Clinical trial: Comparison of Somofilcon A Daily Disposable Test Contact Lens and Somofilcon A Daily Disposable Control Contact Lens (NCT03372551)

Eligibility criteria:
Inclusion Criteria:

          -  Is at least 17 years of age and has full legal capacity to volunteer;

          -  Has had a self-reported oculo-visual examination in the last two years;

          -  Has read, understood, and signed the information consent letter;

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

          -  Has a visual acuity of 20/30 or better (in each eye) with their habitual vision
             correction, or 20/20 best-corrected vision (for binocular distance acuity);

          -  Must be able to achieve 20/30 or better (in each eye) with the study lenses;

          -  Currently wears soft contact lenses for at least 3 days per week, 8 hours each day;

          -  Requires spectacle lens powers between -0.75 and -06.50 diopters sphere (0.25D steps);

          -  Has no more than 0.75 diopters of refractive astigmatism;

          -  Has clear corneas and no active* ocular disease;

          -  Has not worn lenses for at least 12 hours before the examination.

        Exclusion Criteria:

          -  Is presently participating in any other clinical or research study including eye
             related clinical or research study;

          -  Has never worn contact lenses before.

          -  Has any systemic disease affecting ocular health.

          -  Has any active* ocular pathology or severe insufficiency of lacrimal secretion
             (moderate to severe dry eyes) that would affect the wearing of contact lenses.

          -  Is using any systemic or topical medications that will affect a study outcome
             variable, and/or ocular health.

          -  Has any known sensitivity to fluorescein dye or products to be used in the study.

          -  Has persistent, clinically significant corneal or conjunctival staining using sodium
             fluorescein dye.

          -  Has any clinically significant lid or conjunctival abnormalities, active
             neovascularization or any central corneal scars.

          -  Is aphakic.

          -  Has undergone corneal refractive surgery.

          -  Is pregnant, lactating, or planning a pregnancy at the time of enrolment (by verbal
             confirmation at the screening visit).
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 17 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