Evaluation of Orthokeratology Lenses With a 5MM Optic Zone Diameter
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
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
Treatments tested in this trial
- Lens A (paflufocon D)
Treatment groups
70 Participants
are divided into 1 treatment groupSponsors and collaborators
CooperVision International Limited (CVIL)
Lead sponsor
CooperVision, Inc.
Collaborator
Source ClinicalTrials.gov