Health TrialsbyHealthPanel

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

ConditionMyopia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age8+
SponsorCooperVision International Limited (CVIL)

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Paragon CRT®100 Contact Lens

    Device

    Paragon CRT® 100 Contact Lenses for Corneal Refractive Therapy are indicated for use in the reduction of myopic refractive error in nondiseased eyes.

Treatment groups

250 Participants
are divided into 1 treatment group
Group A: Paragon CRT®100 Contact LensExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

product effectiveness

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
2

uncorrected visual acuity

Use standard LogMAR chart to measure the distant uncorrected visual acuity. Use 5.0 system to record LogMAR visual acuity

Time frame
At baseline
3

uncorrected visual acuity

Use standard LogMAR chart to measure the distant uncorrected visual acuity. Use 5.0 system to record LogMAR visual acuity

Time frame
1 day
4

uncorrected visual acuity

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

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

CooperVision International Limited (CVIL)

Lead sponsor

TigerMed

Collaborator

Source ClinicalTrials.gov
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