Evaluation of Orthokeratology Lenses With a 5MM Optic Zone Diameter

ConditionsMyopia Astigmatism

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age7-35

SponsorCooperVision International Limited (CVIL)

About this trial

To evaluate the clinical performance and user-reported experience of Paragon CRT contact lenses with a 5mm Optic Zone Diameter (OZD)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Are 6- 35 years of age

If under 18 years old they are accompanied by a parent or legal guardian who is able to read, understand and sign the parental information and permission document

Have had a self-reported visual exam in the last two years

Are able to read (or be read to), understand and sign the assent document if under 18 years old or are able to read, understand and sign the consent document if aged 18 or older

Disqualifiers

Present at screening visit with the presence of ocular or systemic disease or report the use medications which might interfere with orthokeratology contact lens wear, such as keratoconus, diabetes mellitus, steroid eye drops

Have a post-treatment predicted flat K value ≤38.00D (e.g. Patient baseline flat keratometry value = 40.00, patient has 2.00D of myopic refractive error. 40.00-2.00= 38.00D)

Have a known sensitivity to the diagnostic sodium fluorescein to be used in the study

Are pregnant, planning a pregnancy or lactating

Trial design

Design model

Single group

Treatments tested in this trial

Lens A (paflufocon D)
Device
5 minutes of daily wear

Treatment groups

70 Participants

are divided into 1 treatment group

Group A: Paragon CRT Orthokeratology contact lensOther 1 intervention

Trial outcomes

Primary outcomes

Comfort at 5 Minutes and 1 Month After Final Lens Dispense

To assess participant-reported comfort of empirically fitted orthokeratology contact lenses by comparing comfort scores measured 5 minutes after lens insertion at the final dispense visit with comfort scores reported after 1 month of lens wear. Comfort will be assessed using a 0 to 10 scale, where 0 indicates "painful" and 10 indicates "cannot feel the lenses

Time frame

5 minutes after insertion

Sponsors and contacts

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

CooperVision International Limited (CVIL)

Lead sponsor

CooperVision, Inc.

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: