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New treatment option for Myopia
Official title Post-market Follow Up Study on Paragon CRT® 100 (Paflufocon D)
ClinicalTrials.gov ID: NCT04187599
What this study is testing
- What it's testing
- The main objective of this post market clinical study is to evaluate the effectiveness and safety of the Paragon CRT®100 Contact Lens.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 8 and older. Healthy volunteers may be eligible.
You may be able to join if
- Patient contact lens refraction should fit within the available parameters of the study lenses (spherical power within -4.00D and the cylinder power...
- Is willing to comply with the wear and visit schedule.
- Is willing to participate and signed the informed consent form.
You likely can't join if
- Age under 8 years old
- Any ocular abnormalities, undergone corneal surgery, or history of ocular trauma, active corneal infections (corneal inflammation), corneal curvature...
- 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
See the full eligibility 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.
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, China
- Tianjin, China
- Wenzhou, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 8 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, China; Tianjin, China; Wenzhou, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.