Clinical trial: Multicenter Dispensing Study of Biofinity Lenses in Extended Range (NCT02060539)

Eligibility criteria:
Inclusion Criteria:

          -  Has had an oculo-visual examination in the last two years

          -  Is at least 18 years of age and has full legal capacity to volunteer

          -  Has read and understood the information consent letter

          -  Is willing and able to follow instructions and maintain the appointment schedule

          -  Is correctable to a visual acuity of 20/50 or better (in at least one eye) with their
             habitual vision correction

          -  Currently wears soft contact lenses

          -  They should require contact lens powers between -12.00 and -20.00D or between +8.00
             and +15.00D

          -  Has clear corneas and no active ocular disease

          -  Demonstrates an acceptable fit with the study lenses.

        Exclusion Criteria:

          -  Has any systemic disease affecting ocular health

          -  Is taking medication, such as antihistamine eye drops, oral and ophthalmic
             betaadrenergic blockers (e.g. Propanolol, Timolol), anticholinergics, and any
             prescribed or over-the-counter eye medication, except artificial tears or eye
             lubricants

          -  Have any active ocular disease and/or infection that would contraindicate contact lens
             wear.

          -  Active ocular disease is defined as infection or inflammation which requires
             therapeutic treatment. Mild (i.e. not considered clinically relevant) lid
             abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and
             conjunctival staining and dry eye are not considered active ocular disease.
             Neovascularization and corneal scars are the result of previous hypoxia, infection or
             inflammation and are therefore not active.

          -  Has worn gas permeable contact lenses within the last month.

          -  Is aphakic

          -  Has undergone corneal refractive surgery.

          -  Is participating in any other type of clinical research study

          -  Female who is currently pregnant or is breast-feeding.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.


Patient description (medical language): A 20-year-old man comes to the clinic for his routine checkup. The patient wears glasses for myopia and takes no medications.  Vital signs are normal.  On physical examination, the patient is tall with long upper extremities and fingers.  The face appears narrow with down-slanted palpebral fissures, flattened malar bones, and a small jaw.  The lungs are clear on auscultation.  The abdomen is soft with no organomegaly. The patient is diagnosed with Marfan syndrome, and he is cooperative with his medical appointments. He is working as driver.

Patient description (patient's own words): I'm a 20-year-old guy, working as a driver and I went to the clinic for my routine checkup. I have myopia, so I wear glasses and I don't take any other medications. My vitals were normal. I also did a physical exam, and I was told that I have long legs, arms, and fingers. They also told me that my face is quite narrow, with down-slanted eyes and a small jaw. My lungs were fine and my tummy too. I have been diagnosed with Marfan syndrome and I haven't been skipping any medical appointments since.

Does the patient match the trial criteria? Entailment