Clinical trial: Clinical Performance of the OxyAqua Daily Disposable Silicone Hydrogel Soft Contact Lens (NCT03139201)

Eligibility criteria:
Inclusion Criteria:

          -  Subjects should have normal eyes and use no ocular medications. They may have worn
             contact lenses previously, provided their eyes are shown to be normal at the start of
             the investigation. A normal eye is defined as having the following characteristics:

               1. No anterior segment infection, inflammation or abnormality.

               2. No other active ocular or systemic disease that would contraindicate contact lens
                  wear; and

               3. No medications that would contraindicate contact lens wear.

          -  VA correctable to 0.1 LogMAR or better, with spherical lenses ranging in power from

          -  1.00 to -10.00 D myopia, astigmatism less than 2.00 D

          -  Willing to comply with all study procedures and be available for the duration of the
             study.

          -  Provide signed and dated informed consent form.

        Exclusion Criteria:

          -  Have history of allergies that would contraindicate "normal" contact lens wear.

          -  Have other active ocular or systemic disease such as, but not limited to: anterior
             uveitis (past or present), glaucoma, Sjögren's syndrome, lupus erythematosus,
             sclerodermas, keratoconus or type II diabetes, slip lamp findings greater than grade I
             (such as cornea or interstitial edema).

          -  Have medications that would contraindicate contact lens wear.

          -  Have had any cornea surgery.

          -  Currently pregnant (to the best of the subject's knowledge), is lactating or is
             planning a pregnancy within the next 1 month.

          -  Any active participation in another clinical trial within 30 days prior to this study.

          -  The presence of clinically significant (grade 3 or 4) anterior segment abnormalities;
             inflammations such as iritis; or any infection of the eye, lids, or associated
             structures.

          -  A known history of corneal hypoesthesia (reduced corneal sensitivity), corneal ulcer,
             corneal infiltrates or fungal infections.

          -  A history of papillary conjunctivitis that has interfered with contact lens wear.

          -  No monocular or monovision fits.

          -  Alcoholic or Drug Abused.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 20 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