
|---|---|---|
| Paragon CRT®100 Contact Lens | Experimental | Device: Paragon CRT®100 Contact Lensparticipants will wear the Paragon CRT®100 lens with a follow up for no less than 12 months. |
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (20 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Paragon CRT®100 Contact LensParagon CRT® 100 Contact Lenses for Corneal Refractive Therapy are indicated for use in the reduction of myopic refractive error in nondiseased eyes. | Device | Paragon CRT®100 Contact Lens |
Primary outcome
product effectiveness
Time frame: 1 month
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
Time frame: At baseline
Use standard LogMAR chart to measure the distant uncorrected visual acuity. Use 5.0 system to record LogMAR visual acuity
uncorrected visual acuity
Time frame: 1 day
Use standard LogMAR chart to measure the distant uncorrected visual acuity. Use 5.0 system to record LogMAR visual acuity
uncorrected visual acuity
Time frame: At 1 week
Use standard LogMAR chart to measure the distant uncorrected visual acuity. Use 5.0 system to record LogMAR visual acuity
uncorrected visual acuity
Time frame: At 2 weeks
Use standard LogMAR chart to measure the distant uncorrected visual acuity. Use 5.0 system to record LogMAR visual acuity
uncorrected visual acuity
Time frame: At 1 month
Use standard LogMAR chart to measure the distant uncorrected visual acuity. Use 5.0 system to record LogMAR visual acuity
uncorrected visual acuity
Time frame: At 3 months
Use standard LogMAR chart to measure the distant uncorrected visual acuity. Use 5.0 system to record LogMAR visual acuity
uncorrected visual acuity
Time frame: At 6 months
Use standard LogMAR chart to measure the distant uncorrected visual acuity. Use 5.0 system to record LogMAR visual acuity
uncorrected visual acuity
Time frame: At 9 months
Use standard LogMAR chart to measure the distant uncorrected visual acuity. Use 5.0 system to record LogMAR visual acuity
uncorrected visual acuity
Time frame: 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
Time frame: At Baseline
Measure dioptric power (subjective dioptric power): include spherical power, cylindrical power, and cylindrical axis
The dioptric power of subject
Time frame: At 1 day
Measure dioptric power (subjective dioptric power): include spherical power, cylindrical power, and cylindrical axis
The dioptric power of subject
Time frame: At 1 week
Measure dioptric power (subjective dioptric power): include spherical power, cylindrical power, and cylindrical axis
The dioptric power of subject
Time frame: At 2 weeks
Measure dioptric power (subjective dioptric power): include spherical power, cylindrical power, and cylindrical axis
The dioptric power of subject
Time frame: At 1 month
Measure dioptric power (subjective dioptric power): include spherical power, cylindrical power, and cylindrical axis
The dioptric power of subject
Time frame: At 3 months
Measure dioptric power (subjective dioptric power): include spherical power, cylindrical power, and cylindrical axis
The dioptric power of subject
Time frame: At 6 months
Measure dioptric power (subjective dioptric power): include spherical power, cylindrical power, and cylindrical axis
The dioptric power of subject
Time frame: At 9 months
Measure dioptric power (subjective dioptric power): include spherical power, cylindrical power, and cylindrical axis
The dioptric power of subject
Time frame: At 12 months/final visit
Measure dioptric power (subjective dioptric power): include spherical power, cylindrical power, and cylindrical axis
The relevant important parameters of corneal topography of subject
Time frame: At Baseline
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
Time frame: At 1 day
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
Time frame: At 1 week
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
Time frame: At 2 weeks
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
Time frame: At 1 month
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
Time frame: At 3 months
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
Time frame: At 6 months
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
Time frame: At 9 months
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
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jiang Jun, MD principal investigator
The Affiliated Eye Hospital of Wenzhou Medical University
Qu Xiao Mei, MD principal investigator
Eye & ENT Hospital of Fudan University
Yang Zhi Kuan, MD principal investigator
Changsha Aier Eye Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Paragon CRT®100 Contact Lens in people with Myopia, run by CooperVision International Limited (CVIL) at 4 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jose Vega, OD, MSc (9256402964, jvega2@coopervision.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
product effectiveness (time frame: 1 month). The study lists 28 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2019.